Improvements of Fibrosis and Disease Activity Are Associated With Improvement of Patient‐Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis
| Autor: | Naim Alkhouri, Anita Kohli, Nadege Gunn, Stephen H. Caldwell, Simone I. Strasser, Robert P. Myers, Mitchell L. Shiffman, Ryan S Huss, Peter Ruane, Zachary Goodman, Kris V. Kowdley, Zobair M. Younossi, Mazen Noureddin, Maria Stepanova, Vincent Wai-Sun Wong, Rohit Loomba, Aasim Sheikh |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Cirrhosis media_common.quotation_subject Chronic Liver Disease and Cirrhosis Clinical Trials and Supportive Activities RC799-869 Chronic liver disease Gastroenterology Oral and gastrointestinal Hepatitis Fibrosis Clinical Research Diabetes mellitus Internal medicine Nonalcoholic fatty liver disease medicine media_common Hepatology business.industry Liver Disease Evaluation of treatments and therapeutic interventions Original Articles Diseases of the digestive system. Gastroenterology medicine.disease Clinical trial Good Health and Well Being 6.1 Pharmaceuticals Original Article Worry business Digestive Diseases Body mass index |
| Zdroj: | Hepatology Communications, Vol 5, Iss 7, Pp 1201-1211 (2021) Hepatology Communications Hepatology communications, vol 5, iss 7 |
| Popis: | Patient‐reported outcomes (PROs) are important endpoints for clinical trials. The impact of investigational drugs on PROs of patients with advanced nonalcoholic steatohepatitis (NASH) was investigated. Patients with NASH with bridging fibrosis or compensated cirrhosis were enrolled in a phase 2, randomized, placebo‐controlled study of selonsertib, firsocostat, or cilofexor, alone or in two‐drug combinations (NCT03449446). PROs included Short Form 36 (SF‐36), Chronic Liver Disease Questionnaire (CLDQ)‐NASH, EuroQol Five Dimension (EQ‐5D), Work Productivity and Impairment (WPAI), and 5‐D Itch before and during treatment. A total of 392 patients with NASH (mean ± SD, 60 ± 9 years old; 35% men; 89% white; 72% diabetes; and 56% compensated cirrhosis) were included. Baseline Physical Functioning (PF) and Bodily Pain of SF‐36 and Fatigue and Worry of CLDQ‐NASH were significantly lower in patients with cirrhosis (total CLDQ‐NASH score mean ± SD, 4.91 ± 1.06 with cirrhosis vs. 5.16 ± 1.14 without cirrhosis; P As treatment for NASH advances, it is important to know the new treatments improve patients' experiences with their disease. Furthermore, the side effect profile of the new regimens should not add further impairment on PROs. This knowledge can assist healthcare practitioners counsel patients on expectations of treatment when they become available. |
| Databáze: | OpenAIRE |
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