Evaluation of Efficacy and Tolerability of Perindopril 8 mg in Bangladeshi Hypertensive Patients: Results from an Open-label, Observational, Multi-center Study (CONTROL).

ABSTRACT

Background: The CONTROL (COversyl in Newly diagnosed stage-II & unconTROlled hypertensive patients triaL) was performed with an objective to evaluate the blood pressure (BP) lowering efficacy and tolerability of Perindopril 8mg in newly diagnosed stage II patients and uncontrolled hypertensive patients among Bangladeshi population. Methods: This was an open-label, observational, multi-center study conducted in consultation centers for out-patients located in different cities of Bangladesh. Adults, aged above 18 years with newly diagnosed stage-II hypertension or uncontrolled hypertension, were recruited. Patients were treated with Perindopril 4mg daily for first 1 week, afterwards uptitrated to Perindopril 8 mg daily and continued treatment for 12 weeks. Patients were followed-up at week-1, week-4, week-8 and week-12. Results: In total, 245 patients were enrolled. Among them, 88 were newly diagnosed stage-II (Group- I) and 157 were uncontrolled (Group-II) hypertensive patients. Male and female distribution was 57% and 43% respectively. Mean age of patients was 54.5 ±11.7 years. After 12 weeks treatment, there was a significant reduction in BP from baseline (p<0.001) in overall population as well as in Group I and in Group II. In overall population, the mean BP reduction was -31/-15 mmHg (from 163.7/96.8 mmHg to 132.4/81.7 mmHg. In Group I, the reduction was -33/-16 mmHg (from 166.5/98.2 mmHg to 133.4/82.0 mmHg) and in Group II, -30/-14 mmHg (from 159.3/ 95.6 mmHg to 129.1/81.6 mmHg). 10 patients (4.1%) had to discontinue the treatment due to adverse effects. Dry cough (2%) and hypotension (1.2%) were the main cause of discontinuation. Perindopril 8mg was well tolerated as indicated by the high proportion of physicians (81%) reporting ‘good’ to ‘excellent’ tolerability at week 12. Conclusion: This study suggests that Perindopril 8mg is effective and safe in the treatment of hypertension in Bangladeshi patients.