Archive for Septiembre, 2009

What Is Infertility? What Causes Infertility? How Is Infertility Treated?

Miércoles, Septiembre 30th, 2009

Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse without the use of contraception.

Studies indicate that slightly over half of all cases of infertility are a result of female conditions, while the rest are caused by either sperm disorders or unidentified factors. According to The Mayo Clinic, USAAbout 20% of cases of infertility are due to a problem in the man. About 40% to 50% of cases of infertility are due to a problem in the woman. About 30% to 40% of cases of infertility are due to problems in both the man and the woman. According to Medilexicons medical dictionary, infertility is “Diminished or absent ability to produce offspring; in either the male or the female, not as irreversible as sterility.”

According to the Department of Health and Human Services, USA, approximately 10% to 15% of couples in the USA are infertile meaning they have not conceived after at least one year of regular, unprotected sex.

Many cases of apparent infertility are treatable. Infertility may have a single cause in one of the partners, or it could be the result of a combination of factors.

Chances of conceiving within one year

In Europe, North America and much of the world approximately 85% of couples will conceive within one year if they have regular unprotected sex. Averages in the UK are as follows (National Health Service)20% will conceive within one month70% will conceive within six months85% will conceive within 12 months90% will conceive within 18 months95% will conceive within 24 monthsTherefore, doctors in the UK will not usually diagnose a couple as infertile until 24 months have passed without conception and regular unprotected sex. Most people will see their GP (general practitioner, primary care physician) if there is no pregnancy within 12 months.

According to the National Health Service, UK, a couple that has been trying to conceive for over three years has a maximum 25% chance of conceiving over the subsequent 12 months if they continue trying.What are the risk factors of infertility?In medicine, a risk factor is something that raises the risk of developing a condition, disease or symptom. For example, obese people are more likely to develop diabetes type 2 compared to people of normal weight; therefore, obesity is a risk factor for diabetes type 2.Age a womans fertility starts to drop after she is about 32 years old, and continues doing so. A 50yearold man is usually less fertile than a man in his 20s (male fertility progressively drops after the age of 40).
Smoking smoking significantly increases the risk of infertility in both men and women. Smoking may also undermine the effects of fertility treatment. Even when a woman gets pregnant, if she smokes she has a greater risk of miscarriage.
Alcohol consumption a womans pregnancy can be seriously affected by any amount of alcohol consumption. Alcohol abuse may lower male fertility. Moderate alcohol consumption has not been shown to lower fertility in most men, but is thought to lower fertility in men who already have a low sperm count.
Being obese or overweight in industrialized countries overweight/obesity and a sedentary lifestyle are often found to be the principal causes of female infertility. An overweight man has a higher risk of having abnormal sperm.
Eating disorders women who become seriously underweight as a result of an eating disorder may have fertility problems.
Being vegan if you are a strict vegan you must make sure your intake of iron, folic acid, zinc and vitamin B12 are adequate, otherwise your fertility may become affected.
Overexercising a woman who exercises for more than seven hours each week may have ovulation problems.
Not exercising leading a sedentary lifestyle is sometimes linked to lower fertility in both men and women.
Sexually transmitted infections (STIs) chlamydia can damage the fallopian tubes, as well as making the mans scrotum become inflamed. Some other STIs may also cause infertility.
Exposure to some chemicals some pesticides, herbicides, metals (lead) and solvents have been linked to fertility problems in both men and women.
Mental stress studies indicate that female ovulation and sperm production may be affected by mental stress. If at least one partner is stressed it is possible that the frequency of sexual intercourse is less, resulting in a lower chance of conception. What are the causes of infertility? There are many possible causes of infertility. Unfortunately, in about onethird of cases no cause is ever identified.

Causes of infertility in womenOvulation disorders problems with ovulation are the most common cause of infertility in women, experts say. Ovulation is the monthly release of an egg. In some cases the woman never releases eggs, while in others the woman does not release eggs during come cycles. Ovulation disorders can be due to

Premature ovarian failure the womans ovaries stop working before she is 40.
PCOS (polycystic ovary syndrome) the womans ovaries function abnormally. She also has abnormally high levels of androgen. About 5% to 10% of women of reproductive age are affected to some degree. Also called SteinLeventhal syndrome.
Hyperprolactinemia if prolactin levels are high and the woman is not pregnant or breastfeeding, it may affect ovulation and fertility.
Poor egg quality eggs that are damaged or develop genetic abnormalities cannot sustain a pregnancy. The older a woman is the higher the risk.
Overactive thyroid gland
Underactive thyroid gland
Some chronic conditions, such as AIDS or cancer.
Problems in the uterus or fallopian tubes

The egg travels from the ovary to the uterus (womb) where the fertilized egg grows. If there is something wrong in the uterus or the fallopian tubes the woman may not be able to conceive naturally. This may be due to

Surgery pelvic surgery can sometimes cause scarring or damage to the fallopian tubes. Cervical surgery can sometimes cause scarring or shortening of the cervix. The cervix is the neck of the uterus.
Submucosal fibroids benign or noncancerous tumors found in the muscular wall of the uterus, occurring in 30% to 40% of women of childbearing age. They may interfere with implantation. They can also block the fallopian tube, preventing sperm from fertilizing the egg. Large submucosal uterine fibroids may make the uterus cavity bigger, increasing the distance the sperm has to travel.
Endometriosis cells that are normally found within the lining of the uterus start growing elsewhere in the body.
Previous sterilization treatment if a woman chose to have her fallopian tubes blocked. It is possible to reverse this process, but the chances of becoming fertile again are not high. However, an eightyear study showed tubal reversal surgery results in higher pregnancy and live birth rates and is less costly than IVF.
Medications some drugs can affect the fertility of a woman. These include

NSAIDs (nonsteroidal antiinflammatory drugs) women who take aspirin or ibuprofen longterm may find it harder to conceive.
Chemotherapy some medications used in chemotherapy can result in ovarian failure. In some cases, this side effect of chemotherapy may be permanent.
Radiotherapy if radiation therapy was aimed near the womans reproductive organs there is a higher risk of fertility problems.
Illegal drugs some women who take marijuana or cocaine may have fertility problems. Causes of infertility in men

Semen

Semen is the milky fluid that a mans penis releases during orgasm. Semen consists of fluid and sperm. The fluid comes from the prostate gland, seminal vesicle and other sex glands. The sperm is produced in the testicles. During orgasm a man ejaculates (releases semen through the penis). The seminal fluid helps transport the sperm during ejaculation. The seminal fluid has sugar in it sugar is an energy source for sperm.

