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Lumiracoxib oral de dosis única para el dolor posoperatorio

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Referencias

Referencias de los estudios incluidos en esta revisión

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Chan 2005 {published data only}

Chan VWS, Clark A J, Davis JC, Wolf RS, Kellstein D, Jayawardene S. The post‐operative analgesic efficacy and tolerability of lumiracoxib compared with placebo and naproxen after total knee or hip arthroplasty. Acta Anaesthesiologica Scandinavica 2005;Nov 49(10):1491‐500.

Kellstein 2004 {published data only}

Kellstein D, Ott D, Jayawardene S, Fricke J. Analgesic efficacy of a single dose of lumiracoxib compared with rofecoxib, celecoxib and placebo in the treatment of post‐operative dental pain. International Journal of Clinical Practice 2004;58(3):244‐50.

Zelenakas 2004 {published data only}

Zelenakas K, Fricke JR, Jayawardene S, Kellstein D. Analgesic efficacy of single oral doses of lumiracoxib and ibuprofen in patients with postoperative dental pain. International Journal of Clinical Practice 2004;58(3):251‐6.

Referencias de los estudios excluidos de esta revisión

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Bitner 2004 {published data only}

Bitner M, Katterhorn J, Hatfield C, Gao J, Kellstein D. Efficacy and tolerability of lumiracoxib in the treatment of primary dysmenorrhoea. International Journal Clinical Practice 2004;58(4):340‐5.

Schnitzer 2004 {published data only}

Schnitzer TJ, Beier J, Geusens P, Hasler P, Patel SK, Senftleber I, et al. Efficacy and safety of four doses of lumiracoxib versus diclofenac in patients with knee or hip primary osteoarthritis: A phase II, four week, multicenter randomised, double blind, placebo‐controlled trial. Arthritis and Rheumatism 2004;51(4):549‐57.

Referencias de los estudios en curso

Ir a:

Lumiracoxib(a) {unpublished data only}

Novartis Pharmaceuticals. Efficacy of lumiracoxib in relieving moderate to severe post‐dental pain, compared to both placebo and celecoxib. www.controlled‐trials.com/mrct/trial/printfriendly/179985.

Lumiracoxib(b) {unpublished data only}

Novartis Pharmaceuticals. Efficacy and safety of lumiracoxib in arthroscopic knee surgery. www.controlled‐trials.com/mrct/trialprintfriendly/177605.

Adebayo 2006

Adebayo D, Bjarnason I. Is non‐steroidal anti‐inflammatory drug (NSAID) enteropathy clinically more important than NSAID gastropathy?. Post Graduate Medical Journal 2006;82(965):186‐91.

Bandolier 2007

Bandolier Acute Pain Analgesic League Table. http://www.jr2.ox.ac.uk/Bandolier/booth/painpag/Acutrev/Analgesics/Leagtab.html(accessed March 2007).

Bannwarth 2005

Bannworth B, Berenbaum F. Clinical pharmacology of lumiracoxib, a second generation cyclooxygenase 2 selective inhibitor. Expert Opinion on Investigational Drugs 2005;14(4):521‐33.

Barden 2004

Barden J, Edwards JE, McQuay HJ, Moore RA. Pain and analgesic response after third molar extraction and other postsurgical pain. Pain 2004;107:86‐90.

Benson 2000

Benson WG, Zhao SZ, Burke TA, Zabinski RA, Makuch RW, Maurauth CJ, et al. Upper gastrointestinal tolerability of celecoxib, a COX‐2 specific inhibitor, compared to naproxen and placebo. Journal of Rheumatology 2000;27:1876‐83.

Bruster 1994

Bruster S, Jarman B, Bosanquet N, Weston D, Erens R, Delbanco TL, et al. National Survey of Hospital Patients. BMJ 1994;309(6968):1542‐6.

Cook 1995

Cook RJ, Sackett DL. The number needed to treat: a clinically useful measure of treatment effect. BMJ 1995;310:452‐4.

