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Why drugs should be evaluated in several randomised comparative trials  Editorial  Every year, the Prescrire Drug Awards are based on the reviews published in the Marketing Authorisations section of Prescrire's French edition over the past year. For the 2024 Prescrire Drug Awards, as in previous years, we chose not to give awards to certain drugs that were evaluated in a single comparative trial, even when the trial showed the drug to represent a therapeutic advance for patients. Examples include: darolutamide, for use in combination with docetaxel in certain metastatic prostate cancers; and dostarlimab, for use in combination with first-line chemotherapy in certain endometrial cancers. What is the reason for this choice? Full article available for download (FREE) 1 May 2025

The Prescrire Drug Awards for 2024 Prescrire awarded one Pilule d'Or (Golden Pill) this year, to a drug for a neglected disease. One other drug was deemed "Noteworthy". Although some of the other drugs analysed in Prescrire over the course of 2024 represented a therapeutic advance for certain patients, especially in the field of oncology, we chose not to give them an award because their clinical evaluation was insufficiently robust (see "Why drugs should be evaluated in several randomised comparative trials" Prescrire Int May 2025, FREE). Full article available for download (FREE) 1 May 2025

Linzagolix (Yselty°) in uterine fibroids  Marketing Authorisations  Linzagolix, an oral GnRH antagonist, like relugolix, has been authorised in the European Union as a symptomatic treatment for uterine fibroids. To prevent the menopausal symptoms it induces, the company recommends adding an oestrogen-progestogen combination. Full article available for download by subscribers 1 May 2025

Cabotegravir (Apretude°) in HIV pre-exposure prophylaxis (PrEP)  Marketing Authorisations  Cabotegravir, an HIV integrase inhibitor, administered by intramuscular injection, is already authorised in the European Union under the brand name Vocabria° for use in combination with rilpivirine in HIV-infected patients. It is now also authorised as monotherapy under the brand name Apretude°. Full article available for download by subscribers 1 May 2025

Myocarditis linked to messenger RNA covid-19 vaccines (continued)  Adverse Effects  This article summarises the main data identified in our literature search, conducted in early 2025, concerning the prognosis of myocarditis linked to mRNA covid-19 vaccines. Full article available for download by subscribers 1 May 2025

Sagas  Editorial  Metamizole (also known as dipyrone) is an analgesic and antipyretic drug that exposes patients to a risk of fatal agranulocytosis of unpredictable onset. In late 2024, the European Commission decided to maintain metamizole-containing medicines on the European market. Full article available for download (FREE) 1 April 2025

Fexinidazole (Fexinidazole Winthrop°) in sleeping sickness caused by Trypanosoma brucei rhodesiense  Marketing Authorisations  In 2018, the European Medicines Agency (EMA) evaluated the nitroimidazole antiparasitic drug fexinidazole in the treatment of trypanosomiasis due to T. brucei gambiense. In this situation, the drug represented a major therapeutic advance, with high efficacy at both stages of the disease. More recently, the EMA evaluated fexinidazole in the treatment of human African trypanosomiasis due to T. brucei rhodesiense. Full article available for download by subscribers 1 April 2025

Esketamine (Spravato°) in depression after failure of several antidepressants or with a high risk of suicide?  Marketing Authorisations  The publication in 2023 of results from the trial comparing esketamine to quetiapine provides an opportunity to review the evaluation data on esketamine in the situations for which it is authorised. Since our 2022 analysis, what more is known about the efficacy of esketamine in comparison to that of other treatments? What more is known about its adverse effects? Full article available for download by subscribers 1 April 2025

SSRI antidepressants and venlafaxine: increased risk of injuries  Adverse Effects  A study using French healthcare data, in which each patient acted as their own control, showed that the risk of hospitalisation for an injury (such as a fracture) was about 1.5-fold greater during the first 2 weeks of treatment with escitalopram or paroxetine compared to periods without exposure to these drugs. This difference was statistically significant. Similar results were found with venlafaxine. Full article available for download by subscribers 1 April 2025

Prescrire's ratings of new drugs in 2024  Marketing Authorisations  One major therapeutic advance, a few practical advances for children, but otherwise many new products or indications of little value this year. Full article available for download (FREE) 1 April 2025

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