xxx
xxx
xxx

 

 
  xxxx
Polypill – A good idea? (Published June 30, 2003)

A single pill containing six medications, each of which has been touted as effective in the treatment of heart and blood vessel disease, has been proposed by some British scientists as an effective strategy to treat patients. The fundamental concept of providing patients with cardiovascular disease with a targeted pharmacologic intervention to reduce their risk of a cardiovascular event is of course very sound and makes perfect sense. Or does it?

When each component of this “polypill” is evaluated in isolation, their respective benefit for specific indications are generally clear. Indeed, the evidence base for reduction of cardiovascular events including heart attack, stroke and heart failure is particularly strong for ACE inhibitors, beta-blockers and diuretics. The statins have clearly shown benefit in reduction of heart attacks and strokes. Aspirin has long been a mainstay as an antiplatelet drug to reduce the risk of a second heart attack or stroke. Only folic acid has a weak body of evidence to show a causal relationship between reduction in homocysteine levels and cardiovascular events. But it is empirically being utilized since it is inexpensive and not fraught with significant adverse effects.

So rhetorically, does the use of such a polypill have a role in prevention strategies? In a limited sense, I would say yes. But in the broader sense, I would have major reservations for the following reasons.

Many of my patients have complex medical histories and multiple diagnoses of active problems that require intervention. Superficially, they would seem to be ideal candidates for this polypill. But my patients know that I have certain rules that I try and stand by when starting treatment programs. An extremely important rule is that I try to make only one addition or one change at a time. We all know that all medications have the potential for serious adverse effects that can even be life threatening. I often remind patients that aspirin is potentially one of the most dangerous medications they take, yet most think nothing of it.

If a doctor starts treatment with two theoretically beneficial drugs at the same time, and the patient shortly thereafter stops breathing and is barely resuscitated, I submit it would be a brave patient and a foolish doctor to rechallenge that patient with either drug separately. This could potentially relegate the patient to second line treatments that may not work as well as the first line treatments because of the real concern of causing the serious adverse effect again.

Now let us say that instead of two medications, the doctor starts with six. And they are your best six drugs, just as defined above. If a serious side effect occurs, there could be quite a quandary sorting out the culprit out of six suspects. This problem is magnified if the patient desperately needs treatment.

Of course we do have combination pills in use today, most commonly for the treatment of high blood pressure or high blood fats and most recently, a pill to treat both high cholesterol and high blood pressure with a single combination of two agents. The Ventura Heart Institute has been part of the development research team that validated the utility of several combination pills. The difference here is that each component treatment was tried separately first for safety and efficacy, and the combination used only when combined benefit was validated. The economic benefit of having only one co-pay instead of two, and patient benefit of being able to use lower doses of each agent to minimize dose related side effects are also tangible reasons to use combinations. Essentially all of these combinations come in varying dosage formulations in order to tailor the therapy to the patient. Indeed, exciting gene markers looking at liver enzyme systems are being developed to help doctors know which patient will respond best to which medications with the least risk of adverse effects.

A single polypill runs the risk of creating unattributable side effects, giving patients potent medications they may not need, and underdosing them with medications that they may actually need. It would be a simultaneously extremely unlucky and lucky patient to have all the bad conditions treatable by the perfect dosing of these six medications in one polypill. I do not think that I will be recommending my patients take this pill for prevention unless each agent was tried individually first and that potential drug interactions in my patient's liver enzyme systems were ruled out first.

 

 
   
   

© 2003 Ventura Heart Institure.  All rights reserved.  Minimum requirements:  Microsoft Internet Explorer 5.5 or Netscape Communicator 4.7.  For optimal use of the site, download Adobe Acrobat Reader and either Windows Media Player or RealPlayer G2.  AOL users should use AOL 5.0 and AOL Plus for optimal usage.  Technical questions about our Web site?  Please send e-mail to info@venturaheart.com.