Table 2.
Clinical research on combining and co-delivering strategies against AS
| Combining or co-delivery drugs | Duration | Patient numbers | Efficacy | Study Phase | References | Additional information |
|---|---|---|---|---|---|---|
|
Aspirin + Rivaroxaban vs. Aspirin + Placebo |
3.2 years |
Rivaroxaban (n = 9152) Placebo (n = 9126) |
Primary outcome events of CVD occurred in fewer patients in the Rivaroxaban than in the placebo group. (P < 0.001) | Phase 3 | 500,501 | NCT01776424 |
|
Ezetimibe + Bempedoic acid vs. Ezetimibe + Placebo |
17 weeks |
Bempedoic acid (n = 88) Placebo (n = 181) |
Bempedoic acid reduced LDL-C by 28.5% greater than the placebo group. (P < 0.001) | Phase 3 | 502 | NCT03001076 |
|
Statin + Ezetimibe + Niaspan vs. Statin + Placebo |
2 years | n = 51 | Non-HDL-C was significantly reduced at 12-month triple therapy vs. monotherapy. (P = 0.01) | Phase 4 | 503 | NCT00687076 |
|
Atorvastatin + Ezetimibe vs. Atorvastatin + Placebo |
12 weeks |
Ezetimibe (n = 255) Placebo (n = 248) |
Decreased LDL-C. (P < 0.01) | Phase 3 | 504 | – |
|
Evacetrapib + Statins vs. Evacetrapib |
12 weeks |
Statins (n = 41) Evacetrapib (n = 39) |
A combination of evacetrapib and statin decreased LDL-C. (P < 0.001) | Phase 2 | 505 | NCT01105975 |
|
Atorvastatin + Lovaza vs. Atorvastatin + Placebo |
16 weeks |
Lovaza (n = 123) Placebo (n = 122) |
Significantly reduced median non-HDL-C levels. (P < 0.001) | Phase 3 | 506 | NCT00435045 |
|
Cilostazol + L-Carnitine vs. Cilostazol + Placebo |
0.5 year |
L-Carnitine (n = 80) Placebo (n = 83) |
There was an increase in PWT of 37.9% for L-carnitine, compared with 20.9% for placebo. | Phase 4 | 507 | NCT00822172 |
|
Bempedoic acid + Ezetimibe vs. Bempedoic acid or Ezetimibe |
12 weeks |
Combine (n = 108) Bempedoic acid (n = 110) Ezetimibe (n = 109) |
Significantly lowered LDL-C. (P < 0.001) | Phase 3 | 508 | NCT03337308 |
|
LMT + Alirocumab vs. LMT + Placebo |
62 weeks |
Alirocumab (n = 209) Placebo (n = 107) |
(a) A 48% reduction in LDL-C from baseline (pretreatment) to 24 weeks. (P < 0.0001) (b) Significant reductions in non–HDL-C, total cholesterol, apolipoprotein B, and lipoprotein. (P < 0.0001) (c) A greater portion of patients achieved LDL-C < 70 mg/dL. (P < 0.0001) |
Phase 3 | 509 | ODYSSEY COMBO I NCT01644175 |
|
LMT + Alirocumab vs. LMT + Placebo |
89 weeks |
Alirocumab (n = 1553) Placebo (n = 788) |
(a) Combination of LMT and Alirocumab reduced LDL cholesterol levels by 62% in high-risk patients. (P < 0.001) (b) During the 80 weeks of follow-up, the Combination of LMT and Alirocumab reduced the rate of major adverse cardiovascular events by 48%. (P = 0.02) |
Phase 3 | 510 | ODYSSEY Long Term NCT01507831 |
Primary outcome event of CVD, death, stroke, or myocardial infarction; LDL-C: low-density lipoprotein cholesterol; Non-HDL-C, non–high-density lipoprotein cholesterol; PWT, peak walking time; LMT, lipid-modifying therapy; The rate of main adverse cardiovascular events includes as follows, nonfatal myocardial infarction, a composite end point of death from coronary heart disease, or unsteady angina needing hospitalization, or fatal or nonfatal ischemic stroke