Article Text

PDF
SAT0338 Tolerance and efficacy of a new formulation of diacerein: Results of a multicenter, randomized, double-blind, controlled trial in patients with knee osteoarthritis
  1. X. Chevalier1,
  2. P. Richette2,
  3. F. Rannou3,
  4. B. Avouac1,
  5. M. Dapoigny4,
  6. P. Ducrotte5,
  7. D. Jean Louis6,
  8. B. Savarieau7,
  9. D. Blanc8,
  10. M. Marty1
  1. 1Rheumatology, Hopital Henri Mondor, Creteil
  2. 2Rheumatology, Hopital Lariboisière
  3. 3Rheumatology, Hopital Cochin, Paris
  4. 4Hepato gastroenterology, Hopital Hotel Dieu, Clermont Ferrand
  5. 5Hepato gastroenterology, Hopital de Rouen, Rouen
  6. 6Hepato gastroenterology, Hopital universiraire Nord, Amiens
  7. 7Nukleus, Paris
  8. 8Negma France, Velizy Villacoublay, France

Abstract

Background Diacerein [Symptomatic Slow-Acting Drugs in Osteoarthritis (SYSASOA)], has demonstrated its efficacy in patients with hip or knee osteoarthritis in several randomized placebo controlled clinical trials. The efficacy/safety balance of diacerein is hampered by occurrence of diarrhea. A bioequivalent new formulation of diacerein (ART GT) (44 mg) was developed in order to reduce diarrhea.

Objectives To test the hypothesis of better gastrointestinal safety of a new diacerein formulation (ART GT) compared to the usual formulation (ART®50) in patients with knee osteoarthritis (KOA).

Methods In a randomised double-blind controlled trial, patients with symptomatic KOA (baseline pain >40 mm on a 0-100 mm visual analogue scale [VAS]) seen by office-based physicians in 2009-2010 were randomly assigned to either ART GT or ART®50 for 3 months (twice daily). The primary end point was the “diarrhea event” related to study drug (adjudicated by an independent committee) over the first four weeks of treatment. A “diarrhoea event” was defined as any of the following criteria: at least 3 stools daily for at least 3 consecutive days, diarrhoea hindering daily life for at least 5 days, diarrhoea of sufficient severity to require discontinuation of the study drugs, diarrhoea of sufficient severity to require the use of anti-diarrheic medications. Secondary endpoints included: pain [VAS]) WOMAC score, patient and investigator overall assessments, response to treatment following OMERACT/OARSI criteria, consumption of NSAIDs/analgesics, global safety over a three months.

Results Of 547 randomised patients, 517 patients were included in the full analysis set. The proportion of patients experiencing at least 1 diarrhea event was significantly smaller in the ART GT group (30.5%) than in the ART®50 group (41.0%) (p=0.01). There were more patients who discontinued the study treatment for TEAE in the ART®50 group (23.5%) than in the ART GT group (15.0%) (p=0.012). Analyses of all efficacy endpoints showed no differences between the two groups: overall, mean decrease of pain of 24 mm and 56% responders on OARSI criteria.

Conclusions The safety profile of ART GT was significantly better than that of ART®50 in regard to gastrointestinal disorders with the same level of efficacy. (ClinicalTrials.gov number 2009-009990-84).

Disclosure of Interest X. Chevalier Consultant for: Negma, P. Richette Consultant for: Negma, F. Rannou Consultant for: Negma, B. Avouac Consultant for: Negma, M. Dapoigny Consultant for: Negma, P. Ducrotte Consultant for: Negma, D. Jean Louis Consultant for: Negma, B. Savarieau: None Declared, D. Blanc Employee of: Negma, M. Marty Consultant for: Negma

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.