The recent publication of the Indian Polycap Study (TIPS) has reignited the debate about the feasibility of a single pill or capsule to reduce cardiovascular risk.1
For technical reasons, it is much easier to formulate several medications in a single capsule than to make a single pill.
This short but large-scale study examined the effects of various polycap ingredients on BP, cholesterol and clotting, and also tolerability and safety. The ingredients varied but included hydrochlorothiazide 12.5mg, atenolol 50mg, ramipril 5mg, simvastatin 20mg and aspirin 100mg.
It was not an outcome study but the results overall were very favourable. Further outcome studies are required but it would be surprising if they did not show benefit, considering previous trials of the individual components.
Who will benefit?
So who will benefit from the polycap? As the location of the study suggests, this treatment is being targeted at the poorer nations of the world where the alternative is no treatment at all.
It is simple, affordable and, TIPS suggests, safe. People with a single risk factor will receive a broad treatment of all the risk factors and that makes good sense. This is a population treatment and not an individual treatment strategy.
But is it a suitable treatment for people in the UK? I would argue that, while the single capsule would improve compliance, it is too simple for a nation with an established, more sophisticated scheme of medication.
Any medication should offer benefit that exceeds risk, not something universally true of aspirin, which is why we mainly target the over 50s with pre-existing cardiovascular disease.
Taking the other component medications in turn, atenolol has been shown to benefit people with IHD but its benefit in uncomplicated hypertension is in doubt.
Simvastatin is of proven benefit but there are advantages to a dosage of 40mg rather than the 20mg found in the polycap, and in 2011/12 atorvastatin comes off patent - would we change the polycap composition then?
Is ramipril 5mg the best ACE inhibitor and is it the appropriate dosage? Losartan comes off patent in 2010/11; with its lower side-effect profile would this be a better choice in a combination capsule?
The polycap also presents difficulties with monitoring side-effects. Fifteen per cent of people in TIPS discontinued their treatment, many, but not all, because of side-effects. The obvious problem is that if a patient has side-effects we will not know which drug was responsible.
Are we going to adopt a fire and forget approach with this treatment or will doctors and patients want to know what is happening to their BP and cholesterol levels? In a medical system that already offers tailored therapy and follow-up measurement, would the polycap be a step backwards?
Some people might prefer a single capsule for its simplicity and because of the psychological benefit of not relying on so many pills to stay alive.
It would seem reasonable to make this option available to them but the idea that we would introduce it as a population treatment measure is a different proposition. It would make some doctors' lives simpler, but that alone is not an argument for using the polycap.
If the technology were available, it would certainly be desirable that an individual on a stable mix of treatments could have a single capsule produced for them - but that is a very different concept economically.
Is there a polycap I would find useful in my own practice in the UK? If I had a choice of several different mixes to prescribe, I might be more interested.
Firstly, I would want the best dosages of the most recently introduced generic drugs; in 2012 I would want it to be atorvastatin 40mg. Also I would need to have formulations that were light on aspirin or beta-blockers.
In fact, such drugs are already available, with newer formulations not far away in the form of fixed dosage combinations of two or three cardiovascular drugs.
A recent study, similar to TIPS, has shown the efficacy and safety of using different dosage combinations of atorvastatin and amlodipine, the latter a low-price generic already and the former soon to follow.2
Such a medication would target the most important areas of prevention, BP and cholesterol lowering, but using newer, more efficacious drugs.
The polycap is to be welcomed as an affordable treatment strategy with simple medical intervention for parts of the world where there is no treatment for many people. This does not have the same benefits in the parts of the world where sophisticated, tailored therapy is already in place.
- Dr McCormack is a GP in Whitby, North Yorkshire and an editor of the British Journal of Cardiology
- Declaration of interest: none
1. The Indian Polycap Study (TIPS). Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular (TIPS): a phase II, double-blind, randomised trial. Lancet 2009; 373: 1,341-51.
2. Hobbs F D R, Gensini G, Mancini G B J et al, for the JEWEL Study Group. International open-label studies to assess the efficacy and safety of single-pill amlodipine/atorvastatin in attaining blood pressure and lipid targets recommended by country-specific guidelines. Eur J Cardiovasc Prev Rehab 2009; online ahead of print.