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Spotlight

Every month, the subjects in Prescrire’s Spotlight.

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Ivacaftor + tezacaftor + elexacaftor (Kaftrio°) in cystic fibrosis with at least one delta F508 mutation from 6 years of age

 Marketing Authorisations  Triple therapy with the CFTR modulators ivacaftor + tezacaftor + elexacaftor was initially authorised in the European Union for adults and adolescents who have cystic fibrosis with a delta F508 mutation on at least one of the CFTR alleles. It has also been authorised for use in children in the same situation, aged 6 years and older.
Full article (2 pages) available for download by subscribers
1 June 2023

Drug-induced impairment of lactation

 Adverse Effects  There are numerous causes of insufficient maternal milk production. It is often due to insufficiently frequent suckling and/or failure to "empty" the breasts sufficiently, for example because of nipple disorders. Sometimes, however, drugs are to blame.
Full article (4 pages) available for download by subscribers
1 June 2023

Proving a treatment's efficacy

 Outlook  What is the best way to demonstrate a treatment's efficacy? In other words, how do you establish a causal relationship between the treatment and a clinical improvement of sufficient value that it justifies the risk of experiencing the treatment's known, and as yet unknown, harms?
Full article (4 pages) available for free download.
1 June 2023

Difelikefalin (Kapruvia°) in pruritus associated with chronic kidney disease

 Marketing Authorisations   Difelikefalin is the first drug to be authorised in the European Union for the treatment of moderate to severe pruritis associated with chronic kidney disease in patients on haemodialysis.
Full article (4 pages) available for download by subscribers
1 June 2023

Prescrire's finances: 2022 annual report

Every year, Association Mieux Prescrire, the legal entity responsible for Prescrire's publications, publishes a summary of its annual financial report in the March issue of Prescrire and in the June issue of Prescrire International. The summary of its 2022 annual report is publicly available here.
1 June 2023

Recombinant Beta variant covid-19 vaccine with adjuvant (Vidprevtyn Beta°), as a booster

 COVID-19  The recombinant Beta variant covid-19 vaccine with AS03 adjuvant was authorised in the European Union in mid-November 2022, for use only as a booster in adults who have already received an mRNA or viral-vector vaccine.
Full article (2 pages) available for download by subscribers
1 June 2023

A difficult choice

 Editorial  Corticosteroids have been used for a very long time, and a great deal is known about their adverse effect profile. In some chronic inflammatory diseases, other drugs with immunosuppressive effects are proposed, with the aim of reducing corticosteroid use. These drugs' adverse effects differ in part from those of corticosteroids, but some of them may not yet be known.
1 May 2023

Anifrolumab (Saphnelo°) in systemic lupus erythematosus after failure of standard therapy

 Marketing Authorisations  Anifrolumab is a monoclonal antibody that inhibits receptors for type I interferons. This immunosuppressant has been authorised in the European Union as add-­on therapy for patients with systemic lupus erythematosus in whom standard treatment has been insufficiently effective.
Full article (3 pages) available for download by subscribers
1 May 2023

Dabigatran (Pradaxa°) for venous thrombosis in children and adolescents

 Marketing Authorisations  Dabigatran, an anticoagulant of the thrombin inhibitor class authorised for use in adults after venous thrombosis, a situation in which it does not represent a therapeutic advance, has now also been authorised for patients less than 18 years of age.
Full article (2 pages) available for download by subscribers
1 May 2023

Janus kinase inhibitors: higher incidence of serious adverse effects and death than with TNF-alpha inhibitors

 Adverse Effects  The increased incidence of serious adverse effects associated with tofacitinib and baricitinib, and probably also the three other JAK inhibitors used in chronic inflammatory diseases, raises questions about the harm-benefit balance of drugs of this class.
Full article (1 page) available for download by subscribers
1 May 2023

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