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) </=90mm Hg] on atenolol 50mg daily, while 13% (30.23%) had normal blood pressure (DBP </=90mm Hg) on perindopril 4mg daily (p = 0.013). In the ITT group the sitting systolic blood pressure (SBP) decreased by 14.4 +/- 22.3mm Hg at the end of the treatment period on atenolol from 174.4 +/- 17.9mm Hg at the initial period, and the sitting SBP decreased by 21.6 +/- 20.3mm Hg at the end of perindopril treatment from an initial value of 172.1 +/- 20.3mm Hg (probability 0.091). The sitting DBP decreased by 18.6 +/- 8.7mm Hg on atenolol from 100.5 +/- 4.8mm Hg at the initial period and by 15.8 +/- 9.1mm Hg on perindopril from 100.6 +/- 5.2mm Hg (probability 0.112). Glycaemic control was similar for HbA(1C) fasting and postprandial glucose in the ITT population, while fasting glucose increased over time from 10.7 +/- 4.1 to 12.0 +/- 3.4 mmol/L; p < 0.001 in the PP population in the atenolol group.
CONCLUSIONS: The percentage of normalised patients (sitting DBP </=90mm Hg) was similar in both groups. Patients on perindopril monotherapy required more additional antihypertensive drugs compared with atenolol monotherapy. There was a significant increase in fasting blood sugar in the atenolol-based group (p < 0.001).

RCT Entities:   Population Interventions Outcomes