Daliresp

Zachary Hedrick, PharmD Candidate, Ohio Northern University
 
Daliresp (roflumilast) is a phosphodiesterase- 4 inhibitor indicated for the treatment of bronchitis and chronic obstructive pulmonary disease, and is currently the only medication of its kind.  It was approved early in 2011 by the FDA and is therefore approximately$207 per monthly supply.  Daliresp has shown to provide significant improvement in lung function measured by spirometry and quality of life while significantly reducing the number of COPD symptoms and exacerbations.  Daliresp even showed improvement in asthma symptoms.  Calverley et al. showed that prebronchodilator FEV1 increased by 48 milliliters with Daliresp compared to placebo.  The same study showed that patients with moderate to severe COPD using Daliresp had about 1.14 COPD exacerbations per patient per year compared to 1.37 exacerbations per patient per year for placebo patients.  Tsung et al even went as far to suggest Daliresp only provides a net benefit to patients at high risk for exacerbations.  Rabe et al. showed similar results as well as significant improvements in health- related quality of life.
The most common side effects that were seen in multiple different studies included headache, diarrhea, nausea, and weight loss.  Therefore, Daliresp has labeled warnings for gastrointestinal effects which include weight loss and/or diarrhea and neuropsychiatric effects (depression, anxiety) which are rarely experienced.  During the studies, diarrhea was experienced about ten percent of the time and weight loss was experienced from eight to 20% of the time.  One study showed that most patients who experienced weight loss typically observed weight loss within six months of starting therapy.  In two placebo-controlled clinical trials, 20% of patients treated with Daliresp experienced moderate weight loss classified as five to ten percent of original body weight compared to just seven percent of patients who received placebo.  In the same studies, seven percent of patients receiving Daliresp experienced severe weight loss which was classified as more than ten percent of original body weight compared to only two percent of patients in the placebo arm.
In conclusion, Daliresp is in a new prescription medication approved for the treatment of bronchitis and COPD.   Although it is effective in all patients it seems to have its greatest benefit in patients with more severe forms of COPD.  However, since Daliresp is a newer medication without a generic form it is rather expensive for a monthly supply.  The most common side effects of Daliresp include: diarrhea, nausea, headache, and weight loss. 
Works Cited
1. Lipari M, Benipal H, Kale-Pradhan F. Roflumilast in the management of chronic obstructive pulmonary disease.  Am J Health Syst Pharm. 2013 Dec 1; 70(23): 2087-95.
2. Tsung Y, Fain K, Boyd CM, Singh S, Weiss CO, Tianjing L, et al. Benefits and harms of roflumilast in moderate to severe COPD. Thorax. 2013 Dec 17.
3. Calverley P, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomized clinical trials. The Lancet. 2009 Aug 29; 374(9691): 685-694.
4. Rabe KF. Update on roflumilast, a phosphodiesterase 4 inhibitor for the treatment of chronic obstructive pulmonary disease. British Journal of Pharmacology. 2011 Apr 6; 163(1): 53-67.
5. Calverley PM, Sanchez- Toril F, McIvor A, et al. Effect of 1-year treatment with roflumilast in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2007; 176(2): 154-161.
6. Rabe KF, Bateman ED, O’Donnell D, et al. Roflumilast – an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: A randomized controlled trial. Lancet. 2005; 366 (9485): 563-571.
7. Chong J, Poole P, Leung B, Black PN. Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease (review) Cochrane Database Syst Rev. 2011;5 No. CD002309.
8. Lexicomp [Internet]. Hudson (OH): Lexicomp. 1978 [cited 2014 Jan 8]. Available from: http://online.lexi.com.


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