Saturday, May 31, 2008
polypill
Polypill Progress: Clinical Testing Imminent for Three-Agent Secondary-Prevention Pill Steve Stiles Heartwire 2008. © 2008 Medscape
May 23, 2008 (Buenos Aires, Argentina) - A polypill variant containing aspirin, a statin, and an ACE inhibitor is ready to be tested in secondary-prevention studies intended to show not efficacy, which has been all but settled, but the product's pharmacodynamics and pharmacokinetics. Expected to be completed in about two years, the studies are needed to satisfy regulatory requirements that the three drugs, usually taken on separate occasions, are as potent when they are ingested at the same time, observed Dr Valentin Fuster (Mount Sinai Medical Center, NY), at a press conference here at the World Congress of Cardiology (WCC) 2008 meeting. This particular polypill--there are several varieties under development around the world for primary and secondary prevention--stems from a collaboration between the Spanish National Centre for Cardiovascular Research, for which Fuster holds the position of scientific president, and Ferrer Laboratories, a Barcelona, Spain company, according to a statement from the World Heart Federation (WHF) [1]. Fuster is the immediate past president of the Geneva, Switzerland–based organization, which sponsors the biennial WCC meeting and is a prominent backer of the three-agent pill. At the press conference (conducted in Spanish, with English translators provided by the WHF), Fuster demurred when asked to name which specific statin and ACE inhibitor are being used in the pill. Studies are also planned to test its effect on patient compliance compared with taking the three components separately, Fuster said, noting for reporters that compliance is notorious for diminishing with an increase in the amount of pills that must be taken, a key issue driving the polypill's development. He said the secondary-prevention indication is related to a requirement by the US FDA that each component of an approved multidrug pill be clinically indicated for the target population. At any rate, Fuster said through the interpreter, "I don't think I'd give aspirin to someone who doesn't need it, or any other medication that might have an antihypertensive effect. We want to make sure that every individual receiving the drug needs each of the medications contained in the polypill." The pill's introduction, planned for Spain and Latin America before it is made available elsewhere, is expected to cut the overall prevalence of secondary cardiovascular events, according to Fuster, because it should improve compliance and because a single medication is easier and less costly to distribute than three. Also, it is being developed at a greatly reduced cost compared with the usual commercial channels for drugs intended to be money makers. And, he said, the components are inexpensive, "so we will be able to go into developing countries [that have] fewer resources." The WHF statement puts the projected monthly cost of the pill at somewhere less than $10. At the press conference, Fuster said it could be as low as one or two dollars. As previously recounted by heartwire, the polypill idea was conceived by Drs Nicholas J Wald and Malcolm R Law (Wolfson Institute of Preventive Medicine, London, UK) in a controversial 2003 article in BMJ [2]. Their thesis was that a polypill containing six separate medications could reduce the prevalence of cardiovascular events by 80% if it were taken by everyone older than 55. The hypothetical pill would contain standard doses of aspirin and a statin; half doses of a thiazide, beta blocker, and ACE inhibitor; and folic acid. News outlets, primarily in the UK and British Commonwealth nations, were reporting on and around May 4 that the first samples of a polypill based on the formula of Wald and Law, minus the aspirin, had been manufactured and are now ready to be tested clinically. The London Sunday Times [3] quotes Wald: "Our mission is to make this available to everyone over 55 at an affordable price. The founders of our group would like this pill to be available to everyone for about £1 a day." The pill, according to the story, could be commercially available in the UK within two years; it will be manufactured by Cipla, "one of India’s largest pharmaceutical companies," headquartered in Mumbai. In January, 2007, heartwire reported that the Hyderabad, India drug company Dr Reddy's Laboratories had just completed enrollment of 250 patients with a history of cardiovascular events for a secondary-prevention trial of a polypill containing aspirin, lisinopril, simvastatin, and atenolol. The company was also said to be planning a larger international primary-prevention trial, of patients with cardiovascular risk factors, of a similar polypill that substitutes a thiazide diuretic for the beta blocker.
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polypill
Saturday, May 24, 2008
statin Parkinson
Reuters Health Information 2008. © 2008 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
By David Douglas
NEW YORK (Reuters Health) May 16 - There are indications of an association between use of HMG-CoA reductase inhibitors, ie, statins, and a reduced likelihood of Parkinson's disease, according to California-based researchers.
"Although our study findings suggest the very interesting possibility that statins may protect against Parkinson's disease," lead investigator Dr. Angelika D. Wahner told Reuters Health, "these findings are preliminary and must be confirmed by additional, well-designed studies."
For their study, Dr. Wahner of the UCLA School of Public Health, Los Angeles and colleagues recruited 312 patients with idiopathic Parkinson's disease and 342 controls. All were residents of three California counties and had a median age of about 70 years.
As reported in the April 15th issue of Neurology, 18.7% had taken statins at some point, and overall, there was a higher frequency of statin use in controls than in cases (odds ratio, 0.45).
There was a strong dose-response relationship and the greatest protection was found in participants who had taken statins for 5 years or more (odds ratio, 0.37).
The team found a risk reduction of 60% to 70% with atorvastatin, simvastatin and lovastatin, but not pravastatin. The odds ratio associated with use of this agent was 1.78. A possible explanation, they suggest, "might be postulated differences in statins' lipophilic properties."
"Further inquiry," continued Dr. Wahner, "into whether and why statins may play a protective role in Parkinson's disease is particularly important as our aging population increasingly suffers the burden of Parkinson's and other neurodegenerative diseases."
"Nevertheless," she concluded, "it is too early for clinicians to make recommendations based on our findings."
Neurology 2008;70:1418-1422.
statin cancer
Reuters Health Information 2008. © 2008 Reuters Ltd.
Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
NEW YORK (Reuters Health) May 15 - High-dose lipophilic statin use is associated with a significant reduction in the incidence of cancer, according to results of a study published in the April issue of the American Journal of Medicine.
Antitumorigenic effects for statins have been proposed, "although original reports had actually suggested the potential opposite, procarcinogenic effects of statins," Dr. Louise Pilote, of McGill University, Montreal, Canada, and colleague write. "Despite massive amounts of data, the issue remains inconclusive."
In a retrospective observational study, the researchers examined the association between lipophilic statin use and cancer occurrence in over 30,000 patients discharged from the hospital after admission for acute MI in the province of Quebec. The team linked the Quebec hospital discharge summary database to the drugs claims database.
The researchers defined high-dose statin use as a filled prescription, within 3 days after hospital discharge, at or above the statin-specific target dose, for any of the lipophilic statin medications (atorvastatin, simvastatin, lovastatin, or fluvastatin). Low-dose statin use was defined as a filled prescription, within 3 days after discharge, below the statin-specific target dose.
Overall, 1099 subjects were hospitalized with a cancer diagnosis during follow-up for up to 7 years.
The overall crude incidence rates of hospitalizations for cancer were 13.9, 17.2, and 20.6 per 1000 person-years among statin high-dose users, low-dose users, and non-users, respectively. The adjusted hazard ratios for high-dose statin use and low-dose statin use were 0.75 and 0.89 versus non-use, respectively.
"This is the first study to suggest a dose-response effect of lipophilic statins on cancer occurrence," Dr. Pilote's team notes. "Future studies should provide additional evidence allowing the assessment of long-term effects of statins on cancer risk."
Am J Med 2008;121:302-309.
statin muscle spier myositis
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Wednesday, May 21, 2008
AF en bèta blokkers
Conclusion
Over the 10-year period there was a dramatic increase in the use of beta-blockers in Danish atrial fibrillation patients at the expense of digoxin, nondihydropyridine calcium-channel blockers, and sotalol. In fact, sotalol, the second most used drug in 1995-1996, is rarely used nowadays, while amiodarone and class 1C antiarrhythmics still play a very modest role. Use of oral anticoagulants has increased considerably, but there is a persistent underuse of anticoagulation treatment in the elderly and in women with atrial fibrillation.
