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Aliment Pharmacol Ther. 2008 Aug 15;28(4):431-42. doi: 10.1111/j.1365-2036.2008.03765.x. Epub 2008 Jun 11.

Clinical trial: comparison of ibuprofen-phosphatidylcholine and ibuprofen on the gastrointestinal safety and analgesic efficacy in osteoarthritic patients.

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1
Houston Institute of Clinical Research, Houston, TX, USA.

Abstract

BACKGROUND:

Chronic use of NSAIDs is associated with gastrointestinal (GI) toxicity that increases with age.

AIM:

To evaluate the GI safety and therapeutic efficacy of ibuprofen chemically associated with phosphatidylcholine (PC) in osteoarthritic (OA) patients.

METHODS:

A randomized, double-blind trial of 125 patients was performed. A dose of 2400 mg/day of ibuprofen or an equivalent dose of ibuprofen-PC was administered for 6 weeks. GI safety was assessed by endoscopy. Efficacy was assessed by scores of analgesia and anti-inflammatory activity. Bioavailability of ibuprofen was pharmacokinetically assessed.

RESULTS:

Ibuprofen-PC and ibuprofen provided similar bioavailability/therapeutic efficacy. In the evaluable subjects, a trend for improved GI safety in the ibuprofen-PC group compared with ibuprofen that did not reach statistical significance was observed. However, in patients aged >55 years, a statistically significant advantage for ibuprofen-PC treatment vs. ibuprofen in the prevention of NSAID-induced gut injury was observed with increases in both mean Lanza scores and the risk of developing >2 erosions or an ulcer. Ibuprofen-PC was well tolerated with no major adverse events observed.

CONCLUSION:

Ibuprofen-PC is an effective osteoarthritic agent with an improved GI safety profile compared with ibuprofen in older OA patients, who are most susceptible to NSAID-induced gastroduodenal injury.

PMID:
18549459
PMCID:
PMC3353548
DOI:
10.1111/j.1365-2036.2008.03765.x
[Indexed for MEDLINE]
Free PMC Article

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