Citation

Lipari M, Kale-Pradhan PB. Ther. Clin. Risk Manag. 2014; 10: 969-976.

Copyright

(Copyright © 2014, Dove Press)

DOI

10.2147/TCRM.S55105

PMID

unavailable

Abstract

Rofumilast is a selective phosphodiesterase-4 (PDE-4) inhibitor that was approved by the US Food and Drug Administration in February 2011 for the management of chronic obstructive pulmonary disease (COPD). Literature was retrieved through PubMed using the terms "rofumilast" and "COPD". Reference citations from publications identifed were also reviewed. All articles published in English using the terms "rofumilast" and "COPD" were retrieved. For evaluation of clinical effcacy, published Phase III studies and pooled analyses of Phase III trials were included. In seven published Phase III trials, rofumilast at 500 μg daily showed improvements in lung function as measured by pre- and post-bronchodilator forced expiratory volume in 1 second. Rofumilast appears to be useful in vulnerable patients who are at high risk for exacerbations. Rofumilast was found to be effective when administered alone and with concomitant long-acting bronchodilator therapy in the Caucasian and Asian population. Patients with severe-to-very severe COPD, chronic bronchitis, and frequent history of exacerbations derived the greatest beneft with rofumilast. Compared to the standard of care therapies, rofumilast is more cost-prohibitive. Rofumilast was well tolerated, with the most common adverse events observed in clinical trials being diarrhea, nausea, and headache. Weight loss and increased risk of psychiatric events have also been observed with rofumilast in clinical trials. Rofumilast is a safe and effective option for the treatment of COPD. © 2014 Lipari and Kale-Pradhan.

Language: en

Keywords

human; suicide; Review; ischemic heart disease; insomnia; depression; anxiety; suicide attempt; heart failure; comorbidity; disease severity; Asian; mental disease; weight reduction; drug metabolism; area under the curve; headache; gastrointestinal symptom; osteoporosis; drug safety; placebo; drug cost; drug efficacy; beta adrenergic receptor blocking agent; diarrhea; nausea; cost effectiveness analysis; drug withdrawal; disease exacerbation; beta adrenergic receptor stimulating agent; corticosteroid; cardiovascular disease; respiratory tract disease; cholinergic receptor blocking agent; Caucasian; muscle weakness; drug half life; chronic obstructive lung disease; body weight disorder; quality adjusted life year; drug bioavailability; muscarinic receptor blocking agent; single drug dose; antiinflammatory activity; drug protein binding; tiotropium bromide; maximum plasma concentration; salmeterol; forced expiratory volume; chronic bronchitis; roflumilast; bisoprolol; phase 3 clinical trial (topic); beta 1 adrenergic receptor blocking agent; bronchoconstriction; Child Pugh score; corticosteroid induced myopathy; hyperinflation; St. George Respiratory Questionnaire