Have you ever worried about mixing different medications? Have you ever been prescribed several medicines at once and found it difficult to keep track of different pills? Researchers at Barts in London think they have an answer, proposing that several drugs currently prescribed for cardiovascular risk reduction could be combined in a ‘polypill,’ available cheaply and perhaps even without prescription to people who appear at risk. Questions remain about whether there is a large enough market for this kind of drug, and thus whether this idea will work in practice.
The authors of an unusual new trial, published in July, think it will. The 84 participants were allocated at random to treatment or placebo in the first of two 12 week periods (receiving the second option in the second period to allow each person to be their own control). Their allocation was unknown to both participants and to researchers for the duration of the trial. Perhaps unsurprisingly it showed that a combination of three anti-hypertensives (amlodipine, losartan and hydrochlorothiazide) and a statin reduced both blood pressure and LDL cholesterol. However the authors admitted that the participants were scarcely ‘standard’ research subjects. Many were friends and colleagues of the researchers, and included such medical celebrities as Richard Smith, former editor of the BMJ. Most took their pills throughout the trial despite reporting side effects (indeed one of only two drop outs withdrew because she wanted to be sure that she got active treatment). This was in stark contrast to previous trials of the polypill where quite large proportions (between 15 and 30%) reduced or stopped medication.
Writing in the Financial Times, Andrew Jack argues that a good idea – and novel approach to drug development – is being held up by commercial and regulatory pressures which create demands for further large and expensive trials. But I doubt that there is a large market for the polypill – and this highly unusual trial does nothing to persuade me otherwise. Attempts to market low dose statins direct to consumers in the UK a few years ago failed miserably due to low demand. People often refuse preventive drugs on prescription, or quietly stop taking them. This is not only true for the anti-hypertensives which have long and relatively well-known lists of side effects (swelling, fatigue, dizziness, diarrhea, dry cough etc.), but also for the statins which are generally seen as more benign. If they can avoid it people simply don’t like feeling dependent on drugs. Indeed one of the trial authors recently published another study based on 20 different trials, finding that perhaps half of people without established heart disease had given up on their drugs for CVD risk reduction. Not only do people worry about less immediate physical effects such as dependence – taking a drug also changes the way people feel about themselves, making them feel ‘ill’. If epidemiologists and cardiologists want to persuade more of us to take and keep taking drugs for prevention they’re going to need to work harder at understanding this reluctance.