Date: August 21, 2024 • Issue no: #104
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🍺 Our PC study of the month: Resmetirom to treat liver fibrosis 👀 Fenofibrate for diabetic retinopathy?
👂 Asprin for hearing loss? 🦵 Methotrexate in knee osteoarthritis |
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✅ Study of the Month: Resmetirom to Treat Liver Fibrosis |
🍺 What is the role of resmetirom in patients with MASH and liver fibrosis? -
The MAESTRO-NASH trial (February 2024, n=644) compared resmetirom (at a dose of 100 mg once daily) to a matching placebo in adult patients with MASH and liver fibrosis. The key exclusion criteria included alcohol consumption > 20 g/day for women and > 30 g/day for men, glycated hemoglobin level > 9.0% at screening, and causes of chronic liver disease other than noncirrhotic MASH.
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There was a significant increase in MASH resolution with no worsening fibrosis (29.9% vs. 9.7%; AD 20.7%, 95% CI 15.3 to 26.2, NNT=4). There was also a significant increase in reduction in low-density lipoprotein cholesterol level at week 24 (16.3% vs. -0.1%; AD 16.4%, 95% CI 12.6 to 20.1) and a significant increase in fibrosis improvement by ≥ 1 stage with no worsening of NAFLD activity score (25.9% vs. 14.2%; AD 11.8%, 95% CI 6.4 to 17.2).
Conclusion: In adult patients with MASH and liver fibrosis, resmetirom was superior to placebo with respect to MASH resolution with no worsening fibrosis.
You’ll find more of the latest studies relevant to primary care below. For a more comprehensive catalog of recent practice-changing trials, head over to Pathway!
👀 What is the effect of fenofibrate in patients with diabetes mellitus and non-referable diabetic retinopathy or maculopathy? -
The LENS trial (August 2024, n=1151) compared fenofibrate (at an oral dose of 145 mg/day) to a matching placebo in adults with diabetes mellitus and non-referable diabetic retinopathy or maculopathy. The key exclusion criteria included clinically significant diabetic retinopathy, history of gallbladder disease, acute or chronic pancreatitis, eGFR < 30 mL/min/1.73 m², cirrhosis, or any other serious hepatic disease, and/or RRT.
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There was a significant decrease in progression to referable diabetic retinopathy or maculopathy or treatment for retinopathy or maculopathy (22.7% vs. 29.2%; HR 0.73, 95% CI 0.58 to 0.91, NNT=15). One of the secondary outcomes saw a borderline significant decrease in the development of macular edema (3.8% vs. 7.5%; HR 0.5, 95% CI 0.3 to 0.84).
Conclusion: In adults with diabetes mellitus and non-referable diabetic retinopathy or maculopathy, fenofibrate was superior to placebo with respect to progression to referable diabetic retinopathy or maculopathy or treatment for retinopathy or maculopathy. 👂 What is the role of low-dose aspirin in the progression of age-related hearing loss in healthy older adults? -
The ASPREE-Hearing trial (July 2024, n=279) compared aspirin (100 mg daily dose of enteric-coated aspirin) to a matching placebo in healthy community-dwelling individuals aged ≥ 70 years for the prevention of age-related hearing loss. The key exclusion criteria included a history of a cardiovascular event, serious intercurrent illness likely to cause death within 5 years, cognitive impairment or dementia, disability, bilateral extended-wear or internal hearing aids, or bilateral cochlear implants.
- There was no significant difference in mean deterioration in the 4-frequency average hearing threshold at year 3 (3.3 dB vs. 3 dB; MD 0.31, 95% CI -0.72 to 1.34). One of the secondary outcomes showed no significant difference in mean deterioration in speech reception threshold at year 3 (0.9 dB vs. 0.9 dB; MD -0.1, 95% CI -1.2 to 1).
Conclusion: In healthy community-dwelling individuals aged ≥ 70 years, aspirin was not superior to placebo with respect to mean deterioration in the 4-frequency average hearing threshold at year 3. 🦵 What is the role of oral methotrexate for pain reduction in patients with knee OA? -
The PROMOTE trial (July 2024, n=155) compared methotrexate (once-weekly oral dose, with a 6-week escalation from 10 to 25 mg, over 12 months and continued usual analgesia) to a matching placebo in patients with knee OA. The key exclusion criteria included inflammatory arthritis, use of intra-articular hyaluronic in the past 4 months, use of corticosteroids in the past 3 months, and significant knee injury or knee surgery in the past 6 months.
- There was a significant increase in mean pain reduction at 6 months (1.3 points vs. 0.6 points; MD 0.79, 95% CI 0.08 to 1.51).
Conclusion: In patients with knee OA, methotrexate was superior to placebo with respect to mean pain reduction at 6 months. |
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Acknowledgements:
Editorial Team: Jeremy Swisher, MD, Cole Phillips, MD, Khudhur Moh, MD, Hovhannes K, MD |
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