UMPIRE - Use of a Multidrug Pill In Reducing Cardiovascular Events
Summary
People with established cardiovascular disease need secondary prevention that addresses multiple risk factors. Complexity \& cost confer particularly difficult barriers to uptake of treatment; recovery from a stroke or heart attack typically necessitates multiple drugs for cholesterol, blood pressure and platelet function. A low-cost, fixed-dose, once-daily combination polypill, the Red Heart Pill, has been formulated by Dr Reddy's Laboratories. UMPIRE will evaluate whether provision of this polypill compared with usual medications improves adherence and clinical outcomes among high-risk patients in Europe and India. The results will be used to develop recommendations for equitable access.
Timeline
- Start
- 2010-06
- Primary completion
- 2012-07
- Completion
- 2012-09
Outcome
Met primary endpoint
paper The FDC group had improved adherence vs usual care (86% vs 65%; relative risk [RR] of being adherent, 1.33; 95% CI, 1.26-1.41; P < .001) PMID 24002278 ↗
paper concurrent reductions in SBP (-2.6 mm Hg; 95% CI, -4.0 to -1.1 mm Hg; P < .001) PMID 24002278 ↗
paper and LDL-C (-4.2 mg/dL; 95% CI, -6.6 to -1.9 mg/dL; P < .001) at the end of the study. PMID 24002278 ↗
Publications
- Background Thom S, Field J, Poulter N, Patel A, Prabhakaran D, Stanton A, Grobbee DE, Bots ML, Reddy KS, Cidambi R, Rodgers A. Use of a Multidrug Pill In Reducing cardiovascular Events (UMPIRE): rationale and design of a randomised controlled trial of a cardiovascular preventive polypill-based strategy in India and Europe. Eur J Prev Cardiol. 2014 Feb;21(2):252-61. doi: 10.1177/2047487312463278. Epub 2012 Oct 4.
- Thom S, Poulter N, Field J, Patel A, Prabhakaran D, Stanton A, Grobbee DE, Bots ML, Reddy KS, Cidambi R, Bompoint S, Billot L, Rodgers A; UMPIRE Collaborative Group. Effects of a fixed-dose combination strategy on adherence and risk factors in patients with or at high risk of CVD: the UMPIRE randomized clinical trial. JAMA. 2013 Sep 4;310(9):918-29. doi: 10.1001/jama.2013.277064.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 75 mg | Oral |
| Subject | Atenolol | Other / unclassified | 50 mg | Oral |
| Subject | Hydrochlorothiazide | Unknown | 12.5 mg | Oral |
| Subject | LISINOPRIL ANHYDROUS | Small molecule | 10 mg | Oral |
| Subject | Simvastatin | Small molecule | 40 mg | Oral |