Cilostazol treatment of claudication in diabetic patients

Marc Rendell, Alan T. Cariski, Norbert Hittel, Peter Zhang

Research output: Contribution to journalArticle

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Abstract

Objective: To compare the efficacy and safety of cilostazol in diabetic and non-diabetic patients from eight (six placebo- and two active-controlled) randomised, double-blind phase III trials. Design: We only included patients from the trial data set receiving cilostazol 100 mg twice daily (216 diabetic/599 non-diabetic) or placebo (220/616). Efficacy was measured by absolute claudication distance (ACD), using standard treadmill exercise protocols. Results: Among diabetic and non-diabetic patients, cilostazol was superior to placebo (estimated treatment effect 1.15, 95% confidence interval, 1.05-1.25, p = 0.001; and 1.24, 1.18-1.31, p <0.0001, respectively). There was no statistical difference in response between diabetic and non-diabetic subjects. In the efficacy analysis, cilostazol-treated diabetic subjects with the lowest baseline ACD (but not those with greater baseline ACD) walked approximately 34% farther than at baseline, whereas their non-diabetic counterparts walked 23% farther. There was no significant difference in the adverse event profile of the diabetic and non-diabetic patients on cilostazol. No excess haemorrhagic events occurred in cilostazol-treated diabetic patients. Trial duration varied from 12 to 24 weeks. Conclusions: Diabetic and non-diabetic patients with intermittent claudication respond favourably to cilostazol, with no significant difference in their overall response. Diabetic individuals with the most severe claudication respond better than those less affected, but the response of non-diabetic patients increases as baseline ACD increases. Adverse event incidence was comparable in the two populations, although diabetic patients might be expected to experience greater morbidity. Cilostazol is a safe and effective treatment for claudication in diabetic and non-diabetic populations.

Original languageEnglish
Pages (from-to)479-487
Number of pages9
JournalCurrent Medical Research and Opinion
Volume18
Issue number8
DOIs
StatePublished - 2002

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Placebos
Therapeutics
Intermittent Claudication
cilostazol
Population
Confidence Intervals
Exercise
Morbidity
Safety
Incidence
Datasets

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Cilostazol treatment of claudication in diabetic patients. / Rendell, Marc; Cariski, Alan T.; Hittel, Norbert; Zhang, Peter.

In: Current Medical Research and Opinion, Vol. 18, No. 8, 2002, p. 479-487.

Research output: Contribution to journalArticle

Rendell, Marc ; Cariski, Alan T. ; Hittel, Norbert ; Zhang, Peter. / Cilostazol treatment of claudication in diabetic patients. In: Current Medical Research and Opinion. 2002 ; Vol. 18, No. 8. pp. 479-487.
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N2 - Objective: To compare the efficacy and safety of cilostazol in diabetic and non-diabetic patients from eight (six placebo- and two active-controlled) randomised, double-blind phase III trials. Design: We only included patients from the trial data set receiving cilostazol 100 mg twice daily (216 diabetic/599 non-diabetic) or placebo (220/616). Efficacy was measured by absolute claudication distance (ACD), using standard treadmill exercise protocols. Results: Among diabetic and non-diabetic patients, cilostazol was superior to placebo (estimated treatment effect 1.15, 95% confidence interval, 1.05-1.25, p = 0.001; and 1.24, 1.18-1.31, p <0.0001, respectively). There was no statistical difference in response between diabetic and non-diabetic subjects. In the efficacy analysis, cilostazol-treated diabetic subjects with the lowest baseline ACD (but not those with greater baseline ACD) walked approximately 34% farther than at baseline, whereas their non-diabetic counterparts walked 23% farther. There was no significant difference in the adverse event profile of the diabetic and non-diabetic patients on cilostazol. No excess haemorrhagic events occurred in cilostazol-treated diabetic patients. Trial duration varied from 12 to 24 weeks. Conclusions: Diabetic and non-diabetic patients with intermittent claudication respond favourably to cilostazol, with no significant difference in their overall response. Diabetic individuals with the most severe claudication respond better than those less affected, but the response of non-diabetic patients increases as baseline ACD increases. Adverse event incidence was comparable in the two populations, although diabetic patients might be expected to experience greater morbidity. Cilostazol is a safe and effective treatment for claudication in diabetic and non-diabetic populations.

AB - Objective: To compare the efficacy and safety of cilostazol in diabetic and non-diabetic patients from eight (six placebo- and two active-controlled) randomised, double-blind phase III trials. Design: We only included patients from the trial data set receiving cilostazol 100 mg twice daily (216 diabetic/599 non-diabetic) or placebo (220/616). Efficacy was measured by absolute claudication distance (ACD), using standard treadmill exercise protocols. Results: Among diabetic and non-diabetic patients, cilostazol was superior to placebo (estimated treatment effect 1.15, 95% confidence interval, 1.05-1.25, p = 0.001; and 1.24, 1.18-1.31, p <0.0001, respectively). There was no statistical difference in response between diabetic and non-diabetic subjects. In the efficacy analysis, cilostazol-treated diabetic subjects with the lowest baseline ACD (but not those with greater baseline ACD) walked approximately 34% farther than at baseline, whereas their non-diabetic counterparts walked 23% farther. There was no significant difference in the adverse event profile of the diabetic and non-diabetic patients on cilostazol. No excess haemorrhagic events occurred in cilostazol-treated diabetic patients. Trial duration varied from 12 to 24 weeks. Conclusions: Diabetic and non-diabetic patients with intermittent claudication respond favourably to cilostazol, with no significant difference in their overall response. Diabetic individuals with the most severe claudication respond better than those less affected, but the response of non-diabetic patients increases as baseline ACD increases. Adverse event incidence was comparable in the two populations, although diabetic patients might be expected to experience greater morbidity. Cilostazol is a safe and effective treatment for claudication in diabetic and non-diabetic populations.

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