The second lipid-lowering phase III study of Pfizer PCSK9 inhibitor lipid-lowering drug bococizumab was successful April 06, 2016 Source: Bio Valley US pharmaceutical giant Pfizer recently announced that it has succeeded in researching PCSK9 inhibitor lipid-lowering drug bococizumab in the lipid-lowering phase III SPIRE-AI (AutoInjector) study. The study was the second phase III lipid-lowering study successfully completed in the bococizumab Phase III SPIRE clinical program. The previously announced first lipid-lowering phase III study, SPIRE-SI (statin tolerance), was performed in adult patients with statin intolerance to hyperlipidemia and also reached the primary endpoint for lowering LDL-C. The SPIRE-AI study was a 12-week, double-blind, placebo-controlled, randomized, parallel-group, multicenter clinical study of 299 patients who were receiving statin therapy and had LDL-C ≥ 70 mg/dL hyperlipidemia. The efficacy, safety, and tolerability of bococizumab 150 mg and 75 mg prefilled injections administered subcutaneously were evaluated in patients with mixed dyslipidemia. Common primary endpoints for this study included: (1) percent change in LDL-C from baseline at week 12 of treatment; and (2) success rate of drug delivery system, defined as the proportion of patients who successfully operated bococizumab prefilled injection pens. The data shows that the study reached a common primary endpoint. In the study, bococizumab was safe and well tolerated. Overall, the proportion of patients experiencing treatment-related adverse events was similar in each treatment group. The full data of the study will be published at a future scientific conference. Currently, Pfizer is steadily advancing the phase III SPIRE clinical project of bococizumab. The project is a large global clinical development project involving approximately 32,000 patients, including 6 lipid-lowering phase III studies (SPIRE-SI, SPIRE-AI, SPIRE-HR, SPIRE-FH, SPIRE-LL, SPIRE-LDL) ) and 2 cardiovascular prognostic studies (SPIRE-1, SPIRE-2). Among them, 6 lipid-lowering phase III studies were conducted in adult patients with a risk of cardiovascular events, and bococizumab was investigated to reduce the efficacy, safety, and tolerability of LDL-C. Two phase III cardiovascular prognostic studies are performed in a wide range of high-risk primary prevention (prevention of disease in asymptomatic individuals) and secondary prevention (prevention of death or recurrence of disease in individuals with existing symptoms) Conducted in the population to investigate the potential of bococizumab to reduce the risk of cardiovascular events. Vitamins Xi'an complex bio-tech CO.,LTD. , https://www.complexpowder.com