Abstract
A long-term comparative clinical trial was made with oral hypoglycemic agents to evaluate their efficacy in diabetic retinopathy. The protocol for the trial was fully described in the preceding paper. In this paper, the results obtained, particularly as regards the degree of satisfaction with the treatment of diabetes mellitus as well as the criteria for the acceptability of data collected, the analysis of background factors and the safety of oral hypoglycemic agents are dealt with. Of a total of 286 patients participating in the trial, 279 were finally included in the analysis of pertinent data [84 receiving Gliclazide (SE), 116 receiving other sulfonylureas (SU) and 79 on dietary treatment (Diet) alone]. Patients receiving SE and those receiving SU were found to be populations with nearly identical background factors; those on Diet alone were obviously somewhat dissimilar to these populations in this respect. Most patients in the SE group had previously received SU. The degree of satisfaction with the treatment of the disease was higher with the Diet group, with a score of 3.1±1.8 compared to 4.2±2.0 for the SE and 4.7±1.9 for the SU groups respectively. Rating the parameter on an ordinary scale consisting of the categories of “good”, “fair” and “poor”, it was also found that Diet was accepted significantly more satisfactorily, the response being good or better in 70.8 per cent and fair or better in 86.0 per cent of the patients treated as compared to 47.6 and 67.8 per cent with SE and 34.5 and 67.3 per cent with SU, respectively. These data were subjected to further analysis in different stratified subgroups of patients. Evaluation of safety was in terms of manifestations of hypoglycemia, ECG findings, adverse reactions and laboratory values. No remarkable side-effects were observed with SE with the exception of skin rash, which was somewhat more common with the agent.
