Archives : 2023

Practicalities

Editorial A drug is more than just an active substance mixed with excipients. There is more to consider than its pharmacological properties or its economic success. A drug is also a physical product that is part of the patient's daily life. And its packaging components, such as its box, the blister packs, bottle, vial or syringe, and the patient leaflet, are an integral part of this.

1 September 2023

Nivolumab (Opdivo°) in advanced gastric or oesophageal cancer

Marketing Authorisations Nivolumab, a monoclonal antibody directed against PD-1, has been authorised for patients with metastatic or inoperable gastric or oesophageal adenocarcinoma or squamous cell carcinoma. In these situations, does nivolumab represent a therapeutic advance compared to the treatments already available, and, in particular, does it extend survival?
Full article (3 pages) available for download by subscribers

1 September 2023

Dulaglutide, exenatide, liraglutide and other GLP-1 receptor agonists: thyroid cancer

Adverse Effects In 2022, a French research team published a case-control study which investigated the association between exposure to a GLP-1 receptor agonist and the risk of developing thyroid cancer.
Full article available for download by subscribers

1 September 2023

Glucarpidase (Voraxaze°) for high-dose methotrexate toxicity

Marketing Authorisations Glucarpidase has been granted marketing authorisation in the European Union for reducing plasma concentrations of methotrexate in patients who have received high-dose methotrexate for cancer treatment when elimination is delayed due to impaired renal function. In this situation, does glucarpidase reduce an excessively high plasma concentration of methotrexate? Does it limit the serious dose-dependent adverse effects of this cytotoxic drug? And what are its adverse effects?
Full article (2 pages) available for download by subscribers

1 September 2023

Prescrire's annual review of drug packaging: progress is too slow

A drug's packaging contains a set of components for use by patients, their caregivers and healthcare professionals. It is important that packaging is well designed with a view to ease of use and the prevention of errors with dangerous consequences.
Full article (4 page) available for download (free)

1 September 2023

R&D costs: secrecy at every level

In France, the pharmaceutical industry has managed to turn a law to ensure transparency about the public funding it receives into a promotional opportunity.
Full article available for download (free)

1 September 2023

Conditional marketing authorisation: easier to grant than to revoke

Progesterone is ineffective at preventing preterm delivery, but proved difficult to withdraw from the market. It is not the only example of this phenomenon.
Full article available for download (free)

1 September 2023

Interdisciplinary collaboration

Editorial Many healthcare professionals routinely provide care for a specific patient by working together or as part of a multidisciplinary team. When well organised, such collaborations are synergistic, and beneficial for patients.

1 July 2023

Daridorexant (Quviviq°) in insomnia

Marketing Authorisations The clinical evaluation of daridorexant in patients with chronic insomnia was not designed to demonstrate a potential advance compared with already available sleep-inducing drugs. While its mechanism of action is indeed different, there is no evidence that it represents a tangible clinical advance for patients.
Full article (4 pages) available for download by subscribers

1 July 2023

Clinical trials in children: many results go unreported

A group of US researchers have determined the proportion of clinical trials in children that were stopped prematurely, as well as the proportion of completed trials whose results were not reported.

1 July 2023

"Hybrid closed-loop" systems for blood glucose control: another way of delivering intensive insulin therapy

"Hybrid closed-loop" systems for blood glucose control in type 1 diabetes appear to maintain blood glucose close to physiological levels slightly more of the time than a "conventional" insulin pump, in particular at night. However, they also appear to slightly increase the incidence of hyperglycaemic episodes, mainly through malfunctions.
Full article (4 pages) available for download by subscribers

1 July 2023

Venlafaxine in the first trimester of pregnancy: possible risk of birth defects, especially cardiac malformations

Adverse Effects Venlafaxine is more dangerous than "selective" serotonin reuptake inhibitor antidepressants. It has been on Prescrire's list of drugs to avoid since 2014. As of 2023, various studies have shown that venlafaxine use during the first trimester of pregnancy carries a risk of birth defects, especially cardiac malformations.
Full article (2 pages) available for download by subscribers

1 July 2023

Good sources

Editorial The most robust evidence of a treatment's efficacy comes from comparative trials, conducted in accordance with a rigorous methodology to ensure that the comparison was not biased. Yet few health professionals have both the time and experience required to analyse trials themselves and put their results into perspective.

