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Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a prospective randomized 13-week study versus placebo and celecoxib

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Abstract

The objective of this study was to evaluate the efficacy, safety and tolerability of lumiracoxib compared with placebo and celecoxib in patients with osteoarthritis (OA). Following a 3- to 7-day washout period for previous non-steroidal anti-inflammatory drugs, 1600 patients aged ≥18 years with primary knee OA were randomized to receive lumiracoxib 200 or 400 mg once daily (o.d.), celecoxib 200 mg o.d. or placebo for 13 weeks. Primary efficacy variables were OA pain intensity in the target knee, patient’s global assessment of disease activity and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale and total scores at week 13. Secondary variables included OA pain intensity in the target knee and physician’s and patient’s global assessments of disease activity by visit. Exploratory analysis of responder rates using the Outcomes Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) criteria was performed. Safety and tolerability were assessed. Lumiracoxib was superior to placebo in all primary and secondary variables and was generally similar to celecoxib. There were no statistically significant differences between the two doses of lumiracoxib. All active treatments were significantly more effective than placebo at weeks 2 and 13 in terms of response to treatment assessed using OMERACT-OARSI criteria. The incidence of adverse events was similar across the groups. Lumiracoxib 200 mg o.d. is a well-tolerated and effective treatment option for OA of the knee, providing pain relief and improved functional status with efficacy superior to placebo and similar to celecoxib. Lumiracoxib demonstrated a tolerability profile similar to placebo and celecoxib.

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Acknowledgements

Study supported by Novartis Pharma AG. The authors would like to acknowledge Ornella Della Casa Alberighi for her invaluable contribution on the OARSI-OMERACT data interpretation.

Author information

Authors and Affiliations

  1. University of Texas Southwestern Medical Center, Radiant Research Dallas, 5939 Harry Hines Boulevard, Dallas, TX, 75235, USA

    Roy Fleischmann

  2. Miami Research Associates, Miami, FL, USA

    Eric Sheldon

  3. Rheumatology Section, IREP, Buenos Aires, Argentina

    José Maldonado-Cocco

  4. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

    Dipen Dutta, Sue Yu & Victor S. Sloan

Authors
  1. Roy Fleischmann
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  2. Eric Sheldon
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  3. José Maldonado-Cocco
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  4. Dipen Dutta
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  5. Sue Yu
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  6. Victor S. Sloan
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Corresponding author

Correspondence to Roy Fleischmann.

Investigators

Investigators

Argentina

Dr. Eduardo Albiero, Cordoba; Dr. Alejandra Babini, Cordoba; Dr. Francisco Caeiro, Cordoba; Dr. Osvaldo Hubscher, Buenos Aires; Dr. Eduardo Kerzberg, Buenos Aires; Dr. José Maldonado-Cocco, Buenos Aires; Dr. Bernardo Pons Estell, Rosario, Dr. Guillermo Tate, Buenos Aires; Dr. José Zanchetta, Buenos Aires.

Chile

Dr. Maria Teresa Contreras, Santiago; Dr. Oscar Neira, Santiago.

Colombia

Dr. Oswaldo Lazala, Colombia; Dr. Federico Rondon, Colombia.

Peru

Dr. Felipe Becerra, Lima.

Uruguay

Dr. Mirtha Carleo, Montevideo.

Venezula

Dr. Emesto Garcia MacGregor, Estado Zulia; Dr. Jose Herrera, Caracas.

Switzerland

Dr. A Aeschlimann, Zurzach; Dr. Jean Dudler, Lausanne; Dr. Paul Hasler, Basel; Dr. Peter John, Jenoure; Dr. Daniel Van Linthoud, La Chaux-de-Fonds; Dr. Urs Moser, Liestal; Dr. M Pellaton, Neuchâtel; Dr. Hans-Ulrich Rentsch, St. Gallen; Dr. Hans Schwarz, Basel; Dr. Jurg Sturzenegger, Kreuzlingen; Dr. R Theiler, Aarau; Dr. Madeleine Trachsel, Montreux; Dr. Daniel Uebelhart, Zürich; Dr. Jean-Jacques Volken, Sierre.

