479
Views
0
CrossRef citations to date
0
Altmetric
Original Research

A comprehensive analysis of liver safety across zibotentan oncology trials: knowledge of the past offers new perspectives on the present

, , , , , , , & show all
Pages 477-486 | Received 20 Dec 2023, Accepted 05 Mar 2024, Published online: 24 Mar 2024

References

  • Channick RN, Simonneau G, Sitbon O, et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet. 2001 Oct 6;358(9288):1119–1123. doi: 10.1016/S0140-6736(01)06250-X
  • Rubin LJ, Badesch DB, Barst RJ, et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002 Mar 21;346(12):896–903. doi: 10.1056/NEJMoa012212
  • Eriksson C, Gustavsson A, Kronvall T, et al. Hepatotoxicity by bosentan in a patient with portopulmonary hypertension: a case-report and review of the literature. J Gastrointestin Liver Dis. 2011 Mar;20(1):77–80.
  • Galiè N, Olschewski H, Oudiz RJ, et al. Ambrisentan for the treatment of pulmonary arterial hypertension: results of the ambrisentan in pulmonary arterial hypertension, randomized, double-blind, placebo-controlled, multicenter, efficacy (ARIES) study 1 and 2. Circulation. 2008 Jun 10;117(23):3010–9. doi: 10.1161/CIRCULATIONAHA.107.742510
  • Patel KR, Blair CJ, Tislow JD. Hepatic safety of ambrisentan alone and in combination with tadalafil: a post-hoc analysis of the AMBITION trial. Pulm Circ. 2018 Oct;8(4):2045894018797273. doi: 10.1177/2045894018797273
  • Ben-Yehuda O, Pizzuti D, Brown A, et al. Long-term hepatic safety of ambrisentan in patients with pulmonary arterial hypertension. J Am Coll Cardiol. 2012 Jul 3;60(1):80–1. doi: 10.1016/j.jacc.2012.03.025
  • Galiè N, Hoeper MM, Gibbs JS, et al. Liver toxicity of sitaxentan in pulmonary arterial hypertension. Eur Respir J. 2011 Feb;37(2):475–6.
  • Kenna JG, Stahl SH, Eakins JA, et al. Multiple compound-related adverse properties contribute to liver injury caused by endothelin receptor antagonists. J Pharmacol Exp Ther. 2015 Feb;352(2):281–90.
  • Fattinger K, Funk C, Pantze M, et al. The endothelin antagonist bosentan inhibits the canalicular bile salt export pump: a potential mechanism for hepatic adverse reactions. Clin Pharmacol Ther. 2001 Apr;69(4):223–231.
  • Chen M, Borlak J, Tong W. A model to predict severity of drug-induced liver injury in humans. Hepatology. 2016 Sep;64(3):931–40. doi: 10.1002/hep.28678
  • Chen M, Borlak J, Tong W. High lipophilicity and high daily dose of oral medications are associated with significant risk for drug‐induced liver injury. Hepatology. 2013;58(1):388–396. doi: 10.1002/hep.26208
  • Travere Therapeutics. Filspari highlights of prescribing information 2023 [cited 2023 Aug 10]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216403s000lbl.pdf
  • Drugbank Online. Sparsentan. 2023 [cited 2023 Aug 10]. Available from: https://go.drugbank.com/drugs/DB12548
  • Drugbank Online. Bosentan. 2023 [cited 2023 Aug 10]. Available from: https://go.drugbank.com/drugs/DB00559
  • Drugbank Online. Sitaxentan. 2023 [cited 2023 Aug 10]. Available from: https://go.drugbank.com/drugs/DB06268
  • Drugbank Online. Zibotentan. 2021 [cited 2023 Aug 10]. Available from: https://go.drugbank.com/drugs/DB06629
  • Drugbank Online. Atrasentan. 2021 [cited 2023 Aug 10]. Available from: https://go.drugbank.com/drugs/DB06199
  • Clouthier DE, Hosoda K, Richardson JA, et al. Cranial and cardiac neural crest defects in endothelin-A receptor-deficient mice. Development. 1998;125(5):813–824. doi: 10.1242/dev.125.5.813
  • Spence S, Anderson C, Cukierski M, et al. Teratogenic effects of the endothelin receptor antagonist L-753,037 in the rat. Reprod Toxicol. 1999 Jan;13(1):15–29.
  • Heerspink HJL, Kiyosue A, Wheeler DC, et al. Zibotentan in combination with dapagliflozin compared with dapagliflozin in patients with chronic kidney disease (ZENITH-CKD): a multicentre, randomised, active-controlled, phase 2b, clinical trial. Lancet. 2023 Nov 2;402(10416):2004–2017. doi: 10.1016/S0140-6736(23)02230-4
