Comparison of drug information in package inserts with standard medical textbook of pharmacology

Background: Accurate and reliable drug product information is important for the safe and effective use of medicines. But there are variations in the quantity and quality of information mentioned in different drug information sources and a single credible benchmark is lacking. This study was carried out to compare the presentation and completeness of clinical information in package inserts (PIs) marketed by pharmaceutical companies in India with standard medical textbook of pharmacology.Methods: Out of eighty five PIs of different drugs, only 55 were found eligible to be included in this study after applying inclusion and exclusion criteria. These PIs and medical textbook were analysed for quantitative and qualitative drug information and were compared using Chi square test of two proportions. The p value of 0.05 was used as cut off to evaluate statistical significance.Results: Quantitatively medical textbook was significantly better statistically in context of treatment of overdose and references. No statistically significant difference was observed in relation to information related to mechanism of action (MOA) and pharmacokinetics (Pk). After qualitative analysis, medical textbook was significantly better statistically in context of size and readability, references related to adverse drug reactions (ADRs) and indications and pictures. No statistically significant difference was observed in context of dosing interval, frequency of doses and pharmacokinetic parameters.Conclusions: PIs can be used as a reliable source of drug information by health care professionals in addition to other sources like medical textbooks.

A survey on the knowledge and perception of computer assisted learning among undergraduate medical students in a tertiary care teaching institute of North India

Background: Computer assisted learning (CAL) in the classroom as well as laboratory in the medical profession has been rising in the present scenario worldwide. CAL can replace laboratory based animal experiments to a large extent and prevent the unnecessary harm or killing of animals. In India, only few studies have been conducted on CAL till date. Aims and objective of the study was to evaluate the knowledge and perception on CAL among undergraduate medical students.Methods: This cross sectional study was carried out on the medical students (MBBS-Second Professional) in the department of pharmacology at Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India. Feedback was obtained from 105 students who had already performed animal experiments in CAL laboratory.Results: It was seen that Computer simulated models (CSMs) are useful for undergraduate teaching (by 98.1%), CAL enrich learning experience about drug effects (by 97.1%), CSMs in CAL is user friendly (by 97.1%) and use of CSMs in teaching is ethical (by 97.1%).Conclusions: CAL is an innovative teaching and learning technique for the medical students. This is an effective mode of teaching pharmacology to the students and it also helps the students to apply their theoretical knowledge of drugs to the practical aspects (without use of animal) on computer simulated models.

Comparative study: Efficacy and tolerability of vildagliptin vs. pioglitazone as an add-on therapy to metformin in poorly controlled type 2 diabetes mellitus patients in Punjab.

Introduction: The incidence of diabetes in urban Punjab is on the rise and the number of diabetics is increasing year by year. Material and methods: This 24 week study was designed to compare vildagliptin versus pioglitazone as an add-on therapy in patients of type 2 diabetes mellitus inadequately controlled with metformin alone in Punjabi population. Sixty patients were randomized in two groups to receive either vildagliptin 100 mg (group 1) or pioglitazone 30 mg (group 2) in addition to metformin 1000 mg. The primary efficacy end point was change in FBG, PPG and HbA1c. Secondary end point included lipid profile, body weight and peripheral edema. Results: There was no significant difference between mean reduction in FBG, PPG and HbA1c in both groups. There was significant decrease in mean body weight in group 1 in contrast to significant increase in group 2. Both the treatment groups reported a significant decrease in TG, TC, LDL and increase in HDL. Conclusion: Vildagliptin displays robust efficacy with the added benefits of a much lower risk of peripheral edema, hypoglycemia and no weight gain, making it a promising alternative to pioglitazone as an add-on therapy to metformin in Punjabi population.

Comparative evaluation of voglibose versus pioglitazone on glycaemic control and lipid profile in patients of type 2 diabetes mellitus on glimepiride and metformin in punjabi population.

Background: Type 2 Diabetes mellitus (DM) is a heterogeneous group of disorders associated with both microvascular and macrovascular complications. Due to progressive nature of type 2 DM, dual / triple drug therapy produce additive effects, less side effects and allows the use of submaximal doses of individual agents. Therefore, the present study was designed to study the effect of voglibose in comparison to pioglitazone on glycaemic and lipid profile as an add-on drug in patients with DM whose glycaemic status was uncontrolled with glimepiride and metformin. Methods: The present study was open, randomized parallel group comparison of two active treatment groups over a six months period. Sixty patients of either sex in the age group of 30-75 years, suffering from type 2 DM, with FBG> 126 mg/dl and HbA1c between 7- 10 % were selected at random. The effect of voglibose and pioglitazone were observed on various parameters i.e. FBG, PPBG, HbA1c and lipid profile (Total cholesterol, TG, LDL, VLDL). Results: At the end of 6 months it was observed that though both pioglitazone and voglibose reduced FBG, PPBG and HbA1C significantly but pioglitazone caused a significantly greater percentage change in FBG as well as in PPBG whereas the difference in mean percentage change in HbA1C was not significant. Also, fall in total cholesterol, TG, LDL and VLDL was significantly greater with pioglitazone than voglibose. Few side effects were observed with voglibose and not with pioglitazone. Conclusions: Though pioglitazone and voglibose were equally effective in lowering HbA1C levels yet pioglitazone showed better results in improving FBG, PPBG and lipid profile as compared to voglibose. Pioglitazone had minimal side effects as compared to voglibose.