Title: The risk of diabetes mellitus among statin users: A disproportionality analysis using FAERS data
Authors: Ajinkya Pawar, BS1
1College of Pharmacy, University of Rhode Island, Kingston, RI
Objective: To evaluate diabetes mellitus adverse events reported for the statin use. ¬
Background : Statins, a class of medications prescribed to reduce blood levels of LDL cholesterol, have been found to increase the risk of developing diabetes mellitus (DM).1 Such association has been observed in multiple observational studies, prospective randomized trials as well as meta-analyses.2,3
A recent retrospective cohort study of US health adults using a propensity score to match statin users and nonusers found the overall proportion of patients who developed diabetes during the follow-up period was approximately 14%. Among propensity score matched 3351 statin users and 3351 nonusers, statin users had higher odds of new-onset diabetes (odds ratio [OR] 1.87; 95 % confidence interval [95 % CI] 1.67-2.01), …show more content…
One of the review evaluating statin related adverse events using FAERS data identified Diabetes-Statin reports to be surging over 10x the quarterly average of 297 to 3703 from 2013 Q2 to 2014 Q1.7 However, the disproportionality analysis of these cases haven’t been studied in this review.
Moreover, FDA report5 refers increased risk of DM due to statins as 'small ' and state that "heart benefit of statins outweighs this small increased risk". The proportionality analysis evaluating DM reporting risk among statin user is necessary for understanding the patterns of such risk. This study would help quantify DM events reported among statins users in terms of proportionality reporting ratio (PRR) and reporting odds ratio
Authors: Ajinkya Pawar, BS1
1College of Pharmacy, University of Rhode Island, Kingston, RI
Objective: To evaluate diabetes mellitus adverse events reported for the statin use. ¬
Background : Statins, a class of medications prescribed to reduce blood levels of LDL cholesterol, have been found to increase the risk of developing diabetes mellitus (DM).1 Such association has been observed in multiple observational studies, prospective randomized trials as well as meta-analyses.2,3
A recent retrospective cohort study of US health adults using a propensity score to match statin users and nonusers found the overall proportion of patients who developed diabetes during the follow-up period was approximately 14%. Among propensity score matched 3351 statin users and 3351 nonusers, statin users had higher odds of new-onset diabetes (odds ratio [OR] 1.87; 95 % confidence interval [95 % CI] 1.67-2.01), …show more content…
One of the review evaluating statin related adverse events using FAERS data identified Diabetes-Statin reports to be surging over 10x the quarterly average of 297 to 3703 from 2013 Q2 to 2014 Q1.7 However, the disproportionality analysis of these cases haven’t been studied in this review.
Moreover, FDA report5 refers increased risk of DM due to statins as 'small ' and state that "heart benefit of statins outweighs this small increased risk". The proportionality analysis evaluating DM reporting risk among statin user is necessary for understanding the patterns of such risk. This study would help quantify DM events reported among statins users in terms of proportionality reporting ratio (PRR) and reporting odds ratio