Dosage adjustment for hepatic dysfunction based on Child–Pugh scores

Spray, Jeffery W.; Willett, Kristine C.; Chase, David; Sindelar, Rachel; Connelly, Sarah E.

doi:10.2146/ajhp060287

Cited by 22 publications

(19 citation statements)

References 1 publication

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“…This is because until recent years, patients with Child-Pugh C were excluded in the development of new drugs for ethical reasons. Despite regulating agencies EMA and FDA recommend to study the research drugs in order to predict their behavior in patients with hepatic insufficiency and to being able to recommend dose adjustment, according to a recent survey, the number of drugs with specific adjustment recommendations based on the hepatic function with Child-Pugh scores is still very limited (24), probably due to hepatic insufficiency as exclusion criteria in most of the clinical trials. This would explain the lack of data in many cases in the SPC about dosage adjustment in moderate-severe hepatic insufficiency.…”

Section: Discussionmentioning

confidence: 99%

Drug dosage recommendations in patients with chronic liver disease

Periáñez-Párraga

Martínez-López

Ventayol-Bosch

et al. 2012

Rev. esp. enferm. dig.

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Chronic liver diseases (CLD) alter the kinetics of drugs. Despite dosage adjustment is based on Child-Pugh scores, there are no available recommendations and/or algorithms of reference to facilitate dosage regimens.A literature review about dose adjustment of the drugs from the hospital guide -which are included in the list of the WHO recommended drugs to be avoided or used with caution in patients with liver disease-was carried out. The therapeutic novelties from the last few years were also included. In order to do so, the summary of product characteristics (SPC), the database DrugDexMicromedex, the WHO recommendations and the review articles from the last 10 years in Medline were reviewed. Moreover, the kinetic parameters of each drug were calculated with the aim of establishing a theoretical recommendation based on the proposal of Delcò and Huet.Recommendations for 186 drugs are presented according to the SPC (49.5%), DrugDex-Micromedex (26.3%) and WHO (18.8%) indications; six recommendations were based on specific publications; the theoretical recommendation based on pharmacokinetic parameters was proposed in four drugs.The final recommendations for clinical management were: dosage modification (26.9%), hepatic/analytical monitoring of the patient (8.6%), contraindication (18.8%), use with caution (19.3%) and no adjustment required (26.3%).In this review, specific recommendations for the practical management of patients with chronic liver disease are presented. It has been elaborated through a synthesis of the published bibliography and completed by following a theoretical methodology.

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Section: Discussionmentioning

confidence: 99%

Drug dosage recommendations in patients with chronic liver disease

Periáñez-Párraga

Martínez-López

Ventayol-Bosch

et al. 2012

Rev. esp. enferm. dig.

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“…Today, Child‐Pugh classification system is the most frequently used clinical tool to stratify pharmacotherapy or individualize drug doses. However, it is rarely found in specific product characteristics (e.g., package inserts) (Spray et al., ). Moreover, surrogates such as Child‐Pugh system hold important shortcomings, for example, lack of sensitivity (Verbeeck, ).…”

Section: Discussionmentioning

confidence: 99%

Association of Liver Stiffness with Hepatic Expression of Pharmacokinetically Important Genes in Alcoholic Liver Disease

Theile

Haefeli

Seitz

et al. 2012

Alcoholism Clin & Exp Res

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“…Specific recommendations for dose adjustment based on Child-Pugh classification are often vague, imprecise, or lacking [76,77]. For drugs with a narrow therapeutic index, it is sometimes recommended that both initial and maintenance doses should be reduced by at least 50 %; however, this kind of recommendation is totally empirical [2].…”

Section: Dose Recommendationsmentioning

confidence: 99%