"Polypill" For Heart Passes Big Test

One Pill Combines Blood Pressure, Cholesterol Medicines To Combat Heart Disease And Strokes

(AP)  A single daily pill that combines aspirin and four blood pressure and cholesterol medicines has passed its first big test, potentially offering a cheap, simple way to prevent both heart disease and stroke.

The experimental “polypill” proved as effective as nearly all of its components taken alone, with no greater side effects, a major study found. Taking it could cut a person's risk of heart disease and stroke roughly in half, the study concludes.

This “one-size-fits-most” approach could make heart disease prevention much more common and effective, doctors say.

“Widely applied, this could have profound implications,” said Dr. Robert Harrington, an American College of Cardiology spokesman and chief of Duke University's heart research institute. “President Obama is trying to offer the greatest care to the greatest number. This very much fits in with that.”

The polypill also has big psychological advantages, said Dr. James Stein of the University of Wisconsin-Madison.

“If you take any medicines, you know that every pill you see in your hand makes you feel five years older. Patients really object to pill burden,” and respond by skipping doses, he said.

The study was led by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, and Dr. Prem Pais of St. John's Medical College, Bangalore, India. Results were presented Monday at the cardiology college's conference in Florida and published online by the British medical journal Lancet.

The study tested the Polycap, an experimental combo formulated by Cadila Pharmaceuticals of Ahmedabad, India. It contains low doses of three blood pressure medicines (atenolol, ramipril and the “water pill” thiazide), plus the generic version of the cholesterol-lowering statin drug Zocor, and a baby aspirin (100 milligrams).

Participants were about 2,000 people at 50 centers across India, average age 54, with at least one risk factor for heart disease - high blood pressure, high cholesterol, obesity, diabetes or smoking.

Four hundred were given the polypill. The rest were placed in eight groups of 200 and given individual components of the pill or various combinations. Treatment lasted 12 weeks.

Compared to groups given no blood pressure medicines, the polypill lowered systolic blood pressure (the top number) by more than 7 units and diastolic (bottom number) by about 6 - comparable to levels for people given the three drugs without aspirin and the cholesterol drug.

LDL, or bad cholesterol, dropped 23 percent on the polypill versus 28 percent in those taking the statin drug separately. Triglycerides dropped 10 percent on the combo pill versus 20 percent with individual statin use. Neither pill affected levels of HDL, or good cholesterol.

Anti-clotting effects seemed the same with the polypill as with aspirin alone.

Side effect rates also were the same for the polypill as for the five separate medicines.

“That was a big surprise. I would have expected five times the number of people to have side effects,” said Dr. Christopher Cannon, a cardiologist at Harvard-affiliated Brigham and Women's Hospital in Boston who had no role in the study.

Collectively, the results show the polypill could cut the risk of heart disease by 62 percent and the risk of stroke by 48 percent, based on what previous studies show from lowering risk factors by these amounts, the study concludes.

Polycap's maker sponsored the study, and Yusuf has been a paid speaker for several makers of heart drugs. No price for the polypill is available, but its generic components cost only $17 a month, Cannon said.

A bigger study is now needed to see whether the polypill actually does cut heart attacks and strokes, he wrote in a commentary in the medical journal.

“It won't be for everybody,” he said. Some people would be overtreated by getting medicines for conditions they don't yet have, such as high cholesterol. Others may be undertreated by too-low doses in the combo pill. Several polypills of different strengths may be needed, Cannon said.

“We have to be cautious about assuming that one size fits all,” Stein said. “Treating risk factors is a lot like cooking - the ingredients count.”

A polypill also would need federal Food and Drug Administration approval, even though all of its components have long been sold separately. The dosing issue could become a regulatory nightmare, Cannon warned.

“A final challenge: would the availability of a single magic bullet for the prevention of heart disease lead people to abandon exercise and appropriate diet?” he wrote in the medical journal.

That could make the risk of heart disease worse, and undo the good of the drug, Cannon said.