Abnormal semen is responsible for about 75% of all cases of male infertility. Unfortunately, in many cases doctors never find out why. The following semen problems are possible

Low sperm count (low concentration) the man ejaculates a lower number of sperm, compared to other men. Sperm concentration should be 20 million sperm per milliliter of semen. If the count is under 10 million there is a low sperm concentration (subfertility).
No sperm when the man ejaculates there is no sperm in the semen.
Low sperm mobility (motility) the sperm cannot “swim” as well as it should.
Abnormal sperm perhaps the sperm has an unusual shape, making it more difficult to move and fertilize an egg.
Sperm must be the right shape and able to travel rapidly and accurately towards the egg. If the sperms morphology (structure) and motility (movement) are wrong it is less likely to be able to reach the egg and fertilize it.

The following may cause semen to be abnormal
Testicular infection
Testicular cancer
Testicular surgery
Overheating the testicles frequent saunas, hot tubs, very hot baths, or working in extremely hot environments can raise the temperature of the testicles. Tight clothing may have the same effect on some people.
Ejaculation disorders for some men it may be difficult to ejaculate properly. Men with retrograde ejaculation ejaculate semen into the bladder. If the ejaculatory ducts are blocked or obstructed the man may have a problem ejaculating appropriately.
Varicocele this is a varicose vein in the scrotum that may cause the sperm to overheat.
Undescended testicle one (or both) testicle fails to descend from the abdomen into the scrotum during fetal development. Sperm production is affected because the testicle is not in the scrotum and is at a higher temperature. Healthy sperm need to exist in a slightly lowerthanbody temperature. That is why they are in the scrotum, and not inside the body.
Hypogonadism testosterone deficiency can result in a disorder of the testicles.
Genetic abnormality a man should have an X and Y chromosome. If he has two X chromosomes and one Y chromosome (Klinefelters syndrome) there will be an abnormal development of the testicles, low testosterone, and a low sperm count (sometimes no sperm at all).
Mumps this viral infection usually affects young children. However, if it occurs after puberty inflammation of the testicles may affect sperm production.
Hypospadias the urethral opening is at the underside of the penis, instead of its tip. This abnormality is usually surgically corrected when the male is a baby. If it is not the sperm may find it harder to get to the females cervix. Hypospadias occur in about 1 in every 500 newborn boys.
Cystic fibrosis Cystic fibrosis is a chronic disease that affects organs such as the liver, lungs, pancreas, and intestines. It disrupts the bodys salt balance, leaving too little salt and water on the outside of cells and causing the thin layer of mucus that usually keeps the lungs free of germs to become thick and sticky. This mucus is difficult to cough out, and it clogs the lungs and airways, leading to infections and damaged lungs. Males with cystic fibrosis commonly have a missing or obstructed vas deferens (tube connecting the testes to the urethra; it carries sperm from the epididymis to the ejaculatory duct and the urethra).
Radiotherapy radiation therapy can impair sperm production. The severity usually depends on how near to the testicles the radiation was aimed.
Some diseases the following diseases and conditions are sometimes linked to lower fertility in males

Anemia
Cushings syndrome
Diabetes
Thyroid disease

Medications

Sulfasalazine this antiinflammatory drug can significantly lower a mans sperm count. The drug is often prescribed for patients with Crohns disease or rheumatoid arthritis. Usually this side effect goes away after the patient stops taking the medication.

Anabolic steroids often taken by bodybuilders and athletes; anabolic steroids, especially after long term use can seriously reduce sperm count and mobility.

Chemotherapy some medicines may significantly reduce sperm count.

Illegal drugs consumption of marijuana and cocaine can lower a mans sperm count. Diagnosing infertilityMost people will visit their GP (general practitioner, primary care physician) if there is no pregnancy after 12 months of trying. For anybody who is concerned about fertility, especially if they are older (women over 35), it might be a good idea to see a doctor earlier. As fertility testing can sometimes take a long time, and female fertility starts to drop when a woman is in her thirties, seeing the doctor earlier on if you are over 35 makes sense.

A GP can give the patient advice and carry out some preliminary assessments. As it takes two to make a baby it is better for both the male and female to see the doctor together.

Before undergoing testing for fertility it is important that the couple be committed. The doctor will need to know what the patients sexual habits are, and may make recommendations regarding them. Tests and trials might extend over a long period. Even after thorough testing, no specific cause is ever found for 30% of infertility cases.

In some countries where universal healthcare cover does not exist, evaluation and eventual treatment may be expensive.

Tests for malesGeneral physical exam the doctor will ask the man about his medical history, medications, and sexual habits. The physician will also carry out an examination of his genitals. The testicles will be checked for lumps or deformities, while the shape and structure of the penis will be examined for any abnormalities.
Semen analysis the doctor may ask for some specimens of semen. They will be analyzed in a laboratory for sperm concentration, motility, color, quality, infections and whether any blood is present. As sperm counts can fluctuate, the man may have to produce more samples.
Blood test the lab will test for several things, including the mans level of testosterone and other male hormones.
Ultrasound test the doctor will determine whether there is any ejaculatory duct obstruction, retrograde ejaculation, or other abnormality.
Chlamydia test if the man is found to have Chlamydia, which can affect fertility, he will be prescribed antibiotics to treat it. Tests for femalesGeneral physical exam the doctor will ask the woman about her medical history, medications, menstruation cycle, and sexual habits. She will also undergo a gynecological examination.
Blood test several things will be checked, for example, whether hormone levels are correct and whether the woman is ovulating (progesterone test).
Hysterosalpingography fluid is injected into the womans uterus which shows up in Xray pictures. Xrays are taken to determine whether the fluid travels properly out of the uterus and into the fallopian tubes. If the doctor identifies any problems, such as a blockage, surgery may need to be performed.
Laparoscopy a thin, flexible tube with a camera at the end (laparoscope) is inserted into the abdomen and pelvis to look at the fallopian tubes, uterus and ovaries. A small incision is made below the belly button and a needle is inserted into the abdominal cavity; carbon dioxide is injected to create a space for the laparoscope. The doctor will be able to detect endometriosis, scarring, blockages, and some irregularities of the uterus and fallopian tubes.
Ovarian reserve testing this is done to find out how effective the eggs are after ovulation.
Genetic testing this is to find out whether a genetic abnormality is interfering with the womans fertility.
Pelvic ultrasound high frequency sound waves create an image of an organ in the body, which in this case is the womans uterus, fallopian tubes, and ovaries.
Chlamydia test if the woman is found to have Chlamydia, which can affect fertility, she will be prescribed antibiotics to treat it.
Thyroid function test according to the National Health Service (UK) between 1.3% and 5.1% of infertile women have an abnormal thyroid. What are the treatment options for infertility? This will depend on many factors, including the age of the patient(s), how long they have been infertile, personal preferences, and their general state of health. Even if the woman has causes that cannot be corrected, she may still become pregnant.