Cooper 1991

Cooper SA. Single‐dose analgesic studies: the upside and downside of assay sensitivity. In: Max MB, Portenoy RK, Laska EM editor(s). The design of analgesic clinical trials. Advances in Pain Research and Therapy. Vol. 18, New York: Raven Press, 1991:117‐24.

Day 1988

Day RO, McLachlan AJ, Graham GG, Williams KM. Pharmokinetics of non‐steroidal anti‐inflammatory drugs in synovial fluid. Baillieres Clinical Rheumatology 1988;2:363‐93.

Edwards 1999

Edwards JE, McQuay HJ, Moore A, Collins SL. Reporting of adverse effects in clinical trials should be improved: Lessons from acute postoperative pain. Journal of Pain and Symptom Management 1999;18(6):427‐37.

Edwards 2004

Edwards JE, Moore RA, McQuay HJ. Individual patient analysis of single‐dose rofecoxib in postoperative pain. BMC Antesthesiology 2004;4(3):1‐10.

Eypasch 1995

Eypasch E, Lefering R, Kum CK, Troidl H. Probability of adverse events that have not yet occurred: a statistical reminder. BMJ 1995;311:619‐20.

Fortun 2005

Fortun PJ, Hawkey CJ. Nonsteroidal antiinflammatory drugs and the small intestine. Current Opinion in Gastroenterology 2005;21(2):169‐75.

GarciaRodriguez 2003

Garcia Rodriguez LA, Hernandez‐Diaz S. Non‐steroidal anti‐inflammatory drugs as a trigger of clinical heart failure. Epidemiology 2003;14:240‐6.

Griffin 2000

Griffin MR, Yared A, Ray WA. Nonsteroidal antiinflammatory drugs and acute renal failure in elderly persons. American Journal of Epidemiology 2000;151:488‐96.

Henry 1997

Henry D, Page J, Whyte I, Nanra R, Hall C. Consumption of non‐steroidal anti‐inflammatory drugs and the development of functional renal impairment in elderly subjects. Results of a case‐control study. British Journal of Clinical Pharmacology 1997;44:85‐90.

Hernandez‐Diaz 2000

Hernández‐Diaz S, García Rodriguez LA. Association between nonsteroidal anti‐inflammatory drugs and upper gastrointestinal tract bleeding and perforation: An overview of epidemiological studies published in the 1990s. Archives of Internal Medicine 2000;160:2093‐9.

Hernandez‐Diaz 2006

Hernandez‐Diaz S, Varas‐Lorenzo C, Garcia Rodriguez LA. Non‐steroidal antiinflammatory drugs and the risk of acute myocardial infarction. Basic Clinical Pharmacology and Toxicology 2006;98(3):266‐74.

Jadad 1996b

Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled Clinical Trials 1996;17:1‐12.

Kearney 2006

Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono. Do selective cyclo‐oxygenase‐2 inhibitors and traditional non‐steroidal anti‐inflammatory drugs increase the risk of atherothrombosis? Meta‐analysis of randomised trials. BMJ 2006;332:1302‐08.

Laine 2006

Laine L, Smith R, Min K, Chen C, Dubois RW. Systematic review: the lower gastrointestinal adverse effects of non‐steroidal anti‐inflammatory drugs. Alimentary Pharmacology and Therapeutics 2006;Sep 24(5):751‐67.

McGettigan 2006

McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 2006;296(13):1633‐44.

Moore 1996

Moore A, McQuay H, Gavaghan D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics. Pain 1996;66(2‐3):229‐37.

Moore 1997a

Moore A, McQuay H, Gavaghan D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: Verification from independent data. Pain 1997;69(1‐2):127‐30.

Moore 1997b

Moore A, Moore O, McQuay H, Gavaghan D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: Use of pain intensity and visual analogue scales. Pain 1997;69(3):311‐5.

Moore 1998

Moore RA, Gavaghan D, Tramer MR, Collins SL, McQuay HJ. Size is everything ‐ large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain 1998;78(3):209‐16.

