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Scientific and ethical issues in add-on designs for antidiabetic drugs

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Abstract

This editorial describes the clinical trials related to antidiabetic drugs, most of them following an “add-on” design of where the new drug is added to metformin and the comparative arm is metformin plus placebo. Many drugs are already approved for therapy following this design; the authors believe that it is unethical to continue this trend because it makes it impossible to stratify the many antidiabetic drugs according to their efficacy and toxicity.

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Acknowledgements

The authors are grateful to Judith Bagott for language editing.

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Authors and Affiliations

  1. Department of Cardiovascular Medicine, Istituto Di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy

    Lidia Staszewsky

  2. Istituto Di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, 20156, Milan, Italy

    Silvio Garattini

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  1. Lidia Staszewsky
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  2. Silvio Garattini
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SG and LS have design and written the manuscript. Both authors read and approved the final manuscript.

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Correspondence to Silvio Garattini.

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Staszewsky, L., Garattini, S. Scientific and ethical issues in add-on designs for antidiabetic drugs. Eur J Clin Pharmacol 78, 1399–1401 (2022). https://doi.org/10.1007/s00228-022-03351-w

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  • DOI: https://doi.org/10.1007/s00228-022-03351-w

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