The effect of lercanidipine or lercanidipine/enalapril combination on blood pressure in treatment-naïve patients with stage 1 or 2 systolic hypertension

PURPOSE: To describe the efficacy of a stratified approach on automatic office blood pressure (BP), 24-hour ambulatory BP, and BP variability (BPV) in treatment-naïve patients with systolic hypertension using lercanidipine for stage 1 and lercanidipine/enalapril for stage 2. PATIENTS AND METHODS: This was an open-label, prospective interventional study conducted in 22 general practices in South Africa. Treatment-naïve patients with stage 1 hypertension received lercanidipine 10 mg and patients with stage 2 received lercanidipine 10 mg/enalapril 10 mg. After 6 weeks, patients not reaching target (<140/90 mmHg) were up-titrated to lercanidipine 10 mg/enalapril 10 mg or lercanidipine 10 mg/enalapril 20 mg, respectively, for a further 6 weeks. Office BP was determined at each visit, and 24-hour ambulatory BP monitor (ABPM) at baseline and 12 weeks. The primary end point was changes in office BP, and secondary end points were changes in 24-hour ABPM and BPV. RESULTS: Of the 198 patients, 48% had stage 1 and 52% stage 2 hypertension. The mean age was 55 years, body mass index was 29.2 kg/m(2), 48.5% were female, and 15.1% were diabetic. The mean (SD) office SBP and DBP at baseline, 6 weeks, and 12 weeks was 158.2 (13.8), 141.6 (11.1), and 138.7 (16.7) mmHg (P<0.00001), and 92.2 (10.6), 84.6 (11.1), and 82 (13.3) mmHg (P<0.00001), respectively. The mean (SD) systolic and diastolic daytime ABPM at baseline and 12 weeks was 157 (16.63) and 142 (14.41) mmHg (P<0.0001) and 88 (12.34) and 81 (10.79) mmHg (P<0.0001), and the nighttime ABPM was 146 (15.68) and 133 (13.94) mmHg (P<0.0001) and 79.5 (11.64) and 72.5 (10.05) mmHg (P<0.009), respectively. There were few adverse events. CONCLUSION: Lercanidipine and lercanidipine/enalapril for stage 1 or 2 hypertension highly improves office SBP and DBP, overall 24-hour BP, daytime BP, and nighttime BP, also reducing BPV with few adverse effects.