Here it comes… the first cardiovascular polypill

Those suffering from cardiovascular disorder know what a drag it is to swallow multiple pills each day. A pill for hypertension, another for managing cholesterol levels, another for preventing blood clotting. For many patients, especially the elderly, keeping tract of all these medications can present a challenge.

Now, at last, somebody has the idea to create a polypill – a pill containing several drugs. The brains behind the polypill (called Polycap) is the Indian company Cadila Pharmaceuticals. Polycap is a 5-in-1 pill containing three antihypertensive drugs, a statin and aspirin. Polycap has been tested in a phase 2 clinical trial (The Indian Polypill Study [TIPS]) and the data, published in the latest issue of the Lancet, look very promising.

The TIPS trial was a double-blind study [which] enrolled 2053 patients aged 45 to 80 years without cardiovascular disease but with one risk factor-type 2 diabetes, high blood pressure, smoker within past five years, increased waist-to-hip ratio, or abnormal lipids-at 50 centers in India. They were randomly assigned to one of nine groups for 12 weeks: 412 received Polycap, with hydrochlorothiazide 12.5 mg, atenolol 50 mg, ramipril 5 mg, simvastatin 20 mg and aspirin 100 mg. The remainder were assigned to eight other groups, with around 200 patients in each, including the same doses of aspirin alone, simvastatin alone, hydrochlorothiazide alone, three combinations of two BP-lowering drugs, three BP-lowering drugs alone, and an arm with three BP-lowering drugs plus aspirin. All participants were also counseled on appropriate lifestyle modification.

The results showed:

• Polycap successfully lowered blood pressure by on average, 7 mm Hg systolic.
• Polycap also successfully lowered heart rate.
• No interactions were observed between the drugs contained in the polypill.
• The degree of cholesterol lowering by Polycap was slightly less than in patients who got simvastatin alone.
• The adverse effects in all treatment groups were similar.

According to a commentary by Dr. Christopher Cannon of Brigham and Women’s Hospital, Boston, MA

The concept is simple. Several different drugs are available (generically and thus inexpensively) to treat many of the cardiac risk factors. So, combining them in one pill could reduce heart disease by 80%. This approach has obvious appeal, and vast implications for global health, because heart disease is the leading cause of death worldwide. The Indian Polycap Study (TIPS), reported in The Lancet today, moves us one step closer to realising this dream.

It would be interesting to know how the big pharmaceutical companies feel about this latest development. Cardiovascular drugs are among the blockbusters of many of these companies, earning billions of dollars in revenues annually. Last December, the big pharma firms were dealt with a major blow when experts declared that generic heart drugs were just as good brand name drugs. If approved for marketing, the polypill will most likely cut into the sales of these drugs.

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