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Page 1
Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol.
Ray KK, Wright RS, Kallend D, Koenig W, Leiter LA, Raal FJ, Bisch JA, Richardson T, Jaros M, Wijngaard PLJ, Kastelein JJP; ORION-10 and ORION-11 Investigators. Ray KK, et al. N Engl J Med. 2020 Apr 16;382(16):1507-1519. doi: 10.1056/NEJMoa1912387. Epub 2020 Mar 18. N Engl J Med. 2020. PMID: 32187462 Free article. Clinical Trial.
RESULTS: A total of 1561 and 1617 patients underwent randomization in the ORION-10 and ORION-11 trials, respectively. Mean (SD) LDL cholesterol levels at baseline were 104.738.3 mg per deciliter (2.710.99 mmol per liter) and 105.539.1 mg per deciliter (2.731.01 mmol …
RESULTS: A total of 1561 and 1617 patients underwent randomization in the ORION-10 and ORION-11 trials, respectively. Mean (SD …
Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial.
Ray KK, Troquay RPT, Visseren FLJ, Leiter LA, Scott Wright R, Vikarunnessa S, Talloczy Z, Zang X, Maheux P, Lesogor A, Landmesser U. Ray KK, et al. Lancet Diabetes Endocrinol. 2023 Feb;11(2):109-119. doi: 10.1016/S2213-8587(22)00353-9. Epub 2023 Jan 5. Lancet Diabetes Endocrinol. 2023. PMID: 36620965 Free article. Clinical Trial.
The aim of this study was to assess the effect of long-term dosing of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol. METHODS: ORION-3 was a 4-year open-label extension study of the placebo-controlled, phase 2 ORION-1 trial, conduc …
The aim of this study was to assess the effect of long-term dosing of inclisiran in patients with high cardiovascular risk and elevated LDL …
Analgesia and sedation in patients with ARDS.
Chanques G, Constantin JM, Devlin JW, Ely EW, Fraser GL, Gélinas C, Girard TD, Guérin C, Jabaudon M, Jaber S, Mehta S, Langer T, Murray MJ, Pandharipande P, Patel B, Payen JF, Puntillo K, Rochwerg B, Shehabi Y, Strøm T, Olsen HT, Kress JP. Chanques G, et al. Intensive Care Med. 2020 Dec;46(12):2342-2356. doi: 10.1007/s00134-020-06307-9. Epub 2020 Nov 10. Intensive Care Med. 2020. PMID: 33170331 Free PMC article. Review.
Updates in Small Interfering RNA for the Treatment of Dyslipidemias.
Carugo S, Sirtori CR, Gelpi G, Corsini A, Tokgozoglu L, Ruscica M. Carugo S, et al. Curr Atheroscler Rep. 2023 Nov;25(11):805-817. doi: 10.1007/s11883-023-01156-5. Epub 2023 Oct 4. Curr Atheroscler Rep. 2023. PMID: 37792132 Free PMC article. Review.
RECENT FINDINGS: The safety and efficacy of LDL-C lowering with the siRNA inclisiran has been documented in the open-label ORION-3 trial, with a follow-up of 4 years. While the outcome trial is pending, a pooled analysis of ORION-9, ORION-10, and ORION …
RECENT FINDINGS: The safety and efficacy of LDL-C lowering with the siRNA inclisiran has been documented in the open-label ORION-3 tr …
An update on inclisiran for the treatment of elevated LDL cholesterol.
Barkas F, Ray K. Barkas F, et al. Expert Opin Pharmacother. 2024 Mar;25(4):349-358. doi: 10.1080/14656566.2024.2337253. Epub 2024 Apr 8. Expert Opin Pharmacother. 2024. PMID: 38549399 Review.
Clinical trials, including pivotal phase-III placebo-controlled studies (ORION-9, -10, -11), the open-label ORION-3 and pooled safety analysis of these trails including the open-label phase of ORION-8, as well as real-word data are discussed to provide a comp …
Clinical trials, including pivotal phase-III placebo-controlled studies (ORION-9, -10, -11), the open-label ORION-3 and pooled …
Effects of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Inclisiran: An Analysis of the ORION-7 and ORION-1 Studies.
