From the Journals

In PAH trials, clinical worsening risk rose with time

Publish date: May 7, 2018
By
Andrew D. Bowser

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Key clinical point: A meta-analysis calls into question the need to perform pulmonary arterial hypertension (PAH) trials beyond 6 to 12 months of treatment in the future.

Major finding: The mean number needed to treat was stable at 52 weeks of follow-up and thereafter, while the mean relative risk of clinical worsening progressively increased from approximately 0.38 at week 16 to 0.68 at week 104.

Study details: A systematic review of 3,801 patients enrolled in 15 randomized clinical trials.

Disclosures: The authors reported disclosures related to Actelion Pharmaceuticals, Bayer, and GlaxoSmithKline, among other entities.

Source: Lajoie AC et al. Chest. 2017 May;153(5):1142-52.


 

FROM CHEST®

Current clinical trials evaluating combination therapy for pulmonary artery hypertension (PAH) may be longer than what is needed to demonstrate treatment benefit, results of a recent meta-analysis suggest.

In PAH trials of combination therapy, the absolute risk reduction of clinical worsening beyond 6-12 months was relatively constant, according to results of the study published in the May issue of the journal Chest®.

A man with chest pain. Rawpixel/iStock/Getty Images
That finding “questions the requirement for longer-term event-driven trials beyond that duration in an orphan disease such as PAH,” wrote investigator Annie C. Lajoie, MD, of the Pulmonary Hypertension Research Group, Quebec City, and her coauthors.

The meta-analysis by Dr. Lajoie and her colleagues included 3,801 patients enrolled in one of 15 previously published randomized clinical trials. Of those trials, four were long-term, event driven studies, with a mean duration of 87 weeks, while the remainder were shorter studies with a mean duration of 15 weeks.

For the long-term, event-driven trials, the mean number needed to treat (NNT) was 17.4 at week 16, gradually decreasing to 8.8 at 52 weeks of follow-up, remaining stable after that, according to investigators.

Consistent with that finding, the mean relative risk of clinical worsening was 0.38 at 16 weeks, and similarly, 0.41 at 26 weeks, investigators reported. After that, the relative risk progressively increased to 0.54 at 52 weeks and 0.68 at 104 weeks.

Looking at all trials combined, Dr. Lajoie and her colleagues observed that longer trial duration had a positive correlation with relative risk of clinical worsening (P = .0002).

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