The goal of this multicenter, randomized, double-masked, parallel-group study was to assess the effects of lercanidipine versus those of hydrochlorothiazide (HCTZ) on the lipoprotein and apolipoprotein profile of patients with mild-to-moderate essential hypertension. After a 2-week washout period, 52 patients (age range, 18 to 70 years) were randomly allocated to receive lercanidipine 10 mg (n = 26) or HCTZ 12.5 mg (n = 26) once a day for 24 weeks. In nonresponding patients, the dose was increased to 20 or 30 mg of lercanidipine once a day and to 25 or 37.5 mg of HCTZ once a day, after 4 and 8 weeks, respectively. To assess long-term effects, patients receiving lercanidipine entered an additional 24-week follow-up period at the end of the controlled phase of the study. At study end, 73% of patients receiving lercanidipine and 52% of patients receiving HCTZ were still receiving the initial dose of 10 mg and 12.5 mg, respectively; only 1 patient in each group had increased to the highest dose. Lercanidipine and HCTZ were equally effective in lowering systolic and diastolic blood pressures; heart rate remained unchanged in both groups. Lercanidipine treatment did not modify the serum concentrations of total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, or apolipoproteins A-I and B. HCTZ treatment increased triglyceride levels from 94.8 ± 34.3 mg/dL at baseline to 118.5 ± 39.9 mg/dL after 24 weeks, a statistically significant change (P <0.05). The lack of any unwanted side effect on the lipid profile by lercanidipine was confirmed during the long- term follow-up period. Results of this study demonstrate that long-term treatment with lercanidipine did not negatively affect the lipid profile in patients with mild-to-moderate essential hypertension, whereas unwanted side effects were seen with the diuretic, even when used at the low doses currently recommended. Lercanidipine consequently can be safely used in patients with hypertension, even when abnormalities in the lipid profile occur.
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