Cv2 Cardiovascular Risk of Selective Cyclooxygenase-2 Inhibitors Compared to Other Nonsteroidal Anti-Inflammatory Agents: An Observational Study of a Medicaid Population

Shaya, FT; Blume, SW; Blanchette, CM; Mullins, C. Daniel; Weir,

doi:10.1016/s1098-3015(10)62064-5

Value in Health

2004

DOI: 10.1016/s1098-3015(10)62064-5

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Cv2 Cardiovascular Risk of Selective Cyclooxygenase-2 Inhibitors Compared to Other Nonsteroidal Anti-Inflammatory Agents: An Observational Study of a Medicaid Population

FT Shaya¹,

SW Blume²,

CM Blanchette³

et al.

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“…Five other studies, published in abstract form only, were also reported prior to APPROVe. [6][7][8][9][10] Of these five studies, three found no relation between use of rofecoxib and MI risk. 6,8,9 Kimmel found no increased risk with rofecoxib versus non-use of NSAIDs.…”

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“…[6][7][8][9][10] Of these five studies, three found no relation between use of rofecoxib and MI risk. 6,8,9 Kimmel found no increased risk with rofecoxib versus non-use of NSAIDs. However, in that study there was an increased risk when rofecoxib was compared with celecoxib and with nonselective NSAIDs, both of which had a significantly decreased risk compared with non-use of NSAIDs.…”

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Observational studies and the withdrawal of rofecoxib

Watson

Santanello

2006

Pharmacoepidemiology and Drug

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The withdrawal of rofecoxib has led to renewed discussion on the role of observational studies in regulatory decision making. 1 To draw firm conclusions from observational data one must see consistent, strong associations in a number of well-designed studies in different settings. Prior to the results of the APPROVe study, the observational data on rofecoxib did not, in our opinion, meet this standard, were inconsistent with data from randomized controlled trials and were therefore insufficient for regulatory decision-making.The APPROVe study began in December 1999, prior to the publication of any observational studies of rofecoxib. 2 It was one of three randomized placebocontrolled studies that formed the basis of a prespecified data analysis plan, finalized in October 2002, to combine clinical trial results to compare the rate of thrombotic cardiovascular events with rofecoxib versus placebo. The clinical trial data with rofecoxib before the results of APPROVe showed similar rates of thrombotic CV events in patients taking rofecoxib to patients taking either placebo or non-naproxen NSAIDs; a difference had only been observed between rofecoxib and naproxen (summarized in http:// www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090B1_02_MERCK-Vioxx.pdf). APPROVe was the first clinical trial in which a statistically significant difference in thrombotic CV events between rofecoxib and placebo was observed, beginning after 18 months of chronic therapy. Merck voluntarily withdrew rofecoxib from the worldwide market within 1 week of learning of the APPROVe results.Prior to the APPROVe results and the withdrawal of rofecoxib, there were three peer-reviewed observational studies of the risk of MI that included patients prescribed rofecoxib. The first, published in 2002 by Ray et al., showed no significant MI risk with use of rofecoxib up to 25 mg daily (the maximum recommended dose for chronic use). 3 Ray did note a significantly elevated relative risk (RR ¼ 1.93) of serious CHD in patients (specifically new users) prescribed 50 mg of rofecoxib daily, compared with no NSAID use. However, the subgroup in which that result was noted was small (500 total person-years of exposure, 12 exposed cases), and therefore the 95% confidence interval around that estimate was large (1.09, 3.43). The second study, published in 2003 by Mamdani et al., showed no relation between rofecoxib use and CV risk when compared with either non-use of NSAIDs, nonselective NSAIDs, or celecoxib. 4 No analyses by dose were performed in that study. The third study, published in 2004 by Solomon et al., showed no significantly increased risk with rofecoxib when compared with no NSAID use or with use of various non-selective NSAIDs, which was the primary comparison for the study. 5 However, there was a small increased risk with rofecoxib compared with celecoxib overall (OR ¼ 1.24, 95%CI 1.05, 1.46), with modestly greater risk at higher doses for less than 90 days of use and no increased risk for longer use. Thus, prior to the APPROVe results, the peer-revie...

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Observational studies and the withdrawal of rofecoxib

Watson

Santanello

2006

Pharmacoepidemiology and Drug

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Cv2 Cardiovascular Risk of Selective Cyclooxygenase-2 Inhibitors Compared to Other Nonsteroidal Anti-Inflammatory Agents: An Observational Study of a Medicaid Population

Cited by 1 publication

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Observational studies and the withdrawal of rofecoxib

Observational studies and the withdrawal of rofecoxib

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