Patient and Physician Perspectives on Mode of Administration of the PCSK9 Monoclonal Antibody Alirocumab, an Injectable Medication to Lower LDL-C Levels

Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved..

PURPOSE: Clinical trials of the PCSK9 inhibitor alirocumab, an every 2 week injectable monoclonal antibody, have shown significant reductions in LDL-cholesterol. However, many patients requiring lipid-lowering therapy are not experienced with self-injected medication. This study assessed patient and physician perceptions of 2 alirocumab delivery devices.

METHODS: 400 participants (200 physicians, 200 patients) were included from 6 countries. Physicians (99 primary care physicians [PCPs]; 101 specialists) had mean practice experience of 17.8 years and an average of 797 hypercholesterolemic patients. Participating patients had LDL-C levels above their goal and at least one of the following: familial hypercholesterolemia, statin intolerance, high cardiovascular risk, and/or diabetes. Mean patient age was 58.5 years, 51% were female, and 25.5% had injectable medication experience. Following device instruction and demonstration, participants tested either a pre-filled pen or pre-filled syringe, using both 75 and 150 mg doses of single-blinded placebo into a prosthetic pad. Data were collected by self-administered questionnaire.

FINDINGS: Participant acceptance of both devices was positive, with 83-100% agreeing with ease-of-use statements. After testing, physicians estimated that 66% (pen) and 58% (syringe) of their patients would be willing to self-inject using the device (relative increases from pre-testing of 22% and 16%, respectively; both P<0.05). Specialist estimates were higher than PCP estimates: for the pen, 60% versus 47% (pre-testing), respectively, and 72% versus 61% (post-testing); for the syringe, 57% versus 43% (pre-testing), 63% versus 54% (post-testing; all P<0.05, specialist vs PCP). After testing, 72% (pen) and 63% (syringe) of patient-participants were very willing to self-inject (relative increases from pre-testing of 26% [P<0.05] and 11%, respectively); 96% (pen) and 93% (syringe) were either very willing or somewhat willing to self-inject. The proportion of patients aged <60 years who were very willing to self-inject with either device was numerically (but not statistically) higher compared with those ≥60 years. Initially, patients with injectable medication experience were generally more willing to use the pen than injection-naive patients; after testing there was no difference between groups. No significant differences were observed in responses to the 2 different doses.

IMPLICATIONS: Responses from physicians and patients to pre-filled pen and syringe devices were positive. Devices were considered easy to operate, with most patients willing to use and accept self-injection. Patient willingness to self-inject increased after demonstration and testing. Results suggest that, in clinical practice, alirocumab administration by either pre-filled pen or syringe would not deter most physicians from prescribing or most patients from self-administering.

Medienart:	E-Artikel

Erscheinungsjahr:	2015
Erschienen:	2015

Enthalten in:	Zur Gesamtaufnahme - volume:37
Enthalten in:	Clinical therapeutics - 37(2015), 9 vom: 01. Sept., Seite 1945-1954.e6

Sprache:	Englisch

Beteiligte Personen:	Roth, Eli M [VerfasserIn] Bujas-Bobanovic, Maja [VerfasserIn] Louie, Michael J [VerfasserIn] Cariou, Bertrand [VerfasserIn]

Links:	Volltext

Themen:	Administration Alirocumab Antibodies, Monoclonal Antibodies, Monoclonal, Humanized Cholesterol, LDL Devices Hydroxymethylglutaryl-CoA Reductase Inhibitors Journal Article Multicenter Study PCSK9 PP0SHH6V16 Pen Randomized Controlled Trial Research Support, Non-U.S. Gov't Syringe

Anmerkungen:	Date Completed 02.05.2016 Date Revised 10.03.2022 published: Print-Electronic Citation Status MEDLINE

doi:	10.1016/j.clinthera.2015.07.008

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	NLM251883086