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Erschienen in: Clinical Pharmacokinetics 4/2015

01.04.2015 | Letter to the Editor

Comment on: “Pharmacokinetics in Patients with Chronic Liver Disease and Hepatic Safety of Incretin-Based Therapies for the Management of Type 2 Diabetes Mellitus”

verfasst von: Emanuel Raschi, Elisabetta Poluzzi, Fabrizio De Ponti

Erschienen in: Clinical Pharmacokinetics | Ausgabe 4/2015

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Excerpt

The debate on alogliptin hepatotoxicity has recently aroused interest after a narrative review on hepatic safety of incretin-based therapies [1]. In fact, Scheen concluded that the overall liver safety of dipeptidyl peptidase-4 inhibitors (DPP-4-I) is reassuring, with the explicit statement that “no hepatotoxicity has been reported in the development programme of alogliptin”. In contrast, Barbehenn et al. [2] questioned these conclusions by detailing the US FDA hepatological assessment and perusing data from the Examination of Cardiovascular Outcomes with Alogliptin Versus Standard of Care (EXAMINE) trial, where a numerical imbalance, albeit not statistically significant, emerged for alogliptin [3]. The updated data provided by Scheen [4] indicate that “alogliptin is associated with a low risk of hepatic toxicity” and challenge the FDA liver panel test before starting alogliptin therapy. …
Literatur
1.
Zurück zum Zitat Scheen AJ. Pharmacokinetics in patients with chronic liver disease and hepatic safety of incretin-based therapies for the management of type 2 diabetes mellitus. Clin Pharmacokinet. 2014;53:773–85.CrossRefPubMed Scheen AJ. Pharmacokinetics in patients with chronic liver disease and hepatic safety of incretin-based therapies for the management of type 2 diabetes mellitus. Clin Pharmacokinet. 2014;53:773–85.CrossRefPubMed
2.
Zurück zum Zitat Barbehenn E, Almashat S, Carome M, Wolfe S. Hepatotoxicity of alogliptin. Clin Pharmacokinet. 2014;53:1055–6.CrossRefPubMed Barbehenn E, Almashat S, Carome M, Wolfe S. Hepatotoxicity of alogliptin. Clin Pharmacokinet. 2014;53:1055–6.CrossRefPubMed
3.
Zurück zum Zitat White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, EXAMINE Investigators, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369:1327–35.CrossRefPubMed White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, EXAMINE Investigators, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369:1327–35.CrossRefPubMed
4.
5.
Zurück zum Zitat Brinker AD, Lyndly J, Tonning J, Moeny D, Levine JG, Avigan MI. Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA Adverse Event Reporting System (FAERS) database. Drug Saf. 2013;36:1169–78.CrossRefPubMed Brinker AD, Lyndly J, Tonning J, Moeny D, Levine JG, Avigan MI. Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA Adverse Event Reporting System (FAERS) database. Drug Saf. 2013;36:1169–78.CrossRefPubMed
6.
Zurück zum Zitat Piccinni C, Motola D, Marchesini G, Poluzzi E. Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting. Diabetes Care. 2011;34:1369–71.CrossRefPubMedCentralPubMed Piccinni C, Motola D, Marchesini G, Poluzzi E. Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting. Diabetes Care. 2011;34:1369–71.CrossRefPubMedCentralPubMed
7.
Zurück zum Zitat Poluzzi E, Raschi E, Piccinni C, De Ponti F. Data mining techniques in pharmacovigilance: analysis of the publicly accessible FDA Adverse Event Reporting System (AERS). In: Karahoca A, editor. Data mining applications in engineering and medicine. Croatia: InTech; 2012. p. 267–301. Poluzzi E, Raschi E, Piccinni C, De Ponti F. Data mining techniques in pharmacovigilance: analysis of the publicly accessible FDA Adverse Event Reporting System (AERS). In: Karahoca A, editor. Data mining applications in engineering and medicine. Croatia: InTech; 2012. p. 267–301.
8.
Zurück zum Zitat Raschi E, Poluzzi E, Koci A, Caraceni P, De Ponti F. Assessing liver injury associated with antimycotics: concise literature review and clues from data mining of the FAERS database. World J Hepatol. 2014;6:601–12.PubMedCentralPubMed Raschi E, Poluzzi E, Koci A, Caraceni P, De Ponti F. Assessing liver injury associated with antimycotics: concise literature review and clues from data mining of the FAERS database. World J Hepatol. 2014;6:601–12.PubMedCentralPubMed
9.
Zurück zum Zitat Suzuki A, Andrade RJ, Bjornsson E, Lucena MI, Lee WM, Yuen NA, et al. Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: unified list based on international collaborative work. Drug Saf. 2010;33:503–22.CrossRefPubMed Suzuki A, Andrade RJ, Bjornsson E, Lucena MI, Lee WM, Yuen NA, et al. Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: unified list based on international collaborative work. Drug Saf. 2010;33:503–22.CrossRefPubMed
10.
Zurück zum Zitat Golightly LK, Drayna CC, McDermott MT. Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors. Clin Pharmacokinet. 2012;51:501–14.CrossRefPubMed Golightly LK, Drayna CC, McDermott MT. Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors. Clin Pharmacokinet. 2012;51:501–14.CrossRefPubMed
Metadaten
Titel
Comment on: “Pharmacokinetics in Patients with Chronic Liver Disease and Hepatic Safety of Incretin-Based Therapies for the Management of Type 2 Diabetes Mellitus”
verfasst von
Emanuel Raschi
Elisabetta Poluzzi
Fabrizio De Ponti
Publikationsdatum
01.04.2015
Verlag
Springer International Publishing
Erschienen in
Clinical Pharmacokinetics / Ausgabe 4/2015
Print ISSN: 0312-5963
Elektronische ISSN: 1179-1926
DOI
https://doi.org/10.1007/s40262-015-0248-4

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