Frequency of intercourse

The couple may be advised to have sexual intercourse more often. Sex two to three times per week may improve fertility if the frequency was less than this. Some fertility experts warn that toofrequent sex can lower the quality and concentration of sperm. Male sperm can survive inside the female for up to 72 hours, while an egg can be fertilized for up to 24 hours after ovulation.

Fertility treatment for menErectile dysfunction or premature ejaculation medication and/or behavioral approaches can help men with general sexual problems, resulting in possibly improved fertility.
Varicocele if there is a varicose vein in the scrotum, it can be surgically removed.
Blockage of the ejaculatory duct sperm can be extracted directly from the testicles and injected into an egg in the laboratory.
Retrograde ejaculation sperm can be taken directly from the bladder and injected into an egg in the laboratory.
Surgery for epididymal blockage if the epididymis is blocked it can be surgically repaired. The epididymis is a coillike structure in the testicles which helps store and transport sperm. If the epididymis is blocked sperm may not be ejaculated properly. Fertility treatment for womenOvulation disorders if the woman has an ovulation disorder she will probably be prescribed fertility drugs which regulate or induce ovulation. These include

Clomifene (Clomid, Serophene) this medication helps encourage ovulation in females who do not ovulate regularly, or who do not ovulate at all, because of polycystic ovary syndrome (PCOS) or some other disorder. It makes the pituitary gland release more FSH (folliclestimulating hormone) and LH (luteinizing hormone).
Metformin (Glucophage) women who have not responded to Clomifene may have to take this medication. It is especially effective for women with PCOS, especially when linked to insulin resistance.
Human menopausal gonadotropin, or hMG, (Repronex) this medication contains both FSH and LH. It is an injection and is used for patients who dont ovulate on their own because of a fault in their pituitary gland.
Folliclestimulating hormone (GonalF, Bravelle) this is a hormone produced by the pituitary gland that controls estrogen production by the ovaries. It stimulates the ovaries to mature egg follicles.
Human chorionic gonadotropin (Ovidrel, Pregnyl) this medication is used together with clomiphene, hMG and FSH. It stimulates the follicle to ovulate.
GnRH (gonadotropinreleasing hormone) analogs for women who ovulate prematurely, before the lead follicle is mature enough during hmG treatment. This medication delivers a constant supply of GnRH to the pituitary gland, which alters the production of hormone, allowing the doctor to induce follicle growth with FSH.
Bromocriptine (Parlodel) this drug inhibits prolactin production. Prolactin stimulates milk production in breast feeding mothers. If nonpregnant, nonbreast feeding women have high levels of prolactin they may have irregular ovulation cycles and have fertility problems. Risk of multiple pregnancies

Injectable fertility drugs can sometimes be the victims of their own success and cause multiple births when the woman gets pregnant she has twins, triplets, or perhaps more babies in one go. Oral fertility drugs also raise the risk of multiple pregnancies, but much less so than injectable ones. It is important to monitor the patient carefully during treatment and pregnancy. The more babies the mother carries inside her the higher is her risk of premature labor.

If a woman needs an HCG injection to activate ovulation and ultrasound scans show that too many follicles have developed, it is possible to withhold the HCG injection. Couples may decide to go ahead regardless if the desire to become pregnant is very strong.

Multifetal pregnancy reduction is possible if too many babies are conceived one or more of the fetuses is removed. Couples will have to consider the ethical and emotional aspects of this procedure.Surgical procedures for women

Fallopian tube surgery if the fallopian tubes are blocked or scarred surgery may repair them, making it easier for eggs to pass through them.
Laparoscopic surgery a small incision is made in the womans abdomen. A thin, flexible microscope with a light at the end (laparoscope) is inserted through the incision. The doctor can then look at internal organs, take samples and perform small operations. For women with endometriosis, laparoscopy removes implants and scar tissue, reducing pain and often aiding fertility. Assisted conceptionIUI (intrauterine insemination) a fine catheter is inserted through the cervix into the uterus to place a sperm sample directly into the uterus. The sperm is washed in a fluid and the best specimens are selected. This procedure must be done when ovulation occurs. The woman may be given a low dose of ovary stimulating hormones.

IUI is more commonly done when the man has a low sperm count, decreased sperm motility, or when infertility does not have an identifiable cause. The procedure is also helpful for males suffering from severe erectile dysfunction.
IVF (in vitro fertilization) sperm are placed with unfertilized eggs in a Petri dish; the aim is fertilization of the eggs. The embryo is then placed in the uterus to begin a pregnancy. Someitmes the embryo is frozen for future use (cryopreserved). Louise Joy Brown, born in England in 1978, was the worlds first IVF baby. Before IVF is done the female takes fertility drugs to encourage the ovaries to produce more eggs than normal.
ICSI (Intracytoplasmic sperm injection) a single sperm is injected into an egg to achieve fertilization during an IVF procedure. The likelihood of fertilization improves significantly for men with low sperm concentrations.
Donation of sperm or egg if there is either no sperm or egg in one of the partners it is possible to receive sperm or eggs from a donor. Fertility treatment with donor eggs is usually done using IVF. In the UK and a growing number of countries the egg donor can no longer remain anonymous the offspring can legally trace his/her biological parent when reaching the age of 18.
Assisted hatching this improves the chances of the embryos implantation; attaching to the wall of the uterus. The embryologist opens a small hole in the outer membrane of the embryo, known as the zona pellucid. The opening improves the ability of the embryo to leave its shell and implant into the uterine lining. Patients who benefit from assistant hatching include women with previous IVF failure, poor embryo growth rate, and older women. In some women, particularly older women, the membrane is hardened, making it difficult for the embryo to hatch and implant.
Electric or vibratory stimulation to achieve ejaculation ejaculation is acheived with electric or vibratory stimulation. This procedure is useful for men who cannot ejaculate normally, such as those with a spinal cord injury.
Surgical sperm aspiration the sperm is removed from part of the male reproductive tract, such as the vas deference, testicle or epididymis. What are the complications of infertility treatment? Ovarian hyperstimulation syndrome (OHSS)