1 June 2023

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

Dutasteride, finasteride: high-grade prostate cancer (continued)

Adverse Effects In the early 2010s, a trial of finasteride versus placebo in about 19 000 men with no clinical signs of prostate cancer found a decrease in the total number of diagnoses of prostate cancer in the finasteride group, but an increased incidence of particularly aggressive prostate cancer.
Full article (2 pages) available for download by subscribers

1 May 2023

Order of magnitude

Editorial In many fields, such as aeronautical or mechanical engineering, accurate measurements and precise execution are essential. This is also true in some fields of medicine, such as pathology, where treatment decisions can hinge on the accuracy of a histological description or test result. However, in medicine in general and health care in particular, accurate measurements are not always available.

1 April 2023

Prescrire's ratings of new drugs in 2022

Marketing Authorisations Only 11 of the 124 new marketing authorisations analysed and rated in our French edition in 2022 represented a notable therapeutic advance for patients.

1 April 2023

Belimumab (Benlysta°) in lupus nephritis

Marketing Authorisations Belimumab, a monoclonal antibody directed against a protein called BLyS (B lymphocyte stimulator), was initially authorised in the European Union for subcutaneous or intravenous use in systemic lupus erythematosus. It has now also been authorised for use in active lupus nephritis.

1 April 2023

Omicron variant BQ.1.1: nirmatrelvir + ritonavir retains activity, monoclonal antibodies do not

COVID-19 The Sars-CoV-2 circulating in France as of December 2022 is the BQ.1.1 sublineage of Omicron variant BA.5. To what degree does this affect the possible benefits of treatment with Sars-CoV-2-specific monoclonal antibodies or the combination of nirmatrelvir + ritonavir (Paxlovid°)? A few studies have provided some answers to this question.

1 April 2023

Ibrutinib: increased risk of sudden death

Adverse Effects Data from clinical trials show a 5-fold greater risk of sudden or cardiac death with ibrutinib than with comparators.

1 April 2023

The Drug Prescrire Awards for 2022: no "Pilule d'Or", one drug on the "Honours List". Details in the March issue of Prescrire International

None of the drugs examined by Prescrire in 2022 represented a major therapeutic advance worthy of a Pilule d'Or ("Golden Pill" Award). One drug made the Honours List, while one other was cited as Noteworthy.

1 March 2023

Spotlight: Archives

Spotlight

2023

Practicalities

Nivolumab (Opdivo°) in advanced gastric or oesophageal cancer

Dulaglutide, exenatide, liraglutide and other GLP-1 receptor agonists: thyroid cancer

Glucarpidase (Voraxaze°) for high-dose methotrexate toxicity

Prescrire's annual review of drug packaging: progress is too slow

R&D costs: secrecy at every level

Conditional marketing authorisation: easier to grant than to revoke

Interdisciplinary collaboration

Daridorexant (Quviviq°) in insomnia

Clinical trials in children: many results go unreported

"Hybrid closed-loop" systems for blood glucose control: another way of delivering intensive insulin therapy

Venlafaxine in the first trimester of pregnancy: possible risk of birth defects, especially cardiac malformations

Good sources

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

Drug-induced impairment of lactation

Proving a treatment's efficacy

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

Prescrire's finances: 2022 annual report

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

A difficult choice

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

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

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

Dutasteride, finasteride: high-grade prostate cancer (continued)

Order of magnitude

Prescrire's ratings of new drugs in 2022

Belimumab (Benlysta°) in lupus nephritis

Omicron variant BQ.1.1: nirmatrelvir + ritonavir retains activity, monoclonal antibodies do not

Ibrutinib: increased risk of sudden death

The Drug Prescrire Awards for 2022: no "Pilule d'Or", one drug on the "Honours List". Details in the March issue of Prescrire International