Friday, May 16, 2008
colon kanker aspirine
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|  "Convincing Evidence" That Aspirin Prevents Colorectal Cancer News Author: Zosia Chustecka
May 14, 2007 — Aspirin (acetylsalicylic acid) can prevent colorectal cancer, concludes an analysis of data from 2 large randomized trials. It found that aspirin at a dosage of 300 mg or more per day for about 5 years reduced the subsequent incidence of colorectal cancer by 37% overall, and by 74% during the period 10 to 15 years after treatment was started. The results, published in the May 12 issue of The Lancet, taken together with previous studies, "provide convincing evidence that aspirin, at biologically relevant doses, can reduce the incidence of colorectal cancer," comments Andrew T. Chan, MD, from Massachusetts General Hospital in Boston, in an accompanying editorial. However, "these findings are not sufficient to warrant a recommendation for the general population to use aspirin for cancer prevention," Dr. Chan notes. He cites concern over the potential risks of long-term aspirin use and also the availability of alternative prevention strategies, such as screening. Peter M. Rothwell, FRCP, from University of Oxford, United Kingdom, and lead author of the study, told Medscape that he agrees with this caution about the general population. Overall from the studies of aspirin use in healthy individuals for the primary prevention of cardiovascular disease, the benefit of aspirin is more or less outweighed by the risk of bleeding (mainly in the gastrointestinal tract, but also in the brain), he noted. However, Dr. Rothwell would argue for use of aspirin to prevent colorectal cancer in certain high-risk populations, for example in first-degree relatives of patients with colorectal cancer. This group has an increase risk for colorectal cancer — whereas the general population has a lifetime risk for colorectal cancer of about 5%, in first-degree relatives the risk is increased about 2- to 4-fold, so their lifetime risk is 10% to 20%, he said. Another example would be patients with vascular disease (angina, or previous myocardial infarction or stroke) who are taking aspirin or an antiplatelet agent such as clopidogrel for secondary cardiovascular prophylaxis. In this group, aspirin would have an additional benefit of also offering protection against colorectal cancer (via its inhibition of the cyclooxygenase [COX] enzymes, COX-1 and COX-2), whereas the other antiplatelet agents do not, as they work through a different mechanism. "This new evidence pushes the balance in favor of aspirin over these other drugs," Dr. Rathwell commented in an interview, and as a result, he would expect to see a shift back towards aspirin and way from the newer agents, which are also more expensive, he noted. One further point Dr. Rothwell made is that screening for colorectal cancer is very advanced in the United States, with regular colonoscopies and regular removal of polyps offered as a standard of care. However, the United States is almost alone in offering such a service, he commented, and in other countries around the world where there is limited access to these procedures, and so little else offered for prophylaxis against colorectal cancer, the benefit of using aspirin as a chemopreventive would be viewed differently. New Analysis of Data From Old StudiesThe latest results come from a new analysis of data that were collected in 2 large trials carried out some time ago: the British Doctors Aspirin Trial (5139 individuals, two thirds allocated to aspirin [500 mg] for 5 years) and the UK Transient Ischaemic Attack (UK-TIA) Aspirin Trial (2449 individuals, two thirds allocated to aspirin [300 or 1200 mg] for 1 - 7 years). Both trials were conducted in the late 1970s/early 1980s, before the effect of aspirin on cancer was recognized, and so colorectal cancer was not a prespecified endpoint. The analysis showed a reduction in the incidence of colorectal cancer, but not any other type of cancer, in individuals who had been taking aspirin compared with the control subjects. The effect was seen only after a latency of 10 years, the researchers comment and was greatest at 10 to 14 years after randomization in patients who had taken aspirin for 5 years or more. "These results are remarkably consistent with several previous observational studies," notes the editorialist. In the current study, Rothwell and colleagues systematically review 19 case-control studies (n = 20,815) and 11 cohort studies (n = 1,136,110) and report that regular use of aspirin or a nonsteroidal anti-inflammatory drugs was consistently associated with a reduced risk for colorectal cancer, especially