Tuesday, March 31, 2009
polypill
'Polypill' promises to bring low cost primary CVD prevention to the masses
30 March 2009
MedWire News: A 'polypill' (Polycap) containing five generic drugs reduced blood pressure and was well tolerated in a large, international, randomized, double-blind study. Results of The Indian Polycap Study (TIPS) were reported at a late-breaking clinical trial session during the 58th Annual Scientific Session of the American College of Cardiology and was published simultaneously online in The Lancet.
“If this pill is shown to be effective, safe and tolerable - and it is - it will make a huge difference in how we treat people for primary prevention. We estimate that the polypill will reduce coronary heart disease by 50% and stroke by 60%,” said Dr. Salim Yusuf (McMaster University, Hamilton, Ontario, Canada). “We estimate that the daily cost of the polypill will be less than a cup of Starbucks coffee,” he added.
Polycap contains generic versions of hydrochlorothiazide, atenolol, ramipril, a statin, and an aspirin and is made by Cadila Pharmaceuticals in India, which sponsored the study but did not participate in data collection or analysis. The study randomized 2053 non-hypertensive participants to Polycap (n=400) or to one of eight other study arms, each with about 200 participants. The other arms included aspirin alone, simvastatin alone, hydrochlorothiazide alone, three combinations of the two blood pressure-lowering drugs (atenolol and ramipril), three blood pressure-lowering drugs alone, and an arm with three blood pressure-lowering drugs plus aspirin.
Subjects were recruited from 50 centers in India between March 5, 2007 and August 5, 2008. Mean age was 54 years and one third of subjects had diabetes. At baseline, mean baseline blood pressure was 134/85 mm Hg, mean cholesterol was 180 mg/dL, mean HDL cholesterol was 44 mg/dL and mean LDL cholesterol was 117 mg/dL.
“Side effect profiles in the different arms of the study were identical. The side effects of one drug tended to counteract another, for example, ACE inhibitors and thiazides counteract each other’s side effects,” Dr. Yusuf told listeners at an official Press Conference.
Compared with groups not receiving blood pressure lowering drugs, the polypill reduced systolic blood pressure by 7.4 mm Hg and diastolic blood pressure by 5.6 mm Hg. A similar reduction was achieved with three blood pressure lowering drugs with or without aspirin, he said.
The reductions in blood pressure increased along with the number of blood pressure lowering drugs, he said. For example, one drug achieved a reduction of -2.2/1.3 mmHg; two drugs, 4.7/3.6 mm Hg; and three drugs, 6.3/4.5 mm Hg.
Dr. Yusuf said that the polypill should be used in people who already take these drugs, such as those with coronary heart disease and stroke. “The bigger question is should high-risk people use it for primary prevention, and I think that is where the field is going. The final question is should we put it in the drinking water. The answer to that is I don’t know, and will withhold judgment for 5 or 10 years,” he said.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009
30 March 2009
MedWire News: A 'polypill' (Polycap) containing five generic drugs reduced blood pressure and was well tolerated in a large, international, randomized, double-blind study. Results of The Indian Polycap Study (TIPS) were reported at a late-breaking clinical trial session during the 58th Annual Scientific Session of the American College of Cardiology and was published simultaneously online in The Lancet.
“If this pill is shown to be effective, safe and tolerable - and it is - it will make a huge difference in how we treat people for primary prevention. We estimate that the polypill will reduce coronary heart disease by 50% and stroke by 60%,” said Dr. Salim Yusuf (McMaster University, Hamilton, Ontario, Canada). “We estimate that the daily cost of the polypill will be less than a cup of Starbucks coffee,” he added.
Polycap contains generic versions of hydrochlorothiazide, atenolol, ramipril, a statin, and an aspirin and is made by Cadila Pharmaceuticals in India, which sponsored the study but did not participate in data collection or analysis. The study randomized 2053 non-hypertensive participants to Polycap (n=400) or to one of eight other study arms, each with about 200 participants. The other arms included aspirin alone, simvastatin alone, hydrochlorothiazide alone, three combinations of the two blood pressure-lowering drugs (atenolol and ramipril), three blood pressure-lowering drugs alone, and an arm with three blood pressure-lowering drugs plus aspirin.
Subjects were recruited from 50 centers in India between March 5, 2007 and August 5, 2008. Mean age was 54 years and one third of subjects had diabetes. At baseline, mean baseline blood pressure was 134/85 mm Hg, mean cholesterol was 180 mg/dL, mean HDL cholesterol was 44 mg/dL and mean LDL cholesterol was 117 mg/dL.
“Side effect profiles in the different arms of the study were identical. The side effects of one drug tended to counteract another, for example, ACE inhibitors and thiazides counteract each other’s side effects,” Dr. Yusuf told listeners at an official Press Conference.
Compared with groups not receiving blood pressure lowering drugs, the polypill reduced systolic blood pressure by 7.4 mm Hg and diastolic blood pressure by 5.6 mm Hg. A similar reduction was achieved with three blood pressure lowering drugs with or without aspirin, he said.
The reductions in blood pressure increased along with the number of blood pressure lowering drugs, he said. For example, one drug achieved a reduction of -2.2/1.3 mmHg; two drugs, 4.7/3.6 mm Hg; and three drugs, 6.3/4.5 mm Hg.
Dr. Yusuf said that the polypill should be used in people who already take these drugs, such as those with coronary heart disease and stroke. “The bigger question is should high-risk people use it for primary prevention, and I think that is where the field is going. The final question is should we put it in the drinking water. The answer to that is I don’t know, and will withhold judgment for 5 or 10 years,” he said.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009
# posted by roodbont @ 12:49 PM 
