Blood-pressure Lowering Efficacy and Safety of Perindopril / Indapamide / Amlodipine Single-pill Combination in Hypertensive Patients: Phase III Trial in India.

BACKGROUND: 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. OBJECTIVE: To assess the blood pressure control rate, safety, tolerability and quality of life with triple-drug SPC in patients with grade II/ III hypertension. METHODS: 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. RESULTS: Out of 218 evaluable patients the observed average blood pressure reduction achieved from baseline to end of study at 6 months was Systolic Blood Pressure (SBP) 28.5 mm Hg / Diastolic Blood Pressure (DBP) 13.8 mm Hg. The quality of life (QoL) questionnaire demonstrated improvement in QoL for all patients. CONCLUSION: 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.

Evaluation of Clinical Acceptability of Perindopril / Indapamide Single-pill Combination in Moderate to Severe Hypertension.

BACKGROUND: Current European hypertension guidelines recommend to initiate the treatment of patients with moderate to severe hypertension with a Single Pill Combination (SPC) containing two drugs, as SPC use leads to more effective and faster blood pressure control. The guidelines also recommend tighter blood pressure control in hypertensive patients with cardiovascular risk factors such as diabetes mellitus. OBJECTIVE: To evaluate efficacy on blood pressure reduction and acceptability of the single pill combination of Perindopril/Indapamide in patients with moderate to severe hypertension. METHODS: In this multicentre, prospective, observational study, patients with moderate to severe hypertension were prescribed Perindopril 4mg/ Indapamide 1.25 mg for 90 days. The primary outcomes were blood pressure decrease and achievement of BP control. Patients were up-titrated to Perindopril 8 mg/Indapamide 2.5 mg SPC, if target BP control (≤140/90 mm Hg) could not be achieved by day 30. RESULTS: In this study, 173 hypertensive patients, with a mean age of 51 years were enrolled at 3 centres from different geographic areas within India. Mean SBP/DBP decreased significantly from baseline (155.70 (±10.39) / 95.72 (±6.99) mmHg) over 90 days (30.31 (±14.15) / 17.14 (±9.33) mmHg; p < 0.0000). Few side effects were reported during the 90-day period. CONCLUSION: : Perindopril/Indapamide given as a SPC was found to be an effective and well-tolerated antihypertensive combination resulting in rapid blood pressure control in patients with moderate to severe hypertension.