Polypill barriers remain

BARRIERS to the global availability of a polypill to prevent cardiovascular disease remain despite growing evidence of its clinical potential, according to former BMJ editor and long-term advocate of the polypill, Dr Richard Smith.

Dr Smith, who was in Melbourne last week to attend the Cardiovascular Combination Pharmacotherapy Global Summit, in conjunction with World Congress on Cardiology, said momentum was starting to gather with growing evidence of increased adherence and clinical benefit with the polypill — a fixed-dose combination of commonly used blood pressure and cholesterol-lowering medications, and aspirin.

“But in terms of actually getting it made available to lots of people, the progress is fairly slow because, although the big drug companies are the people who know how to get a drug on the market, they’re generally not interested”, Dr Smith told MJA InSight.

Dr Smith, director of the Ovations Chronic Disease Initiative, welcomed findings from the Single Pill to Avert Cardiovascular Events (SPACE) project that showed the polypill was associated with a 43% boost in patient adherence to medication at 12 months. (1) (2)

“That’s tremendously dramatic”, he said, of the research that was presented at the cardiology congress. “Generally, if you have people taking treatment for life … after a year [of starting therapy], you’ve only got about 50%̄60% of people [still] taking the treatment, so anything that can increase adherence is really important.”

The SPACE project, led by researchers from the George Institute for Global Health, analysed data from three clinical trials involving 3140 patients, including the Kanyini-GAP trial in Australia. (3)

Dr Ruth Webster, of the George Institute, said the polypill’s capacity to prevent cardiovascular events was “potentially massive”.

“In Australia, 50% of people who should be taking these combination medications don’t take them”, she said. “Globally at least 90% of people in lower income countries who would potentially benefit from these medications are not taking them.”

Dr Webster said the affordability of the polypill could ensure that its benefits were felt in low- as well as high-income nations.

“One of the key aims of the polypill has always been … to make it cheap so that patients can afford it”, said Dr Webster, adding that governments and health care organisations could use their buying power to ensure a cheap and effective pill was available globally.

Although a polypill is available in some Latin American and Asian countries, the UK, the US and Australia do not yet have one on the market.

Dr Webster said the George Institute was actively involved in efforts to have a polypill made available in Australia.

Dr Smith said that Iran was trialling providing the polypill to everyone over the age of 50 years who had at least one risk factor for cardiovascular disease. “The future is going to come not from Australia or Britain or the US, but from these kinds of countries, where … there’s much more to gain … as there are many people not being treated [at all]”, he said.

In addition to regulatory hurdles, cardiologists were also a barrier to polypill development, said Dr Smith, who recently wrote about the key barriers to polypill uptake in his BMJ blog. (4)

“[Cardiologists] think … that constantly titrating the drugs you give people, measuring their blood pressure regularly and their lipids … is a better way of doing things. But the problem is that we have this famous rule of halves — of all of the people at risk, half are not diagnosed; and of the half that are diagnosed, half are not treated; and the half that are treated, are not treated adequately”, he said. “So you end up with a very high proportion of people who are at risk who are not getting good treatment.

“The strongest argument for the polypill is how bad things are at the moment. Not just in low- and middle-income countries where, on the whole, they are terrible, but also in high-income countries because a lot of people are not getting adequate treatment.”

Dr Smith said the polypill had also faced opposition from public health experts concerned that giving people such a pill would discourage improvements in lifestyle and diet.

“But I think that’s a myth that’s been laid to rest because in three trials that have looked at lifestyle, people on the polypill don’t get fatter, they don’t smoke more, they don’t eat unhealthier diets”, he said.

1. Nature 2007; 450: 494-496
2. George Institute for Global Health: SPACE Project
3. BMC Public Health 2010; Online 5 August
4. BMJ Blogs 2014; Online 1 May