It has taken almost a decade for this concept to gain interest, but on September 11, 2014 an FDA panel debated on the pills potential uses. Although no conclusive decision was made during the debate, experts mostly discussed its uses as secondary prevention for patients who’ve had heart attacks and/or strokes and are unlikely to be closely monitored by a physician. The prevailing view was that the polypill was not better than standard care or meant to replace standard care and its uses were mostly concentrated on its potential ability to improve adherence. Currently there are number of clinical trials including TIPS-3, HOPE-3, and Poly-Iran, assessing the viability of the polypill for the reduction of cardiovascular outcomes.
The International Polycap Study 3 (TIPS-3) is a randomized double-blind placebo-controlled trial for the evaluation of a polycap (hydrochlorothiazide 25mg, atenolol 100mg, ramipril 10mg, simvastatin 40mg), low dose aspirin and vitamin D supplementation in primary prevention. In the HOPE-3 trial the investigators will evaluate whether a polypill containing rosuvastatin, and a combination of candesartan or hydrochlorothiazide, used alone or together can reduce the risk of heart attacks, stroke and their sequelae in people without known heart disease and at average risk. Lastly, the Poly-Iran study is set up to determine the effects of a polypill tablet (aspirin 81 mg, enalapril 5 mg (or valsartan 40 mg), atorvastatin 20 mg and hydrochlorothiazide 12.5 mg taken once daily) on primary and secondary prevention of cardiovascular disease in Iranian adults older than 50.
Until proven effective by such studies, the polypill is still only in its concept stages. In a society where we try to treat every patient as an individual, I believe the polypill isn’t a good option. It would be difficult to standardize combinations of medications and their dosage strengths in a single tablet to meet the individual needs of every patient. Another problem arises with physician's prescribing habits. They might over utilize the polypill and such practices will certainly compromise individualized healthcare. On the other hand, in situations such as third world countries where healthcare isn’t easily accessible and medication isn't affordable, the polypill might be beneficial to such targeted populations. Therefore, I think the polypill would only be a candidate for population focused healthcare.
Click on these links for more information on the polypill.
Posted by Jonathan Tang, PharmD. Candidate 2015