Wright RS, Collins MG, Stoekenbroek RM, Robson R, Wijngaard PLJ, Landmesser U, Leiter LA, Kastelein JJP, Ray KK, Kallend D. Wright RS, et al. Mayo Clin Proc. 2020 Jan;95(1):77-89. doi: 10.1016/j.mayocp.2019.08.021. Epub 2019 Oct 17. Mayo Clin Proc. 2020. PMID: 31630870 Clinical Trial.
PATIENTS AND METHODS: The analysis included participants with normal renal function and mild, moderate, and severe RI from the phase 1 ORION-7 renal study (n=31) and the phase 2 ORION-1 study (n=247) who received 300 mg of inclisiran sodium or placebo. RESULTS: In …
PATIENTS AND METHODS: The analysis included participants with normal renal function and mild, moderate, and severe RI from the phase 1 OR …
Efficacy and Safety of Inclisiran in Asian Patients: Results From ORION-18.
Huo Y, Lesogor A, Lee CW, Chiang CE, Mena-Madrazo J, Poh KK, Jeong MH, Maheux P, Zhang M, Wei S, Han Y, Li Y. Huo Y, et al. JACC Asia. 2023 Nov 14;4(2):123-134. doi: 10.1016/j.jacasi.2023.09.006. eCollection 2024 Feb. JACC Asia. 2023. PMID: 38371290 Free PMC article.
OBJECTIVES: The authors sought to evaluate the efficacy and safety of inclisiran in Asian patients with atherosclerotic cardiovascular disease (ASCVD) or high risk of ASCVD, as an adjunct to diet and maximally tolerated statin dose, with or without additional LLTs. METHODS: The …
OBJECTIVES: The authors sought to evaluate the efficacy and safety of inclisiran in Asian patients with atherosclerotic cardiovascular disea …
Plain language summary of results from ORION-10 and ORION-11: two studies to learn how well inclisiran works in people with high cholesterol.
Ray KK, Wright RS. Ray KK, et al. Future Cardiol. 2023 Mar;19(4):175-184. doi: 10.2217/fca-2022-0133. Epub 2023 Jun 6. Future Cardiol. 2023. PMID: 37282500 Review.
WHAT HAPPENED DURING THE ORION-10 AND ORION-11 STUDIES? In the ORION-10 and ORION-11 studies, around half of the participants received inclisiran and around half received a placebo (a placebo looks like the study treatment but has no medicine in it) in …
WHAT HAPPENED DURING THE ORION-10 AND ORION-11 STUDIES? In the ORION-10 and ORION-11 studies, around half of the …
From clinical development to real-world outcomes with inclisiran.
Connolly DL, Sharma V, Ray KK. Connolly DL, et al. Curr Opin Lipidol. 2024 Dec 1;35(6):281-289. doi: 10.1097/MOL.0000000000000954. Epub 2024 Sep 27. Curr Opin Lipidol. 2024. PMID: 39331729 Review.
SUMMARY: Inclisiran has been evaluated in numerous trials, primarily the ORION 9 26 , ORION 10 27 and ORION 11 28 studies, which demonstrated that in patients already on maximally tolerated statin therapy, biannual inclisiran injections reduced LDL cholestero …
SUMMARY: Inclisiran has been evaluated in numerous trials, primarily the ORION 9 26 , ORION 10 27 and ORION 11 28 studi …
Effects of Inclisiran in Patients With Atherosclerotic Cardiovascular Disease: A Pooled Analysis of the ORION-10 and ORION-11 Randomized Trials.
Wright RS, Ray KK, Landmesser U, Koenig W, Raal FJ, Leiter LA, Conde LG, Han J, Schwartz GG. Wright RS, et al. Mayo Clin Proc. 2024 Jul 5:S0025-6196(24)00167-8. doi: 10.1016/j.mayocp.2024.03.025. Online ahead of print. Mayo Clin Proc. 2024. PMID: 39093262 Free article.
OBJECTIVE: To evaluate the efficacy, safety, and tolerability of inclisiran in participants with atherosclerotic cardiovascular disease (ASCVD) from ORION-10 and ORION-11 stratified by key patient characteristics. PATIENTS AND METHODS: Participants were randomized 1 …
OBJECTIVE: To evaluate the efficacy, safety, and tolerability of inclisiran in participants with atherosclerotic cardiovascular disease (ASC …
6,026 results