12-Week Effectiveness and Safety of Low-Density Lipoprotein Cholesterol-Lowering Therapy by Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition in Patients With Familial Hypercholesterolemia and Hypercholesterolemia　― Data From a Real-World Observational Study of Evolocumab in Japan ―

Abstract

FOURIER trial support the efficacy of evolocumab in combination with statin therapy in significantly reducing the risk of CV events (evaluated by major composite CV events) while reducing LDL-C by 59% compared with placebo. 5 Recent clinical evidence-based guidelines, including those from the Japan Atherosclerosis Society (JAS) for FH and HC, recommend maintaining LDL-C values <70 mg/dL, especially in patients at high risk for CV events. 6 The Japanese package insert for evolocumab included randomized trials that provided efficacy and safety data for 565 Japanese subjects. 4 Given that patients with FH, espe

Effectiveness and safety of PCSK9 inhibitors in real-world clinical practice. An observational multicentre study. The IRIS-PCSK9I study

“…Likewise, some research has been undertaken with respect to routine clinical practice, including different population with hypercholesterolemia. Most reported real-life experiences are consistent with the clinical trials [ [21] , [22] , [23] , [24] , [25] , [26] , [27] ].…”

Safety, adherence and efficacy of PCSK9 inhibitors: a retrospective real-world study

“…These findings are consistent with those observed in outcome trials, real-world studies and metaanalyses. 6,7,9,10,[16][17][18][19][20]23,24 ADRs reported by study patients were mostly nonspecific (e.g., gastrointestinal side effects, dizziness, etc.). The relationship to PCSK9 inhibitor use is temporal and causation cannot be inferred.…”

“…Of note, only 13.2% and 9.9% of subjects in the ODYSSEY OUTCOMES and FOURIER trials, respectively, were Asian, and realworld studies of PCSK9 inhibitor use have largely focused on Western cohorts. [8][9][10][11][12][13][14][15] While a few real-world studies have been conducted on Asian cohorts, [16][17][18][19][20][21] Singapore's unique multi-racial population and genetic differences may impact drug tolerability and efficacy; and social and culture factors, drug adherence and access. In this study, we aimed to study the safety and tolerability of PCSK9 inhibitors among Singaporean patients and determine factors, including method of drug payment, affecting their adherence in the real world.…”