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|Title||An efficient randomised, placebo-controlled clinical trial with the irreversible fatty acid amide hydrolase-1 inhibitor PF-04457845, which modulates endocannabinoids but fails to induce effective analgesia in patients with pain due to osteoarthritis of the knee.|
|Author(s)||Huggins JP, Smart TS, Langman S, Taylor L, Young T.|
|Journal, Volume, Issue||Pain. 2012 Jun 20. [Epub ahead of print]|
|Major outcome(s)||A FAAH inhibitor was not more effective than a placebo.|
The effect of PF-04457845, a potent and selective fatty acid amide hydrolase-1
(FAAH1) inhibitor, on pain due to osteoarthritis of the knee was investigated in
a randomised placebo and active-controlled clinical trial. The trial involved 2
periods (separated by a 2-week washout) consisting of a 1-week wash-in phase
followed by 2weeks double-blind treatment. Patients received single-blind placebo
throughout the wash-in and washout periods. Patients were randomised to receive
either 4mg q.d. PF-04457845 followed by placebo (or vice versa), or 500mg b.i.d.
naproxen followed by placebo (or vice versa). The primary end point was the
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain
score. The trial had predefined decision rules based on likelihood that
PF-04457845 was better or worse than the standard of care (considered to be a 1.8
reduction in WOMAC pain score compared to placebo). A total of 74 patients were
randomised to 1 of 4 treatment sequences. The mean differences (80% confidence
intervals) from placebo in WOMAC pain score were 0.04 (-0.63 to 0.71) for
PF-04457845 and -1.13 (-1.79 to -0.47) for naproxen, indicating that whilst
naproxen seemed efficacious, PF-04457845 was not differentiated from placebo. The
study was stopped at the interim analysis for futility. PF-04457845 decreased
FAAH activity by >96% and substantially increased 4 endogenous substrates (fatty
acid amides). PF-04457845 was well tolerated in osteoarthritis patients, and
there was no evidence of cannabinoid-type adverse events. The lack of analgesic
effect of FAAH1 inhibition in humans is in contrast to data from animal models.
This apparent disconnect between species needs further study.
|Participants||74 patients suffering from pain due to osteoarthritis of the|
|Type of publication||Medical journal|
|Address of author(s)||Pfizer Global Research and Development, Sandwich, UK.|