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.
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.
Before the study is made public, one should have asked the principle investigation authorities to answer few question which are missing in the study and like all Indian researches created doubt. # how many deaths occurred while under trail. # how many drop outs in the study for want of any factor. # does doctors were not using these drugs before the magic pill. # any cross check of subjects studied for their reliability - does they in actual exists. # How much money paid to the subjects who offered their living body to trail. # any amount insured for donating living body for study and does that amount paid to dead if any. # Why the public institutions are less in number to private institutions offering study. The data is missing from the tables of the published study and enforce any researcher to think a hypothetical study. Many more questions are to be asked and I wounder how a journal like India today accepted and made the study public.
ReplyDeleteRIPUDAMAN SINGH
134-S, SANT NAGAR, PATIALA
ripu134@gmail.com