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. 2011 Feb;2(1):19–28. doi: 10.1177/2042098610393209

Table 2.

Common side effects and their reported incidence from clinical trials.

Trial Drug regimen Bradycardia Eye disorders including phosphenes
INITIATIVE Ivabradine versus atenolol 2.2% (7.5 mg twice daily) and 5.4% (10 mg twice daily) versus 4.3% atenolol (p = NA) 5 withdrawals in the ivabradine group versus none in the atenolol group (p = NA)
ASSOCIATE Ivabradine versus placebo 19 (4.2%) versus 2 (0.5%) (p = NA) 9 (2%) versus 4 (0.9%) (p = NA)
BEAUTIFUL Ivabradine versus placebo 149 (6%) versus 21 (1%)* (p = NA) 21 (0.4%) versus 12 (0.2%)* (p = NA)
SHIFT Ivabradine versus placebo 150 (5%) versus 32 (1%)$, 184 (6%) versus 48(1%) (both p < 0.0001) 89 (3%) versus 17 (1%) (p < 0.0001)
*

Dropout rates – no reports of total incidence.

$

Symptomatic bradycardia.

Asymptomatic bradycardia.

NA, not available/reported.