Polycap

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Polycap is a specific five-in-one fixed dose combination polypill created by Cadila Pharmaceuticals Limited of Ahmedabad, India that combines moderate levels of five different medications in a single, one-a-day pill aimed at reducing/preventing heart attacks and strokes. Polycap containing three generic blood pressure medications and a statin dramatically reduces the risk of heart-related illness in people with no prior history of heart problems, according to the results of a recent clinical trial presented at the American Heart Association's Scientific Sessions 2020. This result comes as part of the International Polycap Study (TIPS)-3, a randomized, placebo-controlled trial to test the effectiveness of this fixed-dose combination therapy. The study investigators also examined the impact of aspirin alone and in combination with the polypill. When taken on its own, Polycap reduces by 20% the risk of heart attack, stroke, procedures to reopen clogged arteries and other heart disease, the researchers reported. The Polycap combined with daily low-dose aspirin is even more effective, reducing heart health problems by up to 40%. The study results were published online in The New England Journal of Medicine.…

Polycap is a specific five-in-one fixed dose combination polypill created by Cadila Pharmaceuticals Limited of Ahmedabad, India that combines moderate levels of five different medications in a single, one-a-day pill aimed at reducing/preventing heart attacks and strokes. Polycap containing three generic blood pressure medications and a statin dramatically reduces the risk of heart-related illness in people with no prior history of heart problems, according to the results of a recent clinical trial presented at the American Heart Association's Scientific Sessions 2020. This result comes as part of the International Polycap Study (TIPS)-3, a randomized, placebo-controlled trial to test the effectiveness of this fixed-dose combination therapy. The study investigators also examined the impact of aspirin alone and in combination with the polypill. When taken on its own, Polycap reduces by 20% the risk of heart attack, stroke, procedures to reopen clogged arteries and other heart disease, the researchers reported. The Polycap combined with daily low-dose aspirin is even more effective, reducing heart health problems by up to 40%. The study results were published online in The New England Journal of Medicine. Polycap combines 100 milligrams of aspirin, with simvastatin (a generic version of Zocor, the cholesterol-lowering statin; 20 mg) and low doses of three blood pressure medications, beta blocker atenolol (50 mg), ACE inhibitor ramipril (5 mg) and diuretic hydrochlorothiazide (12.5 mg). And despite containing multiple drugs, the pill has a fairly small size which can facilitate swallowing. ==Polycap PK Study== The Polycap (Cadila) has been found to be safe and effective for reducing multiple cardiovascular risk factors. Bioavailability of each component of PolycapTM and absence of their mutual interaction relative to single component reference formulations have been evaluated by a group of scientists led by Dr. Bhaswat Chakraborty. Bioavailability of the components of the Polycap (aspirin, ramipril, simvastatin, atenolol and hydrochlorothiazide) when formulated as a single capsule was compared to identical capsules with each of its components administered separately in a five arm, randomized, single-dose, two-period, two-treatment, two-sequence, crossover trial with at least 2 week washout period in a total of 195 healthy humans. Plasma concentrations of each drug and where applicable its active metabolite were measured using validated LC-MS/MS and UPLC. Mean pharmacokinetic parameters and their standard deviations were computed for each analyte. Comparative bioavailability and absence of drug-drug interaction for each component were computed based on a point estimate of test/reference (T/R) ratio of geometric means falling within 80-125% for Cmax, AUC0-t and AUC0-∞. The ratio of Cmax, AUC0-t and AUC0-∞ for Polycap and reference drugs was within 80-125% for atenolol, hydrochlorothiazide, ramipril, ramiprilat and dose normalized salicylic acid. However, for simvastatin the point estimate of Cmax, AUC0-t and AUC0-∞ for Ln-transformed data were significantly lower (~25%) and for its active metabolite, simvastatin acid, it was significantly higher (~60%). Thus, the increased bioavailability of active simvastatin acid compensated for the loss of bioavailability of simvastatin alone. There was no indication of kinetic drug-drug interaction in any of components. ==References== ==Sources==

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