Skip to main content
Log in

Author’s Reply to Kuss and Rathmann’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”

  • Letter to the Editor
  • Published:
Drug Safety Aims and scope Submit manuscript

The Original Article was published on 15 April 2023

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

References

  1. Kuss O and Rathmann W. 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”. Drug Saf. 2023. https://doi.org/10.1007/s40264-023-01292-6

  2. Alkabbani W, Pelletier R, Beazely MA, Labib Y, Quan B, Gamble JM. Drug-drug interaction of the sodium glucose co-transporter 2 inhibitors with statins and myopathy: a disproportionality analysis using adverse events reporting data. Drug Saf. 2022;45:287–95.

    Article  CAS  PubMed  Google Scholar 

  3. Michel C, Scosyrev E, Petrin M, Schmouder R. Can disproportionality analysis of post-marketing case reports be used for comparison of drug safety profiles? Clin Drug Invest. 2017;37:415–22.

    Article  Google Scholar 

  4. Raschi E, Poluzzi E, Salvo F, Pariente A, De Ponti F, Marchesini G, Moretti U. Pharmacovigilance of sodium-glucsoe co-transporter-2 inhibitors: what a clinician should know on disproportionality analysis of spontaneous reporting systems. Nutr Metab Cardiovasc Dis. 2018;28:533–42.

    Article  CAS  PubMed  Google Scholar 

  5. Antonazzo IC, Poluzzi E, Forcesi E, Salvo F, Pariente A, Marchesini G, De Ponti F, Raschi E. Signal of potentially protective drug-drug interactions from spontaneous reporting systems: proceed with caution. Acta Diabetol. 2020;57:115–6.

    Article  PubMed  Google Scholar 

  6. Kuss O, Rathmann W. A missed protective drug-drug interaction of DPP-4 inhibitors and statins on myopathy risk. Acta Diabetol. 2020;57(1):113–4. https://doi.org/10.1007/s00592-019-01440-4.

    Article  PubMed  Google Scholar 

  7. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). Guidance for industry, good pharmacovigilance practices and pharmacoepidemiologic assessment. 2005. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment. Accessed 25 Feb 2023.

  8. European Medicines Agency. Guidelines on good pharmacovigilance practices (GVP). Module IX Addendum I—methodological aspects of signal detection from spontaneous reports of suspected reactions. 2017. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices. Accessed 16 Feb 2023.

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to John-Michael Gamble.

Ethics declarations

Funding

No direct funding was received for this project.

Conflict of interest

John-Michael Gamble and Wajd Alkabbani declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript.

Ethics approval

Not applicable.

Consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data and material

Not applicable.

Code availability

Not applicable.

Author contributions

All authors contributed to the preparation of the letter and read and approved the final version.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Gamble, JM., Alkabbani, W. Author’s Reply to Kuss and Rathmann’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”. Drug Saf 46, 513–514 (2023). https://doi.org/10.1007/s40264-023-01293-5

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40264-023-01293-5

Navigation