For those (it seems many!) following research on naltrexone, an abstract of the latest study has been posted in the material for Digestive Disease Week. My take (from the point of view of someone who is not a medical doctor but who has read thousands of clinical studies): this is starting to look promising, although the data is still very limited. There are three important pieces of data in this abstract:
1. Clinical remission rate after 12 weeks of treatment was 45%. That places the efficacy within the upper end of the realm achieved with the placebo-controlled studies of the mesalamine drugs (Pentasa, Asacol), which show remission rates of 30 to 45% after around the same time period.
Missing information: The abstract does not give the clinical remission rate with placebo. This is important because there is often a high placebo remission rate in trials of this length and longer. If the placebo remission rate was 25 or 30%, then we're looking at a product that is showing a clinically significant, not just statistically significant, benefit over placebo. If the placebo remission rate was high, say 40%, then the results are less impressive.
2. What they call "endoscopy and histology inflammatory scores" improved significantly compared with placebo. I'd like a little bit more detail on how they scored this, but still, showing any endoscopic or histologic improvement is strong evidence that the medication being tested is having a clinically useful effect.
3. There was no significant difference between the two groups in "laboratory tests for safety." This is promising for the short-term safety of the medication, although they will have to evaluate long-term safety data.
There is no indication whether the laboratory values tested included erythrocyte sedimentation rate (ESR) or C-reactive protein. One would hope to see a significant drop in both in conjunction with the endoscopic and histologic improvement. I will be interested to see if any of these questions are answered in reports on the meeting. Now, what you have been waiting for, the abstract: http://download.abstractcentral.com/DDW2010/myddw/646.html