title: A Polypill for primary prevention of cardiovascular disease: a feasibility study of the World Health Organization.
abstract: BACKGROUND
  The feasibility of conducting a large-scale Polypill clinical trial in developing countries remains unclear. More information is needed regarding the efficacy in reducing the risk factors of cardiovascular disease (CVD), side effects, improvement in adherence and physician/patient "acceptability" of the Polypill.
  
  
  METHODS
  We conducted an open-label, parallel-group, randomized clinical trial involving three sites in Sri Lanka that enrolled a total of 216 patients without established CVD. The trial compared a Polypill (75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide) to Standard Practice. After randomization, patients were followed monthly for three months. Pre-specified primary outcomes included reduction in systolic blood pressure, total cholesterol and estimated 10-year CVD risk. We also evaluated the recruitment process and acceptability of the Polypill by both physicians and patients.
  
  
  RESULTS
  Patients were recruited in a six-month period as planned. Two hundred three patients (94.0%) completed the treatment program and returned for their three-month follow-up visits. No safety concerns were reported. These findings suggest a high rate of patient acceptability, a finding that is bolstered by the majority of patients completing the trial (90%) indicating that they would take the Polypill "for life" if proven to be effective in reducing CVD risk. Approximately 86% of the physicians surveyed agreed with and supported use of the Polypill for primary prevention and 93% for secondary prevention of CVD. Both the Polypill and Standard Practice resulted in marked reductions in systolic blood pressure, total cholesterol and 10-year risk of CVD. However, the differences between the treatment groups were not statistically significant.
  
  
  CONCLUSIONS
  We successfully completed a Polypill feasibility trial in Sri Lanka. We were able to document high acceptability of the Polypill to patients and physicians. We were unable to estimate the risk factor reductions on the Polypill because the control group received similar treatment with individual drugs. The Polypill was however simpler and achieved comparable risk factor reductions, highlighting its potential usefulness in the prevention of CVD.
  
  
  BACKGROUND
  NCT00567307.
authors.affiliation: Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
authors.forename: Elsayed Z
authors.initials: EZ
authors.lastname: Soliman
authors.forename: Shanthi
authors.initials: S
authors.lastname: Mendis
authors.forename: Wasantha P
authors.initials: WP
authors.lastname: Dissanayake
authors.forename: Noel P
authors.initials: NP
authors.lastname: Somasundaram
authors.forename: Padma S
authors.initials: PS
authors.lastname: Gunaratne
authors.forename: I Kumudini
authors.initials: IK
authors.lastname: Jayasingne
authors.forename: Curt D
authors.initials: CD
authors.lastname: Furberg
mesh_terms: D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage; D001241:Aspirin / Q000008:administration & dosage; D001291:Attitude of Health Personnel; D015415:Biomarkers / Q000097:blood; D001794:Blood Pressure / Q000187:drug effects; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D002318:Cardiovascular Diseases / Q000097:blood / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D016009:Chi-Square Distribution; D002784:Cholesterol / Q000097:blood; D004232:Diuretics / Q000008:administration & dosage; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage; D017706:Lisinopril / Q000008:administration & dosage; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011322:Primary Prevention / Q000379:methods*; D018570:Risk Assessment; D012307:Risk Factors; D019821:Simvastatin / Q000008:administration & dosage; D013188:Sri Lanka; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014944:World Health Organization
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D015415:Biomarkers; D002317:Cardiovascular Agents; D004232:Diuretics; D004338:Drug Combinations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D010975:Platelet Aggregation Inhibitors; D006852:Hydrochlorothiazide; D002784:Cholesterol; D019821:Simvastatin; D017706:Lisinopril; D001241:Aspirin