Table 1 Characteristics of randomized controlled trials comparing weight and cardiometabolic changes after short-term treatment of olanzapine/SAM and olanzapine [arranged by year of publication].
Author (year), country | Study design (Sponsor) | Participant | Intervention (mg/day) | Comparator (mg/day) | Outcome and result ( OLZ/SAM vs. OLZ) |
|---|---|---|---|---|---|
Silverman (2018), USA | DBRT, placebo-controlled, 3 weeks (Alkermes) | Aged 18–40 years (average = 26.44 years) Male: 100% Diagnosis: Healthy BMI: 18–25 kg/m2 Mean initial BMI and weight: 22.55 kg/m2 and 67.80 kg | OLZ/SAM = 10/5 mg/day (n = 34) | OLZ = 10 mg/day (n = 35) | Weight change (mean kg): 2.2 vs. 3.1 (p = 0.02) FPG change (mean mmol/L): − 0.1 vs. 0.0 (p = 0.70) HDL change (mean mmol/L): − 0.1 vs. 0.0 (p = 0.41) LDL change (mean mmol/L): 0.1 vs. 0.2 (p = 0.50) TG change (mean mmol/L): 0.2 vs. 0.4 (p = 0.28) All-cause dropouts (n): 7 vs. 6 (p, N/A) Adverse dropouts (n): 3 vs. 3 (p, N/A) |
Martin (2019), Multi-country | DBRT, placebo-controlled, 12 weeks (Alkermes) | Aged 18–50 years (average = 38.86 years) Male: 73.8% Diagnosis: Schizophrenia Mean PANSS total score: 62 BMI: 17–30 kg/m2 Mean initial BMI and weight: 25.18 kg/m2 and 76.91 kg | OLZ/SAM = 5–20/5–20 mg/day (n = 235) | OLZ = 5–20 mg/day (n = 75) | Weight change (mean kg): 1.9 vs. 2.2 (p = 0.02) FPG change (mean mg/dL): 5.4 vs. 4.1 (p, N/A) HDL change (mean mg/dL): − 2.1 vs. − 3.2 (p, N/A) LDL change (mean mg/dL): 7.4 vs. 11.5 (p, N/A) TG change (mean mg/dL): 4.0 vs. 6.5 (p, N/A) All-cause dropouts (n): 69 vs. 19 (p, N/A) Adverse dropouts (n): 21 vs. 3 (p, N/A) |
Correll (2020), USA | DBRT, 24 weeks (Alkermes) | Aged 18–55 years (average = 40.20 years) Male: 72.7% Diagnosis: Schizophrenia Mean PANSS total score: 69.2 BMI: 18–30 kg/m2 Mean initial BMI and weight: 25.45 kg/m2 and 77.37 kg | OLZ/SAM = 10–20/10 mg/day (n = 274) | OLZ = 10–20 mg/day (n = 276) | Weight change (LSM %): 4.21 vs. 6.59 (p = 0.003) FPG change (mean mg/dL): 4.5 vs. 2.3 (p, N/A) HDL change (mean mg/dL): − 5.1 vs. − 4.5 (p, N/A) LDL change (mean mg/dL): 0.6 vs. 0.9 (p, N/A) TG change (mean mg/dL): 23.9 vs. 24.5 (p, N/A) All-cause dropouts (n): 98 vs. 100 (p, N/A) Adverse dropouts (n): 33 vs. 27 (p, N/A) |
Potkin (2020), USA and Europe | DBRT, placebo-controlled, 4 weeks (Alkermes) | Aged 18–70 years (average = 41.15 years) Male: 62.2% Diagnosis: Schizophrenia Mean PANSS total score: 101.2 BMI: 18–40 kg/m2 Mean initial BMI and weight: 26.90 kg/m2 and 80.04 kg | OLZ/SAM = 10–20/10 mg/day (n = 134) | OLZ = 10–20 mg/day (n = 133) | Weight change (mean kg): 3.02 vs. 2.38 (p, N/A) All-cause dropouts (n): 12 vs. 14 (p, N/A) Adverse dropouts (n): 2 vs. 2 (p, N/A) |
