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In people with diabetes, hypoglycemia may increase dementia risk [4, 5]

Study Population : 2,539 adults without diabetes Average age: 44.9 years Average baseline BMI: 38.0 Average baseline weight: 231.1 pounds 67.5% female 70.1% White, 22.3% Hispanic/Latino, 5.4% Black, 2.2% Other Interventions : Tirzepatide 5 mg once weekly (n=630) Tirzepatide 10 mg once weekly (n=636) Tirzepatide 15 mg once weekly (n=630) Placebo once weekly (n=643) All groups: Counseling for 500-calorie deficit and 150 minutes/week physical activity Duration : 72 weeks Primary Outcome - Mean Percentage Weight Loss : Tirzepatide 5 mg: -15.0% (95% CI: -15.9 to -14.2) Tirzepatide 10 mg: -19.5% (95% CI: -20.4 to -18.5) Tirzepatide 15 mg: -20.9% (95% CI: -21.8 to -19.9) Placebo: -3.1% (95% CI: -4.3 to -1.9) Secondary Outcomes - Categorical Weight Loss (15 mg dose): 5% weight loss : 96.0% tirzepatide vs 34.3% placebo 10% weight loss : 89.4% tirzepatide vs 16.6% placebo 15% weight loss : 78.9% tirzepatide vs 8.2% placebo 20% weight loss : 62.7% tirzepatide vs 1.3% placebo 25% weight loss : 42.4% tirzepatide vs 0.3% placebo Trial Completion Rates : Tirzepatide 5 mg: 84.8% Tirzepatide 10 mg: 85.2% Tirzepatide 15 mg: 83.7% Placebo: 91.4% Safety Data (15 mg dose): Gastrointestinal adverse events: 81.0% tirzepatide vs 63.8% placebo Serious adverse events: 6.2% tirzepatide vs 4.2% placebo Discontinuation due to adverse events: 6.2% tirzepatide vs 2.2% placebo Real-World Evidence: Beyond Clinical Trials While randomized controlled trials provide the highest quality efficacy and safety data, real-world evidence studies examine outcomes in routine clinical practice settings without strict trial protocols

In a case report by Sani et al., the use of semaglutide 1 mg weekly over 12 months in a male with PWS and diabetes resulted in an HbA1c decrease of 3.9% and weight loss of 5.2 kg (41)

De Block CEM, Drinck E, Verhaegen A, van Gaal LF (2022) Efficacy and safety of high-dose glucagon-like peptide-1, glucagon-like peptide-1/glucose-dependent insulinotropic peptide, and glucagon-like peptide-1/glucagon receptor agonists in type 2 diabetes