I am looking for the clinical trial that compared Profenid Protect® (ketoprofen + omeprazole fixed-dose combination) to Vimovo® (naproxen + esomeprazole fixed-dose combination). I need the results or the published paper, does anyone know where I can find it?
I don't know the answer to your question, but I would place a bet that neither study considered the damaging effects of the combination products on damage in the distal small intestine -- a significant limitation given that the small intestine is a major site of NSAID-induced damage, that appears to be worsened by PPIs.
Are you sure that this study has been conducted? None of the database systems that I tried to consult mention anything about this study. At least it is clearly not there in the clinicaltrials.gov registry!
The data thus far are from studies in relevant animal models and some video capsule endoscopy studies from Japan. See Gastroenterology 2011; 141: 1314-1322 "Proton pump inhibitors exacerbate NSAID-induced small intestinal injury via induction of dysbiosis" and/or for reference to clinical studies, see Digest Dis Sci 2013; 58: 3088-3093 "Polypharmacy of osteoarthritis: the perfect intestinal storm" Alternatively you can download both from my page on ResearchGate. PPIs and H2RAs cause significant overgrowth of bacteria in the small intestine (well established observation) and this leads to significantly more ulceration and bleeding induced by NSAIDs in the small intestine. Of course, this damage is more difficult to detect (and is largely asymptomatic), and there are no preventative or curative treatments for NSAID-enteropathy. The fixed-dose combination tablets of NSAID+PPI or H2RA will protect the stomach/duodenum, but at the expense of the more distal small intestine. Damage in the intestine is associated with higher death rates, increased time of hospitalization and increased recurrence rates as compared to upper GI damage caused by NSAIDs.
Dear Thais,
the only paper I found in Pub Med is the following:
Gigante A, Tagarro I. Non-steroidal anti-inflammatory drugs and gastroprotection with proton pump inhibitors: a focus on ketoprofen/omeprazole. Clin Drug Investig. 2012 Apr 1;32(4):221-33.
The pharmaceutical company producing the combination of the two drugs is Meda Pharmaceuticals, Madrid, Spain. It is possible that you can find a mail address on Internet and contact the company to obtain the information you requested. Good luck!
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