Archief Roodbont

Cardioprotective ‘polypill’ trial begins

7 January 2011

MedWire News: A phase III trial to assess the effect of a four-component “polypill” on primary prevention of ischemic heart disease (IHD) and stroke in individuals aged 50 years and older begins in the UK this week, the investigators have announced.

If taken daily, the single tablet containing a statin and three different antihypertensives “could reduce cardiovascular (CV) disease by about 75%,” say Professor Nicholas Wald and Dr David Wald, both from Barts and the London School of Medicine and Dentistry.

Writing in the journal Heart, they explain that the findings from an earlier meta-analysis led by Professor Wald demonstrated that “about one in three people taking the polypill would directly benefit from doing so, and each of these would, on average, gain 11 years of life without a heart attack or stroke.”

At the time of the meta-analysis, the researchers reported that aspirin would be a component of the polypill. However, this decision has since been reversed due to uncertainty over whether the benefits of aspirin outweigh the bleeding risk in patients who are considered healthy.

The researchers are aiming to enrol 100 men and women aged 50 years or older with no history of CV disease.

The participants will be randomly assigned to receive the polypill or placebo for 12 weeks, followed by a cross over to the alternative treatment for a further 12 weeks. The final stage of the trial will be conducted as a 2-year open-label period during which all participants will take the polypill.

The researchers say that participants’ blood pressure and cholesterol levels will be closely monitored throughout, and long-term efficacy and safety outcomes assessed.

Speaking to MedWire News, Dr Wald said that the relatively small study size would not prevent valid conclusions from being drawn from the study’s findings.

“Although the study is small in size, the crossover design means that relatively few participants are required to demonstrate statistically significant effects on cholesterol and blood pressure,” he explained.

Dr Wald added that favorable trial findings could pave the way for the polypill to enter the market.

He said: “One cannot be certain how soon the polypill will enter the market, however we would hope to achieve this within the next 2 years.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a trading division of Springer Healthcare Limited. © Springer Healthcare Ltd; 2011

Heart 2010; 96: 1–4