Monday, April 20, 2009

Polycap (thiazide, atenolol, ramipril, simvastatin, aspirin) reduces cardiovascular risk

The Polypill concept was mentioned by Dr. Salim Yusuf in an editorial in The Lancet in 2002. In a 2003 article in the BMJ, Wald and Law proposed the concept of a polypill combining 6 medications that have been used for decades to treat cardiovascular disease:

- 3 blood-pressure-lowering drugs at low doses - diuretic, atenolol, enalapril
- statin
- aspirin
- folic acid

A Polypill could reduce cardiovascular events by more than 80% in healthy individuals. In this study the authors changed the forumalation by removing folate and examined the effect of the now-called "Polycap" combination on blood pressure, lipids, heart rate, and urinary thromboxane B2, and assessed its tolerability.

The double-blind trial in 50 centers in India inlcluded 2053 individuals without cardiovascular disease, aged 45—80 years, and with one cardiovascular risk factor.

The Polycap consisted of low daily doses of:

- thiazide (12·5 mg)
- atenolol (50 mg)
- ramipril (5 mg)
- simvastatin (20 mg)
- aspirin (100 mg)

The other 8 treatment groups included:, aspirin alone, simvastatin alone, hydrochlorthiazide alone, three combinations of the two blood-pressure-lowering drugs, three blood-pressure-lowering drugs alone, or three blood-pressure-lowering drugs plus aspirin.

Blood Pressure

Compared with groups not receiving blood-pressure-lowering drugs, the Polycap reduced systolic blood pressure by 7·4 mm Hg and diastolic blood pressure by 5·6 mm Hg (4·7—6·4). This reduction was similar when three blood-pressure-lowering drugs were used.

Cholesterol

Cholesterol. Image source: Wikipedia, public domain.

Polycap reduced LDL cholesterol by 0·70 mmol/L, which was less than that with simvastatin alone (0·83 mmol/L).

Heart rate

The reductions in heart rate with Polycap and other groups using atenolol were similar (7·0 beats per min).

Urinary thromboxane B2


Thromboxane B2. Image source: Wikipedia, public domain.

The reductions in 11-dehydrothromboxane B2 were similar with the Polycap (283·1 ng/mmol creatinine) compared with the three blood-pressure-lowering drugs plus aspirin (350·0 ng/mmol creatinine), and aspirin alone (348·8 ng/mmol creatinine).

The authors concluded that a Polycap formulation could be conveniently used to reduce multiple risk factors and cardiovascular risk.

References:
Effects of a polypill (Polycap) on risk factors in middle-aged individuals without cardiovascular disease (TIPS): a phase II, double-blind, randomised trial. The Indian Polycap Study (TIPS). The Lancet, Volume 373, Issue 9672, Pages 1341 - 1351, 18 April 2009.
Cardiologist: Saying No to the Polypill  http://goo.gl/zjfZH
Polypill, from Wikipedia, the free encyclopedia.
Image source: public domain.

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