Review Article

Cardiovascular Outcomes of PCSK9 Inhibitors: With Special Emphasis on Its Effect beyond LDL-Cholesterol Lowering

Table 3

Studies on bococizumab.

S. numberTrialParticipantsComparisonLDL reductionAdverse eventsComments

(1)Dose ranging trial (NCT01592240)Those with LDL-C > 80 mg/dl on stable statin therapyBococizumab versus placebo54.2% versus 2.8%Similar adverse events profileDespite dose reduction in many subjects, bococizumab significantly reduced LDL-C across all the doses

(2)SPIRE-1 and SPIRE-2Those 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 placeboThis 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