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Sophie Nisse-Durgeat, Jean-Louis Imbs, P-230: Antihypertensive effect of candesartan and amlodipine assessed by home blood pressure, American Journal of Hypertension, Volume 14, Issue S1, April 2001, Page 105A, https://doi.org/10.1016/S0895-7061(01)01420-0
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Abstract
To compare the antihypertensive efficacy and tolerance of Candesartan Cilexetil (CC) and Amlodipine (AML) by Home Blood Pressure (HBP).
Multicenter randomized double blind trial with two parallel groups comparing CC (8 to 16 mg/d) to AML(5 to 10 mg/d) given once a day in the morning during 12 weeks. After a 2 week placebo run-in period, mild to moderate hypertensive patients (DBP 95 - 115 mmHg) were included in the treatment period. They were received either CC 8 mg o.d. or AML 5 mg o.d. in the morning for 6 weeks. If BP was not normalised or if the patient was not responder, the dosage was doubled for an additional 6 week treatment period. HBP were measured at home during 5 days (D1 to D5 ; 3 meas. at the morning before taking drug / 3 meas. at the evening before sleeping) before each visit by oscillometric method (OMRON HEM 705CP). Analysis compared the inclusion and treatment periods concerning the mean morning DBP meas. by HBP between D2 and D5. To be included in the evaluable population, patient needs at least 2 days of HBP with 4 meas./day at inclusion and after 12 weeks.
Six hundred thirty eight patients entered the run-in period, 528 were randomized and analysed for safety. The judgement criteria was satisfied in 317 patients. At inclusion, mean age, height, weight, clinic and baseline HBP and HR were similar in either group. The mean of morning DBP meas. assessed by HBP (D2 - D5) are not different at inclusion (CC: 93,2 vs AML: 91,7 p=0,21) and also after 12 weeks ( CC: 84,5 vs AML: 83,6 p=0,57). After 12 weeks of treatment, the evaluation of morning DBP meas. by HBP was not different (CC: -8,7 mmHg, AML: -8 mmHg p=0,62). The number of patient with a high dosage and the number of responder patient at 12 weeks were comparable between the two groups. The patients treated by AML have significantly more adverse events (AE) than those treated by CC (28% vs 20%, p=0,03). The proportion of patient in whom treatment was discontinued due to AE was higher in AML group (6% vs 2%, p=0,02).
These results demonstrated that there is no difference between CC and AML taking into account the evaluation of morning DBP meas. HBP after 12 weeks of treatment. The AEs were stastically higher in AML group.
