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McGill JB, King GL, Berg PH, et al. Clinical safety of the selective PKC ß inhibitor, ruboxistaurin. Expert Opin Drug Saf 2006; 5:835-845. This publication describes the safety of ruboxistaurin in the first 11 placebo-controlled, randomized, double-blind, clinical trials completed as of 2006. Data from 2804 patients with diabetes (1396 taking ruboxistaurin 32 mg/day and 1408 taking placebo) were included. There was no significant difference between these two groups in the proportion of patients who died, reported one or more serious adverse events or discontinued from the study. First-degree atrioventricular block, superficial thrombosis, chalazion, posterior capsule opacification, dyspepsia, increased blood creatine phosphokinase, micturition urgency and skin discoloration were more common in the ruboxistaurin treatment group than in the placebo treatment group.
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