after use for 10 years or more. "However, a consistent association was only seen with use of 300 mg or more of aspirin a day, with diminished and inconsistent results for lower or less frequent doses," the authors write. This effect of aspirin dose may explain why no effect on colorectal cancer was seen in 2 large US studies, the Physicians' Health Study (which used 162.5 mg of aspirin) and the Women's Health Study (which used 50 mg of aspirin), the editorialist notes. More study is needed to determine the optimum dose of aspirin, the editorial suggests, as well as the mechanisms involved. The studies to data "provide proof-of-principle that chemoprevention of colorectal cancer with aspirin is feasible," Dr. Chan concludes. "However, before chemoprevention can be practical, more work is needed to characterize those for whom the potential benefits of aspirin outweigh the hazards." Dr. Rothwell has disclosed receiving honoraria for talks, advisory boards, and clinical trial committees from several pharmaceutical companies with an interest in antithrombotic agents, including Sanofi-BMS, Servier, Bayer, and AstraZeneca. Lancet. 2007;369:1577-1578, 1603-1613. Clinical ContextThe inhibition of COX-2 might have a particularly prominent role in the prevention of colorectal cancer, and randomized trials have demonstrated that aspirin can reduce the recurrence of adenomas among patients with a previous history of colorectal cancer or adenomas by approximately 40%. However, only about 10% of adenomas progress to become malignant, so preventing adenoma formation is not guaranteed to reduce the risk for colon cancer among all adults. For example, aspirin use was not associated with a protective effect against colorectal cancer after a mean of 10 years of follow-up in the Women's Health Study. The Women's Health Study had a longer follow-up period than most trials of aspirin, but the dosage of aspirin (100 mg every other day) was low. The current research examines long-term results of 2 previous studies to determine if higher doses of aspirin and a longer duration of surveillance may result in reduced rates of colorectal cancer. Study Highlights
Pearls for Practice
CME/CE Test Medscape Medical News 2007. ©2007 Medscape Legal Disclaimer The material presented here does not necessarily reflect the views of Medscape or companies that support educational programming on www.medscape.com. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. A qualified healthcare professional should be consulted before using any therapeutic product discussed. Readers should verify all information and data before treating patients or employing any therapies described in this educational activity. | | 
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Some people over 55 are healthy, with normal blood pressure and cholesterol levels. The good news is that those of us who eat healthily, drink in moderation and exercise regularly will be saving the NHS their £1 a day! A healthy lifestyle, not pills is the way to go!
Gilly, Berkhamsted, UK
Wouldn't it be wonderful if people gave ceredit where credit is due? A helpful, life0saving drug has been announced. That is cuase for celebration, surely? Or would people rather die young?
Carrie, Plymouth, England
The Wolfson Institute which brought out this press release is currently receiving funding from Pfizer, Glaxo Smith Kline, Aventis, AstraZeneca and other drug manufacturers. There is not a scrap of evidence that a statin drug has any effect on lifespan.
James McLaughlin, Londonderry, Northern Ireland
The medical industry, which indirectly funds much of the research, is obsessed with quantity of life, not quality and profit. There is some merit in this proposal, especially for those with a familial history of hypertension, but as a universal panacea? No thanks.
Peter Jenks, Salisbury, UK
This seems to me very commercial. I don't think the idea is good.
Goderis Jan, Zuienkerke, Belgium
The poly-pill won't be free Judy. Instead at £1 per day for all over 55's - it will bankrupt the NHS in months. Furthermore it would medicalise normal ageing, extend the nanny-state and fail to address lifestyle issues such as diet, smoking and exercise. Professor Boyle needs lancing!
Richard Falk, Doncaster, South Yorkshire
Statins are a highly active group of compounds with very serious side effects. This is madness. Why don't these companies concentrate on fighting infections, if we don't get some new antibiotics soon we will be in serious trouble.
bob taylor, castelnau, France
Good God something 'free' for the over fifties! This must be a first. It probably kills them off in a Government plot to cull pensioners.
judy, Liverpool, England