FDA Approves Triple-Drug Antihypertensive Polypill – Should you consider a polypill?

Hidden behind all of the Swine flu news stories is this one – which I feel is significantly more important when it comes to public health. The FDA just gave its official thumbs-up to an antihypertensive polypill. Could this pave the way for a preventive medicine polypill? And, should you consider taking a polypill?

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In an earlier blog of mine, Study indicates inexpensive polypill pill may significantly reduce risk of heart attack and stroke. Should you consider it?, I told you about the dramatic studies showing that a “polypill” containing five medications sharply reduced the risk of heart attack and stroke in those who took it, potentially offering an inexpensive way to save millions of lives

Now, the FDA has just approved an antihypertensive “polypill,” Exforge HCT. The new product contains three antihypertensive drugs: the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan, and the diuretic hydrochlorothiazide.

Unfortunately, the FDA approved Exforge HCT only for treatment of hypertension, it was not approved as initial therapy or preventive therapy. (This is not the FDA’s fault, as the company did not test it as a preventive medicine).

So, the FDA approval is only for Exforge HCT to be substituted for patients already on all three individual drugs, or used as add-on or switch therapy for patients not adequately controlled on any two of its component drug classes.

Novartis Pharmaceuticals Corp. of East Hanover, N.J., which is marketing the polypill, said it plans to offer Exforge HCT at the same price as its dual drug combination, Exforge (amlodipine and valsartan), which can cost from $85 to $120 per month (in dose options ranging from 5-mg amlodipine/160-mg valsartan/12.5-mg hydrochlorothiazide to a maximum of 10/320/25).

However, this is a VERY expensive option (although, as the company points out, “in addition to once-daily convenience, this new combination may offer patients potential cost-savings by reducing insurance copays.”) Nevertheless, there’s no way most folks would consider this type of expense for a preventive medicine.

As I told you in my earlier blog, the five-drug polypill was the big focus of attention at the American College of Cardiology meeting in March. Researchers there reported that combining three antihypertensives, a statin, and aspirin in a single capsule achieved the same benefit as giving the drugs individually.
Specifically, “the experimental five-drug combination proved about as safe and effective as each drug given alone,” and “cut a patient’s risk of heart attack by 62 percent and stroke by 48 percent.” WOW!!! 

However, leading cardiologists doubted that a large and expensive trial would be mounted in the U.S. to meet FDA requirements and demonstrate the superiority of the five-drug polypill over various combinations of its ingredients.

Still, some see this FDA approval of a three-drug combination as a step in the polypill direction.

In the meantime, if you wanted the possible preventive benefits of the 5-drug polypill, you’d have to take this combination:

  • thiazide (12.5 mg, a diuretic [fluid pill] that is used to treat high blood pressure), 
  • atenolol (50 mg, a beta-blocker that is used to treat high blood pressure), 
  • ramipril (5 mg, an ACE inhibitor that is used to treat high blood pressure), 
  • simvastatin (20 mg, a statin that is used to treat high cholesterol), and 
  • low-dose aspirin (100 mg).

This combination could cost about  $113 per month ($7, $18, $55, $30, $3, respectively, for each component).

But, a couple of simple substitutions could dramatically lower the cost:

  • thiazide (12.5 mg, a diuretic [fluid pill] that is used to treat high blood pressure), 
  • atenolol (50 mg, a beta-blocker that is used to treat high blood pressure), 
  • lisinopril (5 mg, another ACE inhibitor that is used to treat high blood pressure), 
  • lovaastatin (20 mg, another statin that is used to treat high cholesterol), and 
  • low-dose aspirin (100 mg).

This combination (at Walmart, Walgreens, Kmart, Target, or other stores offering these generic medications at $4 per month or $10 per three months), purchased in 90-day increments, could cost less than $15 per month.

Now, there’s absolutely no proof (yet) that it would work as well as the experimental polypill, but if I had to guess, my guess is that it would.

Of course, you need to discuss this preventive medicine option with your family physician. But, given the current data, if you were at significant risk for heart attack and stroke, I think it’s worthy of consideration.

 

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