CALCIUM-ANTAGONISTS, A USEFUL ADDITIONAL THERAPY IN TREATMENT-RESISTANT HYPERTENSION - COMPARISON OF FELODIPINE ER AND NIFEDIPINE-RETARD BY24-H AMBULATORY BLOOD-PRESSURE MONITORING

Objective: To compare the efficacy and tolerability of felodipine exte nded release (ER) 2.5 mg (F2.5) and 5 me (F5) once daily with nifedipi ne Retard 10 mg (N20) and 20 mg (N40) twice daily as additional therap y in patients who remained hypertensive despite treatment with an ACE- inhibitor, beta-blocker or diuretic, Design and methods: In a multicen tre, double-blind parallel study, 61 men and 54 women, aged 35-75, wit h a supine diastolic blood pressure between 95 and 115 mmHg were rando mised to treatment with F2.5, F5, N20 or N40 for 8 weeks, with optiona l doubling of the dose after 4 weeks. Blood pressure was measured at t he office after 0, 4 and 8 weeks and by 24-h ambulatory monitoring (AB PM) after 0 and 4 weeks, Spontaneously reported adverse events and a s ubjective symptom assessment questionnaire were used for side-effect p rofiling. Results: Mean office systolic/diastolic blood pressure was c linically relevantly reduced in all treatment groups after 4 weeks by 8/7, 12/9, 11/9 and 18/11 mmHg for F25, F5, N20 and N40, respectively, and after 8 weeks (F2.5-5: 17/11 mmHg; F5-10: 18/14 mmHg; N20-40: 19/ 14 mmNg; N40-80: 25/14 mmHg) with no statistically significant differe nces between these groups. The lowest dose of felodipine (F2.5) was th e least effective, After 4 weeks the ABPM showed consistent 24-h reduc tions in blood pressure (4/2: 8/5, 7/5; 10/6 mmHg, respectively) over 24 h for the felodipine ER 5 mg group only and for both nifedipine gro ups. No statistically significant difference between these groups was found. An office responder does not appear to be identical to an ambul atory one and vice versa. The adverse events, mostly oedema, flushing and headache, were dose-related.