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

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.

The comparisons of the efficacy of two fixed dose combinations, i.e. Salmeterol and Fluticasone vs. Formoterol and Tiotropium bromide in moderate to severe COPD patients

Background: Bronchodilators are essential for symptomatic management of all stages of chronic obstructive pulmonary disease (COPD). For patients whose COPD is not sufficiently controlled by monotherapy, combining a ß2-agonist with either inhaled steroid or anticholinergic drug is a convenient way of delivering treatment. Currently, there is no documentation to say that one drug is superior to other or the contrary, but a combination of two drugs is more effective than giving single drug alone in patients suffering from COPD.Methods: The study was prospective, open labelled, randomized, comparative interventional clinical study conducted by the Departments of Pharmacology and Medicine, Basaveshwara Medical College and Hospital, Chitradurga in 60 moderates to severe COPD patients.Results: Both the treatments i.e. Salmeterol/Fluticasone and Tiotropium/Formoterol were equally effective as far as the improvement of the lung functions and Borg dyspnoea score are concerned. The difference in improvement with the combination of Salmeterol/Fluticasone was not statistically significant (p>0.05) compared to the combination of Tiotropium/Formoterol. However, Salmeterol/Fluticasone was found to be better than Tiotropium/Formoterol in improving the lung function of moderate to severe COPD patients.Conclusions: Salmeterol/Fluticasone is efficacious and better than Tiotropium /Formoterol combination for maintenance therapy in moderate to severe COPD patients.