Moore 2005

Moore RA, Edwards JE, McQuay HJM. Acute pain: individual patient meta‐analysis shows the impact of different ways of analysing and presenting results. Pain 2005;116:322‐31.

Morris 1995

Morris JA, Gardner MJ. Calculating confidence intervals for relative risk, odds ratio and standardised ratios and rates. In: Gardner MJ, Altman DG editor(s). Statistics with confidence ‐ confidence intervals and statistical guidelines. London: BMJ, 1995:50‐63.

Mysler 2004

Mysler E. Lumiracoxib (Prexige): a new selective COX‐2 inhibitor. International Journal of Clinical Practice 2004;58(6):606‐11.

Nussmeier 2005

Nussmeier NA, Whelton AA, Brown MT, Langford RM, Hoeft A, Parlow JL, et al. Complications of the Cox‐2 inhibitors parecoxib and valdecoxib after cardiac surgery. New England Journal of Medicine 2005;352(11):1081‐91.

Nussmeier 2006

Nussmeier NA, Whelton AA, Brown MT, Joshi G, Langford RM, Singla NK, et al. Safety and efficacy of the cyclooxygenase‐2 inhibitors parecoxib and valdecoxib after non‐cardiac surgery. Anesthesiology 2006;104(3):518‐26.

Ott 2003

Ott E, Nussmeier NA, Duke PC, Feneck RO, Alston RP, Snabes MC, et al. Efficacy and safety of the cylooxygenase 2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery. Journal of Thoracic and Cardiovascular Surgery 2003;125(6):1481‐92.

Page 2000

Page J, Henry D. Consumption of NSAIDs and the development of congestive heart failure in elderly patients: An underrecognized public health problem. Archives of Internal Medicine 2000;160:777‐84.

Scheiman 2005

Scheiman JM, Fendrick MA. Practical approaches to minimizing gastrointestinal and cardiovascular safety concerns with COX‐2 inhibitors and NSAIDs. Arthritis Research & Therapy 2005;7 (suppl 4):S23‐S29.

Schnitzer 2004a

Schnitzer TJ, Burmester GR, Mysler E, Hochberg MC, Doherty M, Ehrsam E, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet 2004;364(9435):665‐74.

Smith 2001

Smith LA, Moore RA, McQuay H, Gavaghan D. Using evidence from different sources: an example using paracetamol 1000 mg plus codeine 60 mg. BMC Medical Research Methodology 2001;1:1.

Vestergaard 2006

Vestergaard P, Rejnmark L, Mosekilde L. Fracture risk associated with use of nonsteroidal anti‐inflammatory drugs, acetylsalicylic acid, and acetaminophen and the effects of rheumatoid arthritis and osteoarthritis. Calcified Tissue International 2006;79(2):84‐94.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

Chan 2005

Methods

RCT, DB, DD, placebo and active controlled parallel‐group study, 12 hour single dose phase, followed by multi‐dose phase up to 96 hours for patients with moderate to severe pain

Participants

Post operative total knee or hip arthroplasty surgery
Male and females
Age 18 to 80 years
Mean age 64 years
SD 11.0
N = 180

Interventions

Lumiracoxib 400 mg
n = 60

Naproxen 500 mg
(2 x daily)
n = 60

Placebo
n = 60

Outcomes

Patients with >50% PR over six hours: lumiracoxib 20/59,
placebo 11/59

Time to remedication:
Lumiracoxib 3.8 hours
Placebo 2.0 hours

Time to onset:
Lumiracoxib 1.5 hours
Placebo >12 hours

Notes

QS = 5 (R2, D2, W1)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate
Kellstein 2004

Methods

RCT, DB, DD, placebo and active controlled parallel group study, single oral dose with moderate to severe pain up to 24 hours

