Randomised study to compare the efficacy and safety of isapgol plus atorvastatin versus atorvastatin alone in subjects with hypercholesterolaemia.

Soluble fibre has been shown to augment the cholesterol-lowering effects of low-fat diets in individuals with mild to moderate hypercholesterolaemia. Combination therapy with a statin poses advantages in certain settings and may allow use of lower doses of multiple drugs rather than maximum doses of a single drug. The primary objective of the study was to compare the efficacy of combination of isapgol and atorvastatin versus atorvastatin alone, in the same dose, in reduction of low-density lipoprotein cholesterol (LDL-C), total-cholesterol levels in hypercholesterolaemic patients after 12 weeks of therapy. In a 12-week study, 100 subjects from both sexes and of > 20 years having hyperlipidaemia, with LDL-C level > 130 mg/dl and total cholesterol > 220 mg/dl were included, and were randomised to receive either a combination of isapgol powder (Naturolax) 5.6 g twice daily and atorvastatin 10 mg once daily or atorvastatin 10 mg once daily alone orally. Serum levels of total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglyceride were assessed at 8 and 12 weeks. Ninety-seven patients completed the study. At the end of the 8th week, both the groups had a significant reduction in mean LDL-C (20.5% in isapgol + atorvastatin group and 16.0% among atorvastatin alone group) as compared to baseline. But between the groups, however, the difference was not significant. At the end of the 12th week fall in LDL-C at 31.4% for isapgol + atorvastatin was significantly greater than 22.8% among the atorvastatin group (p < 0.05). Serum total cholesterol, HDL-C and triglyceride were significantly lowered within the groups at 8th and 12th weeks but between groups, the difference was not significant. Comparison of adverse events profile in both the groups shows that more number of patients from atorvastatin alone group (n = 14, 28%) had adverse reactions than the number of patients from the combination group (n = 4, 8%; p < 005).

Immunogenicity study of Haemophilus influenzae type B conjugate vaccine in Indian infants.

OBJECTIVE: To assess the immunogenicity in Indian infants to Haemophilus influenzae b oligosaccharide conjugate vaccine (HbOC). DESIGN: Prospective multicenter study. SETTING: Pediatric Out Patient Department of general hospitals in Pune and Mumbai. SUBJECTS: 124 full term healthy infants brought for routine DPT/OPV immunization. METHODS: Infants were administered 3 doses of 0.5 ml of HbOC, on the same day as their DPT/OPV immunization, injected intramuscularly on the limb opposite to that where DPT vaccine was administered. Data on local reactions and general symptoms was collected for three days after every dose. The children had their blood collected for assay of anti PRP (polyribosil ribitol phosphate) antibody titers, along with the first injection and one month after the third injection. One hundred and three infants completed the study protocol with two blood collections. RESULTS: The initial geometric mean titers (GMT) of 0.124 mcg/ml rose by 37 times to 4.552 mcg/ml. Ninety eight children (95.1%) had a final titer of > or = 0.15 mcg/ml, the minimum level associated with protection, and 77 children (74.8%) had a final level of > or = 1.0 mcg/ml, a level associated with long term protection. CONCLUSION: HbOC is immunogenic in Indian infants when used as per the locally recommended DPT/OPV immunization schedule.

Comparative evaluation of the antipyretic efficacy of ibuprofen and paracetamol.

An open multicentric trial was conducted on 175 patients to compare the antipyretic efficacy of ibuprofen (7 mg/kg) and paracetamol (8 mg/kg). Children between the age of 4 months and 12 years with fever were admitted to the study, 85 in the ibuprofen group and 90 in the paracetamol group. The axillary temperatures were recorded at half hourly intervals for 2 hours. The mean fall in temperature at 1, 1.5 and 2 hours was similar in both groups and the differences were not statistically significant (p greater than 0.05). At half hour, the fall in temperature (mean +/- SEM) for ibuprofen was 0.1975 +/- 0.0409 and for paracetamol was 0.3843 +/- 0.0490. This absolute difference of 0.19 degrees C was statistically significant (p less than 0.05). We conclude that ibuprofen has antipyretic activity comparable to that of paracetamol and that it could be a valuable alternative antipyretic in clinical practice. There is a need to repeat this trial with higher doses of ibuprofen, to establish a dose response of the drug, if any, and to find an optimally effective dose.