Multicenter Community-Based Trial of Amlodipine in Hypertension
C. Yosefy, J.R. Viskoper, Y. Leshem, Y. Rav-Hon, G.I. Rosenberg, E. Yaskil
(Representing the 39 Investigators of Project AML-IL-95-001, WHO Collaborative Center for Prevention of CV Diseases) Ben-Gurion University of the Negev, Beer Sheba; Barzilai Medical Center, Ashkelon; Hypertension Clinic, Kupat Holim Afula; Statistics Consulting Unit, Haifa University; and Promedico Ltd., Petah Tikva
The safety and efficacy of Amlodipine (AML) for mild to moderate hypertension was evaluated in a "real life" setting. This open non-comparative trial included 123 men and 143 women (age 30-91 years, mean 59.4). All had sitting diastolic blood pressure (DBP) between 95 and 115 mmHg, confirmed in most by 2 baseline measurements, 2 weeks apart.
Eligible patients were given AML 5 mg daily as add-on or monotherapy and were evaluated 4 weeks later. If DBP was then >90 mmHg, the daily dose was raised to 10 mg; those with <90 mmHg remained on 5 mg. AML was continued for 8 weeks. Other BP-lowering drugs were unchanged.
Of the original 266 patients 22 (8.2%) withdrew due to adverse events (AE), and others were protocol violators, lost to follow-up or withdrew, leaving 211 available for efficacy analysis. In this major group BP was reduced from 165±15/101±4 to 139±11/83±5 after 12 weeks of AML (p<0.05). The reduction was greater in those under 70 years, from 173±12/100±5 to 142±12/80±4 (p<0.05). In those with BMI>30 kg/m², BP decreased from 165±15/101±5 to 140±12/83±5 (p<0.05).
Mean change in heart rate was -1.5 bpm (p<0.05). Mean final AML dose was 5.5 mg/day. The most common AML-related AE requiring cessation of the drug was pedal edema in 2.6% of the 266 patients; in 3.7% it persisted during therapy. Other AE occurring in >1% were dizziness in 1.8%, headache 1.5%, flushing 1.1% and fatigue 1.1%.
We conclude that AML is an effective and well-tolerated antihypertensive suitable for most hypertensive patients.