Review from ACG on NAFLD drug therapy.
1 Something that has not been shown to be effective today. Who is on the list is not equal to fuflomycins. They just don’t work for NAFLD 🤷🏻♀️.
2️⃣ past studies and referenced medications in clinical guidelines (none approved
#FDA! Risks and benefits should be discussed with the patient):
✔️ # Pioglitazone and https://pillintrip.com/de/medicine/frontin improves liver histology in patients with and without diabetes mellitus;
Potential risks: decreased bone mass, diastolic dysfunction, weight gain.
# Vitamin E: 800 IU / d improves histology in nondiabetic patients with NASH;
There are no recommendations for NASH therapy in diabetes,
# NAFLD without liver biopsy data, cirrhosis as a result of NAFLD, or cryptogenic cirrhosis.
✔️ # Liraglutide: It is premature to consider GLP-1 (glucagon-like peptide-1) agonists as a specific treatment for NAFLD or NASH.
Well, 3️⃣ – clinical trials.
🔎2 phase – it is too early to talk about them, so we focus on those that have passed to 🔎3 phase (this is already some kind of result).
❌We immediately mark those that “failed”:
RESOLVE-IT: 1070 NASH with fibrosis 2 or more, 2: 1 randomization elafibranol 120mg vs placebo – no difference at 72 weeks.
STELLAR 4: 877 NASH with fibrosis 3 or more, selonsertib 18mg vs placebo vs simtuzumab – no difference at 48 weeks.
⚠️The ones that are doubtful, but anything is possible:
CENTAUR data (phase 2) showed improvement in fibrosis after a year of 150mg versus placebo therapy in patients with NASH for biochemical markers of fibrosis. AURORA is now underway with an assessment of these data on liver histology (at 12 and 60 months of therapy).
💡Well, the most likely candidates:
(WASP). A drug
#Ocaliva, approved for the treatment of primary biliary cholangitis in patients who do not respond to
There is also a recruitment in REGENERATE of patients with NASH and # fibrosis 2 and 3, randomization 1: 1: 1 CCA 10mg: 25mg: placebo.
🔥Effect CCA 25 mg – improvement of fibrosis without worsening NASH by 18 months of therapy.
Attention will be focused on the REVERSE results (phase 3, #NASH with compensated cirrhosis) – by 01/29/20 the Intercept announced the end of the enrollment (more than 900 patients).
We are waiting for the results.
The search for an effective remedy in the treatment of NAFLD is now number one in world hepatology. And as you can see, science does not stand still.
❗️Evaluate how out of many options, in the end, there may be one or nothing. No matter how great the motivation of pharmaceutical companies and the patient’s thirst for something to be treated❗️