An acute experimental study to evaluate the effect of gatifloxacin on blood sugar levels in diabetic and non-diabetic rabbits

Background: Diabetes mellitus is a condition characterized by chronic hyperglycemia and disturbance of carbohydrate, fat and protein metabolism associated with absolute or relative deficiencies in insulin secretion and/or insulin action. The objective of this study was to evaluate the effects of gatifloxacin on blood sugar levels in non-diabetic rabbits and alloxan induced diabetic rabbits.Methods: Animals were fasted for 20 hours. Blood was collected for baseline investigations. After giving single oral dose of 2% gum acacia blood samples were drawn at 1, 2 and 4 hours for estimation of glucose and serum insulin. After 2 days a repeat blood sample for baseline was collected after 20 hours fasting and single oral dose of gatifloxacin 25 mg/kg was given. Samples of blood were taken at 1, 2 and 4 hours. After a wash out period of 7 days injection alloxan 140 mg/kg was given slowly intravenously to induce diabetes in the animals. On day 3 after alloxan induction, blood samples were taken from the animals (fasting 20 hours), for baseline investigations. Same procedure of blood collection and timing was followed as done before diabetes induction. The animals were given a single dose of gatifloxacin 25 mg/kg with blood samples drawn at 1, 2 and 4 hours for FBS and serum insulin.Results: In non-diabetic rabbits, the effect of control and gatifloxacin on FBS levels at 1, 2 and 4 hours after administration was 100.3, 101.35, 102.89 mg/dl and 73.83, 73.04, 82.11 mg/dl respectively, on serum insulin levels at 2 hours interval was 3.62 and 4.16 μ IU/ml respectively. 48 hours after alloxan induction FBS and insulin levels were 219.13 and 1.19 μ IU/ml. After alloxan induction, FBS levels at 1, 2, 4 hours for control and gatifloxacin are 221.01, 224.13, 228 and 218.60, 218.53, 220.01 respectively. At 2 hours interval serum insulin levels were 1.15 and 1.21 μ IU/ml for control and gatifloxacin.Conclusions: This study is in line with previous reports that gatifloxacin causes increased release of insulin leading to hypogycemia. The fall in blood sugar levels following a single oral dose of gatifloxacin is not limited to diabetic states alone and is more marked in non-diabetic rabbits

A pharmacovigilance study in patients of chronic non-infective respiratory diseases attending outpatient department of pulmonary medicine in a tertiary care teaching hospital

Background: Adverse drug reactions (ADR) are the known dangers of any medicinal therapy. They are not only responsible for increasing the mortality and morbidity but also for multiplying the health care expenditure. It is important to monitor the adverse effects of the drugs in the patients on treatment for chronic non-infective respiratory diseases attending OPD of pulmonary medicine in a tertiary care teaching hospitalMethods: The study was single-centric, non-randomized and observational hospital-based study which was carried out for a period of 1 and a half years in JJ Hospital. The patients who were included in the study suffered from either of the 4 diseases-Chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis or interstitial lung diseases (ILD). Data were analyzed by using Microsoft excel sheet. Based on the outcome of modified Hartwig and Siegel severity assessment scale, ADRs were grouped into various severity categories.Results: One hundred and thirty-two number of ADRs were seen in 69 out of 352 patients (19.6 %) of the study population. The occurrence of ADR was found slightly higher in males i.e., 53.62% as compared to females i.e., 46.38%. The patients who were on treatment for ILD showed highest percentage of ADRs i.e., 57.89% which is followed by bronchiectasis (17.39%), COPD (16.17%) and lastly asthma (10.26%). The ADRs belonging to GIT system were highest in number i.e., 80. The most frequently occurring ADR in the study was palpitation which occurred in 14 cases i.e., 20.29%. Out of 132 ADRs observed, 96 i.e., 72.73% belonged to the mild category and 36 ADRs i.e., 27.27% belonged to the moderate category. Not a single severe ADR was found in the study.Conclusions: It was found that 19.6% of the patient population suffered from ADRs, which is a considerable number. It is essential that health care professionals should support ADR monitoring process for the safety of the medicinal product. Proper implementation of ADR monitoring will help to reduce the harmful effects by early detection of drug safety problems in patients, assessing the risk-benefit in an individual and the population, improving the selection, rational use of drugs through the provision of timely warning to healthcare professionals