The ovaries become very swollen, leaking excess fluid into the body. The ovaries produce too many follicles (small fluid sacs in which an egg develops). OHSS usually occurs as a result of taking medications to stimulate the ovaries, such as clomifene and gonadtrophins, and can also develop after IVF. Symptoms can include

BloatingConstipationDark urineDiarrheaNauseaPain in the abdomenVomiting
In most cases symptoms are mild and easy to treat. On very rare occasions the patient may develop a blood clot (thrombosis) in an artery or vein, liver or kidney problems, and respiratory distress. In very severe cases OHSS can be potentially fatal.
Ectopic pregnancy

This is a pregnancy when the fertilized egg does not implant in the womb in most cases the fertilized egg grows in the fallopian tube. If it stays in the fallopian tube the mother will usually miscarry before complications develop, such as the rupture of the fallopian tube. Women receiving fertility treatment have a slightly higher risk of having an ectopic pregnancy. An ultrasound scan can detect an ectopic pregnancy.
Coping mentally

As it is impossible to know how long treatment will go on for and how successful it will be, coping and persevering can be stressful. The emotional toll on both partners might be considerable and can have an impact on their relationship. Some people find that joining a support group helps being able to talk to others who share similar problems, aspirations and anxieties can be uplifting. It is important to tell your doctor if you are suffering mentally and/or emotionally. Most fertility doctors have access to counselors, as well as other people and professionals who can offer helpful support.

Washington Post Examines Va. Gubernatorial Candidates Voting Records On Abortion, Other Issues

Miércoles, Septiembre 30th, 2009

A Washington Post analysis of Virginia gubernatorial candidates Creigh Deeds (D) and Robert McDonnells (R) voting records in the state Legislature shows that both men have supported some restrictions on abortion access, though McDonnell has taken a much more severe approach. According to the Post, the candidates legislative records also demonstrate opposing philosophies on the role of government, spending of taxpayer dollars and restrictions on gay rights and guns.

Deeds supported bills that required parental notification for minors seeking abortions but did not support bills requiring parental consent or waiting periods. He voted for measures that banned socalled “partialbirth” abortion but later reversed his position, saying that he worried the bills were unconstitutional. Deeds also voted to allow pharmacists to dispense emergency contraception prior to FDAs decision allowing it to be sold over the counter.

McDonnell supported the partialbirth abortion ban, parental consent for minors and a 24hour waiting period before abortion procedures, all of which passed. He voted against the measure allowing pharmacists to dispense EC.

Planned Parenthood has criticized McDonnells voting record as extreme. The group has canvassed neighborhoods and called voters to promote its position (Kumar, Washington Post, 9/27).

Post Analyzes Campaign Ad

The Post also published an analysis of an ad Deeds released last week criticizing McDonnells stance on womens issues. According to the Post, the ad aims to appeal to women, especially in Northern Virginia, and “seems to assume its viewers have already heard about” McDonnells 1989 masters thesis, in which he called working women and feminists “detrimental” to the family. The ad states that McDonnell sponsored 35 bills on abortion issues; he was chief sponsor on eight of those, according to the Post. The ad also states that McDonnell opposes birth control for married adults. The Post reports that McDonnell supported two bills restricting birth control access but has since said that he does not oppose the use of birth control by married couples (Helderman, Washington Post, 9/27).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Los Angeles Times Examines Antiabortion-Rights Groups Push For Personhood Ballot Measures

Martes, Septiembre 29th, 2009

Abortionrights opponents are escalating their efforts to place socalled “personhood” measures on several state ballots in 2010 as a way to end legalized abortion, the Los Angeles Times reports. Their goal is to put referendums before state voters on whether states constitutions should be amended to declare that personhood and rights accorded to human beings begin at conception. According to the Times, personhoodamendment advocates believe that legally establishing personhood from conception would undo legalized abortion under the U.S. Supreme Courts 1973 Roe v. Wade decision, in which the court declared that a fetus is not legally a person.

Advocates of the personhood amendments are gathering signatures, raising funds and pressuring state legislatures to support the measures in California, Florida, Louisiana and other states. Keith Mason, cofounder of Personhood USA, said the group has “big and small efforts” under way in 30 states, adding, “Our goal is to activate the population.” Mason said, “This is an uphill battle. Even though we may not have the votes or the political equity, we have to start somewhere.”

Abortionrights supporters say personhood amendments threaten some forms of contraception, including intrauterine devices and birth control pills, as well as in vitro fertilization and embryonic stem cell research. They also say voters will reject the measures as a government intrusion into their privacy. Ted Miller, a spokesperson for NARAL ProChoice America, said that personhood measures are “a backdoor abortion ban.”

The Times reports that advocates on both sides of the debate think the logic behind the personhood movement is “farfetched,” and personhood supporters so far have been unsuccessful at changing any laws. Colorado in 2008 became the first state to put a personhood amendment before voters, who rejected it 78% to 27% after the possibility of criminalizing birth control came up in the debate. State legislatures in Montana and North Dakota rejected similar measures earlier this year, but abortionrights advocates took note of the close votes. North Dakotas House passed a bill calling for a constitutional amendment on personhood, but the Senate rejected it. The Montana Senate passed a similar bill, which died in a House committee, according to NARAL ProChoice Montanas Executive Director Allyson Hagen.

