Correction: Sugiyama, K.; et al. Management of Dyslipidemia in Type 2 Diabetes: Recent Advances in Nonstatin Treatment. Diseases 2018, 6, 44
Reference
- Sugiyama, K.; Saisho, Y. Management of Dyslipidemia in Type 2 Diabetes: Recent Advances in Nonstatin Treatment. Diseases 2018, 6, 44. [Google Scholar] [CrossRef] [PubMed]
Variable | IMPROVE-IT [17] | FOURIER [18] | ODYSSEY Outcomes [19] |
---|---|---|---|
No. of patients | 18,144 | 27,564 | 18,924 |
No. of patients with diabetes | 4933 (27%) | 11,031 (40%) [20] | 5444 (29%) |
Mean age (years) | 64 | 63 | 58 |
Clinical characteristics | ACS within 10 days | ASCVD and LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL on statin | ACS within 12 months; LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL or ApoB ≥80 mg/dL on high-intensity statin |
Intervention | Simvastatin 40 mg and ezetimibe 10 mg vs. simvastatin 40 mg | Evolocumab 140 mg q 2w or 420 mg q 4w vs. placebo | Alirocumab 75–150 mg q 2w vs. placebo |
Primary endpoint | CV death, MI, stroke, hospitalization for UA, coronary revascularization | CV death, MI, stroke, hospitalization for UA, coronary revascularization | CHD death, MI, ischemic stroke, hospitalization for UA |
Median f/u (years) | 6 | 2.2 | 2.8 |
Achieved LDL-C (mg/dL) | 53.7 vs. 69.5 | 30 vs. 92 | 53.3 vs. 101.4 |
Primary endpoint | 32.7% vs. 34.7%; HR 0.936 (95% CI 0.89–0.99); p = 0.016 | 9.8% vs. 11.3%; HR 0.85 (95% CI 0.79–0.92); p < 0.001 | 9.5% vs. 11.1%; HR 0.85 (95% CI 0.78–0.93); p = 0.0003 |
3-point MACE (CV death, MI, stroke) | 22.2% vs. 20.4%; HR 0.90 (95% CI 0.84–0.96); p = 0.003 | 5.9% vs. 7.4%; HR 0.80 (95% CI 0.73–0.88); p<0.001 | 10.3% vs. 11.9%; HR 0.86 (95% CI 0.79–0.93); p = 0.0003 * |
CV death | 6.8% vs. 6.9%; HR 1.00 (95% CI 0.89–1.13); p = 1.00 | 1.8% vs. 1.7%; HR 1.05 (95% CI 0.88–1.25); p = 0.62 | 2.5% vs. 2.9%; HR 0.88 (95% CI 0.74–1.05); p = 0.15 |
All-cause death | 15.3% vs. 15.4%; HR 0.99 (95% CI 0.91–1.07); p = 0.78 | 3.2% vs. 3.1%; HR 1.04 (95% CI 0.91–1.19); p = 0.54 | 3.5% vs. 4.1%; HR 0.85 (95% CI 0.73–0.98); p = 0.026 |
Adverse events | Similar safety in both groups | Injection-site reactions: 2.1% vs. 1.6% Neutralizing antibodies: 0% in both groups | Injection site reactions: 3.8% vs. 2.1% Neutralizing antibodies: 42% vs. 6% |
Variable | IMPROVE-IT [17] | FOURIER [18] | ODYSSEY Outcomes [19] |
---|---|---|---|
No. of patients | 18,144 | 27,564 | 18,924 |
No. of patients with diabetes | 4933 (27%) | 11,031 (40%) [20] | 5444 (29%) |
Mean age (years) | 64 | 63 | 58 |
Clinical characteristics | ACS within 10 days | ASCVD and LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL on statin | ACS within 12 months; LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL or ApoB ≥80 mg/dL on high-intensity statin |
Intervention | Simvastatin 40 mg and ezetimibe 10 mg vs. simvastatin 40 mg | Evolocumab 140 mg q 2w or 420 mg q 4w vs. placebo | Alirocumab 75–150 mg q 2w vs. placebo |
Primary endpoint | CV death, MI, stroke, hospitalization for UA, coronary revascularization | CV death, MI, stroke, hospitalization for UA, coronary revascularization | CHD death, MI, ischemic stroke, hospitalization for UA |
Median f/u (years) | 6 | 2.2 | 2.8 |
Achieved LDL-C (mg/dL) | 53.7 vs. 69.5 | 30 vs. 92 | 53.3 vs. 101.4 |
Primary endpoint | 32.7% vs. 34.7%; HR 0.936 (95% CI 0.89–0.99); p = 0.016 | 9.8% vs. 11.3%; HR 0.85 (95% CI 0.79–0.92); p < 0.001 | 9.5% vs. 11.1%; HR 0.85 (95% CI 0.78–0.93); p = 0.0003 |
3-point MACE (CV death, MI, stroke) | 22.2% vs. 20.4%; HR 0.90 (95% CI 0.84–0.96); p = 0.003 | 5.9% vs. 7.4%; HR 0.80 (95% CI 0.73–0.88); p<0.001 | 10.3% vs. 11.9%; HR 0.86 (95% CI 0.79–0.93); p = 0.0003 * |
CV death | 6.8% vs. 6.9%; HR 1.00 (95% CI 0.89–1.13); p = 1.00 | 1.8% vs. 1.7%; HR 1.05 (95% CI 0.88–1.25); p = 0.62 | 2.5% vs. 2.9%; HR 0.88 (95% CI 0.74–1.05); p = 0.15 |
All-cause death | 15.3% vs. 15.4%; HR 0.99 (95% CI 0.91–1.07); p = 0.78 | 3.2% vs. 3.1%; HR 1.04 (95% CI 0.91–1.19); p = 0.54 | 3.5% vs. 4.1%; HR 0.85 (95% CI 0.73–0.98); p = 0.026 |
Adverse events | Similar safety in both groups | Injection-site reactions: 2.1% vs. 1.6% Neutralizing antibodies: 0% in both groups | Injection site reactions: 3.8% vs. 2.1% Neutralizing antibodies: 0.4% vs. 0.1% |
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Sugiyama, K.; Saisho, Y. Correction: Sugiyama, K.; et al. Management of Dyslipidemia in Type 2 Diabetes: Recent Advances in Nonstatin Treatment. Diseases 2018, 6, 44. Diseases 2018, 6, 61. https://doi.org/10.3390/diseases6030061
Sugiyama K, Saisho Y. Correction: Sugiyama, K.; et al. Management of Dyslipidemia in Type 2 Diabetes: Recent Advances in Nonstatin Treatment. Diseases 2018, 6, 44. Diseases. 2018; 6(3):61. https://doi.org/10.3390/diseases6030061
Chicago/Turabian StyleSugiyama, Kazutoshi, and Yoshifumi Saisho. 2018. "Correction: Sugiyama, K.; et al. Management of Dyslipidemia in Type 2 Diabetes: Recent Advances in Nonstatin Treatment. Diseases 2018, 6, 44" Diseases 6, no. 3: 61. https://doi.org/10.3390/diseases6030061
APA StyleSugiyama, K., & Saisho, Y. (2018). Correction: Sugiyama, K.; et al. Management of Dyslipidemia in Type 2 Diabetes: Recent Advances in Nonstatin Treatment. Diseases 2018, 6, 44. Diseases, 6(3), 61. https://doi.org/10.3390/diseases6030061