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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.

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

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.

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

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

Startling new statistics on the worldwide prevalence of Alzheimers disease and related dementias are being released today as countries across the globe join together in recognition of World Alzheimers Day.

According to the World Alzheimer Report, released today by Alzheimers Disease International (ADI), an estimated 35.6 million people worldwide will be living with dementia in 2010. This is a 10 per cent increase over previous global dementia prevalence reported in 2005 in The Lancet. According to the new report, dementia prevalence will nearly double every 20 years, to 65.7 million in 2030 and 115.4 million in 2050.

“The information in the 2009 World Alzheimer Report makes it clear that the crisis of dementia cannot be ignored,” says Debbie Benczkowski, Interim CEO of the Alzheimer Society of Canada. “Unchecked, dementia will impose enormous burdens on individuals, families, health care infrastructures, and global economy.”

The report also focuses on the impact of dementia. For example, statistics cited in the new report suggest that 40 to 75 per cent of caregivers have significant psychological illness as a result of their caregiving, and 15 to 32 per cent have depression. Challenges faced by governments and health care systems worldwide are also outlined, and eight global recommendations are offered based on report findings.

This international report is being delivered today amongst a global message of Diagnosing Dementia Seeing it Sooner. The Alzheimer Society is joining Alzheimer organizations across the world, speaking out about the importance of early diagnosis.

“Early diagnosis is an essential first step towards receiving appropriate help and support. Delay in diagnosis means that people with dementia and their caregivers suffer unnecessarily from uncertainty about what is happening, are deprived of the treatment and care they need, and are unable to begin planning for the future,” says Dr. Jack Diamond, Scientific Director of the Alzheimer Society of Canada.

The full 2009 World Alzheimer Report, including the methodology used to prepare it, can be found at alz.co.uk/worldreport.

Source
Alzheimer Society

We are faced with making decisions all the time. Often, we carefully deliberate the pros and cons of our choices, taking into consideration past experiences in similar situations before making a final decision. However, a new study suggests that cognitive stress, such as distraction, can influence this balanced, logical approach to decision making.

Psychologists Jane Raymond and Jennifer L. OBrien of Bangor University in the United Kingdom wanted to investigate how cognitive stress affects rational decision making. In this study, participants played a simple gambling game in which they earned money by deciding between stimuli—in this case, two pictures of different faces. Once their selection was made, it was immediately clear if they had won, lost, or broken even. Each face was always associated with the same outcome throughout this task. In the next stage of the experiment, the volunteers were shown each face individually and had to indicate whether they had seen those faces before. Sometimes volunteers were distracted during this task while other times they were not.

The results, reported in the current issue of Psychological Science, a journal of the Association for Psychological Science, reveal that distractions significantly impact decision making. When volunteers were not distracted, they tended to excel at recognizing faces that had been highly predictive of either winning or losing outcomes. However, when they were distracted, they only recognized faces that had been associated with winning.

Schizophrenia is a difficult condition for patients and their families to manage. Relapse is a frequent occurrence, particularly if patients decide to discontinue antipsychotic drug treatment because of unwanted side effects. Psychiatrists say over half of patients relapse within two years and over 80 per cent within five years. Relapse is five times more likely to occur among patients who stop their treatment.

Now a phase III study investigating safety and efficacy of a new drug, soon to be available in the US, has shown the risk of relapse in patients getting the treatment over a period of one year compared to those receiving no treatment was reduced by around 75 per cent. Preventing relapse is important because it enables people with schizophrenia to carry on with their lives normally, without disruption to work, education or relationships, and helps avoid the need for hospital admission. Hopes are high that newer treatments will improve on those already available in keeping patients stable.

The drug featured in the study is a new atypical antipsychotic called asenapine, in development by ScheringPlough. It is taken by mouth, and is the first psychotropic medicine to be administered sublingually. The drug is placed under the tongue twice daily and releases slowly from a small reservoir. “The formulation gives a steady distribution of the drug. It also ensures patients under observation are actually taking their medicine and not pretending to swallow a tablet which they later surreptitiously remove,” explained psychiatrist Professor Steven Potkin, of University of California, who has experience of asenapine. “In addition, it makes it difficult for patients to overdose themselves. If they put too much in the mouth the excess is swallowed and rendered inactive in the gut.”

The drug was approved by the FDA in August for treatment of acute schizophrenia in adults and also for acute episodes of mania in bipolar 1 disorder. The first time a psychotropic medicine has been approved for two indications simultaneously. It will shortly be marketed as Saphris in the US. In Europe it is still under review by the European Medicines Evaluation Agency (EMEA). If approved it will be marketed in European countries as Sycrest. Results presented at ECNPResults of the phase III relapseprevention study in schizophrenia were presented this week to psychiatrists at the 22nd annual congress of the European College of Neuropsychopharmacology (ECNP) in Istanbul. They showed that only 12 per cent of patients who received asenapine relapsed over the course of one year compared with 47 per cent of patients who received placebo. The study consisted of a sixmonth open label phase and a sixmonth randomised double blind phase where asenapine was compared against placebo in 386 patients, most of whom suffered from paranoid schizophrenia. Only patients whose disease had stabilised on asenapine were included in the randomised phase. Most of those receiving asenapine took 10mg twice daily

Patients were deemed to have relapsed on a number of assessments including if their score on the standard schizophrenia assessment tool PANSS (Positive and Negative Syndrome Scale) had increased by more than 20 per cent from the time they entered the doubleblind part of the study or if they scored more than 5 on specific items such as hostility or hallucinatory behaviour. Adverse events were monitored throughout the study by formal assessments including ECGs, laboratory tests, and standard rating scales.

