:.PolyPill.:

There is considerable empirical support for the concept of a single-dose multi-medication therapy, including the following studies that have either been published or that are currently being conducted:

A strategy to reduce cardiovascular disease by more than 80%

 

N. J, Wald and M. R. Law, British Medical Journal, Volume 36, 28 June 2003

This meta-analysis introduced the concept of a single-dose, multi-medication therapy. Analysis suggested significant positive health outcomes, including the reduction of heart attacks by 88% and the reduction of strokes by 80%.

- One in three people would benefit with an average of 11+ added years of life free of heart attack or stroke

- Several risk factors would be lowered at the same time

- Risk factors would be reduced as much as possible

- Intervention with these 3 major groups at risk should begin immediately, regardless of the level of risk

It concluded that if three groups of patients – those 55 years of age or older, those with a diagnosis of CVD and those with diabetes – began taking a single-dose, multi-medication pill immediately: "There is much to gain and little to lose by the widespread use of these drugs. No other preventive method would have so great an impact on public health in the Western world."

 

Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomized trial

The Lancet, Volume 373, Issue 9672, Pages 1341-1351, 18 April 2009

This study demonstrated the efficacy of the use of a single-dose multi-medication therapy in practice. In a double blind trial of 2,053 patients without CVD in India ages 45 – 80 who had one of the following risk factors – hypertension, diabetes, smoking or obesity – it was found that:

- BP was reduced more with increasing number of BP medications

- Overall SBP was reduced 7.4 mm Hg and DBP was reduced 5.6 mm Hg

- LDL was reduced by 30 points for those on a statin

- HR was reduced by 7 bpm for those on atenolol

- ASA reduced clotting activity by 19%

- The expected lower risk of heart attack was 62% and stroke was 48%

 

The Indian Polycap Study 2

Currently being conducted in India

Ongoing study designed to pinpoint the optimal strength of a single-dose, multi-medication therapy, using a formula twice as strong as in the original TIPS study

- Being conducted by Dr. Salim Yusuf – one of the investigators of TIPS

- Trial started in 2010 with 500 patients and expected to finished by the end of the year

- The TIPS investigators have been funded to conduct a 5000-subject study; it will likely start in January 2011 and also be a primary prevention trial.

"The goal is to choose the optimal strength Polycap based on TIPS and TIPS 2 and then assess how it will do vs placebo in reducing clinical events."

 

UMPIRE Study

Currently being conducted in Europe

Use of a Multi-drug Pill in Reducing Cardiovascular Events

- Started in Europe, May 2010, to determine adherence to therapy

- The single-dose, multi-medication pill for this study is known as the "red heart pill"

- Study covers 2000 participants a higher risk of cardiovascular events than those who took part in TIPS