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Friday, 20 July 2012

Randomized Polypill Crossover Trial in People Aged 50 and Over


David S. WaldJoan K. MorrisNicholas J. Wald*
Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom

Abstract Top

Background

A Polypill is proposed for the primary prevention of cardiovascular disease in people judged to be at risk on account of their age alone. Its efficacy in reducing cholesterol and blood pressure is uncertain.

Methods

We conducted a randomized double-blind placebo-controlled crossover trial of a Polypill among individuals aged 50+ without a history of cardiovascular disease and compared the reductions with those predicted from published estimates of the effects of the individual drugs. Participants took the Polypill (amlodipine 2.5 mg, losartan 25 mg, hydrochlorothiazide 12.5 mg and simvastatin 40 mg) each evening for 12 weeks and a placebo each evening for 12 weeks in random sequence. The mean within-person differences in blood pressure and low density lipoprotein (LDL) cholesterol at the end of each 12 week period were determined.

Results

84 out of 86 participants completed both treatment periods. The mean systolic blood pressure was reduced by 17.9 mmHg (95% CI, 15.7–20.1) on the Polypill, diastolic blood pressure by 9.8 mmHg (8.1–11.5), and LDL cholesterol by 1.4 mmol/L (1.2–1.6), reductions of 12%, 11%, and 39% respectively. The results were almost identical to those predicted; 18.4 mmHg, 9.7 mmHg, and 1.4 mmol/L respectively.

Conclusion

The Polypill resulted in the predicted reductions in blood pressure and LDL cholesterol. Long term reductions of this magnitude would have a substantial effect in preventing heart attacks and strokes.

Full study:

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0041297


Two of the ingredients of the polypill:

  • Amlodipine (blood pressure lowering medication) – 2.5 mg
  • Simvastatin (a statin) – 40 mg

FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury.


Do not exceed 20 mg simvastatin daily with:
  • Amlodipine (New)


Graham


2 comments:

Lowcarb team member said...

“Two of the ingredients of the polypill: Amlodipine (blood pressure lowering medication) – 2.5 mg. Simvastatin (a statin) – 40 mg.

FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury. Do not exceed 20 mg simvastatin daily with Amlodipine.”

http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm

This medication is going the way of Actos and Avandia before it gets off the ground. Yet another med with little if any benefit for most, but built in side effects leading to serious injury and death. Looks like a nice earner for the statinaters.


Eddie

Anonymous said...

It's only a matter of time before GP's will try and push this on us,if mine does then I shall politely inform him that I'm not playing the 'Guinea Pig' for the Big Pharma whilst my cholestral and BP is fine on lifestyle choices alone already.

Paul