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ABSTRACT
Objective: To explore the usefulness of number needed to treat to be harmed (NNTH), in benefit-risk assessments, by studying the agreement between NNTH values and withdrawals of medicines from European market due to safety reasons.
Methods: Medicines with data from longitudinal studies were included. Studies were identified from European Medicines Agency’s Reports. Meta-analyses were performed to pool odds ratios (OR) with 95% confidence-intervals (CI). Published control event rates were applied to ORs to calculate NNTHs (95%CI) for selected adverse events.
Results: NNTH (95%CI) decreased from pre- to post-marketing for the eight medicines included: peripheral neuropathy (∞ vs. 12[non-significant; NS] with almitrine; heart valve disease with benfluorex (∞ vs. NNTH ranging from 7[4–13] to 7[5–9]); myopathy (−4096[NS] vs. 797[421–1690]), new-onset diabetes (113[NS] vs. 390[425–778]), bleeding (∞ vs. 517[317–1153]), and infection (∞ vs. 253[164–463]) with niacin-laropiprant; psychiatric disorders (12[7–34] vs. 9[5–24]) with rimonabant; myocardial infarction (MI) [−1305 vs. 270[89–4362]) with rofecoxib; MI (−510 vs. NNTH ranging from 152[55–4003] to 568[344–1350]) with rosiglitazone; cardiovascular events (∞ vs. 245[129–1318]) with sibutramine; and liver injury (∞ vs. 5957[NS]) with ximelagatran.
Conclusion: NNTH have potential of use as a supportive tool in benefit-risk re-evaluations of medicines and may help regulators to making decisions on drug safety.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
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Notes on contributors
Diogo Mendes
D Mendes conceived the study, collected the data, analysed the data and wrote the paper. C Alves and F Batel-Marques conceived the study, analysed the data and reviewed the paper.
Carlos Alves
D Mendes conceived the study, collected the data, analysed the data and wrote the paper. C Alves and F Batel-Marques conceived the study, analysed the data and reviewed the paper.
Francisco Batel Marques
D Mendes conceived the study, collected the data, analysed the data and wrote the paper. C Alves and F Batel-Marques conceived the study, analysed the data and reviewed the paper.