  • Heerspink HJL, Kohan DE, de Zeeuw D. New insights from SONAR indicate adding sodium glucose co-transporter 2 inhibitors to an endothelin receptor antagonist mitigates fluid retention and enhances albuminuria reduction. Kidney Int. 2021 Feb;99(2):346–349. doi: 10.1016/j.kint.2020.09.026
  • Morris CD, Rose A, Curwen J, et al. Specific inhibition of the endothelin a receptor with ZD4054: clinical and pre-clinical evidence. Br J Cancer. 2005 Jun 20;92(12):2148–52. doi: 10.1038/sj.bjc.6602676
  • Nelson JB, Fizazi K, Miller K, et al. Phase 3, randomized, placebo-controlled study of zibotentan (ZD4054) in patients with castration-resistant prostate cancer metastatic to bone. Cancer. 2012 Nov 15;118(22):5709–18. doi: 10.1002/cncr.27674
  • James ND, Caty A, Payne H, et al. Final safety and efficacy analysis of the specific endothelin a receptor antagonist zibotentan (ZD4054) in patients with metastatic castration-resistant prostate cancer and bone metastases who were pain-free or mildly symptomatic for pain: a double-blind, placebo-controlled, randomized phase II trial. BJU Int. 2010 Oct;106(7):966–73.
  • Fizazi K, Higano CS, Nelson JB, et al. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2013 May 10;31(14):1740–7. doi: 10.1200/JCO.2012.46.4149
  • Miller K, Moul JW, Gleave M, et al. Phase III, randomized, placebo-controlled study of once-daily oral zibotentan (ZD4054) in patients with non-metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2013 Jun;16(2):187–92.
  • Cognetti F, Bagnato A, Colombo N, et al. A phase II, randomized, double-blind study of zibotentan (ZD4054) in combination with carboplatin/paclitaxel versus placebo in combination with carboplatin/paclitaxel in patients with advanced ovarian cancer sensitive to platinum-based chemotherapy (AGO-OVAR 2.14). Gynecol Oncol. 2013 Jul;130(1):31–7.
  • Chouaid C, Nathan F, Pemberton K, et al. A phase II, randomized, multicenter study to assess the efficacy, safety, and tolerability of zibotentan (ZD4054) in combination with pemetrexed in patients with advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2011 May;67(5):1203–8.
  • Avigan MI, Bjornsson ES, Pasanen M, et al. Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials. Drug Saf. 2014 Nov;37(Suppl 1):S19–31.
  • Center for Drug Evaluation and Research (CDER) and Biomedical Informatics and Regulatory Review Science (BIRRS) Team. Standard safety tables and figures: integrated guide. 2022 [cited 2023 Aug]. Available from: https://www.regulations.gov/document/FDA-2022-N-1961-0046
  • Merz M, Lee KR, Kullak-Ublick GA, et al. Methodology to assess clinical liver safety data. Drug Saf. 2014 Nov;37(Suppl 1):S33–45.
  • U.S Department of Health and Human Services. Guidance for industry, drug-induced liver injury: premarketing clinical evaluation. 2009 [cited 2023 Sep 12]. Available from: https://www.fda.gov/media/116737/download
  • Wei A, Gu Z, Li J, et al. Clinical adverse effects of endothelin receptor antagonists: insights from the meta-analysis of 4894 patients from 24 randomized double-blind placebo-controlled clinical trials. J Am Heart Assoc. 2016 Oct 26;5(11). doi: 10.1161/JAHA.116.003896
  • Kohan DE, Liew A, Tang SCW, et al. Effects of atrasentan on markers of liver function in patients with type 2 diabetes and chronic kidney disease. Diab Obes Metab. 2023 Aug;25(8):2410–2412.
  • Berthiaume N, Carlson CJ, Rondinone CM, et al. Endothelin antagonism improves hepatic insulin sensitivity associated with insulin signaling in Zucker fatty rats. Metabolism. 2005 Nov;54(11):1515–23.
  • Andrade RJ, Lucena MI, Fernandez MC, et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology. 2005 Aug;129(2):512–21.
  • Tomkinson H, Kemp J, Oliver S, et al. Pharmacokinetics and tolerability of zibotentan (ZD4054) in subjects with hepatic or renal impairment: two open-label comparative studies. BMC Clin Pharmacol. 2011 Mar 17;11(1):3. doi: 10.1186/1472-6904-11-3
  • Francis P, Navarro VJ. Drug-induced hepatotoxicity. Treasure island (FL). eng. (StatPearls) StatPearls Publishing; 2022.
  • Andrade RJ, Chalasani N, Björnsson ES, et al. Drug-induced liver injury. Nat Rev Dis Primers. 2019 Aug 22;5(1):58. doi: 10.1038/s41572-019-0105-0