A 6-week double-blind comparison of amlodipine and placebo in patients with stable exertional angina pectoris receiving concomitant beta-blocker therapy.
This study was a multicenter, double-blind comparison of the antianginal efficacy and safety of amlodipine and placebo as adjunctive therapy with constant recommended maintenance doses of beta-blockers. Patients with stable exertional angina pectoris were randomized to placebo or amlodipine at a starting dose of 5 mg once daily. The amlodipine dose was adjusted to 10 mg daily after 2 weeks if angina attacks were not abolished. Antianginal efficacy was assessed throughout the study with angina diaries, investigators' and patients' global evaluations, and with bicycle exercise tests during a placebo run-in period (baseline) and after 2 and 6 weeks of double-blind treatment. On baseline-final analysis, the exercise time to angina onset increased by 13% with amlodipine compared to 6% with placebo (p < 0.05). The total exercise time increased by 11% on amlodipine compared with 2% on placebo, though this difference did not reach statistical significance. Angina attack frequency and nitroglycerin consumption were both reduced by adding amlodipine to beta-blocker treatment. Amlodipine in combination with beta-blocker therapy was well tolerated, with a low incidence of side effects and laboratory test abnormalities. The study showed clearly that addition of amlodipine to beta-blocker therapy in patients with stable angina pectoris was well tolerated and gave improved antianginal efficacy.
Klein
W
W
Med. Univ. Klinik, Graz, Austria.
Mitrovic
V
V
Neuss
H
H
Schlepper
M
M
Cocco
G
G
Prager
G
G
Fitscha
P
P
Meisner
W
W
D000293:Adolescent; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000787:Angina Pectoris / Q000188:drug therapy* / Q000503:physiopathology; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005080:Exercise Test; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D005996:Nitroglycerin / Q000008:administration & dosage / Q000627:therapeutic use; D005082:Physical Exertion / Q000187:drug effects* / Q000502:physiology; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use
D000319:Adrenergic beta-Antagonists; D002121:Calcium Channel Blockers; D014665:Vasodilator Agents; D017311:Amlodipine; D005996:Nitroglycerin