| Spontaneous reports of hypertension leading to hospitalisation in association with rofecoxib, celecoxib, nabumetone and oxaprozin. | |
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MedLine Citation:
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PMID: 15132714 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND AND OBJECTIVE: Data on file with the US FDA, and other published studies, suggest that the selective cyclo-oxygenase (COX)-2 inhibitor NSAID rofecoxib has a greater hypertensive adverse effect than other NSAIDs, including celecoxib. In this study we describe a pharmacoepidemiologic analysis of spontaneous adverse event reports of acute, clinically serious hypertension (as defined by hospitalisation) reported in association with rofecoxib, celecoxib, nabumetone and oxaprozin. The objective of this analysis is to assess whether postmarketing data are consistent with results of clinical trials. We also collapse cases into series for the identification of possible risk factors for clinically severe, NSAID-associated hypertension. METHODS: Domestic (US) cases of apparently unconfounded, acute hypertension leading to hospitalisation were collected and reviewed from the spontaneous adverse events database of the FDA for rofecoxib, celecoxib, nabumetone and oxaprozin for the initial 3 years of marketing. Drug use data for the same intervals enabled calculation of reporting rates. RESULTS: In an analysis of reporting rates, hospitalisation for acute blood pressure (BP) elevation was reported more frequently (3.8-fold) for rofecoxib compared with celecoxib. A total of 34 cases are collapsed into case series. No cases were identified for either nabumetone or oxaprozin. Inspection of reviewed cases for celecoxib and rofecoxib suggest that these patients (average age 72 years) were potentially high-risk candidates for NSAID therapy. DISCUSSION AND CONCLUSION: During early marketing, hospitalisation for acute BP elevation appears to have been reported more frequently for rofecoxib compared with celecoxib. This is consistent with clinical trial data on file with the FDA, and other published studies that found rofecoxib to have a greater effect on BP than other NSAIDs, including celecoxib. This finding may be particularly relevant in older patients given the prevalence of hypertension and cardiovascular disease in this age group. |
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Authors:
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Allen Brinker; Lawrence Goldkind; Renan Bonnel; Julie Beitz |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Drugs & aging Volume: 21 ISSN: 1170-229X ISO Abbreviation: Drugs Aging Publication Date: 2004 |
Date Detail:
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Created Date: 2004-05-10 Completed Date: 2004-08-27 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9102074 Medline TA: Drugs Aging Country: New Zealand |
Other Details:
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Languages: eng Pagination: 479-84 Citation Subset: IM |
Copyright Information:
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Copyright 2004 Adis Data Information BV |
Affiliation:
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Division of Drug Risk Evaluation, Office of Drug Safety, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20875, USA. brinkera@cder.fda.gov |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Adverse Drug Reaction Reporting Systems / statistics & numerical data* Aged Aged, 80 and over Anti-Inflammatory Agents, Non-Steroidal / adverse effects* Butanones / adverse effects* Clinical Trials as Topic Cyclooxygenase 2 Female Hospitalization / statistics & numerical data Humans Hypertension / chemically induced* Isoenzymes / antagonists & inhibitors Lactones / adverse effects* Male Membrane Proteins Middle Aged Propionic Acids / adverse effects* Prostaglandin-Endoperoxide Synthases Pyrazoles Sulfonamides / adverse effects* Sulfones |
| Chemical | |
Reg. No./Substance:
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0/Anti-Inflammatory Agents, Non-Steroidal; 0/Butanones; 0/Isoenzymes; 0/Lactones; 0/Membrane Proteins; 0/Propionic Acids; 0/Pyrazoles; 0/Sulfonamides; 0/Sulfones; 0/rofecoxib; 169590-42-5/celecoxib; 21256-18-8/oxaprozin; 42924-53-8/nabumetone; EC 1.14.99.1/Cyclooxygenase 2; EC 1.14.99.1/PTGS2 protein, human; EC 1.14.99.1/Prostaglandin-Endoperoxide Synthases |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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