Table 3.
S. number | Trial | Participants | Comparison | LDL reduction | Adverse events | Comments |
---|---|---|---|---|---|---|
(1) | Dose ranging trial (NCT01592240) | Those with LDL-C > 80 mg/dl on stable statin therapy | Bococizumab versus placebo | 54.2% versus 2.8% | Similar adverse events profile | Despite dose reduction in many subjects, bococizumab significantly reduced LDL-C across all the doses |
| ||||||
(2) | SPIRE-1 and SPIRE-2 | Those with background lipid-lowering treatment and have an LDL-C of >/ = 70 mg/dl (SPIRE-1) or LDL-C >/ = 100 mg/dl (SPIRE-2) | Bococizumab versus placebo | This study has been terminated. Completion date: Jan. 2017 |
Bococizumab being a humanized monoclonal antibody, a strong immune response was seen against it which mitigate the LDL-C lowering effect. Anti-drug Ab was seen in 48% patients and neutralizing Ab developed in 29% patients |