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Spotlight

Every month, the subjects in Prescrire’s Spotlight.

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Relugolix + estradiol + norethisterone (Ryeqo°) in uterine fibroids: not acceptable

  Marketing Authorisations  The three-drug combination of relugolix + estradiol + norethisterone was mainly evaluated in two placebo-controlled trials. It markedly reduced menstrual bleeding in most women, but not fibroid volume, and no conclusive evidence of effects on other symptoms was obtained.
Full article (4 pages) available for download by subscribers
1 January 2023

Setmelanotide (Imcivree°) in certain, very rare, genetic forms of obesity: possibly helpful

  Marketing Authorisations  Evaluation of setmelanotide in the very rare patients with obesity due to POMC, PCSK1 or LEPR mutations is only based on two non-comparative trials, in a total of 30 patients treated for one year. These trials suggest that daily subcutaneous injections of setmelanotide help patients feel less hungry, and consequently lose weight, especially those with POMC deficiency.
Full article (3 pages) available for download by subscribers
1 January 2023

Trimebutine: too many cardiac risks

 Adverse Effects  In 2021, using data from 444 575 patients, a Korean team observed that the risk of QT interval prolongation linked to hydroxychloroquine was greater in patients who were also exposed to trimebutine.
Full article available for download by subscribers
1 January 2023

Impending changes to European pharmaceutical regulations: part II

 ADVANCING HEALTHCARE POLICY  In order to prepare its new "Pharmaceutical Strategy for Europe", the European Commission organised several public consultations in advance. The present article reproduces extensive excerpts from a report published by the European Parliamentary Research Service, produced in connection with these consultations, which calls for the creation of a "European Medicines Infrastructure".
Full article (3 pages) available for free download
1 January 2023

Dapivirine vaginal ring in the prevention of HIV

 Marketing Authorisations  Fragile data from a single clinical trial suggest that the dapivirine vaginal ring has at best partial efficacy in the prevention of HIV infection, with a considerable margin of uncertainty.
Full article (4 pages) available for download by subscribers.
1 December 2022

Europe and medicines

 Editorial  The European Commission is due to propose changes to European pharmaceutical legislation in early 2023, in what has been presented as a major revision. No doubt the industry's lobby groups will attempt to shape the legislation in their favour. But civil society organisations will also have their say.
1 December 2022

Opioids: endocrine disruptors

 Adverse Effects  Data from clinical trials, cohort studies and other sources show that opioids also have several endocrine effects, usually in the form of a hormone insufficiency, by acting on the hypothalamic-pituitary axis.
Full article (3 pages) available for download by subscribers.
1 December 2022

Impending changes to European pharmaceutical regulations: part 1

 ADVANCING HEALTHCARE POLICY  In 2020, the European Commission announced its new "Pharmaceutical Strategy for Europe" for the coming years. The new legislation is due to be published in 2023.
Full article (3 pages) available for free download.
1 December 2022

Nivolumab (Opdivo°) as adjuvant treatment for certain oesophageal cancers

 Marketing Authorisations  No proven increase in survival, as of mid-2022, in a double-blind randomised placebo-controlled trial in 794 patients. Longer time before relapse, but with adverse effects that are sometimes serious.
Full article (1 page) available for download by subscribers.
1 December 2022

Bivalent mRNA covid-19 vaccines that also target the Omicron variant: more antibodies

 Marketing Authorisations  Four bivalent messenger RNA (mRNA) vaccines, based on the first Sars-CoV-2 strain isolated and a strain of the Omicron variant of this virus, have been authorised in the European Union. How do Prescrire's editors rate these vaccines?
Full article (2 pages) available for download by subscribers.
1 December 2022

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