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BMJ 2012; 344 doi: (Published 07 June 2012) Cite this as: BMJ 2012;344:e3879

Common drugs combination for pulmonary fibrosis harms rather than helps

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Treatment of idiopathic pulmonary fibrosis with a combination of three drugs—prednisone, azathioprine, and N-acetylcysteine—increases mortality and admission to hospital compared with placebo. This was found in a preplanned analysis half way into a 60 week randomised trial. Meanwhile, no difference between the two groups was seen in the primary outcome—change in forced vital capacity (−0.24 L v −0.23 L for combination treatment v placebo).

The trial will therefore continue only for participants allocated to placebo and those in the third arm, which tests treatment with N-acetylcysteine alone.

All 236 participants had mild to moderate impairment of lung function and had been diagnosed with idiopathic pulmonary sclerosis during the past two years. Ages spanned 35-85 years, with a mean of 68 years.

Adherence to combination treatment fell as the trial went on. At 15 weeks, about three quarters of participants randomised to this arm reported regularly taking all three drugs, whereas at 45 weeks this fell to two thirds, and …

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