Learn about the liver-directed mechanism of action for Rezdiffra1,4
Explore the MOA
Rezdiffra has a demonstrated safety and tolerability profile1,2
Rezdiffra has been studied in >2000 patients, and the first 1050 patients entered MAESTRO-NASH more than 3 years ago1,2
EAIR of common adverse reactions reported in ≥5% of patients in MAESTRO‑NASH (N=888)1,*,†,‡
| Adverse Reaction | Placebo (n=294) n (EAIR§) |
Rezdiffra 80 mg (n=298) n (EAIR§) |
Rezdiffra 100 mg (n=296) n (EAIR§) |
|---|---|---|---|
| Diarrhea | 52 (14) | 78 (23) | 98 (33) |
| Nausea | 36 (9) | 65 (18) | 51 (15) |
| Pruritus | 18 (4) | 24 (6) | 36 (10) |
| Vomiting | 15 (4) | 27 (7) | 30 (8) |
| Constipation | 18 (4) | 20 (5) | 28 (8) |
| Abdominal pain | 18 (4) | 22 (5) | 27 (7) |
| Dizziness | 6 (1) | 17 (4) | 17 (4) |
Adverse reactions leading to discontinuation1
- Rezdiffra 100 mg (8 per 100 PY), 80 mg (5 per 100 PY) vs Placebo (4 per 100 PY)
- Diarrhea and nausea were the most common causes of treatment discontinuation
Most common gastrointestinal adverse reactions1
Diarrhea and nausea were mild to moderate in severity, typically began early in treatment initiation, and were self-limiting.
- Median duration: ~3-4 weeks
- Nearly half of the cases of diarrhea were a worsening of pre-existing diarrhea or intermittent loose stools
| Placebo (n=294) |
Rezdiffra 80 mg (n=298) |
Rezdiffra 100 mg (n=296) |
||
|---|---|---|---|---|
| Diarrhea | Median time (Q1, Q3)|| to event, days | 39 (2, 195) | 17 (3, 70) | 6 (2, 54) |
| Median duration, days | 9 | 20 | 20 | |
| Nausea | Median time (Q1, Q3)|| to event, days | 85 (24, 347) | 28 (2, 162) | 5 (2, 40) |
| Median duration, days | 17 | 26 | 28 | |
*Population includes adult patients with noncirrhotic MASH with liver
fibrosis (stages F2 and F3 at eligibility).1
†Median exposure duration was 68 weeks for placebo, 74 weeks for Rezdiffra 80
mg once daily, and 66 weeks for Rezdiffra 100 mg once daily.1
‡EAIRs are per 100 PY where total PYs were 435, 435, and 407 for placebo, 80
mg once daily, and 100 mg once daily arms, respectively.1
§The EAIR per 100 PY can be interpreted as an estimated number of first
occurrences of the adverse reaction of interest if 100 patients are treated for one
year.1
||This represents the middle 50% (Q1, Q3). 25% of the data fall below Q1 and
25% of the data lie above Q3.3
EAIR=exposure-adjusted incidence rate; NASH=nonalcoholic steatohepatitis; PY=person-years;
Q=quartile.
References:
- Rezdiffra. Prescribing Information. Madrigal Pharmaceuticals, Inc.
- Harrison SA et al. N Engl J Med. 2024;390(6):497-509.
- Thomas S. https://articles.outlier.org/what-are-quartiles-in-statistics. March 26, 2023.
- Karim G, Bansal MB. touchREV Endocrinol. 2023;19(1):60-70.
