| Nonsteroidal anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter randomized, double-blind trial. | |
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MedLine Citation:
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PMID: 20124229 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: The incidence of asymptomatic pericardial effusion is high after cardiac surgery. Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed in this setting, but no study has assessed their efficacy. OBJECTIVE: To assess whether the NSAID diclofenac is effective in reducing postoperative pericardial effusion volume. DESIGN: Multicenter randomized, double-blind, placebo-controlled study. (Clinical trials.gov registration number: NCT00247052) SETTING: 5 postoperative cardiac rehabilitation centers. PATIENTS: 196 patients at high risk for tamponade because of moderate to large persistent pericardial effusion (grade 2, 3, or 4 on a scale of 0 to 4, as measured by echocardiography) more than 7 days after cardiac surgery. INTERVENTION: Random assignment at each site in blocks of 4 to diclofenac, 50 mg, or placebo twice daily for 14 days. MEASUREMENTS: The main end point was change in effusion grade after 14 days of treatment. Secondary end points included frequency of late cardiac tamponade. RESULTS: The initial mean pericardial effusion grade was 2.58 (SD, 0.73) for the placebo group and 2.75 (SD, 0.81) for the diclofenac group. The 2 groups showed similar mean decreases from baseline after treatment (-1.08 grades [SD, 1.20] for the placebo group vs. -1.36 (SD, 1.25) for the diclofenac group). The mean difference between groups was -0.28 grade (95% CI, -0.63 to 0.06 grade; P = 0.105). Eleven cases of late cardiac tamponade occurred in the placebo group and 9 in the diclofenac group (P = 0.64). These differences persisted after adjustment for grade of pericardial effusion at baseline, treatment site, and type of surgery. LIMITATION: The sample was not large enough to find small beneficial effects of diclofenac or assess the cardiovascular tolerance of diclofenac. CONCLUSION: In patients with pericardial effusion after cardiac surgery, diclofenac neither reduced the size of the effusions nor prevented late cardiac tamponade. PRIMARY FUNDING SOURCE: French Society of Cardiology. |
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Authors:
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Philippe Meurin; Jean Yves Tabet; Gabriel Thabut; Pascal Cristofini; Titi Farrokhi; Michel Fischbach; Bernard Pierre; Ahmed Ben Driss; Nathalie Renaud; Marie Christine Iliou; H?l?ne Weber; |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Annals of internal medicine Volume: 152 ISSN: 1539-3704 ISO Abbreviation: Ann. Intern. Med. Publication Date: 2010 Feb |
Date Detail:
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Created Date: 2010-02-03 Completed Date: 2010-02-22 Revised Date: 2010-06-16 |
Medline Journal Info:
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Nlm Unique ID: 0372351 Medline TA: Ann Intern Med Country: United States |
Other Details:
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Languages: eng Pagination: 137-43 Citation Subset: AIM; IM |
Affiliation:
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Les Grands Pr?s, 27 rue Sainte Christine, 77174 Villeneuve Saint Denis, France. philippemeurin@hotmail.com |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00247052 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Anti-Inflammatory Agents, Non-Steroidal
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administration & dosage* Cardiac Surgical Procedures / adverse effects Diclofenac / administration & dosage* Double-Blind Method Female Humans Male Middle Aged Pericardial Effusion / drug therapy*, etiology Prospective Studies |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents, Non-Steroidal; 15307-86-5/Diclofenac |
| Investigator | |
Investigator/Affiliation:
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P Meurin / ; H Weber / ; J Y Tabet / ; A Ben Driss / ; N Renaud / ; A Grosdemouge / |
| Comments/Corrections | |
Comment In:
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Ann Intern Med. 2010 Feb 2;152(3):186-7
[PMID:
20124236
]
Ann Intern Med. 2010 Jun 15;152(12):826-7; author reply 827 [PMID: 20547916 ] |
Summary for patients in:
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Ann Intern Med. 2010 Feb 2;152(3):I32
[PMID:
20124225
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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