Using inhaled corticosteroids in COPD increases TB, pneumonia rates

Mortality rates did not differ between patients with COPD who used inhaled corticosteroids vs those who did not

Tuberculosis and pneumonia are recognized as serious side effects of ICS in patients with COPD, yet overprescription of ICS appears common for this population. Investigators in South Korea sought to examine the real-world impact of ICS on COPD prognosis. Mortality, acute exacerbations, and pneumonia were primary endpoints. Secondary endpoints were heart failure, arrhythmia, hypertension, diabetes mellitus, osteoporosis, lung cancer, cerebrovascular stroke, ischemic heart disease, and tuberculosis were secondary endpoints.

The researchers conducted a retrospective observational study using the Korean National Health and Nutrition Examination Survey (KNHANES) database (including survey data from about 10,000 individuals each year) linked to Health Insurance and Review Assessment (HIRA) data (comprehensive health-care treatments, procedures, pharmaceuticals, and diagnoses for about 50 million beneficiaries in South Korea). The current study included data on 978 patients (4.1% women) with COPD from January 2009 through December 2012; based on their ICS use status, these patients were assigned to the ICS cohort (n=85; mean [SD] age, 66.7 [8.9] years) or the non-ICS cohort (n=893; mean age, 63.7 [9.7] years). The 85 eligible patients using ICS all had a prescription for inhaled respiratory medication for at least 120 days during the observation period (ICS, 13 patients; ICS/long-acting beta-agonists [LABA], 42 patients; ICS/LABA/long-acting muscarinic antagonist [LAMA], 30 patients).

All participants smoked currently or formerly, had a 10 pack-year smoking history with no history of cancer, had a pre-bronchodilator ratio of forced expiratory volume in 1 second to forced vital capacity (FEV₁/FVC) less than 0.7, and were at least 40 years of age. Cox proportional hazard regression analysis was used to identify variables significantly associated with the occurrence of mortality, acute exacerbation, and pneumonia development.

At study enrollment, common comorbidities included hypertension (33.2%), diabetes mellitus (12.2%), and hypercholesterolemia (6.5%), and those using ICS had lower FEV₁, lower FEV₁/FVC ratio, and higher smoking levels than those who did not use ICS upon enrollment.

In comparing the ICS and non-ICS cohorts, the researchers found the ICS cohort had higher rates of acute exacerbations, tuberculosis, and pneumonia as well as hospitalization due to respiratory causes (all P <.05).  Multivariate analyses further showed that: (1) acute COPD exacerbations were independently associated with the development of pneumonia (P <.05); (2) pneumonia, ICS therapy, FEV₁, and older age were independently associated with acute exacerbation occurrence (P <.05); (3) concomitant pneumonia (hazard ratio, 3.353; P =.004) was independently associated with higher mortality (P <.05); and (4) mortality rates did not differ between patients who used ICS vs those who did not.

Study limitations include the underpowered sample size of patients using ICS and the fact that the observation period for this study occurred prior to implementation of current therapeutic standards for COPD.

“Our data demonstrated that the ICS users had a higher rate of pneumonia and tuberculosis and the concomitant pneumonia was independently associated with higher mortality, highlighting the importance of cautious and targeted administration of ICS in COPD,” investigators concluded. They wrote “The number of subjects enrolled in our study is not big enough to conclude the harmful side effects of ICS in subgroups of COPD.”

References:

Park JW, Hong Y, Rhee CK, et al. The impact of inhaled corticosteroids on the prognosis of chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. Published online May 2, 2023. doi:10.2147/COPD.S388367

Source: Pulmonology Advisor