Abstract
The efficacy and safety of amiodipine, 10 mg, a new long-acting calcium antagonist, was compared with placebo in 103 patients with stable angina pectoris in a multicenter double-blind crossover study. The trial consisted of an initial 2-week single-blind placebo period followed by a first period of 4 weeks at double-blind therapy, which was followed by a 1 week washout perioid and then a second 4-week double-blind period after treatments were crossed over. Twenty-four-hour Holter electrocardiographic monitoring was carried out in 12 patients at three centers. In the first double-blind period amiodipine prodcued a significantly greater increase in symptom-limited exercise duration (amiodipine 478.5 to 520.6 vs placebo 484.6 to 485.2 seconds; change +8.8% vs +0.1%, respectively; p = 0.0004) and total work (amiodipine 2426 to 2984 vs placebo 2505 to 2548 kilopondmeters; change +24% vs +1.7%, respectively; p = 0.0006) and a decrease in angina attack frequency (from 3 to 1 per week; p = 0.016) and nitroglycerin consumption (from 2 to 0.5 tablets/wk; p = 0.01) compared with placebo. Holter monitoring revealed significant reductions in numbers (amiodipine 4.65 to 2.22 vs placebo 1.84 to 1.54; change +52% vs +84%, respectively; p = 0.06), absolute total area (amiodipine 87.66 to 11.43 vs placebo 5.76 to 35.24; change +87% vs +513%, respectively; p = 0.02), and duration (amiodipine 12.29 to 2.95 vs 1.66 to 7.74 seconds; change +76% vs +367%, respectively; p = 0.008) of ST-segment depressions after treatment with amiodipine compared with placebo. After the treatments were crossed over changes continued to favor amiodipine. However, there were no significant changes by Holter monitoring in any of the ST-segment parameters during the period after the crossover. The smaller changes with amiodipine during the period after the crossover may be the result of the long half-life of amiodipine or an exercise training effect. The most frequently reported side effects with amiodipine were headache (11%) and edema (8%). We conclude that amiodipine therapy is well tolerated and that it demonstrates antiischemic and antianginal efficacy in the management of stable angina.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 527-535 |
| Number of pages | 9 |
| Journal | American Heart Journal |
| Volume | 129 |
| Issue number | 3 |
| DOIs | |
| State | Published - 1995 |
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ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
Amlodipine in chronic stable angina : Results of a multicenter double-blind crossover trial. / Ezekowitz, Michael D.; Hossack, Kenneth; Mehta, Jawahar L.; Thadani, Udho; Weidler, Donald J.; Kostuk, William; Awan, Najam; Grossman, William; Bommer, William J.
In: American Heart Journal, Vol. 129, No. 3, 1995, p. 527-535.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Amlodipine in chronic stable angina
T2 - Results of a multicenter double-blind crossover trial
AU - Ezekowitz, Michael D.
AU - Hossack, Kenneth
AU - Mehta, Jawahar L.
AU - Thadani, Udho
AU - Weidler, Donald J.
AU - Kostuk, William
AU - Awan, Najam
AU - Grossman, William
AU - Bommer, William J
PY - 1995
Y1 - 1995
N2 - The efficacy and safety of amiodipine, 10 mg, a new long-acting calcium antagonist, was compared with placebo in 103 patients with stable angina pectoris in a multicenter double-blind crossover study. The trial consisted of an initial 2-week single-blind placebo period followed by a first period of 4 weeks at double-blind therapy, which was followed by a 1 week washout perioid and then a second 4-week double-blind period after treatments were crossed over. Twenty-four-hour Holter electrocardiographic monitoring was carried out in 12 patients at three centers. In the first double-blind period amiodipine prodcued a significantly greater increase in symptom-limited exercise duration (amiodipine 478.5 to 520.6 vs placebo 484.6 to 485.2 seconds; change +8.8% vs +0.1%, respectively; p = 0.0004) and total work (amiodipine 2426 to 2984 vs placebo 2505 to 2548 kilopondmeters; change +24% vs +1.7%, respectively; p = 0.0006) and a decrease in angina attack frequency (from 3 to 1 per week; p = 0.016) and nitroglycerin consumption (from 2 to 0.5 tablets/wk; p = 0.01) compared with placebo. Holter monitoring revealed significant reductions in numbers (amiodipine 4.65 to 2.22 vs placebo 1.84 to 1.54; change +52% vs +84%, respectively; p = 0.06), absolute total area (amiodipine 87.66 to 11.43 vs placebo 5.76 to 35.24; change +87% vs +513%, respectively; p = 0.02), and duration (amiodipine 12.29 to 2.95 vs 1.66 to 7.74 seconds; change +76% vs +367%, respectively; p = 0.008) of ST-segment depressions after treatment with amiodipine compared with placebo. After the treatments were crossed over changes continued to favor amiodipine. However, there were no significant changes by Holter monitoring in any of the ST-segment parameters during the period after the crossover. The smaller changes with amiodipine during the period after the crossover may be the result of the long half-life of amiodipine or an exercise training effect. The most frequently reported side effects with amiodipine were headache (11%) and edema (8%). We conclude that amiodipine therapy is well tolerated and that it demonstrates antiischemic and antianginal efficacy in the management of stable angina.
AB - The efficacy and safety of amiodipine, 10 mg, a new long-acting calcium antagonist, was compared with placebo in 103 patients with stable angina pectoris in a multicenter double-blind crossover study. The trial consisted of an initial 2-week single-blind placebo period followed by a first period of 4 weeks at double-blind therapy, which was followed by a 1 week washout perioid and then a second 4-week double-blind period after treatments were crossed over. Twenty-four-hour Holter electrocardiographic monitoring was carried out in 12 patients at three centers. In the first double-blind period amiodipine prodcued a significantly greater increase in symptom-limited exercise duration (amiodipine 478.5 to 520.6 vs placebo 484.6 to 485.2 seconds; change +8.8% vs +0.1%, respectively; p = 0.0004) and total work (amiodipine 2426 to 2984 vs placebo 2505 to 2548 kilopondmeters; change +24% vs +1.7%, respectively; p = 0.0006) and a decrease in angina attack frequency (from 3 to 1 per week; p = 0.016) and nitroglycerin consumption (from 2 to 0.5 tablets/wk; p = 0.01) compared with placebo. Holter monitoring revealed significant reductions in numbers (amiodipine 4.65 to 2.22 vs placebo 1.84 to 1.54; change +52% vs +84%, respectively; p = 0.06), absolute total area (amiodipine 87.66 to 11.43 vs placebo 5.76 to 35.24; change +87% vs +513%, respectively; p = 0.02), and duration (amiodipine 12.29 to 2.95 vs 1.66 to 7.74 seconds; change +76% vs +367%, respectively; p = 0.008) of ST-segment depressions after treatment with amiodipine compared with placebo. After the treatments were crossed over changes continued to favor amiodipine. However, there were no significant changes by Holter monitoring in any of the ST-segment parameters during the period after the crossover. The smaller changes with amiodipine during the period after the crossover may be the result of the long half-life of amiodipine or an exercise training effect. The most frequently reported side effects with amiodipine were headache (11%) and edema (8%). We conclude that amiodipine therapy is well tolerated and that it demonstrates antiischemic and antianginal efficacy in the management of stable angina.
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UR - http://www.scopus.com/inward/citedby.url?scp=0028968795&partnerID=8YFLogxK
U2 - 10.1016/0002-8703(95)90281-3
DO - 10.1016/0002-8703(95)90281-3
M3 - Article
C2 - 7872184
AN - SCOPUS:0028968795
VL - 129
SP - 527
EP - 535
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
IS - 3
ER -