Risk–efficacy balance of ulipristal acetate compared to surgical alternatives

Autor: Pierre M. Bet, Wouter J. K. Hehenkamp, Joost P H Drenth, Judith A.F. Huirne, Mei-An Middelkoop
Rok vydání: 2021
Předmět:
hepatopharmacology
medicine.medical_specialty
Norpregnadienes
Uterine fibroids
medicine.medical_treatment
Review Article
Marketing authorization
030226 pharmacology & pharmacy
law.invention
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Quality of life
law
safety pharmacology
Ulipristal acetate
ulipristal acetate
medicine
Humans
Pharmacology (medical)
Prospective Studies
030212 general & internal medicine
Ulipristal
hysterectomy
Intensive care medicine
Review Articles
Pharmacology
Clinical pharmacology
Hysterectomy
Leiomyoma
chemical and drug induced liver injury
business.industry
medicine.disease
Symptomatic relief
Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11]
chemistry
Uterine Neoplasms
Quality of Life
Female
clinical pharmacology
business
Zdroj: British Journal of Clinical Pharmacology, 87, 7, pp. 2685-2697
British Journal of Clinical Pharmacology, 87, 2685-2697
British Journal of Clinical Pharmacology
ISSN: 1365-2125
0306-5251
DOI: 10.1111/bcp.14708
Popis: Contains fulltext : 235681.pdf (Publisher’s version ) (Open Access) AIMS: Uterine fibroids are benign tumours that cause various complaints. These complaints may significantly compromise quality of life, necessitating a clinical intervention in 25-50% of the affected women. Hysterectomy, myomectomy or embolization may offer symptomatic relief, but are costly, include a recovery period, can cause serious side-effects, sometimes fail to treat symptoms completely and are not always desired by patients. Ulipristal is a conservative long-term treatment that has a fibroid-volume decreasing effect, acceptable side-effects while preserving fertility and may be an alternative to surgical alternatives. Currently, ulipristal is investigated by the European Medicine Agency and suspended from marketing authorization because it may cause drug-induced liver injury (DILI). However, many drugs can cause severe DILI and prospective studies estimate 14-19 DILI cases/100 000 people. METHODS: This overview will discuss the risk-benefit balance between ulipristal and DILI, describe the safety-efficacy balance of ulipristal and its alternative treatments and the arguments that led to the suspension of its marketing authorization. RESULTS: Ulipristal may be associated with DILI resulting in a risk of severe liver injury in 1.5:100 000 patients and fatal liver injury in 0.1:100 000 patients. This risk needs to be weighed against the higher mortality risk of >1:1000 and higher incidence of severe complications after surgery. CONCLUSION: The DILI risk of ulipristal is considerably lower than that of other medicines that are not suspended, nor need additional safety measures. When evaluating drugs and drug safety, risks that apply to the alternative nonpharmacological treatment options should be taken into consideration.
Databáze: OpenAIRE
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