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Vol.78 No.4
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Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease

Tuberculosis & Respiratory Diseases / Tuberculosis & Respiratory Diseases,
2015, v.78 no.4, pp.321-325







& (2015). Effect of a Dose-Escalation Regimen for Improving Adherence to Roflumilast in Patients with Chronic Obstructive Pulmonary Disease. Tuberculosis & Respiratory Diseases, 78(4), 321-325.
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Abstract

Background: The adverse effects of the phosphodiesterase-4 inhibitor roflumilast, appear to be more frequent in clinicalpractice than what was observed in chronic obstructive pulmonary disease (COPD) clinical trials. Thus, we designed thisstudy to determine whether adverse effects could be reduced by starting roflumilast at half the dose, and then increasinga few weeks later to 500 μg daily. Methods: We retrospectively investigated 85 patients with COPD who had taken either 500 μg roflumilast, or a startingdose of 250 μg and then increased to 500 μg. We analyzed all adverse events and assessed differences between patientswho continued taking the drug after dose escalation and those who had stopped. Results: Adverse events were reported by 22 of the 85 patients (25.9%). The most common adverse event was diarrhea(10.6%). Of the 52 patients who had increased from a starting dose of 250 μg roflumilast to 500 μg, 43 (82.7%) successfullymaintained the 500 μg roflumilast dose. No difference in factors likely to affect the risk of adverse effects, was detectedbetween the dose-escalated and the discontinued groups. Of the 26 patients who started with the 500 μg roflumilastregimen, seven (26.9%) discontinued because of adverse effects. There was no statistically significant difference indiscontinuation rate between the dose-escalated and the control groups (p=0.22). Conclusion: Escalating the roflumilast dose may reduce treatment-related adverse effects and improve tolerance to thefull dose. This study suggests that the dose-escalated regimen reduced the rate of discontinuation. However, longer-termand larger-scale studies are needed to support the full benefit of a dose escalation strategy.

keywords
Pulmonary Disease, Chronic Obstructive, Phosphodiesterase 4 Inhibitors, Clinical Protocols, Therapeutics

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