[jleb956]

If the Polycap works, it would be great. However, some healthy criticism is in order. Are we to trust a trial funded by the maker of the pill? Do the benefits outweigh the risks? No treatment is risk-free. Would the Polycap be patented? Competitors would be able to modify the dose of one medication and thus have a "new" pill. Personally, I would rather take five properly-dosed medications over a "one size fits all" pill. (Note that five medications in the same categories are now available at Walmart for less than $17/month) Finally, medications should be used along with, rather than instead of, a healthy lifestyle.

[tkjtkj]

'Combination drugs' tend to gaurantee one thing: that one or all of the drugs it contains will be in an improper dose.
One's optimal dose of one drug is not the simple ratio that the manufacturer decides to define it to be.
Also, 'baby aspirin' is 82mg, not 100, and might be decided by a practicioner to be given every other day: the effects of aspirin on blood platelets endures for perhaps 2 weeks ... A doctor should decide what the patient needs, not any drug company!

There seems to be no end to the people that will stand in line and pay for the newest scams of Big Pharma. "No Greater Side Effects" is their claim. What a joke. "Cholesterol is the Scam of the Century" and now they follow it up with this. Who thought of taking a synthetic drug laced with side effects as a health preventive? Big Pharma greed has no end. Posted by Baileyccc

[timothyww]

if you use the same amount of each drug how could the outcome differ by combining them??
Many times I've counted the pills in my hand and thought "I must be nearly dead to be taking all these pills". Glad to have a new perspective on the matter.

[brainteaser2]

txlakeside: Sorry your logic of 4 generics = a generic is not true. It is a common big pharma scheme to take two drugs that are going to go generic put them together and obtain a copy right on the "new" drug. Take caduet for example.

[smoknmirrors]

One drug produces a 20% drop while the Big Pill drops 10%. Another drug produces a 28% drop while the BIg Pill bottoms at 23%. Everything else is even. No wait, Big Pill wins! That choice doesn't even start to make any sense. Unless you have something more important to do with your time than take medications that produce better results. Frankly, I'm not in a big enough hurry to pass up a drug that DOUBLES my chances or one that gives me an additional 20% chance of survival. But then, to each his own. Still, before you fill out your dance card with all the extra time you plan to have, you might want to ask where are the %s on heart disease risk and stroke risk for 1500 of the 2000 participants? These do not exist in this article. Wonder why?

Before spending your savings on the Big One all in one place, please consider that rarely are we offered a 5 in 1 pill that doesn't cost at least as much as the five independently. If the generics in the Big One cost $17, somebody will charge for putting them together, somebody else will charge for thinking of putting them together, someone will charge for putting them all together in a pill form and someone will charge for thinking of putting them all together in a pill form.

Finally, where is the caveat that "fat fighting" drugs have a negative effect on the myelin surrounding the brain?

[estabwary]

Polycap's maker sponsored the study, and Yusuf has been a paid speaker
for several makers of heart drugs.

well there ya go--all you really need to know.

[txlakeside]

Many comments are just dumb as dirt! Did any of the nay sayers even read " offering a cheap, simple way to prevent both heart disease and stroke." All four are generic so a formulary or combo is still "Generic". The insurance Co's would love it as it would wean folks from the more expensive "brand name" non generic drugs. Contrary to many "dumb as dirt comments" insurance makes money by offering you cheaper service not more expensive! Some folks have to complain just for the sake of complaint!

[dafmyturn]

Gee, just think what they can charge of a thirty day supply!! $500 for 30? I am sure it will be like most medicine with terrible side affects!

[barbaraf4]

"The insurance companies will definitely battle it because they will lose money on the
number of claims submitted to them by medical and cardiology practitioners "
~~~~~~~~~~~~~~~~
That is not how it will happen. They will simply charge $5,000 per dose.

The pharmaceutical companies (and the insurance companies who own them) are all crooks. I am a cardiac patient. Merck Medco (from whom I have to order my prescriptions) let a drug slip through that would cause a serious interaction with another I was taking. I caught this and called their pharmacists. After a lot of screaming on both sides (Sorry, I thought I was the customer and they were "service" - not true. They were too busy trying to cover their own but*ts) I now have to go back and round up new, hardcopy prescriptions so they will fill my prescriptions. I'm going to see how many I can offload at Walgreens or Walmart for $4.00.

Between cost and inconvenience, I can see how people stop taking their meds.