B. Heublein et al., NISOLDIPINE VERSUS ISOSORBIDE DINITRATE IN CORONARY HEART-DISEASE - RESULTS OF A DOUBLE-MASKED STUDY, Clinical therapeutics, 18(3), 1996, pp. 448-459
The efficacy and tolerability of a twice-daily dose of 5 mg of nisoldi
pine versus 40 mg of sustained-release isosorbide dinitrate (ISDN) wer
e compared in a randomized, double-masked study in 91 patients. During
the 21-day treatment period, the mean time taken during bicycle ergom
etry to the appearance of an ST segment depression of at least 0.1 mV
compared with the resting value increased from 287 +/- 129 seconds to
391 +/- 150 seconds in the nisoldipine group and from 254 +/- 140 seco
nds to 350 +/- 191 seconds in the ISDN group. The mean value at the en
d of treatment calculated by using analysis of covariance was 383 seco
nds in both groups. The difference between the two treatment groups wa
s not statistically significant. The mean ST segment depression at ind
ividually maximal workload decreased from 0.19 +/- 0.07 mV to 0.12 +/-
0.08 mV in the nisoldipine group and from 0.18 +/- 0.07 mV to 0.14 +/
- 0.08 mV in the ISDN group. The mean total duration of exercise incre
ased from 420 +/- 161 seconds to 497 +/- 140 seconds in the nisoldipin
e group and from 425 +/- 167 seconds to 456 +/- 168 seconds in the ISD
N group. In the nisoldipine group, 9 patients reported 12 adverse even
ts that were considered to be possibly or probably related to the test
medication; in the ISDN group, 13 patients reported 26 adverse events
. Although the anti-ischemic effect of the two treatments was comparab
le, nisoldipine was descriptively superior to ISDN in terms of tolerab
ility.