Preferred S-adenosylmethionine prescription in routine practice for intrahepatic cholestasis management: results of a multinomial logistic regression grid-optimization approach

Abstract

Background:

S-adenosylmethionine (AdoMet) is available for the treatment of intrahepatic cholestasis in different doses and in different administration forms. The aim of this study was to develop a categorization model, also called a nomogram, to discern if there was a relationship between prescribers’ treatment preferences and patient baseline characteristics for the treatment options, and to assess whether effectiveness was positively correlated with prescriber preference.

Materials and methods:

Baseline characteristics of patients in a post-marketing observational study (PMOS) were analyzed by multinomial logistic regression to produce preference probabilities for the prescription of different AdoMet starting regimens: 400 mg injection, 800 mg injection, and 800 mg oral tablets. Grid-optimization based on the preference probabilities was used to subdivide the patients into seven relative treatment preference categories. Subsequently, for each category, the effectiveness of the three treatments was assessed by determining the response rate after 2 weeks of treatment for each treatment group.

Results:

Elevated total bilirubin values, high Child–Pugh scores, and symptomatic cholestasis were associated with prescriber preference for the 800 mg injection, whereas low total bilirubin and low Child–Pugh scores were related to prescriber preference for the 400 mg injection. In the absence of cholestatic symptoms, the 800 mg tablet starting regimen was preferred. In the category where the baseline characteristics did not come to a more- or less-preferred treatment, the response rates were highest for the 800 mg tablets group (67%) and lowest in the 400 mg injection group (50%); however, the total sample size in this category was small (N = 22).

Conclusion:

Categorization of patients into treatment preference groups based on baseline data might be an interesting approach to assess the validity of the treatment preference versus the respective treatment effectiveness as shown in a PMOS with three AdoMet treatment regimens.

Keywords::

• S-adenosylmethionine
• intrahepatic cholestasis
• multinomial logistic regression
• propensity scores
• grid optimization
• prescriber preference

Acknowledgments

The authors would like to thank several people involved in the post-marketing observational study used as the basis for the MLR analysis, without whom research would have been impossible: Prof Natalia Kharchenko, Department of Gastroenterology, Dietology and Endoscopy; PL Shupik, National Medical Academy of Post-Graduate Education, Ukraine; as well as Irina Magdik, Volodymyr Moshchych, Nadiia Sotnychenko, Oleksandr Kuzmenko, and Ruslan Nafieiev from Abbott Laboratories, Ukraine. Also, the authors would like to thank the following colleagues for their support and assistance: Elke Kahler from Abbott Laboratories GmBH, Germany, and Heike Dreher from Abbott Healthcare Products B.V., The Netherlands. Josh Lilly of Alpharmaxim Healthcare Communications provided medical writing support, which was funded by Abbott Healthcare Products B.V., The Netherlands. Abbott Products Operations AG sponsored the design, research, analysis, data collection, and interpretation of the study, and the writing, reviewing of the publication. The current affiliation of Mario JNM Ouwens is AstraZeneca R&D, Mölndal, Sweden.

Author contributions

All authors contributed toward data analysis, drafting and revising the paper and agree to be accountable for all aspects of the work.

Disclosure

At the time of writing, Mario JNM Ouwens was an employee of Abbott Healthcare Products B.V., The Netherlands. Suntje Sander-Struckmeier is an employee of Abbott Laboratories GmbH, Germany, and Stefan GAJ Driessen is an employee of Abbott Established Pharmaceuticals Division, The Netherlands. The authors report no other conflicts of interest in this work.