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Pulmonary Adverse Events in Patients Receiving Low-Dose Methotrexate in the Randomized, Double-Blind,
Jeffrey A Sparks1, Paul F Dellaripa1, Robert J Glynn1
1Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Low-dose methotrexate (MTX) increases the risk of pulmonary adverse events (AEs), including pneumonitis. Risk factors for MTX-related pulmonary AEs include white race, older age, female sex, and insulin use.
Area of Science:
- Cardiology
- Pulmonology
- Pharmacology
Background:
- Low-dose methotrexate (MTX) is used for various conditions.
- Previous studies indicated a potential link between MTX and pulmonary adverse events (AEs).
Purpose of the Study:
- To identify predictors and assess the severity of pulmonary AEs in patients receiving low-dose MTX.
- To analyze data from the Cardiovascular Inflammation Reduction Trial (CVIRT) focusing on pulmonary complications.
Main Methods:
- A prespecified analysis of pulmonary AEs was conducted within the CVIRT.
- Adults with cardiovascular disease and diabetes/metabolic syndrome were randomized to low-dose MTX or placebo.
- Pulmonary AEs were adjudicated in a blinded manner, and risk factors were examined.
Main Results:
- Pulmonary AEs, including pneumonitis, were more frequent in the low-dose MTX group compared to placebo.
- Risk factors for any pulmonary AE in the MTX group included female sex, white race, and insulin use.
- Older age at baseline was the only identified risk factor for severe pulmonary AEs.
Conclusions:
- Low-dose MTX is associated with an increased risk of pulmonary AEs, though uncommon.
- Specific patient characteristics, including race, age, sex, and medication use, predict the risk of pulmonary AEs.
- These findings are crucial for risk-benefit assessments in patients treated with low-dose MTX.
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