Published: 2019-08-28

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

Dharmaraj B., Abhijith L. M., Jagadeesh K., Basavaraj S.


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.


Adverse drug reactions, Safety, LABA, ICS, COPD, GOLD

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Lozano R, Naghavi M, Foreman K. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2095-128.

Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (Online). Updated 2018. Available at: Item.asp. Accessed on 3 June 2019.

Lopez AD, Shibuya K, Rao C, Mathers CD, Hansell AL, Held LS, et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006;27:397-412.

Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005;142:233-9.

Celli BR, MacNee W. ATS/ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: A summary of the ATS/ERS position paper. Eur Respir J. 2004;23:932–46.

Oostenbrink JB, Rutten-van Mölken MP, Al MJ, van Noord JA, Vincken W. One-year cost-effectiveness of tiotropium versus ipratropium to treat chronic obstructive pulmonary disease. Eur Respir J. 2004;23:241–9.

Wedzicha JA, Calverley PMA, Seemungal TA. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/ fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med. 2008;177:19–26.

Hanania NA, Crater GD, Morris AN. Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD. J Respir Med. 2012;106:91-101.