THE POTENTIAL CARDIOVASCULAR RISK OF ROSIGLITAZONE COMPARING TO OTHER ANTI-DIABETES AGENTS- A RETROSPECTIVE DESCRIPTIVE STUDY
Author(s)
Deng Y, Guo JJ, Lin AC
University of Cincinnati College of Pharmacy, Cincinnati, OH, USA
OBJECTIVES: The discussion around the cardiovascular risk caused by rosiglitazone continues, as the results from recent pharmacoepidemiologic studies were believed inconclusive. The objective of this study is to do a descriptive study on the adverse events, especially cardiovascular events caused by rosiglitazone and other commonly used anti-diabetes agents. METHODS: FDA adverse event reporting system (FAERS) database was used for data analysis; reports were drawn from 1997 to 2011. Study drugs include rosiglitazone, pioglitazone, metformin, glipizide and glyburide. Adverse events during time were calculated to see the trend. Frequency of different adverse events described and stratified by age and gender. Different outcomes like the cardiovascular events, death and hospitalization associated with each study drug were calculated each year. RESULTS: The adverse events of all drugs did not vary much during years, except that rosiglitazone has a sharply increase from 2008 and decreased in 2011, in accordance with the 2007 meta-analysis published. Adverse events of different drugs differ in gender: there are 10% more adverse events of glyburide and 14% more of rosiglitazone in male than female; while metformin cause 8% more in female than male. Rosiglitazone has significantly more deaths (5568) and hospitalizations (28387) comparing to other four drugs (average 2225 death and 11521 hospitalization), and it also has more cardiovascular events (36.37%) than other four drugs (average 11.52%). CONCLUSIONS: Rosiglitazone seems to have more and severe adverse events, especially cardiovascular events comparing to other four antidiabetic drugs.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PDB6
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Diabetes/Endocrine/Metabolic Disorders