Abstract
A PHARMACOVIGILANCE STUDY ON EVALUATION OF CORRELATION BETWEEN DIFFERENT THERAPY OPTIONS, INHALATION-DEVICES, METHODS OF DEVICES AND SAFETY OUTCOME IN COPD PATIENTS

Bapna Rajendra Singh*, Nema Rajesh Kumar, Vyas Achla, Shrivastava Vivek and Jain Meeta

ABSTRACT

This MAIDEN study is an effort to observe multiple factors simultaneously with number of interesting findings. Study data were first analyzed with the help of PIVOT TABLE to see the correlation between any two or three factors and then statistical tests were applied. Patients with confirm diagnosis of COPD from 30 year to 90 year from both gender were enrolled and observed for four months with recording of all inputs (i.e. drug combination, device and compliance to device) and outputs (i.e. improvement in FEV1, category of disease stage, side effect, infection rate, blood pressure etc). All labeled side effects, including cardiac events were observed in each category and prevalence matched with earlier studies. However, there were patients who did not had any side effect in each drug combination, therefore an appropriate combination can be selected which does not affect quality of life adversely due to side effects and reduce burden of co-prescription. Vertigo and rise in blood pressure were found in significant percentage, which suggests conducting a long-term study to further confirm the causality of ADRs with COPD treatment. Patients receiving Theophylline should be monitored more closely for increase in ADR. 62% patients were not able to comply well with devices specially inhalers, suggesting spacer as better choice followed by Rotacap (DPI). A meticulous follow-up for 6 months after initiating COPD treatment is advised to select the best drug combination for optimum safety and correct use of device.

Keywords: COPD, Inhalation Devices, Safety, Therapy Options, ADR, Side-Effects.


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