According to the Times, personhood advocates in California on Monday will announce a signaturegathering campaign for an initiative to amend the states constitution to define a person as a human beginning at conception. The proposed California Human Rights Amendment states, “The term person applies to all living human beings from the beginning of their biological development regardless of the means by which they were procreated, method of reproduction, age, race, sex, gender, physical wellbeing, function, or condition of physical or mental dependency and/or disability.” Supporters will need to obtain about 690,000 signatures to get the proposal on the 2010 ballot. The initiatives leaders are being advised by the American Life League, which is also assisting campaigns in Colorado, Florida, Missouri and Montana.

Opponents of the California amendment argue that its language goes beyond the discussion of whether a fetus is a person. Katherine Spillar, executive vice president of the Feminist Majority Foundation, said the measure is “so extreme it could literally outlaw IUDs and birth control pills.” Although she called personhood measures “so extreme that people reject them,” she said that “we take nothing for granted” and “will fight it with everything weve got” (Abcarian, Los Angeles Times, 9/28).

Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved.

Labour MPs Show Support For More Investment Into Dementia Research

Lunes, Septiembre 28th, 2009

Eighty percent of Labour MPs believe the government should be spending more on dementia research, according to a new poll released today.

The results of the ComRes survey are revealed ahead of a dementia research fringe event being hosted by Alzheimers Society, the Alzheimers Research Trust and Age Concern and Help the Aged at the Labour Party Conference in Brighton today (Monday 28th September).

In a survey of parliamentarians, Labour MPs were found to be more in favour of an increase in investment than either the Liberal Democrats or the Conservatives although all parties showed more than 70 per cent support. The government currently spends £32.4million on dementia research compared to £248.5million on cancer research.

Results from an Alzheimers Research Trust and Alzheimers Society commissioned YouGov poll also revealed today that 59% of Labour voters believe the government should be putting more money into dementia research. The charities will make this call for an increase in funding and for a coordinated approach at the fringe event, Dementia Decade a cure by 2020?.

Broadcaster, journalist and Alzheimers Society Ambassador Fiona Phillips backed the charities call for greater investment and a coordinated plan. She will meet with Prime Minister Gordon Brown and other senior Labour officials at events during the conference. She said

To see the deterioration Alzheimers caused in first my mum and now my dad has been absolutely heart breaking. It is a cruel disease that robs a person of their dignity and places an incredible strain on the lives of their loved ones. We must do everything we can to find a cure. The only way to do this is through research and the only way research can be carried out is if the government provides the necessary investment.

Professor Simon Lovestone from Alzheimers Research Trust, said

Over the next decade we have a good chance of developing new treatments that slow down the rate of progression of Alzheimers disease and other dementias. If we fail to develop new treatments, we are in deep trouble because of the rising costs of caring for dementia in an ageing population. The government needs to increase its support for dementia research and take full advantage of the UKs worldclass scientists in the race for a cure.

Andrew Harrop, Head of Public Policy at Age Concern and Help the Aged said

Dementia is a cruel disease that robs people who are often otherwise fit and healthy of a happy retirement. Around 700,000 people currently live with dementia in the UK with many more friends and family indirectly affected by this heartbreaking disease. This is why Age Concern and Help the Aged is a major funder of dementia research, notably funding the Disconnected Mind research project and why we strongly support calls for more funding for this vital work.

Neil Hunt, Chief Executive of Alzheimers Society who will chair the fringe event, said

Even in the current economic climate there is an appreciation from MPs and the public of the necessity to do everything we can to defeat this devastating condition.

Dementia costs the UK £17billion a year yet the government spend eight times less on dementia research than cancer research. In order to see the same advancements in care and treatment as we have seen for cancer, spending on dementia research needs to be a higher priority. With the right investment and planning dementia can be defeated.

Last week leading author Terry Pratchett spoke of his experience with a rare form of Alzheimers disease and warned of the dangers of a worldwide tsunami of Alzheimers and other dementia diseases unless changes are made.

Data Presented From Two Phase 3 ERBITUX® Studies In First-Line Metastatic Colorectal Cancer Patients At Joint 15th European Cancer Organisation

Sábado, Septiembre 26th, 2009

According to a recent retrospective analysis of the pivotal Phase 3 CRYSTAL study, ERBITUX® (cetuximab), when added to FOLFIRI, was shown to increase median overall survival to 19.9 months in an intenttotreat (ITT) population of firstline metastatic colorectal cancer (mCRC) patients compared to 18.6 months in those receiving FOLFIRI alone (hazard ratio [HR] 0.878; 95% CI 0.774 0.995; p=0.042). In a subset of mCRC patients with wildtype Kras tumors, median overall survival was increased to 23.5 months in patients who received ERBITUX plus FOLFIRI compared to 20 months for those taking FOLFIRI alone (HR 0. 796; 95% CI 0.670 0.946; p=0.0094).

The retrospective CRYSTAL analysis was conducted as a result of an effort to increase the tissue ascertainment rate to determine the Kras status of patients tumors. The analysis included extended patient follow up of nearly 1.5 years and doubled the tissue ascertainment rate from 45% to 89%. These data are an update from the overall survival results from CRYSTAL that were published in the April 2009 issue of the New England Journal of Medicine.

The recently completed retrospective analysis from CRYSTAL, a multinational study conducted by Merck KGaA, Darmstadt, Germany, marks the first time an overall survival benefit has been demonstrated with an epidermal growth factor (EGFR)inhibitor in the firstline treatment of mCRC in an ITT patient population and in a Kras wildtype subset of patients. An ITT analysis considers all randomized patients in a clinical trial.

In the CRYSTAL trial, the following Grade 3 or 4 adverse events were reported in the April 2009 New England Journal of Medicine as being more frequent with ERBITUX plus FOLFIRI than FOLFIRI alone in the overall patient population skin reactions (which were grade 3 only) (in 19.7% vs. 0.2% of patients, p

Health Reform Ads Confusing Public, News Outlets Try To Dispel The Fog

Viernes, Septiembre 25th, 2009

Advertising on the health care debate, more than $100 million of it spent so far, is offering little understanding on the issue as the dueling sides and media look to dispel myths about whats true and whats not.

The New York Times Prescriptions blog “Nearly $100 million has been spent this year on commercials intended to influence the health care debate, including $30 million in August alone, according to Evan Tracey, founder of the Campaign Media Analysis Group, a research firm in Arlington, Va. In just the last 60 days, 49 different groups have aired nearly 100,000 TV commercials about federal health care policy, Mr. Tracey wrote recently in the trade publication Advertising Age.

