Background

An analysis of the US Food and Drug Administration's Adverse Event Reporting System database found evidence suggesting that the combination of the cholesterol-lowering drug pravastatin and the antidepressant paroxetine, produced a significant increase in average blood glucose measures.

Objective

Our intent was to investigate the reproducibility of these findings by conducting a similar analysis of administrative and prescription claims data from patients receiving primary care at the Palo Alto Medical Foundation.

Method

We conducted an observational, retrospective review of 2149 adult patient records to compare mean measures of blood glucose between groups receiving concomitant paroxetine and pravastatin with the pooled means of those receiving 19 different combinations of a statin and a selective serotonin reuptake inhibitor (SSRI) antidepressant. Analysis of covariance (ANCOVA) was used to compare random glucose, fasting glucose, and glycosylated hemoglobin mean values, while adjusting for the covariates of age, gender, body mass index, and weight in patients with and without a diagnosis of diabetes mellitus.

Result

A total of 65 observations were analyzed from patients receiving concomitant paroxetine and pravastatin and 2084 from those receiving 19 other statin-SSRI pairs. The ANCOVA showed that significant covariate relationships included the diagnosis of diabetes mellitus, male gender, and body weight. After adjusting for covariates, no significant difference was found between the 3 mean glucose measures of the pravastatin-paroxetine pair groups and the corresponding means of the pooled statin-SSRI pair groups (P > 0.05).

Conclusion

Outpatients receiving concomitant pravastatin and paroxetine did not have significantly different mean glucose measures as compared with those receiving other statin-SSRI drug combinations.