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Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study.
Eworuke, Efe; Shinde, Mayura; Hou, Laura; Paterson, Michael J; Jensen, Peter Bjødstrup; Maro, Judith C; Rai, Ashish; Scarnecchia, Daniel; Pennap, Dinci; Woronow, Daniel; Ghosh, Rebecca E; Welburn, Stephen; Pottegard, Anton; Platt, Robert W; Lee, Hana; Bradley, Marie C.
Afiliación
  • Eworuke E; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA efeeworuke@gmail.com.
  • Shinde M; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
  • Hou L; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
  • Paterson MJ; Canadian Network for Observational Drug Effect Studies (CNODES), Montréal, Quebec, Canada.
  • Jensen PB; University of Southern Denmark, Odense, Denmark.
  • Maro JC; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
  • Rai A; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
  • Scarnecchia D; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
  • Pennap D; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Woronow D; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ghosh RE; Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory, London, UK.
  • Welburn S; Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory, London, UK.
  • Pottegard A; Hospital Pharmacy, Odense Universitetshospital, Odense, Denmark.
  • Platt RW; Department of Public Health, Clinical Pharmacology and Pharmacy, University of Southern Denmark, Odense, Denmark.
  • Lee H; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.
  • Bradley MC; Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
BMJ Open ; 13(4): e070985, 2023 04 17.
Article en En | MEDLINE | ID: mdl-37068898
OBJECTIVES: To examine valsartan, losartan and irbesartan usage and switching patterns in the USA, UK, Canada and Denmark before and after July 2018, when the first Angiotensin-Receptor-Blocker (ARB) (valsartan) was recalled. DESIGN: Retrospective cohort study. SETTING: USA, Canadian administrative healthcare data, Danish National Prescription Registry and UK primary care electronic health records. PARTICIPANTS: Patients aged 18 years and older between January 2014 and December 2020. INTERVENTION: Valsartan, losartan and irbesartan. MAIN OUTCOME: Monthly percentages of individual ARB episodes, new users and switches to another ARB, ACE inhibitors (ACEI) or calcium channel blockers containing products. RESULTS: We identified 10.8, 3.2, 1.8 and 1.2 million ARB users in the USA, UK, Canada and Denmark, respectively. Overall proportions of valsartan, losartan and irbesartan use were 18.4%, 67.9% and 5.2% in the USA; 3.1%, 48.3% and 10.2% in the UK, 16.3%, 11.4% and 18.3% in Canada, 1%, 93.5% and 0.6% in Denmark. In July 2018, we observed an immediate steep decline in the proportion of valsartan use in the USA and Canada. A similar trend was observed in Denmark; however, the decline was only minimal. We observed no change in trends of ARB use in the UK. Accompanying the valsartan decline was an increase in switching to other ARBs in the USA, Canada and Denmark. There was a small increase in switching to ACEI relative to the valsartan-to-other-ARBs switch. We also observed increased switching from other affected ARBs, losartan and irbesartan, to other ARBs throughout 2019, in the USA and Canada, although the usage trends in the USA remained unchanged. CONCLUSION: The first recall notice for valsartan resulted in substantial decline in usage due to increased switching to other ARBs. Subsequent notices for losartan and irbesartan were also associated with increased switching around the time of the recall, however, overall usage trends remained unchanged.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Losartán / Hipertensión Tipo de estudio: Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte / Europa Idioma: En Revista: BMJ Open Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Losartán / Hipertensión Tipo de estudio: Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans País/Región como asunto: America do norte / Europa Idioma: En Revista: BMJ Open Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos