JAMA: Data mining can detect unexpected drug interactions
Up to one million patients in the U.S. may be taking two medications that can lead to unexpected increases in blood glucose level when used simultaneously, wrote Tracy Hampton, PhD, in the July 13 edition of the Journal of the American Medical Association.
Citing work from Nicholas Tatonetti, doctoral candidate in the biomedical informatics training program at Stanford University in Stanford, Calif., and colleagues, who published their results in Clinical Pharmacology & Therapeutics, Hampton continued, “Data-mining techniques have revealed that the combination of the antidepressant paroxetine and the cholesterol-lowering medication pravastatin may cause this adverse effect.”
The researchers mined the FDA's Adverse Event Reporting System (AERS) for side-effect profiles involving glucose homeostasis and found a strong signal for co-medication with pravastatin and paroxetine. “We retrospectively evaluated changes in blood glucose in 104 patients with diabetes and 135 without diabetes who had received co-medication with these two drugs, using data in EMR systems of three geographically distinct sites,” Tatonetti and colleagues wrote in their study. “We assessed the mean random blood glucose levels before and after treatment with the drugs.”
The researchers found that pravastatin and paroxetine, when administered together, had a synergistic effect on blood glucose. The average increase was 19 mg/dl (1.0 mmol/l) overall, and in those with diabetes it was 48 mg/dl (2.7 mmol/l). In contrast, neither drug administered singly was associated with such changes in glucose levels. An increase in glucose levels is not a general effect of combined therapy with selective serotonin reuptake inhibitors and statins.
“Our results are consistent with the hypothesis that pravastatin and paroxetine may interact in this manner with biological pathways that are critical for glucose metabolism,” the authors concluded. “Our results highlight not only the possibility of such interactions but the potential clinical significance of these interactions.”
Citing work from Nicholas Tatonetti, doctoral candidate in the biomedical informatics training program at Stanford University in Stanford, Calif., and colleagues, who published their results in Clinical Pharmacology & Therapeutics, Hampton continued, “Data-mining techniques have revealed that the combination of the antidepressant paroxetine and the cholesterol-lowering medication pravastatin may cause this adverse effect.”
The researchers mined the FDA's Adverse Event Reporting System (AERS) for side-effect profiles involving glucose homeostasis and found a strong signal for co-medication with pravastatin and paroxetine. “We retrospectively evaluated changes in blood glucose in 104 patients with diabetes and 135 without diabetes who had received co-medication with these two drugs, using data in EMR systems of three geographically distinct sites,” Tatonetti and colleagues wrote in their study. “We assessed the mean random blood glucose levels before and after treatment with the drugs.”
The researchers found that pravastatin and paroxetine, when administered together, had a synergistic effect on blood glucose. The average increase was 19 mg/dl (1.0 mmol/l) overall, and in those with diabetes it was 48 mg/dl (2.7 mmol/l). In contrast, neither drug administered singly was associated with such changes in glucose levels. An increase in glucose levels is not a general effect of combined therapy with selective serotonin reuptake inhibitors and statins.
“Our results are consistent with the hypothesis that pravastatin and paroxetine may interact in this manner with biological pathways that are critical for glucose metabolism,” the authors concluded. “Our results highlight not only the possibility of such interactions but the potential clinical significance of these interactions.”