The authors wish to make the following changes to their paper [1]. In Table 1, in the last row, the authors reported rates of Neutralizing antibodies: 42% vs. 6% in ODYSSEY Outcomes. Actually, these are patient numbers and not percentages. Due to this fact, we would like to correct this data as 0.4% vs. 0.1% in Table 1. This correction has been made in both Table 1 and in the main text.
Table 1.
Cardiovascular outcome trials of nonstatin drugs.
Table 1.
Cardiovascular outcome trials of nonstatin drugs.
The mistake in the main text
On page 5, Section 3.2.7, the sentence “In ODYSSEY Outcomes [19], neutralizing antibodies developed in 42% and 6% of patients in the alirocumab and placebo group, respectively,” should be replaced with “In ODYSSEY Outcomes [19], neutralizing antibodies developed in 0.4% and 0.1% of patients in the alirocumab and placebo group, respectively”.
The authors would like to apologize for any inconvenience caused to the readers by these changes.
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]
Table 1.
Cardiovascular outcome trials of nonstatin drugs.
| 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% |
Table 1.
Cardiovascular outcome trials of nonstatin drugs.
| 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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