Objective: The DUAL study evaluated the effectiveness and safety of the fixed-dose combination of lercanidipine and enalapril in a real-practice scenario; the effects of this combination on a number of markers of cardiovascular risk have been also investigated.
Research design and methods: This was a 2 month, phase IV, open-label, single-group, prospective observational study. Adult patients with untreated or uncontrolled hypertension (blood pressure [BP] >140/90 mmHg) were eligible for this study. All patients received lercanidipine/enalapril, in a once-daily fixed combination (10 mg/10 mg).
Main outcome measures: The patients were evaluated at baseline, at 1 month and at 2 months. The following parameters were evaluated at all time points: systolic BP (SBP) and diastolic BP (DBP); heart rate (HR). A number of laboratory parameters were measured at baseline and at 2 months. Safety considerations were performed.
Results: In total, 188 patients were enrolled (104 males; mean age 58 ± 12 years). At baseline, mean SBP was 159 ± 10 mmHg and mean DBP was 94 ± 7 mmHg. Treatment with lercanidipine/enalapril in fixed combination was associated with a reduction in both SBP and DBP already at 1 month; this reduction was sustained until month 2 (SBP: 131 ± 7 mmHg; DBP: 79 ± 5 mmHg; p < 0.05 vs baseline). At baseline HR was 78 ± 10 bpm; a significant reduction in this parameter was observed at month 2 (75 ± 7 bpm; p < 0.05 vs baseline). A significant decrease in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and fasting glucose, and a significant increase in K(+), and Ca(2+) was observed at month 2 compared with baseline values. In total, two patients (1%) experienced dry cough. No other adverse effects were reported.
Conclusions: Even with all the limitations of any observational study, these data show that a 2 month treatment with a fixed dose of lercanidipine/enalapril is associated with significant reductions in SBP and DBP, HR, and improvement in a number of laboratory parameters.
Keywords: Combination therapy; Enalapril; Hypertension; Lercanidipine.