The Polypill is Born in India
In 2003 two British professors from the Wolfson Institute of Preventive Medicine in London, proposed a "polypill" containing six ingredients. Now, just 3 1/2 years later, a company in India has begun clinical trials on just such a pill, containing aspirin, the blood pressure (B/P) lowering ACE inhibitor lisinopril, the cholesterol-lowering simvastatin, and the beta-blocker atenolol.This initial trial is utilizing 250 Indian patients who have already had a cardiovascular event. A company spokesman discussing the trial stated that they hoped to gain approval in India for this version of the polypill for secondary prevention on the basis of the results of this trial.
Secondary prevention is the treatment of individuals who have already had an occurrence of a disease and is intended to prevent another disease-related event. The spokesman said, "We believe that we don't need an elaborate outcomes trial for secondary prevention. It is our understanding that as long as there is solid evidence of no drug-drug interaction and that the pill achieves its goals of reducing blood pressure and cholesterol, it will be approved."
To determine the ideal combination for a polypill, the two British professors who introduced the concept several years ago reviewed 750 drug trials (representing 400,000 participants) to identify ingredients that substantially reduced blood pressure and cholesterol. They settled on a potential pill combination of a statin for cholesterol lowering and three blood-pressure-lowering drugs; the latter were potentially a thiazide (diuretic or "water pill"), a beta blocker, and an ACE inhibitor.
They recommended that each of these blood pressure lowering medications be included at half of the standard dose, which would theoretically reduce the chance of side effects from any single drug and increase the opportunity of multiple drugs to have a synergistic effect on blood pressure control. They also planned to add folic acid and aspirin to their version of the pill.
These scientists calculated that their polypill could cut the risk of cardiovascular events by 80% or more and benefit one in three people if everyone over the age of 55 were to take it. Three strengths of the polypill have been developed; trial participants will begin at the lowest dose and be moved up as needed to meet their cholesterol and blood pressure lowering goals. It is designed to be taken as a single dose, once per day. In India the pill will retail for less than $2.00 per month, but it will retail for more in other countries, allowing its costs to be subsidized in India and other low-income countries.
The idea has not been well-received by all. Critics have argued that such a pill would be too large to swallow, there would be adverse effects and drug-drug interactions with medications taken in addition to the poly-pill, and that the pill itself would lull individuals into a false sense of security, causing them to continue to have "risky" lifestyles.
This last statement makes no sense to me. After all, if I just explained to you that since you have already had a heart attack or stroke and I am about to prescribe a pill containing four (four!) medications to control your risks for another such event, would you run right out and eat a salt and cholesterol-laden meal and smoke a pack of cigarettes? I would hope not, and God love you if you do, the pill isn't going to help you one way or another.
If you take one pill containing four medications or the four pills separately, you still have to understand that you have a greater risk of having another event, and having to take any medication should make you realize that your former habits have got to go! I think people are either going to do what they want or not, but the size of the pill isn't going to change that decision.
Personally, I am looking forward to the arrival of this type of combination pill in the US, since I currently prescribe combination meds when I can. They help to increase adherence to a medication plan just because people have fewer pills to take, and overall it costs less out of pocket because an individual has fewer per medication co-pays. I'll be watching for this one to hit our market; how about you?
Laurie
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Technorati Tags: polypill, clinical trial, health-and-wellness, heart disease, cardiovascular, statin, beta-blocker, ACE inhibitor, blood pressure, hypertension
Labels: heart disease, hypertension, medication
