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September 22nd, 2012

Thalidomide Relieves Cough in Pulmonary Fibrosis

Published: September 18, 2012

Action Points
-- A small, randomized, double-blind crossover study found that thalidomide
significantly reduced cough and improved cough-related quality of life in
patients with idiopathic pulmonary fibrosis.
-- Note that the investigators stated that these results should be replicated in a
larger randomized trial.

The once-banned drug thalidomide (Thalomid) relieved the disabling cough associated with idiopathic pulmonary fibrosis (IPF) in a small trial, researchers reported.

In a randomized, double-blind crossover trial, the reduction in coughing was associated with significant improvements in quality of life, according to Maureen Horton, MD, of Johns Hopkins University School of Medicine, and colleagues.

It's the first effective therapy for the constant dry coughing associated with the progressive fatal disorder, Horton and colleagues reported in the Sept. 18 issue of Annals of Internal Medicine.

"The constant cough caused by the disease can affect the quality of life in many ways," Horton said in a statement. "Some no longer go to church or to social gatherings because people think they are infectious. Other patients may have more pronounced urinary incontinence due to the cough, for example, so it has wide-ranging effects."

Once banned because of teratogenic properties, thalidomide and its analogues are making a comeback in the treatment of such diseases as multiple myeloma.

Thalidomide is also being tested as a possible treatment for IPF, and in a previous open-label trial, Horton and colleagues noted an apparent beneficial effect on cough.

To follow up, they designed a placebo-controlled, double-blind, two-period crossover trial with two 12-week treatment periods separated by a 2-week drug-free washout.

All told, 24 patients, with an average age of 67.6 years, were randomly assigned, 23 received treatment, and 20 completed both treatment periods, the researchers reported.

During thalidomide periods, patients began with 50 mg of thalidomide daily at bedtime, which was increased to 100 mg if there was no improvement in cough.

The primary endpoint of the study was cough-specific quality of life, as measured by the Cough Quality of Life Questionnaire. As well, the researchers measured the severity of cough on a visual analogue scale and the overall quality of life, using the St. George's Respiratory Questionnaire.

On each of the measures, a reduction from baseline indicated improvement.

Horton and colleagues found:

Scores on the cough questionnaire significantly improved with thalidomide. On average, the difference versus placebo was a decline of 11.4 points (P<0.001). The drug also significantly improved scores on the visual analogue scale of cough severity, with an average difference versus placebo of minus 31.2 points (P<0.001). Thalidomide patients also had improvements on the symptom and impact domains of the St. George's questionnaire, with drops of 21.1 and 13.1 points (P=0.018 and P<0.001, respectively). There was no significant difference on the St. George's questionnaire activity domain. 74% of thalidomide patients and 22% of placebo patients reported adverse events, a significant difference (P=0.001). Constipation, dizziness, and malaise were more frequent with thalidomide. Despite adverse events, all patients requested continuation of thalidomide at the end of the study. The researchers cautioned that the study was small and conducted at a single site, so results may not apply more broadly. "Although the results were significant, this was a small study and we believe that a larger trial is warranted to confirm these promising results and also assess the drug's impact on the disease itself," Horton said. The study was supported by Celgene Corp. Horton reported financial links with the company. Primary source: Annals of Internal Medicine

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