Results of an Extensive Safety Review of the $19 Billion U.S. Statin Drug Class
AdverseEvents Review of Over 150,000 Muscle-Related Side Effect Reports Indicates That Pravachol and Mevacor Have the Best Safety Profiles While Crestor May Have the Worst
(firmenpresse) - HEALDSBURG, CA -- (Marketwire) -- 10/20/11 -- AdverseEvents, Inc. utilized RxFilter™, its proprietary data aggregation and refinement process, to conduct a class-wide safety comparison of marketed statin drugs with data from the FDA Adverse Event Reporting System (AERS) database. In a review of over 150,000 muscle-related adverse event reports covering the period of 1/1/2004 - 3/31/2011, AdverseEvents found that Pravachol (Bristol-Myers Squibb) and Mevacor (Merck) have the best muscle-related safety profile while Crestor (AstraZeneca) has the worst. Recent scientific literature has conflicting views on within-class safety differences between the major statins, including research that indicates that the drugs share similar muscle-related safety profiles. The report published by AdverseEvents today highlights that this latter conclusion may not be supported in large consumer populations.
"Statins" are the most widely taken mediations in the world, with over 30 million users in the U.S. alone and 19 billion dollars in domestic sales. They are a class of cholesterol management drugs prescribed to reduce the risk of cardiovascular disease, the leading cause of death in most industrialized nations. Their use has been linked to a variety of muscle-related side effects that are grouped into the term "statin myopathy" and occur in up to 10 - 15% of all statin users (i.e. between 3 - 4.5 million people in the United States). Statin myopathies can significantly increase injury risks and affect mobility, especially in older individuals. According to healthcare professionals, these side effects form a significant barrier to statin therapy adherence, while the fear of these myopathies also leads to significant under prescribing.
The RxFilter™ process identified over 150,000 adverse event case reports linked to statins in the AERS database. The most compelling findings of this analysis include differences in side effect risks between the six top-selling statin drugs. Of the seven separate muscle-related adverse event categories searched, Crestor had the highest percentage risk in six categories, while Pravachol and Mevacor appeared to have the least. This is one of the first studies of broad consumer patient populations to single out Crestor as potentially having a poor muscle-related safety profile when compared with other statins. Identifying these specific side effect risks creates an important reference point during the selection of specific statins for cholesterol management in general and, especially, for the rechallenge of patients who have experienced muscle-related side effects.
Brian M. Overstreet, president of AdverseEvents, said, "Given the studies conducted to date and the labeling of the statin drugs, we were surprised to find such a variance in serious muscle-related adverse events rates within the class. Such a study would not be feasible without the use of our RxFilter technology which is the first to standardize and normalize the FDA's AERS database. While the FDA maintains that raw AERS data cannot be used to calculate the incidence of an adverse event in the U.S. population, we believe that the scope and breadth of our study raises potential safety issues that deserve further evaluation."
As is the case for any information regarding side effects and adverse events, patients should never discontinue, or alter in any way, the drugs or dosages prescribed by their physician until after consultation with their doctor. Patients should discuss these findings directly with their doctors before making any changes whatsoever to their medicines or prescribed medication regimen.
RxFilter and this study make use of AERS data. AERS data are only as accurate as the information inputted into it from various sources. The FDA estimates that only approximately 10% of all adverse events that are potentially triggered by post-marketed drugs are recorded into AERS. Reporting rates regarding a given adverse event can be influenced by publicity and marketing campaigns. Accordingly, while the RxFilter™ process used by AdverseEvents, Inc. represents an exceptionally useful tool for searching and analyzing AERS data, the output is constrained by the raw data that can be obtained from AERS.
AdverseEvents, Inc. (AEI) is the first service provider to deliver accurate, real-time information on adverse drug events reported to the FDA. AEI utilizes a unique data sourcing method called RxFilter™, a proprietary 17-step data refinement process that standardizes and normalizes the data from the FDA's Adverse Event Reporting System (AERS) into a user-friendly, fully searchable database of all FDA approved medications. Over 500,000 medication adverse events are reported yearly to the FDA; estimated to be only 10 percent of all actual adverse events. As a leading resource for the pharmaceutical industry, AEI supports companies with competitive intelligence and data to inform drug marketing decisions and business development strategies. With AEI, the healthcare industry is able to quantify the benefit-risk assessments of FDA approved drugs to fully understand the scope of safety issues, based on accurate rates of side effects from such medications. For more information about AdverseEvents, please visit .
This message is sent from AdverseEvents Inc., an independent company not associated with the manufacturing of the aforementioned drugs. AdverseEvents, Inc. has not been compensated, directly or indirectly, by any third party for the preparation of this report.
Contact:
Sharon Miller
AdverseEvents, Inc.
917-842-5378
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Datum: 20.10.2011 - 12:00 Uhr
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