Lead author of the study Mary Mackle, a clinical research scientist at Schering Plough in New Jersey, USA, said “The results we saw for asenapine were very good.” The number of patients staying with active treatment was high and the number experiencing a further episode was exceptionally low. Patients were thought to have stayed on treatment because it was effective in controlling symptoms but also because they were not deterred by side effects. “This is a welltolerated drug, obviously, with a good side effect profile. It doesnt cause a lot of weight gain or sedation compared to some other antipsychotics.” In fact, treatmentemergent and treatmentrelated side effects occurred more frequently in the placebo group, she noted.

Another Schering Plough clinical research scientist, Dr John Panagides also commented on how well patients appeared to tolerate treatment “Given the known risk/benefit profiles of current antipsychotic drugs, asenapine is pretty favourable.” It is associated to a much lesser extent with side effects of antipsychotic drug therapy such as raised prolactin, weight gain, metabolic effects, sedation and extrapyramidal system effects (involuntary movements), he explained.

“Asenapines effects on these were very modest,” . The most frequently reported adverse events for both the asenapine and placebo groups were anxiety (8.2 per cent with asenapine vs 10,9 per cent with placebo), increased weight (6.7 per cent for asenapine vs 3.6 per cent for placebo) and insomnia (6.2 per cent with asenapine and 13.5 per cent with placebo.) Clinically significant weight gain (more than 7 per cent of baseline weight amounting to around 4kg affected only 3.7 per cent of asenapinetreated patients.) Four times as many placebotreated patients experienced worsening of schizophrenia as did patients receiving asenapine (4.6 per cent vs 16.1 per cent).Negative symptom improvementOne of the emerging benefits of the new treatment is itseffects on the negative symptoms of schizophrenia, remarked Professor Potkin. Negative symptoms include apathy, loss of drive and lack of motivation or interest, and poor social functioning. “In shortterm studies it showed clear efficacy for negative symptoms and in longer term studies, the effect also seems to be maintained. This is a very important finding because negative symptoms are extremely difficult to treat,” he stressed.

A ScheringPlough press release in July this year reported on a study investigating asenapines effects on negative symptoms. In the study, asenapine was significantly more effective than olanzapine in the reduction of negative symptoms as assessed using the 16item Negative Symptom Assessment scale (NSA16).”Full results of the trial, including efficacy, safety and tolerability data, will be submitted for presentation at a medical meeting at a later date,” according to the company statement.

All antipsychotic drugs are different, points out Professor Potkin. “There is no one size fits all drug that suits all patients with schizophrenia. Some people wont respond to one but will respond to another. Different sideeffect profiles allow psychiatrists to tailor treatment to suit particular patients, for example, overweight patients would need a drug that avoids excessive weight gain or metabolic syndrome” he suggested. “All antipsychotics are effective at tackling the positive symptoms of schizophrenia but some agents also target different domains that others dont.”

A poster at ECNP led by University of California and Yale University scientists using a primate model suggests asenapine may have potential to treat cognitive impairment in schizophrenia. The researchers concluded from asenapines effects on serotonergic receptors in monkeys that the drug might also improve cognitive impairment in schizophrenia although they stress large scale clinical studies would be needed for confirmation of these effects in patients.

Regarding its other indication, bipolar 1 mania, or mixed symptoms, a poster at ECNP showed asenapine rapidly reduced symptoms within 2 days and improved scores on all 11 items of the YMRS (Young Mania Rating Scale) the standard measure for mania assessment within two weeks.

Although clinical experience with the drug is limited, some professional guidelines, notably those produced by expert bodies concerned with bipolar disease, are already recommending it to psychiatrists on the strength of evidence produced from numerous clinical trials. As further trials are completed and its performance in clinical practice is studied once it becomes widely available, more will be learned about asenapines strengths.

“There is great optimism that other new drugs will be developed in the future that will also help address the current unmet needs in managing patients with schizophrenia and bipolar disorder,” remarked Professor Potkin

Further information
scheringplough.com

Worldwide, 13% of women who give birth suffer from postnatal depression, which causes a significant deterioration in a mothers quality of life and her ability to care for her baby. Now, Spanish researchers have developed a model to diagnose this illness with a predictive power of 80% the best result to date for this kind of depression.

