4 research outputs found
Effect of ruboxistaurin in patients with diabetic macular edema: Thirty-month results of the randomized PKC-DMES clinical trial
Objective: To evaluate the safety and efficacy of orally administered ruboxistaurin (RBX) as a mesylate salt in patients with diabetic macular edema (DME). 1 Design: Multicenter, double-masked, randomized, placebo-controlled study of 686 patients receiving placebo or RBX orally ( 4, 16, or 32 mg/d) for 30 months. At baseline, patients had DME farther than 300 mu m from the center of the macula, an Early Treatment Diabetic Retinopathy Study retinopathy severity level from 20 to 47A without prior photocoagulation, and an Early Treatment Diabetic Retinopathy Study visual acuity of 75 or more letters in the study eye. The primary study outcome was progression to sight-threatening DME or application of focal/grid photocoagulation for DME. Main Outcome Measure: Masked grading of stereoscopic fundus photographs. Results: The delay in progression to the primary outcome was not statistically significant ( 32 mg of RBX vs placebo, P=.14 [unadjusted]; Cox proportional hazards model adjusted for covariates, hazards ratio=0.73; 95% confidence interval, 0.53-1.0; P=.06). However, application of focal/ grid photocoagulation prior to progression to sight-threatening DME varied by site, and a secondary analysis of progression to sight-threatening DME alone showed that 32 mg of RBX per day reduced progression, compared with placebo (P=.054 [ unadjusted]; Cox proportional hazards model, hazards ratio= 0.66; 95% confidence interval, 0.47-0.93; P=.02). Conclusions: Although progression to the primary outcome was not delayed, daily oral administration of RBX may delay progression of DME to a sight-threatening stage. Ruboxistaurin was well tolerated in this study
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Aspirin Effects on Mortality and Morbidity in Patients With Diabetes Mellitus: Early Treatment Diabetic Retinopathy Study Report 14
Objectives.—This report presents information on the effects of aspirin on mortality, the occurrence of cardiovascular events, and the incidence of kidney disease in the patients enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS).Study Design.—This multicenter, randomized clinical trial of aspirin vs placebo was sponsored by the National Eye Institute.Patients.—Patients (N=3711) were enrolled in 22 clinical centers between April 1980 and July 1985. Men and women between the ages of 18 and 70 years with a clinical diagnosis of diabetes mellitus were eligible. Approximately 30% of all patients were considered to have type I diabetes mellitus, 31% type II, and in 39% type I or II could not be determined definitely.Intervention.—Patients were randomly assigned to aspirin or placebo (two 325-mg tablets once per day).Main Outcome Measures.—Mortality from all causes was specified as the primary outcome measure for assessing the systemic effects of aspirin. Other outcome variables included cause-specific mortality and cardiovascular events.Results.—The estimate of relative risk for total mortality for aspirin-treated patients compared with placebo-treated patients for the entire study period was 0.91 (99% confidence interval, 0.75 to 1.11). Larger differences were noted for the occurrence of fatal and nonfatal myocardial infarction; the estimate of relative risk was 0.83 for the entire follow-up period (99% confidence interval, 0.66 to 1.04).Conclusions.—The effects of aspirin on any of the cardiovascular events considered in the ETDRS were not substantially different from the effects observed in other studies that included mainly nondiabetic persons. Furthermore, there was no evidence of harmful effects of aspirin. Aspirin has been recommended previously for persons at risk for cardiovascular disease. The ETDRS results support application of this recommendation to those persons with diabetes at increased risk of cardiovascular disease.(JAMA. 1992;268:1292-1300