Participants

Post‐operative dental surgery, third molar extraction

Male and females
Age 17 to 41 years
Mean age 22 years

N = 355

Interventions

Lumiracoxib 400 mg
n = 101

Rofecoxib 50 mg
n = 102

Celecoxib 200 mg
n = 101

Placebo n = 51

Outcomes

Patients with >50% PR over six hours: lumiracoxib 48/101,
Placebo 0/51

Time to remedication:
Lumiracoxib 7.2 hours
Placebo 1.3 hours

Time to onset:
Lumiracoxib 0.7 hours
Placebo >12 hours

Notes

QS = 3 (R1, D2, W0)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Zelenakas 2004

Methods

RCT, DB, DD, placebo and active controlled, parallel‐group 12 hour study in patients with moderate to severe pain

Participants

Post‐operative dental surgery, third molar extraction

Male and females
Age >17 years
Mean age 22 years
SD 5.0
N = 202

Interventions

Lumiracoxib 400 mg, n = 50,
100 mg n = 51

Ibuprofen 400 mg n = 51

Placebo n = 50

Outcomes

Patients with >50% PR over six hours: lumiracoxib 32/50,
Placebo 6/50

Time to remedication:
Lumiracoxib >12 hours
Placebo 2.0 hours

Time to onset:
Lumiracoxib 0.6 hours
Placebo >12 hours

Notes

One serious adverse event due to a DVT in a placebo patient
QS = 4 (R1, D2, W1)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Key:
DB ‐ Double blind
DD ‐ Double Dummy
DVT ‐ Deep vein thrombosis
PR ‐ Pain relief
RCT ‐ Randomised Controlled Trial

Characteristics of excluded studies [ordered by study ID]

Ir a:

Study

Reason for exclusion

Bitner 2004

Not post operative pain

Schnitzer 2004

Not post operative pain

Characteristics of ongoing studies [ordered by study ID]

Ir a:

Lumiracoxib(a)

Trial name or title

Efficacy of lumiracoxib in relieving moderate to severe post‐dental surgery pain, compared to both placebo and celecoxib

Methods

Participants

Male and females aged 17 years and over who require extraction of two or more partially impacted or fully bony impacted third molars. At least one of the extractions must be mandibular

Interventions

lumiracoxib 400 mg
celecoxib 400 mg
placebo

Outcomes

Superiority of a single dose of lumiracoxib 400 mg compared to placebo and celecoxib 400 mg based on a Summed (time weighted) Pain Intensity Difference calculated over 0‐8 hours post‐dose (SPID 8)

Starting date

February 2006

Contact information

Notes
Lumiracoxib(b)

Trial name or title

Efficacy and safety of lumiracoxib 400 mg in arthroscopic knee surgery

Methods

Participants

Male and females 18 years and over who require minor ambulatory arthroscopic knee surgery

Interventions

lumiracoxib 400 mg
placebo

Outcomes

Pain intensity in the target knee after movement at the 2 hour time point

Starting date

August 2006

Contact information

Notes

Data and analyses

Open in table viewer
Comparison 1. Lumiracoxib versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 at least 50% pain relief at six hours Show forest plot

3

372

Risk Ratio (M‐H, Fixed, 95% CI)

4.80 [2.91, 7.91]
Analysis 1.1
Comparison 1 Lumiracoxib versus placebo, Outcome 1 at least 50% pain relief at six hours.

Comparison 1 Lumiracoxib versus placebo, Outcome 1 at least 50% pain relief at six hours.

Comparison 1 Lumiracoxib versus placebo, Outcome 1 at least 50% pain relief at six hours.
Figuras y tablas -
Analysis 1.1

Comparison 1 Lumiracoxib versus placebo, Outcome 1 at least 50% pain relief at six hours.

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Comparison 1. Lumiracoxib versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 at least 50% pain relief at six hours Show forest plot

3

372

Risk Ratio (M‐H, Fixed, 95% CI)

4.80 [2.91, 7.91]
Figuras y tablas -
Comparison 1. Lumiracoxib versus placebo
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