Monitoring of nilvadipine (EscorR) treatment of 23 770 hypertensive patients

The antihypertensive efficacy of Escor (nilvadipine) 8 mg (initial dose for n = 18 094) or 16 mg (initial dose for n = 3109), once daily, was evaluated in a multicenter drug monitoring study in 23 770 hypertensive patients over 10 months. Duration of treatment was 65 ± 24 days (mean ± s.d.). Mean age of patients was 63 ± 10 years, 51% males, 49% females, weight 78 ± 12 kg, height 170 ± 8 cm. Hypertension was known for 6 ± 6 years. The most frequent concomitant diseases were disturbances of lipid metabolism, ischemic heart disease, and arthrosis. 81% of patients were maintained on the initial daily dose of 8 mg nilvadipine, in 13% of patients the initial dose of 8 mg was increased to 16 mg per day, in 1% of cases an initial dose of 16 mg per day was reduced to 8 mg.29% of the patients reported full compliance with the nilvadipine drug regimen; 31% had rarely, 20% occasionally, 8% frequently, and 0.2% consistently not complied with the regimen. Compliance was improved vs. previous treatment by the once-daily regimen in 47% of patients. Therapy with Escor was continued in 76% of patients beyond study end because of efficacy of therapy and good tolerability. On a global assessment scale efficacy was rated excellent in 50%, good in 41%, moderate in 5%, insufficient in 2%. The ratio of responders, i.e., diastolic blood pressure > 95 mm Hg at baseline and < 90 mm Hg at end of study, or reduction of diastolic blood pressure by at least 10 mm Hg, was 59% at the first control visit and 84% at study-end visit. Diastolic blood pressure was lowered by 13 ± 9%, systolic blood pressure by 14 ± 8%.Adverse events had been documented in 7.9% of patients; most frequently the symptoms were associated with the therapeutic effect, i.e., vasodilatation (incidence 3.35%), headache (2.4%), tachycardia (1.18%), edema (0.95%), dizziness (0.78%). A relation of adverse events to Escor was rated very probable in 4%, probable in 2% and possible in 1%. Serious adverse events reportedly occurred in 0.2% (55) patients, including 36 cases of hospitalization or surgery; among the latter, 8 patients also experienced tachycardia, 3 vasodilatation, 2 increased sweating. Nine deaths were reported, but a relation to Escor treatment was denied. Tolerability was rated excellent in 52%, good in 40%, moderate in 3% and insufficient in 2% of patients.