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DEAR DR FULTON,

 

I recently reviewed the July/August 2011 edition of Clinical Nurse Specialist containing the article by Patricia O'Malley entitled "Reduce Disease Burden and Improve Lung Function-Roflumilast." We were happy to see that our new product for chronic obstructive pulmonary disease (COPD) received this coverage; however, I think it is important that I contact you regarding a few inaccuracies that were noted.

 

* The subtitle, "Approved for Moderate to Severe COPD: Update for the Clinical Nurse Specialist," is inaccurate, as roflumilast is only approved for patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

 

* On page 1, column 2, the dose range is listed as 250 to 1000 [mu]g once daily. Roflumilast is approved only at a dose of 500 [mu]g once daily.

 

* On page 2, column 1, it is reported that "Most common adverse effects have included insomnia, anxiety and depression." These were not the most common adverse effects; however, insomnia was reported by 2.4% of patients taking roflumilast versus 1.0% who received placebo. Anxiety and depression were reported at rates less than 2% and not greater than placebo.

 

* On page 2, column 1, it is reported that "Dose should be reduced in patients with significant renal or hepatic impairment." Renal impairment does not significantly affect roflumilast, and the prescribing information states that "No dosage adjustment is necessary in patients with renal impairment."

 

* On page 2, column 1, it is reported that "A greater incidence of lung and prostate cancer has been reported in roflumilast-treated groups (60%)." This percentage is incorrect and could misleadingly imply that 60% of patients treated with roflumilast were affected by cancer. Our data show that during the entire roflumilast COPD development program in more than 12,000 patients, a total of 218 cancer events were reported (1.8%). Of these, 131 (60%) cancers were in the roflumilast group.

 

* Finally, in the conclusions, the first sentence states "evidence supports only the use of roflumilast for patients with moderate to severe COPD." To reiterate my earlier comment, roflumilast is not approved for use in patients with moderate COPD but only for patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

 

 

We understand that authors and editors make every effort to provide scientifically rigorous and accurate reporting and that occasional errors or inaccuracies may occur. I respectfully ask you to consider publishing a correction to this article about roflumilast so that medical professionals have the most current and accurate information available to inform their prescribing decisions.

 

Martino Laurenzi, MD, MPH

 

Senior Medical Director, Internal Medicine

 

Forest Research Institute

 

Harborside Financial Center, Plaza V

 

Jersey City, New Jersey 07311

 

martino.laurenzi@frx.com