Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES
Background: Patients with recent acute coronary syndrome (ACS) commonly experience chest pain, which affects quality of life even when not due to recurrence of ACS. This post hoc analysis of ODYSSEY OUTCOMES assessed the effect of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor...
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| Language: | English |
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Elsevier
2024-12-01
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| Series: | American Journal of Preventive Cardiology |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666667724002691 |
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| author | Gregory P. Geba Ruifeng Chen Kasturi Talapatra Taylor Brackin Kusha A. Mohammadi Robert Pordy Garen Manvelian David J. Maron Gregory G. Schwartz Michael Szarek Ph. Gabriel Steg Sergio Fazio |
| author_facet | Gregory P. Geba Ruifeng Chen Kasturi Talapatra Taylor Brackin Kusha A. Mohammadi Robert Pordy Garen Manvelian David J. Maron Gregory G. Schwartz Michael Szarek Ph. Gabriel Steg Sergio Fazio |
| author_sort | Gregory P. Geba |
| collection | DOAJ |
| description | Background: Patients with recent acute coronary syndrome (ACS) commonly experience chest pain, which affects quality of life even when not due to recurrence of ACS. This post hoc analysis of ODYSSEY OUTCOMES assessed the effect of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, on the incidence of chest pain not due to recurrent ACS. Methods: Patients with recent ACS (n = 18,894) and elevated atherogenic lipoprotein levels despite optimized statin therapy were randomized to subcutaneous alirocumab or matching placebo every 2 weeks. Alirocumab dose was adjusted to target low-density lipoprotein cholesterol (LDL-C) 25–50 mg/dL (0.6–1.3 mmol/L) and to avoid consecutive LDL-C <15 mg/dL (0.39 mmol/L). Non-hospitalized chest pain adverse events and chest pain events requiring hospitalization but negatively adjudicated for recurrent ACS were assessed. Results: Chest pain not requiring hospitalization was reported as an adverse event in 1490 patients, including 7.5 % and 8.3 % of alirocumab and placebo groups, respectively. Hospitalization for chest pain negatively adjudicated for recurrent ACS occurred in 952 patients, including 4.8 % and 5.3 % of alirocumab and placebo groups, respectively. Adjusting for baseline covariates, alirocumab use was associated with 8.1 % lower risk of chest pain (either non-hospitalized or hospitalized events) versus placebo (HR: 0.919; 95 % CI: 0.845–0.998; P = 0.046); a landmark analysis at 7 months showed a larger, 11.7 % risk reduction (HR: 0.883; 95 % CI: 0.793–0.984; P = 0.024). Conclusions: Alirocumab use is associated with reduced incidence of chest pain events after ACS, including those not requiring hospitalization and those requiring hospitalization but not adjudicated as recurrent ACS. Trial registration: NCT01663402 |
| format | Article |
| id | doaj-art-91b0e94fe6454c6c9212d853fda1c717 |
| institution | Kabale University |
| issn | 2666-6677 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
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| series | American Journal of Preventive Cardiology |
| spelling | doaj-art-91b0e94fe6454c6c9212d853fda1c7172024-12-11T05:57:48ZengElsevierAmerican Journal of Preventive Cardiology2666-66772024-12-0120100900Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMESGregory P. Geba0Ruifeng Chen1Kasturi Talapatra2Taylor Brackin3Kusha A. Mohammadi4Robert Pordy5Garen Manvelian6David J. Maron7Gregory G. Schwartz8Michael Szarek9Ph. Gabriel Steg10Sergio Fazio11Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USARegeneron Pharmaceuticals, Inc., Tarrytown, NY, USARegeneron Pharmaceuticals, Inc., Tarrytown, NY, USARegeneron Pharmaceuticals, Inc., Tarrytown, NY, USARegeneron Pharmaceuticals, Inc., Tarrytown, NY, USARegeneron Pharmaceuticals, Inc., Tarrytown, NY, USARegeneron Pharmaceuticals, Inc., Tarrytown, NY, USAStanford University School of Medicine, Stanford, California, USAUniversity of Colorado School of Medicine, Aurora, Colorado, USAState University of New York, Downstate School of Public Health, Brooklyn, New York, USA; CPC Clinical Research and Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USAUniversité Paris-Cité, Paris, France; FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris, FranceRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; Corresponding author at: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.Background: Patients with recent acute coronary syndrome (ACS) commonly experience chest pain, which affects quality of life even when not due to recurrence of ACS. This post hoc analysis of ODYSSEY OUTCOMES assessed the effect of alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, on the incidence of chest pain not due to recurrent ACS. Methods: Patients with recent ACS (n = 18,894) and elevated atherogenic lipoprotein levels despite optimized statin therapy were randomized to subcutaneous alirocumab or matching placebo every 2 weeks. Alirocumab dose was adjusted to target low-density lipoprotein cholesterol (LDL-C) 25–50 mg/dL (0.6–1.3 mmol/L) and to avoid consecutive LDL-C <15 mg/dL (0.39 mmol/L). Non-hospitalized chest pain adverse events and chest pain events requiring hospitalization but negatively adjudicated for recurrent ACS were assessed. Results: Chest pain not requiring hospitalization was reported as an adverse event in 1490 patients, including 7.5 % and 8.3 % of alirocumab and placebo groups, respectively. Hospitalization for chest pain negatively adjudicated for recurrent ACS occurred in 952 patients, including 4.8 % and 5.3 % of alirocumab and placebo groups, respectively. Adjusting for baseline covariates, alirocumab use was associated with 8.1 % lower risk of chest pain (either non-hospitalized or hospitalized events) versus placebo (HR: 0.919; 95 % CI: 0.845–0.998; P = 0.046); a landmark analysis at 7 months showed a larger, 11.7 % risk reduction (HR: 0.883; 95 % CI: 0.793–0.984; P = 0.024). Conclusions: Alirocumab use is associated with reduced incidence of chest pain events after ACS, including those not requiring hospitalization and those requiring hospitalization but not adjudicated as recurrent ACS. Trial registration: NCT01663402http://www.sciencedirect.com/science/article/pii/S2666667724002691Acute coronary syndromeAlirocumabCardiovascular diseaseChest painProprotein convertase subtilisin/kexin type 9Low-density lipoprotein cholesterol |
| spellingShingle | Gregory P. Geba Ruifeng Chen Kasturi Talapatra Taylor Brackin Kusha A. Mohammadi Robert Pordy Garen Manvelian David J. Maron Gregory G. Schwartz Michael Szarek Ph. Gabriel Steg Sergio Fazio Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES American Journal of Preventive Cardiology Acute coronary syndrome Alirocumab Cardiovascular disease Chest pain Proprotein convertase subtilisin/kexin type 9 Low-density lipoprotein cholesterol |
| title | Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES |
| title_full | Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES |
| title_fullStr | Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES |
| title_full_unstemmed | Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES |
| title_short | Alirocumab and chest pain after acute coronary syndrome: An analysis of ODYSSEY OUTCOMES |
| title_sort | alirocumab and chest pain after acute coronary syndrome an analysis of odyssey outcomes |
| topic | Acute coronary syndrome Alirocumab Cardiovascular disease Chest pain Proprotein convertase subtilisin/kexin type 9 Low-density lipoprotein cholesterol |
| url | http://www.sciencedirect.com/science/article/pii/S2666667724002691 |
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