Efficacy, safety and acceptability of biphasic insulin aspart 30 in Indian patients with type 2 diabetes: results from the PRESENT study.

AIM: The Physicians' Routine Evaluation of Safety and Efficacy of NovoMix 30 Therapy (PRESENT) study was done to assess the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in patients with type 2 diabetes mellitus in routine clinical practice. MATERIALS AND METHODS: This was a prospective, multicentric, multinational, observational study in type 2 diabetes patients. The patients were transferred to BIAsp 30 with or without oral antidiabetic drugs (OADs). We present the results of 6 months of treatment in the Indian cohort (n = 3559) with type 2 diabetes mellitus who were inadequately controlled on current treatment. RESULTS: At three and six months, significant reductions from baseline were observed in the mean glycated haemoglobin (HbA1c) (-1.32% and -1.94%), fasting plasma glucose (-56.16 mg/dl and -75.24 mg/dl) and post-prandial plasma glucose (-88.74 mg/dl and -119.16 mg/dl) (p < 0.001). A significantly greater proportion of patients achieved target HbAlc of less than 7% at six months (31.1%), compared with baseline (3.1%), of which 70.4% did not report hypoglycaemia. The rate of total hypoglycaemia was reduced from 3.1 events per patient-year at baseline to 1.5 events per patient-year at end of the study. Episodes were mostly minor and diurnal. Except for two serious adverse drug reactions (ADRs) reported by one patient at 3 months, there were no reports of ADRs during the treatment period. More than 95% of patients and doctors were "very satisfied" or "satisfied" with BIAsp 30 treatment, compared to previous treatment. CONCLUSIONS: The use of BIAsp 30 monotherapy or in combination with OADs in clinical practice was effective and safe in poorly controlled Indian type 2 diabetes patients. Both patients and doctors showed a high degree of treatment satisfaction.

Pediatric tonsillopharyngitis--an evaluation of cefprozil in Indian patients.

OBJECTIVE: The emergence of penicillin resistant strains and the presence of co-pathogens have made the treatment of bacterial infections in children a challenge. Streptococcal tonsillopharyngitis, which is a common infection has been well treated with cefprozil, a novel third generation cephalosporin. The aim of the present study was to evaluate cefprozil in pediatric tonsillopharyngitis. An assessment of the clinical cure and bacteriological eradication rates and an overall tolerability was made. METHODS: It was a prospective, open, non-comparative multicentric study. 316 children (mean age 6.61 years) with tonsillopharyngitis were included. Patients were given cefprozil susp 15 mg/kg/day in two divided doses a day for 10 days. RESULTS: A clinical cure of 96.6% and bacteriological eradication of 94.29% was achieved with cefprozil. Overall tolerability of cefprozil was assessed by physicians and 46% rated tolerability of cefprozil as excellent, 38% as very good, 10% as good, 6% as fair and none as poor. CONCLUSION: Cefprozil has been found to be an excellent drug of superior microbiological and clinical activity in the treatment of pediatric patients with tonsillopharyngitis. The drug also has an expanded spectrum.

Comparative evaluation of cefpodoxime versus cefixime in children with lower respiratory tract infections.

OBJECTIVE: The emergence of penicillin and macrolide resistant strains, responsible for Acute Lower Respiratory Tract Infections in children has offered third generation cephalosporins the platform to perform. The aim of the present study was to evaluate two third generation oral cephalosporins for their empirical use in community acquired lower respiratory tract infections in pediatric patients. An assessment of the clinical cure and bacteriological eradication rates and an overall tolerability was made. METHODS: It was a prospective, open, comparative, multicentric study. 776 children (Mean age 10 years) with LRTIs were included and randomly allotted to two groups respectively. A total of 396 children were given cefpodoxime susp 5 mg/kg b.i.d. and 380 patients on cefixime 4 mg/kg b.i.d. for 10-14 days. RESULTS: At the end of therapy, the clinical success with cefpodoxime was 97% as against 86.8% with cefixime. Bacterial eradication was 93.4% with cefpodoxime and 82.9% with cefixime. CONCLUSION: Cefpodoxime has been found to be a well-tolerated and superior alternative to cefixime synergistically documenting the extended spectrum of activity.

Possible role of histamine receptors in the central regulation of immune responses.

The present study was designed to delineate the role of H1- and H2-histamine receptors in the neuro-immune regulation in rats. The effects of H1- and H2-receptor antagonists on humoral and cell-mediated immune (HI and CMI) responses were investigated after intraperitoneal (i.p.) and intra-cerebroventricular (i.c.v.) administration. HI response was assayed by anti-sheep red blood cell (SRBC) antibody titre in presence and absence of 2-mercaptoethanol (2-ME). The CMI responses were evaluated by delayed type hypersensitivity (DTH) reaction (in vivo), i.e., measurement of footpad thickness, and lymphokine activity such as leucocyte migration inhibition (LMI) test (in vitro). On i.p. administration, both H1- (pheniramine and astemizole) and H2-receptor antagonists (ranitidine and cimetidine) were observed to produce significant enhancement of anti-SRBC antibody response. However, only H2- and not H1-receptor blockers were observed to stimulate CMI response significantly. When administered by icv route, only H2-receptor antagonists caused a statistically significant increase in both HI and CMI responses, while the H1-receptor blockers failed to modify the same. Thus, H2-receptors appear to play a major role in the histaminergic mechanisms involved in immunomodulation both at the level of immunocompetent cells active in the peripheral tissues as well as through the central nervous system structures involved in the central regulation of neuro-immune interaction.

Critical evaluation of references in drug advertisements: an Indian experience.

Drug advertisements have important effect in prescribing habits of physicians. WHO states that all the claims in drug advertisements should be supported by suitable documentary evidences (references). The present study evaluated citations (mentioned/not mentioned), sources (journals, books, conferences/symposia, personal testimonial, unpublished data in file) and adequacy (complete/incomplete) of the references in 585 drug advertisements supplied by medical detail persons to different clinical departments of our hospital. The references were cited only in 37.9% of the drug advertisements. In total, 1032 references (76% of journals, 15% of books, 2% of conferences/symposia, 4% of personal testimonials, 1% of unpublished data and 2% of data in file) were cited. Only 10% references of journals, 7% of books and 12% of conferences/symposia were found complete (according to standard bibliographic norms). The current situation can be improved if the government, industry and the prescribers formulate some guidelines for the mentioning of adequate references in drug advertisements.