ONE YEAR EXPERIENCE WITH INCLISIRAN IN AN ACADEMIC LIPID CLINIC:
Therapeutic Area: Pharmacologic Therapy Background: Real-world data examining inclisiran use in US clinical practice are limited. We report a one-year experience with inclisiran in an academic lipid clinic. Methods: Retrospective chart review of patients prescribed inclisiran since FDA approval in D...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-09-01
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| Series: | American Journal of Preventive Cardiology |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666667723001083 |
| _version_ | 1797676585579446272 |
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| author | Tommy T. Chiou, BA Kimberly Tomasi, RN, BSN Pam R. Taub, MD Michael J. Wilkinson, MD |
| author_facet | Tommy T. Chiou, BA Kimberly Tomasi, RN, BSN Pam R. Taub, MD Michael J. Wilkinson, MD |
| author_sort | Tommy T. Chiou, BA |
| collection | DOAJ |
| description | Therapeutic Area: Pharmacologic Therapy Background: Real-world data examining inclisiran use in US clinical practice are limited. We report a one-year experience with inclisiran in an academic lipid clinic. Methods: Retrospective chart review of patients prescribed inclisiran since FDA approval in December 2021. Results: 80 patients were prescribed inclisiran over 14 months (Table). Inclisiran was approved by insurance for 70 (88%) and denied for 10 (12%). 48 (60%) could not tolerate any statin as background lipid-lowering therapy (LLT). All patients with Medicare received approval for inclisiran, compared to 12 of 22 (55%) of non-Medicare patients. Approved patients were older (71±8 vs 59±15 years, p=0.004), disproportionately Medicare enrollees (83%, p<0.001), more had ASCVD (69% vs 31%, p=0.031), less had HeFH (20% vs 80%, p=0.013), and fewer were on statins as background LLT (33% vs 67%, p=0.035).61 of 70 (87%) patients with approval have received at least one dose of inclisiran (19 received one dose, 37 received two, 5 have received three). 3 (5%) reported side-effects (1 injection site pain, 1 fever, 1 paresthesia and swelling in extremity leading to discontinuation).Using most recent LDL-C measured at least 30 days after first dose of inclisiran (n=38, 6 received one dose, 27 received two, 5 have received three), mean LDL-C decreased from 121±56 mg/dL to 85±55 mg/dL (-21%, p=0.003). Among the 25 patients who did not switch from a PCSK9i mAb (n=9) or stop their background LLT (n=5), LDL-C decreased from 139±44 mg/dL to 72±30 mg/dL (-49%, p<0.001) (Figure). LDL-C reduction differed by background PCSK9i mAb use (p<0.001) and discontinuation of background LLT (p=0.003), but not by sex, history of ASCVD or HeFH, background statin use, or number of inclisiran injections received. Conclusions: During the initial 14 months of prescribing inclisiran, 100% of patients on Medicare obtained insurance approval compared to roughly half of those with non-Medicare insurance who were younger and more likely to have HeFH. Among patients who had follow-up LDL-C, did not discontinue background LLT, and were not transitioning to inclisiran from a PCSK9i mAb, we observed LDL-C reductions of ∼50% which is similar in magnitude to those observed in clinical trials with inclisiran. |
| first_indexed | 2024-03-11T22:31:22Z |
| format | Article |
| id | doaj.art-e35a57ef5d5b4a72bc378dc22152983f |
| institution | Directory Open Access Journal |
| issn | 2666-6677 |
| language | English |
| last_indexed | 2024-03-11T22:31:22Z |
| publishDate | 2023-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | American Journal of Preventive Cardiology |
