Comparison of safety pattern of drugs used in chronic obstructive pulmonary disease patients in a tertiary care hospital

ABSTRACT

Background: As per GOLD (Global initiative for chronic obstructive lung disease) guidelines bronchodilators are required for symptomatic treatment of chronic obstructive pulmonary disease (COPD) patients. Currently there is no evidence to say about the safety of fixed dose combinations used in COPD patients. Since the drugs are to be taken for longer period, it is essential to know the safety aspects of these drugs. Moreover we don’t have adequate studies and documentation to say that a particular drug combination is better and safer for COPD patients.Methods: Prospective, open labelled, randomized, comparative, interventional clinical study conducted by the Departments of Pharmacology and Pulmonary Medicine of Basaveshwara Medical College and Hospital, Chitradurga in 40 COPD patients.Results: The fixed dose combinations of drugs used in both the treatment groups i.e. salmeterol/fluticasone and tiotropium/formoterol were equally safer and well tolerated. Some side effects noticed during the course of treatment were statistically significant when compared between the 2 groups, however they were milder and predictable adverse drug reactions.Conclusions: Systemic and severe adverse drug reactions were not observed during 8 week treatment period and the local side effects observed were mild in both the treatment groups. Hence the fixed dose combinations of salmeterol or fluticasone and tiotropium or formoterol are found to be safer for maintenance therapy in COPD patients.