A while back, I remember seeing a cartoon with a dissatisfied patron leaving a restaurant and saying “my compliments to the photographer.”
Sometimes reading journal titles has the same feel. The title does not always indicate what you are really going to get. A recent study (V Ratziu et al. Gastroenterol 2016; 150: 1147-59) has the following title: “Elafibranor, an Agonist of the Peroxisome Proliferator –Activated Receptor –α and –β, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening.” Sounds great –a new effective treatment for NASH, right?
Here’s are the results:
- “In intention-to-treat analysis, there was no significant difference between elafibranor and placebo groups in the protocol-defined primary outcome.”
- However, based on a post-hoc analysis with a modified definition, the treatment group had a 19% NASH resolution compared with 12% of the placebo group.
This study examined 276 patients in a randomized double-blind placebo-controlled trial.
To me these results are not impressive. The associated editorial (pg 1073) expresses more optimism and indicates that there have been evolving outcome measures in NASH studies to look for the combination of NASH resolution without worsening fibrosis. Thus, prior studies that used only NASH resolution, such as pioglitazone (47%), vitamin E (36%) and obeticholic acid (22%) cannot be compared to his current study.
My take: Pretty picture or not, what this really means -is that we need more studies, including the outcome of phase III studies of this medication.