Tuesday, June 14, 2011

First placebo-controlled polypill study | theheart.org

Sydney, Australia - The first randomized, placebo-controlled study of a polypill has suggested that use of such a product in primary prevention could bring about a halving of heart disease and stroke events, the authors say.

While the authors conclude that a polypill such as this is a potentially highly cost-effective strategy that could alone achieve most of World Health Organization's goals for reducing noncommunicable disease, others see it as a step backward, saying it represents a "dumbing down" of medical practice.

The current study, published online May 25, 2011 in PLoS One, involved 378 individuals without an indication for any component of the polypill but who had an estimated five-year cardiovascular disease risk over 7.5%, determined by the Framingham risk function using data on age, gender, blood pressure, total cholesterol, HDL cholesterol, diabetes status, and cigarette smoking status. They were randomized to the polypill containing aspirin 75 mg, lisinopril 10 mg,hydrochlorothiazide 12.5 mg, and simvastatin 20 mg or to placebo. Results showed that the polypill was associated with a 9.9-mm-Hg drop in systolic blood pressure and a 0.8-mmol/L reduction in LDL cholesterol over a 12-week treatment period.

Adverse effects occurred in 58% of the polypill group vs 42% of the placebo patients, with 23% of the polypill group discontinuing therapy vs 18% of the placebo group.

The authors estimate that if individuals stayed on therapy long term, these effects would translate into an approximate 60% reduction in heart disease and ischemic stroke risk, little overall effect on hemorrhagic stroke risk (the beneficial effects of blood-pressure lowering balancing out the adverse effects of aspirin), and a 50% increase in the risk of extracranial bleeding.

More ...

http://www.theheart.org/article/1231481.do

Related:

http://life.nationalpost.com/2011/06/14/one-magic-pill-to-rule-cardiac-health-ills/