Evidence map›Paper›PMID 18328090›Full record

Trial reportBMC musculoskeletal disorders2008

Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily: a randomised controlled trial in patients with osteoarthritis.

Roy Fleischmann, Hyman Tannenbaum, Neha P Patel, Marianne Notter, Peter Sallstig, Jean-Yves Reginster

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00145301 (A 52-week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability and Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid and Celecoxib 200 mg od in Patients With Primary Osteoarthritis of Hip, Knee, Hand or Spine), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00145301 phase3completednot on this map

A 52-week, International, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Clinical Trial to Compare Retention on Treatment, Safety, Tolerability and Efficacy of Lumiracoxib 100 mg od, Lumiracoxib 100 mg Bid and Celecoxib 200 mg od in Patients With Primary Osteoarthritis of Hip, Knee, Hand or Spine

TypeinterventionalSponsorNovartisRan2004Enrolled3,036ConditionsOsteoarthritisArmsLumiracoxib
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 3 countries.

Roy FleischmannThe University of Texas Southwestern Medical Center at Dallas, MCRC, Dallas, Texas, USA. rfleischmann@arthdocs.com
Hyman Tannenbaum
Neha P Patel
Marianne Notter
Peter Sallstig
Jean-Yves Reginster
Novartis (Switzerland) · CHCentre Hospitalier Universitaire de Liège · BENovartis (United States) · USThe University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy, safety and tolerability of lumiracoxib, a novel selective cyclooxygenase-2 (COX-2) inhibitor, has been demonstrated in previous studies of patients with osteoarthritis (OA). As it is important to establish the long-term safety and efficacy of treatments for a chronic disease such as OA, the present study compared the effects of lumiracoxib at doses of 100 mg once daily (o.d.) and 100 mg twice daily (b.i.d.) with those of celecoxib 200 mg o.d. on retention on treatment over 1 year.

methodsIn this 52-week, multicentre, randomised, double-blind, parallel-group study, male and female patients (aged at least 40 years) with symptomatic primary OA of the hip, knee, hand or spine were randomised (1:2:1) to lumiracoxib 100 mg o.d. (n = 755), lumiracoxib 100 mg b.i.d. (n = 1,519) or celecoxib 200 mg o.d. (n = 758). The primary objective of the study was to demonstrate non-inferiority of lumiracoxib at either dose compared with celecoxib 200 mg o.d. with respect to the 1-year retention on treatment rate. Secondary outcome variables included OA pain in the target joint, patient's and physician's global assessments of disease activity, Short Arthritis assessment Scale (SAS) total score, rescue medication use, and safety and tolerability.

resultsRetention rates at 1 year were similar for the lumiracoxib 100 mg o.d., lumiracoxib 100 mg b.i.d. and celecoxib 200 mg o.d. groups (46.9% vs 47.5% vs 45.3%, respectively). It was demonstrated that retention on treatment with lumiracoxib at either dose was non-inferior to celecoxib 200 mg o.d. Similarly, Kaplan-Meier curves for the probability of premature discontinuation from the study for any reason were similar across the treatment groups. All three treatments generally yielded comparable results for the secondary efficacy variables and all treatments were well tolerated.

conclusionLong-term treatment with lumiracoxib 100 mg o.d., the recommended dose for OA, was as effective and well tolerated as celecoxib 200 mg o.d. in patients with OA.

trial registrationclinicaltrials.gov NCT00145301.

Indexed as

AgedArthralgiaCanadaCardiovascular DiseasesCelecoxibChemical and Drug Induced Liver InjuryCyclooxygenase 2 InhibitorsDiclofenacDouble-Blind MethodDrug Administration ScheduleEuropeFemaleGastrointestinal DiseasesHumansMaleMiddle AgedCelecoxibCyclooxygenase 2 InhibitorsDiclofenaclumiracoxibPyrazolesSulfonamides

Identifiers

PMID18328090
PMCPMC2322990
OpenAlexW1981918285

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.