Summary

Objective: To evaluate amlodipine efficacy in reducing miocardial ischemic featores, symptomatic or not, exercise induced, in stable chronic angina patients with a positive ergometric test.

Material and mehods: There were studied through an open, prospective, consecutive, non-controlled trial in 52 patients presenting with stable angina and coronary artery disease, angiographically established, but without a revascularization’s indication. After a 2 week run-in-period without medication (except nitrates as necessary), all showed a positive ergometric test. The therapy was started with a 5mg amlodipine dosage, that copuld be titrated to 10mg, as clinically needed. The sample was represented by 56 patients, 42 male (75%) with mean age 62 ± 10 years. Most were white (76,8%). There were 14 patiens (25%) with previous myocardial infarction, 12 (21,4%) were diabetics and 17 (30,4%) were smokers; 33 (58,9%) presented with any dyslipidemia type and 40 (71.4) were hypertensives.

Nine (16%) were in regular use of lipid lowering drugs and 9 (16%) used anti-hypertensives agents without anti-ischemic action and 31 (55,3%) used ASA and ticlopidine on regular basis.

Results: Among the sample, 48 patients completed the trial, using 10mg (34%), 5mg (53,2%) or 7,5 mg (12,8%) amlodipine dosage. One patient used other anti-anginal agent different from sub-lingual nitrates during the study. Thus, according to the protocol, 47 patients were analysed about efficacy effects. In the ergometric test performed after 10 weeks therapy, comparing with the basal test, there was a statystical significative improvement in exercise lenght (9,8 ± 3,5 min vs 7,0 ± 3,2 min; p<0,001), in load performed (52,3 ±18,1 mpH% vs 38,0 ±18,4; p<0,001) and in the heart rate for the initial ST segment depression (135,2 ± 19,9 vs 128,6 ± 24,0; p<0,01). Also ocurred increase time to beginning of the ST segment depression (7,3 ± 3,8 vs 4,3 ± 2,6 min; p<0,001) and to angina development (8,2 ± 3,3 vs 4,8 ± 2,6 min; p<0,001) and its lenght reduction (3,9 + 3,3 vs 5,0 + 2,4 min; p<0,05) in the 18 patients (37,5%) presenting with angina. Of the patients, 11 (19,6%) related adverse events, the most frequent being slight to moderate maleolar edema.

Conclusion: Monotherapy with amlodipine, was effective in the miocardial ischemic crisis, as increasing its wedge appearance, as reducing its lenght. The total load and the exercise time developped by the patients were significantly greater, ocurring concurrently heart rate and systolic blood pressure maitenance in the peak exercise.

In this anginal cohort occurred significant blood pressure reduction at rest, as most of patients presented previous arterial hypertension.