Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update

Purpose Patients with polyvascular disease (PVD) are at very high cardiovascular risk and require intensive lipid-lowering therapy. This analysis describes the lipid-lowering efficacy and safety of inclisiran versus placebo in patients with and without PVD. Methods In this post hoc analysis of the ORION-9, ORION-10, and ORION-11 trials, patients were randomized 1:1 to receive 284 mg inclisiran (300 mg inclisiran sodium) or placebo on day 1, day 90, and 6-monthly thereafter. Percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to day 510 and corresponding time-adjusted change from day 90 and up to day 540 were evaluated per patients’ PVD status. Safety was assessed over 540 days. Results Of 3454 patients, 470 (13.6%) had PVD, and 2984 (86.4%) did not. Baseline characteristics were generally balanced between the treatment arms in both cohorts. A greater proportion of patients with PVD had comorbidities versus those without. The mean (95% confidence interval [CI]) placebo-corrected LDL-C percentage change from baseline to day 510 was −48.9% (−55.6 to −42.2) in patients with PVD and −51.5% (−53.9 to −49.1) in patients without. Proportions of patients with reported treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events were similar between treatment arms, irrespective of PVD status, except for an excess of mild or moderate clinically relevant TEAEs at the injection site with inclisiran. Conclusion Twice-yearly inclisiran dosing (after the initial and 3-month doses) was well tolerated and provided effective and sustained lipid-lowering in patients, irrespective of PVD status.

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Efficacy and Safety of Inclisiran in Patients with Polyvascular Disease: Pooled, Post Hoc Analysis of the ORION-9, ORION-10, and ORION-11 Phase 3 Randomized Controlled Trials

Köenig

Conde

Landmesser

et al. 2022

Cardiovasc Drugs Ther

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Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis

Wechsler,

Nair,

Terrier

et al. 2024

N Engl J Med

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Good Publication Practice (GPP) guidelines for company-sponsored biomedical research from the point of view of the diverse authors involved in its publication

Citrome,

DeTora,

Toroser

et al. 2024

Current Medical Research and Opinion

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Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update

Cited by 6 publications

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Efficacy and Safety of Inclisiran in Patients with Polyvascular Disease: Pooled, Post Hoc Analysis of the ORION-9, ORION-10, and ORION-11 Phase 3 Randomized Controlled Trials

Efficacy and Safety of Inclisiran in Patients with Polyvascular Disease: Pooled, Post Hoc Analysis of the ORION-9, ORION-10, and ORION-11 Phase 3 Randomized Controlled Trials

Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis

Good Publication Practice (GPP) guidelines for company-sponsored biomedical research from the point of view of the diverse authors involved in its publication

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