Thalidomide Eases Cough in Lung Fibrosis Patients

Thalidomide Eases Cough in Lung Fibrosis Patients

PRESCRIPTION DRUGS, SEPTEMBER 19, 2012 - Researchers have determined that a drug that used to be banned called thalidomide (Thalomid) is able to ease the immobilizing cough that is linked to lung fibrosis. The results were released in the Sept. 18, 2012 issue of Annals of Internal Medicine. The specialists from Johns Hopkins University School of Medicine stated that in a random, double-blind crossover trial, the drug helped to reduce the coughing and therefore improved the value of life for patients that have idiopathic pulmonary fibrosis (IPF).

This is the first successful therapy for the continuous dry coughing that is related to the progressive fatal disorder according to Maureen Horton, MD of Johns Hopkins University School of Medicine. IPF is a progressive, fatal disease that makes the lungs become scarred and stiff therefore not allowing oxygen from leaving the lungs to go to the rest of the body. There is no cause. Currently, 80% of patients with IPF have a dry, irritating cough that there is no helpful treatment available to help.

"The constant cough caused by the disease can affect the quality of life in many ways," Horton stated in a report. "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."

The drug thalidomide is a powerful anti-inflammatory medicine that used to be used in the 1950s to assist in sleep and to treat morning sickness. In 1961, it was removed from the market because it was reported to cause severe birth defects when pregnant women took the medication. These days, thalidomide is prescribed with stringent control in order to treat several illnesses such as kidney cancer and myeloma. Previously, it hadn't been used to treat lung disease.

Study Synopsis

Background: Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal disorder of unknown cause with no effective treatment. Cough affects up to 80% of patients with IPF, is frequently disabling, and lacks effective therapy.

Objective: To determine the efficacy of thalidomide in suppressing cough in patients with IPF.

Design: 24-week, double-blind, 2-treatment, 2-period crossover trial. ( registration number: NCT00600028)

Setting: 1 university center.

Participants: 98 participants were screened, 24 were randomly assigned, 23 received treatment (78.3% men; mean age, 67.6 years; mean FVC, 70.4% predicted), and 20 completed both treatment periods.

Measurements: The primary end point was cough-specific quality of life measured by the Cough Quality of Life Questionnaire (CQLQ). Secondary end points were visual analogue scale of cough and the St. George's Respiratory Questionnaire (SGRQ). For all measures, lower scores equaled improved cough or respiratory quality of life.

Results: CQLQ scores significantly improved with thalidomide (mean difference vs. placebo, −11.4 [95% CI, −15.7 to −7.0]; P < 0.001). Thalidomide also significantly improved scores on the visual analogue scale of cough (mean difference vs. placebo, −31.2 [CI, −45.2 to −17.2]; P < 0.001). In participants receiving thalidomide, scores from the total SGRQ, SGRQ symptom domain, and SGRQ impact domain improved compared with those of participants receiving placebo. Adverse events were reported in 74% of patients receiving thalidomide and 22% receiving placebo; constipation, dizziness, and malaise were more frequent with thalidomide.

Limitation: This was a single-center study of short duration and small sample size focused on symptom-specific quality of life.

Conclusion: Thalidomide improved cough and respiratory quality of life in patients with IPF. A larger trial is warranted to assess these promising results.

Primary Funding Source: Celgene Corporation.