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Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes
Atherosclerotic cardiovascular disease remains a major cause of death and disability, especially for high-risk familial hypercholesterolemia individuals. PCSK9i (proprotein convertase subtilisin kexin type 9 inhibitors) reduce low-density lipoprotein cholesterol levels and cardiovascular event rates...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665275/ https://www.ncbi.nlm.nih.gov/pubmed/31331194 http://dx.doi.org/10.1161/CIRCOUTCOMES.118.005404 |
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author | Myers, Kelly D. Farboodi, Niloofar Mwamburi, Mkaya Howard, William Staszak, David Gidding, Samuel Baum, Seth J. Wilemon, Katherine Rader, Daniel J. |
author_facet | Myers, Kelly D. Farboodi, Niloofar Mwamburi, Mkaya Howard, William Staszak, David Gidding, Samuel Baum, Seth J. Wilemon, Katherine Rader, Daniel J. |
author_sort | Myers, Kelly D. |
collection | PubMed |
description | Atherosclerotic cardiovascular disease remains a major cause of death and disability, especially for high-risk familial hypercholesterolemia individuals. PCSK9i (proprotein convertase subtilisin kexin type 9 inhibitors) reduce low-density lipoprotein cholesterol levels and cardiovascular event rates. However, PCSK9i prescriptions are rejected at high rates by payers, and use is often delayed or eventually abandoned as a treatment option. We tested the hypothesis that acute coronary syndromes, coronary interventions, stroke, and cardiac arrest are more prevalent in patients with rejected or abandoned PCSK9i prescriptions than for those with paid PCSK9i prescriptions. METHODS AND RESULTS: We identified 139 036 individuals aged ≥18 years who met the following 3 criteria: prescribed PCSK9i between August 2015 and December 2017, had claims history, and had an established date of exposure for paid, rejected, or abandoned status. To compare the effects of rejected versus paid and abandoned versus paid status, propensity score matching was performed to minimize confounding because of baseline differences in patient groups. Cox regression analyses and incidence density rates for cardiovascular events were estimated on the propensity score-matched cohorts. Patients who received 168 or more days of paid PCSK9i medication within a 12-month period were defined as paid. The hazard ratios for composite cardiovascular events outcome in propensity score-matched analyses were 1.10 (95% CI, 1.01–1.19; P=0.02) for rejected versus paid and 1.12 (95% CI, 1.01–1.24; P=0.03) for abandoned versus paid. In a stricter analysis where paid patients were defined by receiving 338 or more days of therapy within 12-months, hazard ratio was 1.16 (95% CI, 1.02–1.30; P=0.04) for rejected versus paid and 1.21 (95% CI, 1.04–1.38; P=0.03) for the abandoned versus paid status. Higher PCSK9i rejection rates were observed with women, racial minorities, and lower-income groups. CONCLUSIONS: Individuals in the rejected and abandoned cohorts had significantly increased risk of cardiovascular events compared with those in the paid cohort. Rejection, abandonment, and disparities related to PCSK9i prescriptions are related to higher cardiovascular outcome rates. |
format | Online Article Text |
id | pubmed-7665275 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-76652752020-11-16 Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes Myers, Kelly D. Farboodi, Niloofar Mwamburi, Mkaya Howard, William Staszak, David Gidding, Samuel Baum, Seth J. Wilemon, Katherine Rader, Daniel J. Circ Cardiovasc Qual Outcomes Original Articles Atherosclerotic cardiovascular disease remains a major cause of death and disability, especially for high-risk familial hypercholesterolemia individuals. PCSK9i (proprotein convertase subtilisin kexin type 9 inhibitors) reduce low-density lipoprotein cholesterol levels and cardiovascular event rates. However, PCSK9i prescriptions are rejected at high rates by payers, and use is often delayed or eventually abandoned as a treatment option. We tested the hypothesis that acute coronary syndromes, coronary interventions, stroke, and cardiac arrest are more prevalent in patients with rejected or abandoned PCSK9i prescriptions than for those with paid PCSK9i prescriptions. METHODS AND RESULTS: We identified 139 036 individuals aged ≥18 years who met the following 3 criteria: prescribed PCSK9i between August 2015 and December 2017, had claims history, and had an established date of exposure for paid, rejected, or abandoned status. To compare the effects of rejected versus paid and abandoned versus paid status, propensity score matching was performed to minimize confounding because of baseline differences in patient groups. Cox regression analyses and incidence density rates for cardiovascular events were estimated on the propensity score-matched cohorts. Patients who received 168 or more days of paid PCSK9i medication within a 12-month period were defined as paid. The hazard ratios for composite cardiovascular events outcome in propensity score-matched analyses were 1.10 (95% CI, 1.01–1.19; P=0.02) for rejected versus paid and 1.12 (95% CI, 1.01–1.24; P=0.03) for abandoned versus paid. In a stricter analysis where paid patients were defined by receiving 338 or more days of therapy within 12-months, hazard ratio was 1.16 (95% CI, 1.02–1.30; P=0.04) for rejected versus paid and 1.21 (95% CI, 1.04–1.38; P=0.03) for the abandoned versus paid status. Higher PCSK9i rejection rates were observed with women, racial minorities, and lower-income groups. CONCLUSIONS: Individuals in the rejected and abandoned cohorts had significantly increased risk of cardiovascular events compared with those in the paid cohort. Rejection, abandonment, and disparities related to PCSK9i prescriptions are related to higher cardiovascular outcome rates. Lippincott Williams & Wilkins 2019-07-23 /pmc/articles/PMC7665275/ /pubmed/31331194 http://dx.doi.org/10.1161/CIRCOUTCOMES.118.005404 Text en © 2019 The Authors. Circulation: Cardiovascular Quality and Outcomes is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution Non-Commercial-NoDerivs (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited, the use is noncommercial, and no modifications or adaptations are made. |
spellingShingle | Original Articles Myers, Kelly D. Farboodi, Niloofar Mwamburi, Mkaya Howard, William Staszak, David Gidding, Samuel Baum, Seth J. Wilemon, Katherine Rader, Daniel J. Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes |
title | Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes |
title_full | Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes |
title_fullStr | Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes |
title_full_unstemmed | Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes |
title_short | Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes |
title_sort | effect of access to prescribed pcsk9 inhibitors on cardiovascular outcomes |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665275/ https://www.ncbi.nlm.nih.gov/pubmed/31331194 http://dx.doi.org/10.1161/CIRCOUTCOMES.118.005404 |
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