| spelling | doaj.art-e35a57ef5d5b4a72bc378dc22152983f2023-09-23T05:13:05ZengElsevierAmerican Journal of Preventive Cardiology2666-66772023-09-0115100567ONE YEAR EXPERIENCE WITH INCLISIRAN IN AN ACADEMIC LIPID CLINIC:Tommy T. Chiou, BA0Kimberly Tomasi, RN, BSN1Pam R. Taub, MD2Michael J. Wilkinson, MD3Division of Cardiovascular Medicine, Department of Medicine, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093Division of Cardiovascular Medicine, Department of Medicine, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093Division of Cardiovascular Medicine, Department of Medicine, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093Division of Cardiovascular Medicine, Department of Medicine, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA, 92093Therapeutic Area: Pharmacologic Therapy Background: Real-world data examining inclisiran use in US clinical practice are limited. We report a one-year experience with inclisiran in an academic lipid clinic. Methods: Retrospective chart review of patients prescribed inclisiran since FDA approval in December 2021. Results: 80 patients were prescribed inclisiran over 14 months (Table). Inclisiran was approved by insurance for 70 (88%) and denied for 10 (12%). 48 (60%) could not tolerate any statin as background lipid-lowering therapy (LLT). All patients with Medicare received approval for inclisiran, compared to 12 of 22 (55%) of non-Medicare patients. Approved patients were older (71±8 vs 59±15 years, p=0.004), disproportionately Medicare enrollees (83%, p<0.001), more had ASCVD (69% vs 31%, p=0.031), less had HeFH (20% vs 80%, p=0.013), and fewer were on statins as background LLT (33% vs 67%, p=0.035).61 of 70 (87%) patients with approval have received at least one dose of inclisiran (19 received one dose, 37 received two, 5 have received three). 3 (5%) reported side-effects (1 injection site pain, 1 fever, 1 paresthesia and swelling in extremity leading to discontinuation).Using most recent LDL-C measured at least 30 days after first dose of inclisiran (n=38, 6 received one dose, 27 received two, 5 have received three), mean LDL-C decreased from 121±56 mg/dL to 85±55 mg/dL (-21%, p=0.003). Among the 25 patients who did not switch from a PCSK9i mAb (n=9) or stop their background LLT (n=5), LDL-C decreased from 139±44 mg/dL to 72±30 mg/dL (-49%, p<0.001) (Figure). LDL-C reduction differed by background PCSK9i mAb use (p<0.001) and discontinuation of background LLT (p=0.003), but not by sex, history of ASCVD or HeFH, background statin use, or number of inclisiran injections received. Conclusions: During the initial 14 months of prescribing inclisiran, 100% of patients on Medicare obtained insurance approval compared to roughly half of those with non-Medicare insurance who were younger and more likely to have HeFH. Among patients who had follow-up LDL-C, did not discontinue background LLT, and were not transitioning to inclisiran from a PCSK9i mAb, we observed LDL-C reductions of ∼50% which is similar in magnitude to those observed in clinical trials with inclisiran.http://www.sciencedirect.com/science/article/pii/S2666667723001083 |
| spellingShingle | Tommy T. Chiou, BA Kimberly Tomasi, RN, BSN Pam R. Taub, MD Michael J. Wilkinson, MD ONE YEAR EXPERIENCE WITH INCLISIRAN IN AN ACADEMIC LIPID CLINIC: American Journal of Preventive Cardiology |
| title | ONE YEAR EXPERIENCE WITH INCLISIRAN IN AN ACADEMIC LIPID CLINIC: |
| title_full | ONE YEAR EXPERIENCE WITH INCLISIRAN IN AN ACADEMIC LIPID CLINIC: |
| title_fullStr | ONE YEAR EXPERIENCE WITH INCLISIRAN IN AN ACADEMIC LIPID CLINIC: |
| title_full_unstemmed | ONE YEAR EXPERIENCE WITH INCLISIRAN IN AN ACADEMIC LIPID CLINIC: |
| title_short | ONE YEAR EXPERIENCE WITH INCLISIRAN IN AN ACADEMIC LIPID CLINIC: |
| title_sort | one year experience with inclisiran in an academic lipid clinic |
| url | http://www.sciencedirect.com/science/article/pii/S2666667723001083 |
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