A pharmacovigilance study in patients of chronic non-infective respiratory diseases attending outpatient department of pulmonary medicine in a tertiary care teaching hospital

Background: Adverse drug reactions (ADR) are the known dangers of any medicinal therapy. They are not only responsible for increasing the mortality and morbidity but also for multiplying the health care expenditure. It is important to monitor the adverse effects of the drugs in the patients on treatment for chronic non-infective respiratory diseases attending OPD of pulmonary medicine in a tertiary care teaching hospitalMethods: The study was single-centric, non-randomized and observational hospital-based study which was carried out for a period of 1 and a half years in JJ Hospital. The patients who were included in the study suffered from either of the 4 diseases-Chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis or interstitial lung diseases (ILD). Data were analyzed by using Microsoft excel sheet. Based on the outcome of modified Hartwig and Siegel severity assessment scale, ADRs were grouped into various severity categories.Results: One hundred and thirty-two number of ADRs were seen in 69 out of 352 patients (19.6 %) of the study population. The occurrence of ADR was found slightly higher in males i.e., 53.62% as compared to females i.e., 46.38%. The patients who were on treatment for ILD showed highest percentage of ADRs i.e., 57.89% which is followed by bronchiectasis (17.39%), COPD (16.17%) and lastly asthma (10.26%). The ADRs belonging to GIT system were highest in number i.e., 80. The most frequently occurring ADR in the study was palpitation which occurred in 14 cases i.e., 20.29%. Out of 132 ADRs observed, 96 i.e., 72.73% belonged to the mild category and 36 ADRs i.e., 27.27% belonged to the moderate category. Not a single severe ADR was found in the study.Conclusions: It was found that 19.6% of the patient population suffered from ADRs, which is a considerable number. It is essential that health care professionals should support ADR monitoring process for the safety of the medicinal product. Proper implementation of ADR monitoring will help to reduce the harmful effects by early detection of drug safety problems in patients, assessing the risk-benefit in an individual and the population, improving the selection, rational use of drugs through the provision of timely warning to healthcare professionals.</jats:p

Safety and Immunogenicity of a novel three-dose recombinant nanoparticle rabies G protein vaccine administered as simulated post exposure immunization: A randomized, comparator controlled, multicenter, phase III clinical study

Background Rabies vaccines are lifesaving in human post animal exposure. However, the compliance to the complete course of vaccine is found to be only 60%. Hence, there is a need for safe and immunogenic, shorter course vaccine that can enhance the compliance and effectively prevent the disease. Objectives To establish a noninferiority of a novel three-dose recombinant rabies G protein vaccine to be administered as simulated postexposure prophylaxis when compared to five-dose WHO prequalified vaccine for better safety and immunogenicity. Methods A multi-centric, open label, assessor blind, center-specific block randomized, parallel design, phase III clinical study was conducted among 800 subjects. The eligible subjects were randomized in 2:1 ratio for recombinant rabies G protein vaccine and the reference vaccine. Subjects in recombinant rabies G protein vaccine arm received three doses of vaccine on days 0, 3, and 7, while subjects in reference vaccine arm received five doses of WHO prequalified vaccine on days 0, 3, 7, 14, and 28. Results The socio-demographic characteristics of the two arms were comparable. About 9.9% subjects in recombinant rabies G protein vaccine arm and 17.2% subjects in reference arm reported adverse events. The sero-protection on day 14 was found to be 99.24% and 97.72% in recombinant rabies G protein vaccine arm and reference vaccine arm respectively and the difference was statistically nonsignificant. Conclusion The novel three-dose recombinant rabies G protein vaccine administered as simulated postexposure prophylaxis was noninferior to five dose WHO prequalified vaccine in terms of safety and immunogenicity