ABSTRACT
Background: The research and marketing of a new drug requires a lot of money by the pharmaceutical companies. Promotion through advertising brochures and leafl ets is widely used to infl uence the physicians. Most of the times, this information is the only source of new drug information for the physicians. Hence, this study to analyze the appropriateness, accuracy, and validity of promotional drug literatures was undertaken. Methods: Promotional materials were collected from outpatient departments of C. U. Shah Medical College and Hospital, Surendranagr. They were evaluated according to the “WHO criteria, 1988,” and the references cited to support the claims were checked for their validity and authenticity. The images and the pictorial content were evaluated to fi nd out any biased nature of gender representation. Results: Evaluation of the total 486 brochures showed that none of them fulfi lled all the nine criteria. Of the 308 claims, only 208 (42.79%) gave references to support the claims. Only 27 (39.13%) of the research articles among the 125 journal article cited were of high methodological quality. Among the 218 human fi gures, 144 were patients, and 103 were doctors. Female patients (62.5%) were depicted more than male patients (37.5%). Conclusion: The present study showed that pharmaceutical companies do not strictly follow the WHO guidelines and majority of the research were sponsored by companies. Hence, more stringent regulations need to be implemented for the proper promotion and dissemination of information about the new drugs.
ABSTRACT
Background: Cardiovascular diseases (CVDs) are the major cause of death globally. Dyslipidemia is one of the most significant risk factors for CVD. 3-hydroxy 3-methyl glutaryl coenzyme A reductase inhibitors (statins), which are used for the treatment of dyslipidemia, has a beneficial effect in both primary and secondary prevention of CVD. Hence, this study was done to compare the efficacy and safety of atorvastatin versus pitavastatin in patients of dyslipidemias. Methods: After obtaining ethical clearance from institution and written informed consent from patients, 100 patients included in the study were randomly allocated to any of the following two groups. (1) Group A: Tablet atorvastatin 10 mg given orally once a day for 12 weeks. (2) Group B: Tablet pitavastatin 2 mg given orally once a day for 12 weeks. The primary endpoint of the study was a comparative assessment of change in lipid profile (triglyceride, low-density lipoprotein [LDL], high-density lipoprotein [HDL]) from baseline and after 12 weeks. The secondary endpoint involved recording all the adverse effects during the study. Results: Analysis of the baseline and post 12 weeks lipid levels by non-parametric unpaired t-test showed a statistically significant increase in HDL-cholesterol (HDL-C) in Group B as compared to Group A (p=0.028 i.e. p<0.05). However, there was no significant difference between two groups in decreasing LDL-cholesterol (LDL-C) (p=0.615). Conclusions: In this study, pitavastatin is found to be more efficacious than atorvastatin in increasing HDL-C levels, while as efficacious as atorvastatin in decreasing LDL-C in dyslipidemic patients. Atorvastatin is better tolerated than pitavastatin.