Vioxx Caused Heart Attacks In 7.4 Months!
2 CommentsBy Ed Silverman // July 25th, 2007 // 5:30 pm
This is just the sort of study finding that can give Merck execs and big shareholders cardiac arrest. The study, which was published today in The New England Journal of Medicine (look here), says Vioxx “was associated with an increased frequency of adverse cardiovascular events among patients with a median treatment of 7.4 months’ duration.”
The results call into question a crucial underpinning of Merck’s legal defense - the risk of heart attacks wasn’t statistically significant until at least 18 months of use. The 2,434-patient study, by the way, was sponsored by Oxford University and an education grant from Merck, but was ended after Vioxx was withdrawn in September 2004. Merck faces some 27,000 lawsuits.
Called Victor, the study was limited by a relatively small number of adverse heart events - just 15 in the Vioxx group and 6 in the placebo group - and its short duration. “However, our findings suggest an increased risk of cardiovascular thrombotic events in patients randomly assigned to receive rofecoxib” during or within 14 days after Vioxx, they wrote.
The researchers added that they found a statistically significant higher risk of adverse heart events among the Vioxx patients, but no statistically significant difference between the Vioxx and placebo groups during the 24 months following closure of the trial. Originally, the study was designed to see if Vioxx could combat recurring colon cancer.
Earlier this week, Graeme Bell, who heads Merck’s investor relations, had this to say in response to an analyst on a teleconferene call: “With regard to Victor and the science behind that, I think we indicated many times that that is but one study, and you know the history in terms of it being stopped prematurely, and that data such in and of itself has been available to all plaintiffs and this has been argued and presented many times in the 15, 16 trials that have actually gone through to juries, and we feel that that one data point in and of itself can draw no conclusion whatsoever, so we remain steadfast based on the scientific evidence relating to the long-term trial.”
Kent Jarrell
Ed, some information from Merck. I think it is important to note that Merck believes that the real story here is in the totality of the data., which does not confirm the VICTOR results.
In addition to the VICTOR study, results form another study, the ViP trial were reported this week in the the journal Current Medical Research and Opinion .
The results from the ViP trial – also aturely terminated chemoprevention trial designed to determine the cumulative incidence of developing prostate cancer over six years of treatment with VIOXX 25 mg/day versus placebo and showed confirmed cardiovascular event for VIOXX and placebo were similar.
As VICTOR and ViP illustrate, it may be misleading to focus on one study to draw conclusions about the CV profile of VIOXX.
.Other large, placebo-controlled clinical trials – specifically the Alzheimer’s studies and the ViP study – did not show any increased risk with VIOXX compared to placebo. Merck believes these data should be considered as a whole and the meaning of the data continues to be a matter of debate in the scientific community.
Here is the official Merck statement
Statement
_____________________________________________________________________________
Statement Regarding the Publications of Two VIOXX Studies:
The ViP Trial in Current Medical Research and Opinion and
The VICTOR Trial in the New England Journal of Medicine
WHITEHOUSE STATION, N.J., July 25, 2007 – The cardiovascular (CV) findings from the ViP trial, a randomized, placebo-controlled trial designed to evaluate the effect of VIOXX in decreasing the risk of prostate cancer, were reported this week in the journal Current Medical Research and Opinion.
Additionally, the CV findings from the VICTOR trial, a randomized, placebo-controlled trial designed to evaluate the effect of VIOXX in treating patients with colorectal cancer, have recently been published in the New England Journal of Medicine.
The ViP trial was stopped early on Sept. 30, 2004, due to the worldwide withdrawal of VIOXX. In early 2005, interim data from this study were provided to the U.S. Food and Drug Administration (FDA) and discussed at the FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Final results from the ViP trial were posted to http://www.clinicalstudyresults.org in September 2005.
In the study, the risk of confirmed CV events during treatment with VIOXX and placebo were similar. Twenty-nine patients (14 VIOXX, 15 placebo) experienced confirmed thrombotic CV events in the ViP trial. A total of 4,741 men were enrolled in the study (2,369 randomized to VIOXX 25 mg, and 2,372 to placebo). Baseline demographics were similar in the two treatment groups, and median duration of treatment was 4.14 months (range 0.03 to 15.9 months).
In the ViP study, all of the CV data were collected prior to patient and investigator unblinding. All reported thrombotic CV events occurring on-treatment or within 14 days after study drug discontinuation were adjudicated by an independent panel of clinical experts blinded to treatment assignment. An independent confirmation of the analyses of the ViP study was performed by Warwick Clinical Trials Unit in Warwick, U.K.
The study authors acknowledge that limitations in the ViP study – specifically, the short period of drug exposure, the uncompleted enrollment, and the relatively small number of thrombotic CV events observed – do not allow firm conclusions to be drawn regarding the relative CV safety of VIOXX 25 mg compared to placebo from this study alone.
The purpose of reporting the results from the ViP study is to provide the scientific community with the CV safety data in a peer-reviewed scientific publication in order to add to
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