Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial
Autor(a) principal: | |
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Data de Publicação: | 2011 |
Outros Autores: | , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | International Braz J Urol (Online) |
Texto Completo: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1677-55382011000600003 |
Resumo: | PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs). As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174) or ketoprofen 100 mg IV plus placebo (n = 164). 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174) or ketoprofen 100 mg IV(n = 164) plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID) at 30 minutes by visual analog scale (VAS) (per-protocol population). An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD) mPID30 min was 33.84 (24.61) and 35.16 (26.01) for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen) the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile. |
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International Braz J Urol (Online) |
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Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trialparecoxibketoprofenrenal coliclithiasispainanalgesiaCOX-2 selectivePURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs). As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174) or ketoprofen 100 mg IV plus placebo (n = 164). 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174) or ketoprofen 100 mg IV(n = 164) plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID) at 30 minutes by visual analog scale (VAS) (per-protocol population). An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD) mPID30 min was 33.84 (24.61) and 35.16 (26.01) for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen) the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.Sociedade Brasileira de Urologia2011-12-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1677-55382011000600003International braz j urol v.37 n.6 2011reponame:International Braz J Urol (Online)instname:Sociedade Brasileira de Urologia (SBU)instacron:SBU10.1590/S1677-55382011000600003info:eu-repo/semantics/openAccessGlina,SidneyDamiao,RonaldoAfif-Abdo,JoaoMaria,Carlos Francisco SantaNovoa,RaúlCairoli,Carlos Eurico DornellesWajsbrot,DaliaAraya,Gastoneng2012-02-16T00:00:00Zoai:scielo:S1677-55382011000600003Revistahttp://www.brazjurol.com.br/ONGhttps://old.scielo.br/oai/scielo-oai.php||brazjurol@brazjurol.com.br1677-61191677-5538opendoar:2012-02-16T00:00International Braz J Urol (Online) - Sociedade Brasileira de Urologia (SBU)false |
dc.title.none.fl_str_mv |
Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial |
title |
Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial |
spellingShingle |
Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial Glina,Sidney parecoxib ketoprofen renal colic lithiasis pain analgesia COX-2 selective |
title_short |
Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial |
title_full |
Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial |
title_fullStr |
Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial |
title_full_unstemmed |
Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial |
title_sort |
Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial |
author |
Glina,Sidney |
author_facet |
Glina,Sidney Damiao,Ronaldo Afif-Abdo,Joao Maria,Carlos Francisco Santa Novoa,Raúl Cairoli,Carlos Eurico Dornelles Wajsbrot,Dalia Araya,Gaston |
author_role |
author |
author2 |
Damiao,Ronaldo Afif-Abdo,Joao Maria,Carlos Francisco Santa Novoa,Raúl Cairoli,Carlos Eurico Dornelles Wajsbrot,Dalia Araya,Gaston |
author2_role |
author author author author author author author |
dc.contributor.author.fl_str_mv |
Glina,Sidney Damiao,Ronaldo Afif-Abdo,Joao Maria,Carlos Francisco Santa Novoa,Raúl Cairoli,Carlos Eurico Dornelles Wajsbrot,Dalia Araya,Gaston |
dc.subject.por.fl_str_mv |
parecoxib ketoprofen renal colic lithiasis pain analgesia COX-2 selective |
topic |
parecoxib ketoprofen renal colic lithiasis pain analgesia COX-2 selective |
description |
PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs). As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174) or ketoprofen 100 mg IV plus placebo (n = 164). 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174) or ketoprofen 100 mg IV(n = 164) plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID) at 30 minutes by visual analog scale (VAS) (per-protocol population). An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI) for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD) mPID30 min was 33.84 (24.61) and 35.16 (26.01) for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen) the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile. |
publishDate |
2011 |
dc.date.none.fl_str_mv |
2011-12-01 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1677-55382011000600003 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1677-55382011000600003 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
10.1590/S1677-55382011000600003 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
text/html |
dc.publisher.none.fl_str_mv |
Sociedade Brasileira de Urologia |
publisher.none.fl_str_mv |
Sociedade Brasileira de Urologia |
dc.source.none.fl_str_mv |
International braz j urol v.37 n.6 2011 reponame:International Braz J Urol (Online) instname:Sociedade Brasileira de Urologia (SBU) instacron:SBU |
instname_str |
Sociedade Brasileira de Urologia (SBU) |
instacron_str |
SBU |
institution |
SBU |
reponame_str |
International Braz J Urol (Online) |
collection |
International Braz J Urol (Online) |
repository.name.fl_str_mv |
International Braz J Urol (Online) - Sociedade Brasileira de Urologia (SBU) |
repository.mail.fl_str_mv |
||brazjurol@brazjurol.com.br |
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1750318072399396865 |