“Early diagnosis of postnatal depression would make it possible to intervene to prevent it from developing among women at risk”, Salvador Tortajada, lead author of the study and a researcher at the Polytechnic University of Valencia (UPV), tells SINC.

The experts studied data on 1,397 Spanish women who gave birth between December 2003 and October 2004 in seven hospitals in Spain, and devised various models that can predict with an 80% success rate which mothers run the risk of developing depression during the first weeks after giving birth.

This study, which is the first of its kind in Spain and has been published recently in the journal Methods of Information in Medicine, gives the best results to date in terms of predicting this illness. “Now it needs clinical evaluation, and for psychiatrists to start to test it directly on patients in order to study the true potential of these tools”, says Tortajada.

The researchers used artificial neuronal networks and extracted a series of risk factors highlighted in previous studies the extent of social support for the mother, prior psychiatric problems in the family, emotional changes during the birth, neuroticism and polymorphisms in the serotonin transport gene (genes with high levels of expression lead to an increased risk of developing the illness).

They also discovered two protection factors that reduce the risk of depression age (the older the woman the lower her chance of depression), and whether or not a woman has worked during pregnancy (which reduces the risk). The researcher points out that “it can be seen that these factors are relevant in the neuronal networks, but not by using other statistical methods”. The path is now clear for future studies to corroborate these findings.

However, many studies have shown that between 10 and 15% of women who give birth suffer from depression, normally between the second and third month after having given birth. This illness affects the patients emotional and cognitive functions (in extreme cases leading to suicidal tendencies), and may have serious knockon effects on the childs future development.

Source
SINC

A comparison of outcomes of different eras of conservative treatment for localized prostate cancer indicates that overall and prostate cancerspecific survival rates are higher for men diagnosed from 1992 through 2002 compared to men diagnosed in the 1970s and 1980s, according to a study in the September 16 issue of JAMA.

“Among men, prostate cancer is the most common nonskin cancer and the second most common cause of cancer death in the United States. When diagnosed, prostate cancer is contained within the prostate in approximately 85 percent of cases, and standard treatment options usually include surgery, radiation, or conservative management (active surveillance or deferral of treatment until necessitated by disease signs or symptoms),” according to background information in the article. “Despite its potential as a reasonable treatment choice, however, conservative management has been used in only about 10 percent of patients, perhaps because of a limited understanding of and contemporary data on the anticipated course and outcomes of this approach.” The authors add that this lack of reliable contemporary information makes it difficult for patients and their physicians to anticipate outcomes and make informed treatment decisions.

Grace L. LuYao, M.P.H., Ph.D., of the Cancer Institute of New Jersey and UMDNJRobert Wood Johnson Medical School, Piscataway, N.J., and colleagues analyzed data for men with localized T1 or T2 prostate cancer to evaluate the outcomes of conservatively managed localized prostate cancer diagnosed in the contemporary prostatespecific antigen (PSA) era. The populationbased cohort study included 14,516 men age 65 years or older when they were diagnosed (19922002) with stage T1 or T2 prostate cancer and whose cases were managed without surgery or radiation for 6 months after diagnosis. Living in areas covered by the Surveillance, Epidemiology, and End Results (SEER) program, the men were followed up for a median (midpoint) of 8.3 years (through December 2007). The median age at diagnosis was 78 years.

The researchers found that tenyear prostate cancerspecific mortality was 8.3 percent for men with welldifferentiated tumors, 9.1 percent for moderately differentiated, and 25.6 percent for those with poorly differentiated tumors. The corresponding 10year risks of dying of causes other than prostate cancer were 59.8 percent, 57.2 percent, and 56.5 percent for each respective group.

Tenyear diseasespecific mortality for men age 66 to 74 years diagnosed with moderately differentiated disease was 60 percent to 74 percent lower than earlier studies. “Survival results in our contemporary PSA era study cohort were more favorable than results previously reported. For example, in the current study, 10year prostate cancerspecific mortality was 6 percent in the contemporary PSA era (19922002) compared with results of previous studies (15 percent23 percent) in earlier eras (19491992) for men aged 65 to 74 years diagnosed with moderately differentiated disease. Improvement in survival among men with older age or poorly differentiated disease was also observed,” the authors write.

“The substantial improvement in survival that we observed in our study compared with previous reports might be explained, in part, by additional lead time, overdiagnosis related to PSA testing, or grade migration, among other factors. Prostatespecific antigen testing identifies disease 6 to 13 years before it presents clinically. Contemporary patients identified through such testing would be expected to live at least 6 to 13 years longer because of this lead time. In addition, previously documented systematic upgrading of modern tumors compared with earlier eras makes more recently graded tumors appear to have a more benign course, resulting in longer survivals. Finally, it is also possible that advancements in medical care might have led to improved outcomes.”

“The net overall effect is that outcomes following conservative management are now significantly better than those reported in previous eras; therefore, physicians and their patients may need to reconsider this management option, particularly in light of randomized trial data from the prePSA era suggesting little if any benefit to more aggressive intervention.”

JAMA 2009;302[11]12021209.