RESUMO
Objective: : To observe the effect of statins on cardiac autonomic neuropathy in patients with diabetes and to study the correlation between cardiac autonomic neuropathy as assessed by cardiac autonomic reflex tests (CARTs) and by Composite Autonomic Symptom Scale (COMPASS)-31. Materials and Methods: A cross-sectional observational study was conducted on 62 patients having Type 2 diabetes mellitus for more than 5 years. Patients were randomized into two groups, one group received standard antidiabetic therapy and other group received standard antidiabetic along with statin medication at least for more than 1 year. Each patient underwent CART and heart rate variability to assess autonomic dysfunction. In addition, COMPASS 31 questionnaire was used to evaluate symptoms subjectively. Statin Experience Assessment Questionnaire was used to note adverse effects of statins. Chi-square test, Spearman correlation test, and Mann–Whitney U-test were used for statistical analysis. Results: A significant difference in severity of cardiac autonomic dysfunction was observed between two groups as measured by CART (P = 0.016) and COMPASS-31 questionnaire (P = 0.008). Moreover, COMPASS score of >16 was observed in patients with advanced cardiac autonomic neuropathy. A significant correlation was found between COMPASS 31 score and CART results (r = 0.29, P = 0.02). Conclusion: Our study highlights the potential utility of statins in curbing progression of cardiac autonomic neuropathy and can be safely administered in patients with Type 2 diabetes mellitus. COMPASS 31 questionnaire can be used as an effective screening tool for CART referral, facilitating the early detection of cardiac autonomic neuropathy.
RESUMO
Background: Directly observed treatment short course (DOTS) is a cornerstone of Revised National Tuberculosis Control Program of India. Adverse drug reactions (ADRs) induced by this therapy is common and it causes signifi cant morbidity and mortality. Hence, the present study was undertaken to determine the incidence and pattern of ADRs and to assess causality and severity. Methods: We conducted prospective, observational study at DOTS center of tertiary care hospital, Pune. 150 pulmonary tuberculosis patients undergoing DOTS therapy were enrolled. They were monitored weekly in an intensive phase and monthly in the continuation phase. The suspected ADRs were recorded and assessed for causality and severity by standard algorithms. Results: Incidence of ADRs due to DOTS was 19.33% & total 35 ADRs had occurred in our study. Gastrointestinal intolerance, arthralgia & itching with or without rashes were most common ADRs (incidence rates: 12.67%, 2.67% and 2.67%, respectively). On evaluation of causality by Naranjo algorithm, majority of ADRs 91.43% were “possible.” As per WHO- Uppsala Monitoring Center scale, majority of ADRs 91.43% were “possible.” As per Modifi ed Hartwig and Siegel scale, majority of ADRs were “moderate” (48.57%) but 8.57% were “severe.” Female gender was found to be a signifi cant risk factor for developing ADRs (odds ratio: 3.08, 95% confi dence interval: 1.33-7.12. 3.33%). ADRs & hepatotoxicity was major reason for defaulting from DOTS (60%). Conclusion: ADRs induced by DOTS are common and there is need of incorporating pharmacovigilance system for this vital public health program. Counseling of patients for timely prevention, detection, and management of ADRs will help in minimizing the further occurrence of ADRs.