Clinical safety of the selective PKC-β inhibitor, ruboxistaurin

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

Research output: Contribution to journalReview article

34 Scopus citations

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-β (PKC-β) 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.

Original languageEnglish
Pages (from-to)835-845
Number of pages11
JournalExpert Opinion on Drug Safety
Volume5
Issue number6
DOIs
StatePublished - Nov 1 2006

Keywords

  • C-β
  • Diabetes
  • Protein kinase
  • Ruboxistaurin
  • Visual loss

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    McGill, J. B., King, G. L., Berg, P. H., Price, K. L., Kles, K. A., Bastyr, E. J., & Hyslop, D. L. (2006). Clinical safety of the selective PKC-β inhibitor, ruboxistaurin. Expert Opinion on Drug Safety, 5(6), 835-845. https://doi.org/10.1517/14740338.5.6.835