Comment on: "Drug–Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data"

Noguchi, Yoshihiro

doi:10.1007/s40264-022-01191-2

Cited by 3 publications

(3 citation statements)

References 14 publications

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“…Data mining and statistical analyses were performed using Microsoft Access 2016 (Microsoft Co., Ltd., Tokyo, Japan). We independently developed the aggregation system using Microsoft Access and confirmed that the calculation of these indices yielded consistent results compared to previous studies [ 34 , 35 ].…”

Section: Methodssupporting

confidence: 78%

Drug-drug interaction assessment based on a large-scale spontaneous reporting system for hepato- and renal-toxicity, and thrombocytopenia with concomitant low-dose methotrexate and analgesics use

Honma,

Onda,

Masuyama

2024

BMC Pharmacol Toxicol

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Background Methotrexate (MTX) is the cornerstone of rheumatoid arthritis (RA) treatment and is highly effective with low-dose intermittent administration. MTX is occasionally used in combination with non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (APAP)/paracetamol for pain or inflammation control. With MTX treatment, the side effects, such as hepatotoxicity, renal failure, and myelosuppression should be considered. These are also seen with analgesics treatment. Methods We used a large spontaneously reported adverse event database (FAERS [JAPIC AERS]) to analyze whether the reporting of adverse events increased upon MTX and analgesic therapy in patients with RA. Results After identifying RA cases, the crude reporting odds ratios (cRORs) for hepatotoxicity, renal failure, and thrombocytopenia associated with the use of MTX, APAP, or NSAIDs were calculated by disproportionality analysis, which revealed significantly higher cRORs for these events. No analgesics showed consistent positive signals for drug-drug interaction (DDI) with concomitant low-dose MTX analyzed using four algorithms for DDI interaction (the Ω shrinkage measure, additive or multiplicative, and combination risk ratio models). However, in renal failure and thrombocytopenia, loxoprofen (Ω025 = 0.08) and piroxicam (Ω025 = 0.46), and ibuprofen (Ω025 = 0.74) and ketorolac (Ω025 = 3.52), respectively, showed positive signals in the Ω shrinkage measure model, and no consistency was found among adverse events or NSAIDs. Conclusions Studies using spontaneous reporting systems have limitations such as reporting bias or lack of patient background; however, the results of our comprehensive analysis support the results of previous clinical or epidemiological studies. This study also demonstrated the usefulness of FAERS for DDI assessment.

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Section: Methodssupporting

confidence: 78%

Drug-drug interaction assessment based on a large-scale spontaneous reporting system for hepato- and renal-toxicity, and thrombocytopenia with concomitant low-dose methotrexate and analgesics use

Honma,

Onda,

Masuyama

2024

BMC Pharmacol Toxicol

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“…13 A subsequent re-analysis of the same dataset was subject to most of these limitations. 14 SGLT2 inhibitors and statins are often used together; in fact, realworld data show that up to 77% of SGLT2 inhibitor users may use statins concurrently. 15,16 However, pharmacoepidemiologic studies attempting to quantify the risk of myotoxicity and especially rhabdomyolysis associated with the interaction between SGLT2 inhibitors and statins at the drug class and also at the individual compound level are not likely to yield conclusive findings.…”

Section: Introductionmentioning

confidence: 99%

“…However, the study had some potential limitations, including use of a restricted dataset, use of data mining methods that may underperform in settings of rare adverse events, lack of analyses on severe forms of myotoxicity such as rhabdomyolysis and lack of methods to account for stimulated reporting 13 . A subsequent re‐analysis of the same dataset was subject to most of these limitations 14 …”

Section: Introductionmentioning

confidence: 99%

Concomitant use of statins and sodium‐glucose co‐transporter 2 inhibitors and the risk of myotoxicity reporting: A disproportionality analysis

Gravel

Krewski

Mattison

et al. 2023

Brit J Clinical Pharma

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Aims Recent case reports have suggested that sodium‐glucose co‐transporter 2 (SGLT2) inhibitors may interact with statins to increase their risk of myotoxicity. We assessed the risk of myotoxicity reporting associated with concomitant use of SGLT2 inhibitors and statins. Methods We queried the US Food and Drug Administration Adverse Event Reporting System (FAERS) from 2013 to 2021 for reports including SGLT2 inhibitors, statins or both. We estimated several measures of disproportionate reporting of myopathy and rhabdomyolysis associated with concomitant use of SGLT2 inhibitors and statins: reporting odds ratio (ROR) with 95% confidence interval (CI), Ω shrinkage measure (safety signal if >0) and an extension of the proportional reporting ratio (PRR) (two‐criteria set, safety signal if both criteria are met), using the full FAERS dataset as the reference set. In sensitivity analyses, we focussed on specific SGLT2 inhibitor‐statin pairs with higher interaction potential (canagliflozin‐rosuvastatin, empagliflozin‐rosuvastatin) and accounted for stimulated reporting. Results There were 456 myopathy and 77 rhabdomyolysis reports involving both an SGLT2 inhibitor and a statin. Concomitant use of SGLT2 inhibitors and statins was not associated with an increased risk of myopathy (ROR 0.79, 95% CI 0.70 to 0.89) or rhabdomyolysis (ROR 0.58, 95% CI 0.41 to 0.83) reporting. For both outcomes, the Ω shrinkage measure was negative and only one criterion of the PRR extension was met. SGLT2 inhibitor‐statin pairs with higher interaction potential yielded potential signals for rhabdomyolysis; these signals disappeared after accounting for stimulated reporting. Conclusion There was no increased risk of myotoxicity reporting associated with concomitant use of SGLT2 inhibitors and statins or for specific drug pairs.

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Authors’ Reply to Noguchi’s comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data.”

Gamble

Alkabbani

2022

Drug Saf

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Comment on: "Drug–Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data"

Cited by 3 publications

References 14 publications

Drug-drug interaction assessment based on a large-scale spontaneous reporting system for hepato- and renal-toxicity, and thrombocytopenia with concomitant low-dose methotrexate and analgesics use

Drug-drug interaction assessment based on a large-scale spontaneous reporting system for hepato- and renal-toxicity, and thrombocytopenia with concomitant low-dose methotrexate and analgesics use

Concomitant use of statins and sodium‐glucose co‐transporter 2 inhibitors and the risk of myotoxicity reporting: A disproportionality analysis

Authors’ Reply to Noguchi’s comment on: “Drug-Drug Interaction of the Sodium Glucose Co-transporter 2 Inhibitors with Statins and Myopathy: A Disproportionality Analysis Using Adverse Events Reporting Data.”

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