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Amlodipine: A once-daily calcium antagonist in the treatment of angina pectoris—A parallel dose-response, placebo-controlled study
Amlodipine: A once-daily calcium antagonist in the treatment of angina pectoris-A parallel dose-response, placebo-controlled study Udho Thadani,
MD, and the Amlodipine
Study Group,*
Amlodipine, a long-acting dihydropyridine calcium antagonist, was evaluated for antianginal and antiischemic efficacy in patients with stable angina pectoris. METHODSANDRESULTS
In this multicenter, parallel design study, patients, ages 32 to 78 years, who stopped treadmill exercise because of From the University of Oklahoma Health Sciences Center. Reprint requests: Udho Thadani, MD, The University of Oklahoma, Health Sciences Center, 800 N.E. 13th St., Oklahoma City, OK 73194. *Amlodipine Study Group principal investigators: Duane G. Wombolt, Norfolk, Va.; Brian M. Chesnie, Huntington Beach, Calif.; Krishan K. Goyle, Wichita, KS.; John W. Allen, Los Angeles, Calif.; David C. Dean, Buffalo, N.Y.; Gary J. Luckasen, Fort Collins, Cola.; Akira Nishikawa, Houston, Texas; Benjamin L. Rosin, Torrance, Calif.; Bernard Tabatznik, Baltimore, Md.; John H. Morledge, Madison, Wis.; William J. Rogers, Birmingham, Ala.; Harold Silberman, Coral Gables, Fla.; Udho Thadani, Oklahoma City, Okla.; Robert C. Touchon, Huntington, W.Va.; Luis Campos, Houston, Texas; Douglas Boehm, Wichita, KS. 4/o/15314
Table
Oklahoma
City, Okla.
angina and developed 1 1 mm ST segment depression, received single-blind placebo, once a day, for 2 weeks. Exercise tests were repeated at weekly intervals. Patients meeting the study entrance criteria (L three episodes of angina1 attacks during the 2-week placebo treatment and exercise limited because of angina plus 2 1 mm ST segment depression) were randomly assigned to one of five groups (1.25, 2.5, 5, or 10 mg of amlodipine or placebo), Double-blind medication was prescribed once a day for 4 weeks, and exercise tests were repeated at the end of 4 weeks. The percentage changes in various parameters at the end of double-blind treatment were as shown below in Table I. COMMENT
The 5 and 10 mg doses of amlodipine reduced angina frequency, but only the IO mg dose significantly increased exercise duration.
I. Study results (percentage change at study completion compared with controls)
Angina1attacks per week Nitroglycerin Exercise time Total exercise ST at maximum Rate pressure *p < 0.01 compared
tablets/wk to angina time common product with double-blind
load
placebo
Placebo (n = 26)
1.25 mg (n = 24)
2.5 mg (n = 25)
-50 -20 +20.1 +1.3 -21 -3.8
-33 -20 +7.6 +9.3 -39 -2.6
-50 -50 +3.6 +2.0 -31 -1.8
5 w (n = 27) -67* -33 f18.4 +7.0 -20 -1.6
10 mg (n = 30) -67* -50* +28.1 +15.7* -27 -1.6
period.
1135
MD, and the Amlodipine
Study Group,*
Amlodipine, a long-acting dihydropyridine calcium antagonist, was evaluated for antianginal and antiischemic efficacy in patients with stable angina pectoris. METHODSANDRESULTS
In this multicenter, parallel design study, patients, ages 32 to 78 years, who stopped treadmill exercise because of From the University of Oklahoma Health Sciences Center. Reprint requests: Udho Thadani, MD, The University of Oklahoma, Health Sciences Center, 800 N.E. 13th St., Oklahoma City, OK 73194. *Amlodipine Study Group principal investigators: Duane G. Wombolt, Norfolk, Va.; Brian M. Chesnie, Huntington Beach, Calif.; Krishan K. Goyle, Wichita, KS.; John W. Allen, Los Angeles, Calif.; David C. Dean, Buffalo, N.Y.; Gary J. Luckasen, Fort Collins, Cola.; Akira Nishikawa, Houston, Texas; Benjamin L. Rosin, Torrance, Calif.; Bernard Tabatznik, Baltimore, Md.; John H. Morledge, Madison, Wis.; William J. Rogers, Birmingham, Ala.; Harold Silberman, Coral Gables, Fla.; Udho Thadani, Oklahoma City, Okla.; Robert C. Touchon, Huntington, W.Va.; Luis Campos, Houston, Texas; Douglas Boehm, Wichita, KS. 4/o/15314
Table
Oklahoma
City, Okla.
angina and developed 1 1 mm ST segment depression, received single-blind placebo, once a day, for 2 weeks. Exercise tests were repeated at weekly intervals. Patients meeting the study entrance criteria (L three episodes of angina1 attacks during the 2-week placebo treatment and exercise limited because of angina plus 2 1 mm ST segment depression) were randomly assigned to one of five groups (1.25, 2.5, 5, or 10 mg of amlodipine or placebo), Double-blind medication was prescribed once a day for 4 weeks, and exercise tests were repeated at the end of 4 weeks. The percentage changes in various parameters at the end of double-blind treatment were as shown below in Table I. COMMENT
The 5 and 10 mg doses of amlodipine reduced angina frequency, but only the IO mg dose significantly increased exercise duration.
I. Study results (percentage change at study completion compared with controls)
Angina1attacks per week Nitroglycerin Exercise time Total exercise ST at maximum Rate pressure *p < 0.01 compared
tablets/wk to angina time common product with double-blind
load
placebo
Placebo (n = 26)
1.25 mg (n = 24)
2.5 mg (n = 25)
-50 -20 +20.1 +1.3 -21 -3.8
-33 -20 +7.6 +9.3 -39 -2.6
-50 -50 +3.6 +2.0 -31 -1.8
5 w (n = 27) -67* -33 f18.4 +7.0 -20 -1.6
10 mg (n = 30) -67* -50* +28.1 +15.7* -27 -1.6
period.
1135