title: Randomized Polypill crossover trial in people aged 50 and over.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Controlled-Trials.com ISRCTN36672232.
authors: Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
authors: David S
authors: DS
authors: Wald
authors: Joan K
authors: JK
authors: Morris
authors: Nicholas J
authors: NJ
authors: Wald
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage; D000924:Anticholesteremic Agents / Q000008:administration & dosage; D000959:Antihypertensive Agents / Q000008:administration & dosage; D001794:Blood Pressure; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods*; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage; D006937:Hypercholesterolemia / Q000188:drug therapy*; D006973:Hypertension / Q000188:drug therapy*; D019808:Losartan / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010919:Placebos; D019821:Simvastatin / Q000008:administration & dosage
chemical_list: D000924:Anticholesteremic Agents; D000959:Antihypertensive Agents; D010919:Placebos; D006852:Hydrochlorothiazide; D017311:Amlodipine; D019821:Simvastatin; D019808:Losartan