Antihypertensive Effect and Tolerability of Perindopril in Indian Hypertensive and Type 2 Diabetic Patients: 1-Year Randomised, Double-Blind, Parallel Study vs Atenolol.

Objective: This study compared the antihypertensive effect and acceptability of a perindopril-based group with that of an atenolol-based group in Indian hypertensive type 2 (non-insulin-dependent) diabetic patients.

Design And Setting: 100 ambulant patients aged between 35 and 69 years were recruited into this monocentric, randomised, double-blind study in two parallel groups for 1 year after a 1-month washout period on placebo. The setting was a tertiary care institution.

Patients: All patients had stable, essential hypertension between 95mm Hg and 115mm Hg, type 2 diabetes with glycosylated haemoglobin (HbA(1C)) <12%, and albuminuria between 300mg and 3.5g/24 hours. There were 50 patients per treatment group and two patient population groups were studied, intention-to-treat (ITT) and per-protocol (PP). The former constituted all patients, whilst the latter included those without major protocol deviation and who completed the 12-month study.

Interventions: The study drugs were perindopril 4 to 8mg once daily or atenolol 50 to 100mg once daily. In each group therapeutic adjustment was planned by doubling the dose and then by the addition of hydrochlorothiazide 25mg daily. Nifedipine 30 to 60mg daily was subsequently added if the desired drop in blood pressure was not obtained. The ITT group was analysed by Student's t-test, and a 2-way analysis of variance was performed for the PP population.

Main Outcome Measures: A comparison of the control of hypertension, biochemical abnormalities, blood sugar and adverse effects was performed in the atenolol group versus the perindopril group.

Results: On single-dose therapy after 1 month 17 patients (60%) had normal blood pressure [diastolic blood pressure (DBP)
Conclusions: The percentage of normalised patients (sitting DBP