PCSK9 inhibitors in clinical practice: Delivering on the promise?

Abstract

The observed lipid reductions and side effects profile of PCSK9 inhibitors in a routine care setting were comparable to observations in clinical trials.

Real‐world study: Escalating targeted lipid‐lowering treatment with PCSK9‐inhibitors and lipoprotein apheresis

“…In the RCT setting, 4.9%‐18.0% of patients discontinued PCSK9 antibody treatment, a proportion of only 6.5%‐21.8% of patients with any TEAE. Underlying causes for this observation could be higher sensitivity for any TEAE, including those with minor clinical relevance and higher adherence to study medication in a randomized controlled trial . Also, referral of a highly selected patient population to tertiary care centers for escalation of targeted LLT plays a role.…”

Lipid‐lowering therapy with PCSK9‐inhibitors in the real‐world setting: Two‐year experience of a regional lipid clinic

“…Adverse effects were quite prevalent (39%), with flu‐like symptoms and injection site reaction being the most frequent and 8% discontinuing therapy. A second report from the Netherlands is the largest real‐life cohort study of PCSK9 inhibitors to date, including 238 patients (67% FH and 43% statin intolerance) from an outpatient clinic in Amsterdam . However, 99 of these patients were initially treated by PCSK9 inhibitors as part of a clinical trial, and therefore may have been a more adherent population that may not adequately represent real‐life patients.…”

Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial

“…[1][2][3][4] Recently published real-world studies indicate that 42.9-67.0% of patients are statin intolerant before receiving PCSK9 inhibitor monoclonal antibody therapy, thereby emphasizing statin intolerance as an important realworld therapeutic challenge. [5][6][7][8] In the 24-week, randomized, double-blind ODYSSEY ALTERNATIVE study (NCT01709513), the PCSK9 inhibitor alirocumab 75 mg administered every 2 weeks (Q2W; with possible dose adjustment to 150 mg Q2W) reduced low-density lipoprotein cholesterol (LDL-C) by 45.0% vs 14.6% with ezetimibe in patients with primary hypercholesterolemia who were intolerant to statins, defined as the inability to tolerate $2 statins, including 1 at the lowest-approved starting dose, due to muscle symptoms. 9 All patients who had successfully completed the double-blind treatment period (DBTP) were eligible to enter an optional open-label treatment period (OLTP).…”