Designer insulins regimens in clinical practice--pilot multicenter Indian study.

BACKGROUND: Newer insulin analogues viz., premix insulin analogue (biphasic insulin aspart) and insulin glargine are now available in India. A multicenter all-India study was done to document the patient profile and responses to these analogues in routine clinical practice. METHODS: The study was conducted prospectively at 4 diabetes care clinics in different regions of India and collected data on the use of either of the two regimens A. Premix insulin analogue given twice-daily B. Basal-bolus analogue regimen (insulin aspart with every meal and insulin glargine once-a-day at bedtime). The centers collected all data at 3 time-points--baseline, 4 weeks later and end of 12 weeks. The study measures were FPG (fasting plasma glucose), PPPG (postprandial plasma glucose), HbA1c and insulin dose. FPG and PPPG were recorded at each of the three time points. HbA1c was recorded at baseline and end of study. Safety was assessed based on reported adverse drug reactions and occurrence of hypoglycaemias. RESULTS: Data of 145 patients was available for analysis (n=114 on premix insulin analogue and n=31 on basal-bolus analogue regimen). Baseline demography was comparable in the two groups. Both the regimens lowered all blood glucose parameters including HbA1c significantly as compared to baseline. However, the premix insulin analogue fared better than the basal-bolus regimen in lowering HbA1c (1.58 vs. 1.16% respectively; p<0.05). Also 41% more patients in the premix group could achieve target HbA1c of < 7% at the end of study. The mean insulin dose was lower with the premix analogue group at the end of 12 weeks. There was no significant difference between the two groups in terms of change in body weight. No major hypoglycaemias were reported and the percentage of patients experiencing a minor episode was lower with the premix analogue than the basal-bolus regimen both at 4 and 12 weeks (11.4 vs. 35.48%; 16.7 vs. 58.06% respectively). No adverse drug reactions were reported throughout the study. CONCLUSION: We conclude that both premix analogue administered twice a day and four times a day basal bolus regimen appear to be a convenient, safe and effective way of initiating insulin therapy in people with type-2 diabetes. The premix analogues achieves target better than the basal bolus regimen as has better compliance.

Outbreak of human anthrax in Ramabhadrapuram village of Chittoor district in Andhra Pradesh.

Thirty human anthrax cases were reported from Ramabhadrapuram village of Chittoor district in Andhra Pradesh during November-December, 1989. These cases occurred following an epizootic of anthrax among cattle and sheep of the village and ingestion of contaminated meat by the villagers. The overall attack rate was 24.39 per cent with a case fatality of 16.67 per cent. All age groups and both sexes were affected. Ten cases were of cutaneous form with typical black eschar formation which were confirmed bacteriologically. Fever and headache were common systemic manifestations. They responded well to penicillins and there was no mortality. The possibility of human to human spread is suggested. The twenty cases of internal anthrax comprised intestinal, septicemic, peritonitis, meningeal and pulmonary forms. Sub-clinical forms also occurred. Fever, abdominal pain, ascites, anorexia and vomiting were notable features. Diagnosis was made clinically and also on epidemiological basis. All deaths during this outbreak occurred in women with internal anthrax, the case fatality rate for the latter being 25 per cent. Prophylactic administration of penicillin was done for individuals at risk.