Comments on: Vioxx Caused Heart Attacks In 7.4 Months! http://www.pharmalot.com/2007/07/vioxx-caused-heart-attacks-in-74-months/ News, Comment and Conversation Fri, 10 Feb 2012 18:07:51 +0000 http://wordpress.org/?v=2.6.2 By: Simon Passanante - Vioxx caused heart attack in 7.4 months http://www.pharmalot.com/2007/07/vioxx-caused-heart-attacks-in-74-months/#comment-16008 Simon Passanante - Vioxx caused heart attack in 7.4 months Mon, 30 Jul 2007 16:04:38 +0000 http://www.pharmalot.com/2007/07/vioxx-caused-heart-attacks-in-74-months/#comment-16008 [...] Pharmalot notes, this finding could possibly undermine Merck’s Vioxx litigation defense claim that the [...] [...] Pharmalot notes, this finding could possibly undermine Merck’s Vioxx litigation defense claim that the [...]

]]> By: Kent Jarrell http://www.pharmalot.com/2007/07/vioxx-caused-heart-attacks-in-74-months/#comment-15824 Kent Jarrell Thu, 26 Jul 2007 13:12:30 +0000 http://www.pharmalot.com/2007/07/vioxx-caused-heart-attacks-in-74-months/#comment-15824 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 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 - 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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