Canada

Dr. Nabil Attie, QC; Dr. Rav Baker, Richmond, BC; Dr. André Beaulieu, Sainte-Foy, QC; Dr. Stephen Coyle, Winnipeg, MA; Dr. Nicholas Peter Koutras, Windsor, ON; Dr. Wayne Olsheski, Toronto, ON; Dr. Jean-Pascal Ouellet, Sherbrooke, QC; Dr. Brian Zidel, Mississauga, ON.

USA

Dr. Omer Abdullah, Fredericksburg, VA; Dr. Jacob Aelion, Jackson, TN; Dr. Richard Alberv, Phoenix, AZ; Dr. Joan Benz, Cedar Rapids, IA; Dr. Marshall Block, Phoenix, AZ; Dr. Eugene Boling, Upland, CA; Dr. Jerome Brem, Portland, OR; Dr. Frances Burch, San Antonio, TX; Dr. Jacques Caldwell, Daytona Beach, FL; Dr. Mary Chester Wasko, Pittsburgh, PA; Dr. Vishala Chindalore, Anniston, AL; Dr. John Condemi, Rochester, NY; Dr. Richard Craven, Virginia Beach, VA; Dr. Marv Cronin, Milwaukee, WI; Dr. Darrell Fiske, Stuart, FL; Dr. Roy Fleischmann, Dallas, TX; Dr. Maria Greenwald, Rancho Mirage, CA; Dr. Kevin Hackshaw, Columbus, OH; Dr. Douglas Haselwood, Fair Oaks, CA; Dr. George Ho, Greenville, NC; Dr. Michele Hooper, Beachwood, OH; Dr. Steven Hugenberg, Indianapolis, IN; Dr. John Hurley, Omaha, NE; Dr. Terence Isakov, Lyndhurst, OH; Dr. Douglas Lain, Colorado Springs, CO; Dr. James LaSalle, Excelsior Springs, MO; Dr. Lawrence Jacobs, Tulsa, OK; Dr. Shelly Kafka, Duncansville, PA; Dr. Phillip Kempf, Arlington, VA; Dr. Joel Kremer, Albany, NY; Dr. Clarence Legerton, Charleston, SC; Dr. Richard Lies, Wichita, KS; Dr. James Loveless, Boise, ID; Dr. Abe Marcadis, Boyton Beach, FL; Dr. Howard Marker, Memphis, TN; Dr. Harris McIllwain, Tampa, FL; Dr. Richard Meehan, Denver, CO; Dr. S David Miller, North Darmouth, MA; Dr. William Palmer, Omaha, NE; Dr. Daniel Paulson, Richmond, VA; Dr. Pamela Prete, Long Beach, CA; Dr. Anthony Puopolo, Milford, MA; Dr. Philip Molloy, Plymouth, MA; Dr. Ronald Rapoport, Fall River, MA; Dr. Basem Ratrout, Red Wing, MN; Dr. Lowell Robinson, Memphis, TN; Dr. Brenda Rogers, Kansas City, MO; Dr. Sid Rosenblatt, Irvine, CA; Dr. Joy Schectman, Glendale, AZ; Dr. Michael Schmalz, Milwaukee, WI; Dr. Thomas Schnitzer, Chicago, IL; Dr. Eric A Sheldon, Miami, FL; Dr. Lynn Smith, Lewisburg, WV; Dr. John Tesser, Phoenix, AZ; Drs Ross Tonkens/James Snyder, Henderson, Dr. Jame Udell, Philadelphia, PA; Dr. Peter Valen, LaCrosse, WI; Dr. Robert Valente, Lincoln, NE; Dr. Robert Williams, Augusta, GA; Dr. Walter Yarbrough, Birmingham, AL; Drs Barbara Zedler/Ruth Numberg, Richmond, VA.

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Fleischmann, R., Sheldon, E., Maldonado-Cocco, J. et al. Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a prospective randomized 13-week study versus placebo and celecoxib. Clin Rheumatol 25, 42–53 (2006). https://doi.org/10.1007/s10067-005-1126-5

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  • DOI: https://doi.org/10.1007/s10067-005-1126-5

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