The aim of this study was to compare the efficacy and safety of lercanidipine and amlodipine in the treatment of hypertensive patients with acute cerebral ischemic stroke.
Research design and methods:
An open label, controlled, randomized, parallel-group study was conducted on 104 hypertensive patients (blood pressure [BP]4130/80 mmHg) diagnosed with ischemic stroke. Enrolled subjects were randomly assigned to a 4 week treatment with lercanidipine 20 mg/day or amlodipine 10 mg/day. The treatment was administered during the acute phase of the stroke, either immediately after the diagnosis or during an observation period of maximum 6 days.
Both lercanidipine and amlodipine were able to significantly reduce mean clinical systolic BP (SBP)/diastolic BP (DBP), mean 24 h ambulatory BP and day-time and night-time BP. In particular, mean clinical SBP/DBP was reduced from 168.9 21.6/96.2 13.6 mmHg to 147.1 22.0/87.1 14.0 mmHg in the lercanidipine group (p50.001 for SBP and p50.01 for DBP) and from 167.1 19.9/97.8 14.5 mmHg to 143.3 21.9/82.8 14.1 mmHg in the amlodipine-treated group (p50.001 for both SBP and DBP). No statistical difference was observed between the two treatments in the reduction of clinical BP. The response and normalization rates registered in the two groups of patients were also similar, with no significant difference between the two drugs. In addition, both treatments reported comparable
results in terms of early morning BP surge reduction and BP stabilization, measured through trough–peak ratio and smoothness index. However lercanidipine showed a better tolerability profile than amlodipine, with fewer adverse events and a lower percentage of patients suffering from side effects.
Lercanidipine is as effective as amlodipine in the reduction and stabilization of BP in hypertensive patients after a stroke, and presents some advantages in terms of safety. Larger studies are necessary to further evaluate these preliminary findings.