“But, he added, the patchwork of messages from organizations with competing agendas has made it more difficult for those groups to influence viewers. And it has left the public more confused than informed.” In August opponents of reform outspent supporters, but that dynamic has not switched, The Times reports (Seelye, 9/23).

Politifact continues to examine claims in ads and statements by politicians about health care and finds many of them “false” or “halftrue.” The factchecking Web site rates a claim by Health Care For America Now that one out of five insurance claims is denied as “False.”

McClatchy Newspapers/The Kansas City Star tries to address some of the misinformation in advertising with a Q&A on reform efforts. “Three House committees and the Senate Health committee have finished writing their versions of legislation. Yet to come is a bill from the Senate Finance Committee. But even when theres legislation to examine, respected analysts disagree on its meaning” McClatchy offers answers to questions that have relative consensus on topics like coops, a public option and keeping the coverage you have now (Lightman, 9/23).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Mens Blood Pressure Increased By High-Sugar Diet

Jueves, Septiembre 24th, 2009

Study 1 highlights Just two weeks on a highfructose diet raises blood pressure in men.

A drug used to treat gout seems to protect against that blood pressure increase and some aspects of metabolic syndrome. Study 2 highlights A study in mice finds that the time of day when fructose is consumed is linked to abnormalities in blood pressure, weight gain and behavior. Abstract P127

A highfructose diet raises blood pressure in men, while a drug used to treat gout seems to protect against the blood pressure increase, according to research reported at the American Heart Associations 63rd High Blood Pressure Research Conference.

“This is the first evidence of a role of fructose in raising blood pressure and a role for lowering uric acid to protect against that blood pressure increase in people,” said Richard Johnson, M.D., coauthor of the study and professor and head of the division of Renal Diseases and Hypertension at the University of ColoradoDenver medical campus in Aurora, Colo.

In the study, excessive fructose consumption seemed to increase new onset of metabolic syndrome, a cluster of risk factors associated with the development of cardiovascular disease and type 2 diabetes. On the other hand, the gout drug seemed to halt it most likely by lowering uric acid, which affects blood pressure.

Fructose, one of several dietary sugars, makes up about half of all the sugar molecules in table sugar and in highfructose corn syrup, a sweetener often used in packaged products because its relatively cheap and has a long shelf life. Glucose makes up the other half. Fructose is the only common sugar known to increase uric acid levels.

Patients with high blood pressure, diabetes and kidney disease often have high uric acid levels and gout. But all the ways in which those conditions might contribute to the development or worsening of the others isnt completely understood, Johnson said.

Johnson and coauthor Santos PerezPozo, M.D., a nephrologist at Mateo Orfila Hospital in Minorca, Spain who led the study, evaluated 74 adult men, average age 51, who consumed a diet that included 200 grams (g) of fructose per day in addition to their regular diet. The amount is much higher than the estimated U.S. daily intake of 50 g to 70 g of fructose consumed by most U.S. adults. Half of the men were randomly assigned to get the gout drug allopurinol and the other half acted as controls.

After only two weeks on the diet, the highfructose plus placebo group experienced significant average blood pressure increases of about 6 millimeters of mercury (mm Hg) in systolic blood pressure (the pressure when the heart beats) and about a 3 mm Hg rise in diastolic blood pressure (the pressure between heartbeats). They were measured with strapon monitors that record blood pressure periodically around the clock.

In contrast, men on the highfructose diet plus allopurinol had significantly lower uric acid levels and virtually no increase in systolic blood pressure (only 1 mm Hg). The blood pressure levels of most of the men returned to normal within two months of the studys conclusion when the participants returned to their normal dietary intake, Johnson said.

The study also found changes in the incidence of metabolic syndrome. The United States and the international community define the syndrome slightly differently, so researchers used both criteria in the study. In general, metabolic syndrome is defined as having three or more of these five risk factors Increased waist circumference;

High triglyceride levels;

Low levels of highdensity lipoprotein (HDL), a component of total cholesterol thought to have a protective effect;

High blood pressure; and

High fasting blood sugar. After just two weeks, the incidence of metabolic syndrome more than doubled in the men who consumed a heavy fructose diet and took the placebo pill. The incidence went from 19 percent at baseline to 44 percent at the studys end, according to the U.S. National Cholesterol Education ProgramATP III (NCEPATP III) definition, and from 25 percent to 58 percent under the International Diabetes Federation (IDF) definition.

Among men consuming fructose plus allopurinol, virtually no change in the rate of metabolic syndrome occurred perhaps because the gout drug prevented the blood pressure rise associated with increased fructose consumption.

The study should be viewed as a pilot and more investigations are needed before doctors consider lowering uric acid in the clinical setting, said Johnson, noting that allopurinol can have rare but serious side effects.

Men in both groups had an increase in fasting triglycerides and an indication of insulin resistance by a method called homeostatic model assessment (HOMA), while on the increased fructose diet. The HOMA method is used to quantify insulin resistance and betacell function. Allopurinol treatment appeared to lower lowdensity lipoprotein cholesterol (LDL), a component of total blood cholesterol linked to the development of cardiovascular disease, compared to placebo, the researchers reported.

“These results suggest that fructose may be a cause of metabolic syndrome,” Johnson said. “They also suggest that excessive fructose intake may have a role in the worldwide epidemic of obesity and diabetes.”

Fruit, which has just 4 g to 10 g of fructose per serving, also contains many beneficial substances including antioxidants, vitamin C, potassium and fiber that are believed to counter the effects of fructose alone. The main risk for excessive fructose consumption in the Western diet comes from sweetened drinks and foods rich in sugar or high fructose corn syrup, he said.

“When you give fructose to animals, they absolutely develop every feature of metabolic syndrome they get abdominal fat, high triglycerides, low HDL, their blood pressure goes up and they get insulin resistance,” Johnson said. “However, you must give massive amounts of fructose to rats to raise uric acid levels, because rats and most other animals have an enzyme that breaks down uric acid. Humans lack that enzyme. It turns out humans get gout but other animals dont.”

If you inhibit the enzyme in rats that breaks down uric acid, it takes only a small amount of fructose to cause uric acid to rise and the symptoms of metabolic syndrome to appear in the animals, he said.

