A recent phase III trial revealed that an inexpensive antidepressant, mirtazapine, proved to be no more effective than a placebo in alleviating severe and persistent breathlessness in patients with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). This study, led by Irene Higginson, BMBS, PhD, from Kings College London, found that after 56 days of treatment, there was no significant difference in the “worst breathlessness” experienced by patients who received mirtazapine compared to those who received a placebo. This finding is crucial given the limited medication options available to treat severe breathlessness, which affects 75 million individuals globally.
Severe breathlessness is a common issue among COPD and ILD patients and often leads to emergency admissions. In the absence of effective treatments, healthcare professionals have resorted to off-label medications such as opioids, benzodiazepines, and antidepressants. Mirtazapine, an oral tetracyclic antidepressant known for reducing feelings of panic, seemed a promising option based on previous case reports and a feasibility study. However, the current study failed to demonstrate any significant benefit of mirtazapine in alleviating severe breathlessness.
The results of this study suggest that using mirtazapine or other antidepressants off-label to treat severe breathlessness may not be advisable. In her closing remarks, Higginson emphasized the need for caution when utilizing medications outside their approved indications. Given the lack of substantial benefits observed in the trial, healthcare professionals should consider alternative approaches to managing severe breathlessness in COPD and ILD patients. The editorial accompanying the study highlighted the importance of individualized care that addresses the physical, psychological, social, and spiritual aspects of breathlessness.
The BETTER-B trial enrolled 225 patients with severe breathlessness from COPD, ILD, or both, who were randomized to receive either mirtazapine or a placebo. Participants were monitored for 56 days, with outcomes measured using a 0-10 numeric rating scale. While the study did not demonstrate a significant difference in breathlessness scores between the two groups, patients receiving mirtazapine reported higher rates of adverse events and healthcare utilization. These findings underscore the importance of careful consideration when prescribing off-label medications to manage symptoms in respiratory patients.
It is essential to acknowledge the limitations of the study, including its recruitment challenges and the impact of external factors such as the COVID-19 pandemic. The trial was underpowered due to lower-than-expected enrollment, which may have influenced the study outcomes. Moving forward, additional research is needed to explore more effective and targeted interventions for managing severe breathlessness in patients with COPD and ILD. A personalized approach that considers the holistic needs of the patient could lead to better outcomes and improved quality of life.
The study findings suggest that mirtazapine is not a viable option for alleviating severe breathlessness in COPD and ILD patients. Healthcare professionals should exercise caution when considering off-label medications and focus on holistic approaches to symptom management. By taking into account the physical, psychological, social, and spiritual aspects of breathlessness, caregivers can provide more comprehensive and effective support to patients with respiratory conditions.
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