Single-Pill Triple Drug Combination Of Perindopril, Indapami
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Hypertension is the biggest contributor to global burden of disease and mortality. Increasing compliance with antihypertensive treatment and achieving a wide BP control in the population represents a major challenge for clinical practice. The benefits of single pill combination versus free-equivalent combination has been demonstrated in several meta-analyses and is now strongly supported by the latest 2018 ESC/ESH guidelines. The RAAS blocker with CCB and thiazide like diuretic is proposed as the optimal combination in patients inadequately controlled by two drugs.

This study aimed to assess the blood pressure control rate, safety, tolerability and quality of life with triple-drug SPC in patients with grade II/ III hypertension.

Hypertensive patients uncontrolled (BP ? 140/90 mmHg) on two-drug therapy were recruited in an open-label, phase III clinical trial conducted in outpatient setting in India with 6 months treatment period. No other antihypertensive medication except the study medication was received by the patients.

246 patients were screened, 241 (ITT) recruited and 218 (PP) patients completed the study as per the protocol. The patients recruited were of both sexes with the age group of 24-64 years with hypertension history of at least 3 or more years with inadequate control of hypertension on two-drug treatment. The 2 drug combination treatments consisted of various permutations and combinations between Calcium Channel Blockers (CCB), Angiotension-1 Receptor blockers (AT1RB), Angiotensin Converting Enzyme (ACE) inhibitors and/or diuretics (DU) as a single pill or free combination. From inclusion visit patients received only the triple drug study medication (SPC) for the treatment of hypertension.

-- Highly significant and gradual BP reduction was observed in all patients from the baseline to the end of study in both ITT (SBP/DBP -28.12/ -13.21 mm Hg respectively) and PPS (-28.47 / -13.8 mm Hg DBP) groups and was comparable.

-- After 15 days treatment with study medication (visit 2 ) already 60% of patients had achieved target BP of 140/90 mm Hg or lower and almost 90% were controlled after 2 months of treatment (day 60).

-- The sustaining effect on the BP reduction was maintained from month 3 (day 90) onwards until the end of the study in both the ITT and PP groups.

-- After 3 months of treatment, 204/218 patients from PP group (94%) achieved target BP demonstrating uniform efficacy of the study medication.

-- Patients with diabetes mellitus (n=49) also achieved the target BP at the end of study. (BP reduction below 130/85 mm Hg) After the Up- titration performed in 19 patients at different visits all of them achieved the target BP control.

Conclusively, this study showed the clinical efficacy, safety and acceptability of the perindopril/indapamide/amlodipine SPC in patients with grade 2/3 hypertension inadequately controlled with two-drug therapy. The clinical effectiveness was observed in more than 96 % patients. The benefit of single-pill combination (SPC) therapy in hypertension control was reconfirmed in this study.