Johnsons other coauthors are Jesse Schold, Ph.D., and Julian Lopez Lillo, M.D. Author disclosures are on the abstract.

The National Institutes of Health funded the study.

SEE ALSO

Abstract P237

Timing of fructose intake affects weight gain, blood pressure and behavior

Researchers found that abnormalities in blood pressure and weight gain were linked to the timing of the availability of fructose, a dietary sugar, in a study conducted in mice. When sugary liquids were consumed during the day (the usual sleeping period for mice), mice showed greater weight gain and a reversal in blood pressure rhythms.

Researchers implanted small ambulatory monitors to measure blood pressure around the clock in mice. Mice were given either continuous access to fructose water (10 percent) or restricted access for 12 hours during the day (light) or 12 hours at night (dark).

“The first thing we noticed was that the mice on restricted access rushed to their drinking bottles to load up on the sweetened beverage, similar to teenagers who drink too many soft drinks,” said Mariana Morris, Ph.D., study coauthor and vice president for graduate studies and chair of the Pharmacology and Toxicology Department, in the Boonshoft School of Medicine at Wright State University in Dayton, Ohio.

Researchers reported that groups consuming fructose continuously or during the dark period, showed an increase in blood pressure with a characteristic spike during the night when mice are usually active.

However, in mice that consumed fructose during the day, the blood pressure pattern was reversed, high in the day and low in night. The blood pressure change was also associated with higher stress hormone levels.

“The reversal in the day/night rhythm is similar to the pattern seen in human diabetics, suggesting the timing of fructose intake may be important in cardiovascular pathologies,” Morris said.

Researchers also observed increased weight gain in mice given fructose during the light period. This weight gain occurred even though total calorie consumption (fructose water and solid food) was similar.”This model may be similar to the human condition of night time binging of fructose laden foods and beverages,” Morris said. “The results indicate that consideration must be given not only to the amount of calories consumed but also the timing of intake.”

Co authors are Swapnil V. Shewale, a masters degree candidate and Danielle Senador, Ph.D., a postdoctoral associate. Author disclosures are on the abstract.

Source
Karen Astle

Survival Benefit Maintained In Long Term Follow-up Of IES With Pfizers AROMASIN(R) (Exemestane Tablets)

Jueves, Septiembre 24th, 2009

Pfizer Inc announced new, longerterm data from the Intergroup Exemestane Study (IES) showing that women who switched to AROMASIN® (exemestane tablets) after taking tamoxifen for two to three years experienced a significant reduction (18%) in the risk of diseasefree survival (DFS) events (HR=0.82; 95% CI 0.730.92; P=0.0009), compared to women who continued on tamoxifen for a full five years of treatment.1 In addition, IES showed that AROMASIN prolonged overall survival (OS) in the ER+/unknown population with a 14% reduction in the risk of dying (HR=0.86; 95% CI 0.750.99; P=0.04).1 These results demonstrate that the benefits of treatment are maintained in long term followup. These results were presented at the joint ECCO 15/ESMO 34 meeting in Berlin, Germany.1

“These new, longterm followup data of the IES demonstrate a significant survival benefit for patients who switched to AROMASIN compared to those who stayed on tamoxifen,” said Charles Coombes, head of the oncology department at Imperial College, London, UK and principal investigator of the IES. “These findings are important to patients and physicians alike as they reaffirm their confidence in switching to AROMASIN after two to three years of tamoxifen.”

IES is a landmark trial with the longest followup of endocrine treatment in the adjuvant switch setting. It is a randomized, doubleblind, multinational trial of postmenopausal women with early breast cancer.2 IES evaluates the clinical benefits of switching 2,352 patients to AROMASIN after two to three years of tamoxifen versus continuing 2,372 patients on tamoxifen for a full five years of therapy. The primary endpoint of the study was DFS in the intenttotreat (ITT)i population. Within the IES, 97% of the study population was oestrogenreceptor positive/unknown.1

In postmenopausal women with early breast cancer at a median followup of 91 months, switching to AROMASIN after two to three years of tamoxifen, for a total of five years of treatment, was shown to result in a

16% reduction in the risk of DFS events, defined as local or distant recurrence of breast cancer, contralateral breast cancer, or death from any cause, compared to staying on tamoxifen for five years (HR=0.84; 95% CI 0.750.94; P=0.002) in the ITTi population.1

For the secondary endpoint of overall survival in the ITT population, there was an 11% relative risk reduction of death. There was a statistically significant 14% reduction in the risk of death noted in the ER+/unknownii population (HR=0.86 95% CI 0.750.99 P=0.04).1

These DFS and OS data are consistent with the previous IES update at 55.7 months. Additionally, AROMASINs safety profile at 91 months was similar to that shown previously. An analysis of events of interest including cardiovascular and musculoskeletal showed no new serious adverse events in comparison to the previous analysis.1

“AROMASIN has proven to be an effective treatment for postmenopausal women with oestrogenreceptor positive early breast cancer after 23 years of tamoxifen treatment,” said Mace Rothenberg, MD, senior vice president, clinical development and medical affairs, Pfizer Oncology. “The extraordinarily longterm follow up of patients enrolled in this study adds to the body of data supporting AROMASINs benefits and further underscores Pfizers commitment to oncology.”

About AROMASIN® (exemestane tablets)3

In Europe, AROMASIN is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer, following two to three years of initial adjuvant tamoxifen therapy. AROMASIN is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following antioestrogen therapy. Efficacy has not been demonstrated in patients with oestrogen receptor negative status.

In the United States, AROMASIN is indicated for the adjuvant treatment of postmenopausal women with oestrogenreceptor positive early breast cancer who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy. AROMASIN is also indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

Important AROMASIN® (exemestane tablets) Safety Information3

AROMASIN should not be used in women who are premenopausal, are nursing or pregnant, have a known hypersensitivity to the drug, or are taking oestrogencontaining agents. Dose modification is recommended for patients who are receiving certain medications, including strong CYP 3A4 inducers such as rifampicin and phenytoin. In patients with early breast cancer, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving AROMASIN than either tamoxifen or placebo. Reductions in bone mineral density over time are seen with the use of AROMASIN.

