Clinical safety of the selective PKC-&bgr; inhibitor, ruboxistaurin

Author: McGill Janet B   King George L   Berg Paul H   Price Karen L   Kles Keri A   Bastyr Edward J   Hyslop David L  

Publisher: Informa Healthcare

ISSN: 1474-0338

Source: Expert Opinion on Drug Safety, Vol.5, Iss.6, 2006-11, pp. : 835-845

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Abstract

The aim of this manuscript is to report the safety profile of patients treated with ruboxistaurin mesylate (RBX; LY333531), a selective protein kinase C-&bgr; (PKC-&bgr;) inhibitor, for up to 4 years. Data from patients with diabetes (1396 RBX 32 mg/day; 1408 placebo) were combined from 11 placebo-controlled, double-masked studies. The proportion of patients who reported one or more serious adverse events was greater in the placebo group than in the RBX-treated group (23.2 versus 20.8%, respectively). There were 51 deaths (21 RBX; 30 placebo) reported in this patient cohort; none of the deaths was attributed to study drug by the investigators. Common adverse drug reactions (≥ 1/100 – < 1/10 patients) that were reported in the RBX-treated patients were dyspepsia and increased blood creatine phosphokinase. In controlled, randomised clinical trials, RBX had an adverse event profile comparable to placebo, and was well tolerated.