About Pfizer Oncology

Pfizer Oncology is committed to the discovery, investigation and development of innovative treatment options for cancer patients worldwide. Our robust pipeline consists of 21 biologics and small molecules in clinical development. Pfizer Oncology has over 200 clinical trials including robust Phase 3 clinical trial programs in renal cell carcinoma, prostate cancer, nonsmall cell lung cancer, metastatic breast cancer, and hepatocellular carcinoma.

By working collaboratively with academic institutions, researchers, governments, and licensing partners, Pfizer Oncology strives to transform treatment by targeting the right drug for the right patient at the right time.

For more information please visit Pfizer.com.

1. Coombes RC, et al. Survival and safety post study treatment completion an updated analysis of the Intergroup Exemestane Study (IES). Results presented at ECCO/ESMO September 22, 2009. Abstract 5.010.

2. Coombes, RC, et al. Survival and safety of exemestane versus tamoxifen after 23 years tamoxifen treatment (Intergroup Exemestane Study) a randomized controlled trial. The Lancet. 2007 369 55970

3. Data on File.

i ITT Intenttotreat population is generally interpreted as including all patients in a study population, regardless of whether they actually satisfied the entry criteria, the treatment actually received, and subsequent withdrawal or deviation from the protocol.

AAPS Co-Sponsors Workshop Focusing On Modified Release Drug Products

Miércoles, Septiembre 23rd, 2009

Therapeutic equivalence to be highlighted in event cosponsored by the Product Quality Research Institute and the International Pharmaceutical Federation

WHO The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific society of approximately 12,000 members employed in industry, academia, government and other research institutes worldwide. Founded in 1986, AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to public health. AAPS offers timely scientific programs, ongoing education, information resources, opportunities for networking, and professional development. This workshop is cosponsored with the Product Quality Research Institute (PQRI) and International Pharmaceutical Federation (FIP).

WHAT In partnership with PQRI and FIP, AAPS is pleased to present the workshop Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products. This twoday event will discuss some of the challenges presented by the complexity of Modified Release (MR) dosage forms. The workshop will consist of talks by experts from the pharmaceutical industry, academia, and the U.S. Food and Drug Administration.

WHYThis workshop aims to convene pharmaceutical scientists from academia, industry and regulatory agencies to review advances and regulations related to MR dosage forms, examine current and emerging issues, and identify critical paths to establishing scientific and regulatory standards for ensuring therapeutic equivalence and therapeutic interchangeability of MR products.

WHEN October 12, 2009
Sheraton Inner Harbor Hotel
Baltimore, MD, USA

Source
Joseph Catapano

New Type Of Sirolimus-Eluting Stent Demonstrates Superior Results

Martes, Septiembre 22nd, 2009

A new type of sirolimuseluting stent (SES) successfully showed significantly greater neointimal suppression than the paclitaxeleluting stent (PES) with greater vessel wall integrity surrounding the stent, confirming the finding of superiority of the SES over the PES stent for the trials primary endpoint of instent late loss.

Results from the RESELUTION I Trial on the safety and effectiveness of a new sirolimuseluting stent in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries will be presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

RESELUTION I, which began in March 2008, is a multicenter, randomized, singleblind controlled trial comparing the sirolimuseluting reservoirbased stent (SES) with a paclitaxeleluting stent (PES) system in de novo native coronary artery lesions. A total of 394 subjects were randomized to treatment with either the sirolimuseluting or paclitaxeleluting stents. Principal investigators of the trial included Alexandre Abizaid, MD, John Ormiston, MD and Christian Spaulding, MD.

Clinical results will be presented by John A. Spertus, MD on Thursday, September 24 at 245 p.m. during the Featured Clinical Trials First Report Investigations session in Room 131. In addition to the oral presentation, a detailed intravascular ultrasound (IVUS) analysis is being displayed as a poster abstract (TCT360) on Tuesday, September 22 between 800 a.m. and 1000 a.m. in Hall D of The Moscone Center. The poster is being presented by Hiromasa Otake, MD of Stanford University (Stanford, Calif.) on behalf of the RESELUTION I investigators.

This new sirolimuseluting stent (SES) utilizes a reservoir technology that incorporates a number of small wells, each acting as a depot into which drugpolymer compositions are loaded. The stents design achieves both a significant reduction in total polymer load as well as a reduction in tissuepolymer contact by more than 75% compared to conventional DES in which the entire stent surface is coated with polymer. Its use of a bioresorbable polymer is another theoretical advantage from the safety perspective, allowing the drugeluting stent to become simple bare metal within the vessel wall approximately 3 months after deployment.

In this clinical trial, detailed arterial responses to the new DES technology were also investigated in vivo using intravascular ultrasound (IVUS). With IVUS, a tiny catheter is inserted into a coronary vessel where highfrequency sound waves reflect off tissue or vessel walls. The reflected waves create a crosssectional image from within the vessel to aid in visualizing its structure, thereby providing both quantitative and qualitative information on vessel reaction after stenting.

Serial IVUS (immediately poststenting and 6month followup) was performed in a predefined IVUS subset of 100 patients (52 SES in 50 patients; 52 PES in 50 patients). Volumetric IVUS analysis demonstrated significantly less neointimal proliferation in the sirolimuseluting stent (% neointimal volume 5.5±11.0 vs. 11.5±9.7, p=0.016), resulting in less late lumen area loss and smaller maximum crosssectional narrowing (neointimal area/stent area) than PES. In addition, serial IVUS analysis revealed significantly less outward vessel remodeling in the SES than in PES. The incidence of lateacquired incomplete stent apposition (ISA) was similar between the SES and PES. However, SES was associated with less outward vessel remodeling at the ISA segment, possibly suggesting different underlying mechanisms of this phenomenon.

“Our study is the first report investigating the detailed arterial responses to this new DES technology, with a randomized, blinded comparison of sirolimuseluting stents with paclitaxeleluting stents in human de novo native coronary lesions,” said Dr. Otake.

“The combination of a different formulation strategy with different types of drug appeared to impact arterial response after DES therapy,” Dr. Otake added. “Our study confirmed that the advanced formulation strategy of this new DES can perform with efficacy exceeding a firstgeneration DES with the potential for improved longterm safety because it turns into a bare metal stent within 3 months. This stent may be a promising DES option to treat the patients with coronary artery disease while embracing the longterm safety of bare metal stents.”

Source
Judy Romero