Details

Autor(en) / Beteiligte

• Wright, R Scott S
• Ray, Kausik K
• Raal, Frederick J
• Kallend, David
• Jaros, Mark
• Koenig, Wolfgang
• Leiter, Lawrence A
• Landmesser, Ulf E
• Schwartz, Gregory G
• Wijngaard, Peter
• Kastelein, John J

Titel

Abstract 16427: Efficacy and Safety of Inclisiran According to Age: A Pooled Analysis of Phase III Studies (ORION 9, 10 and 11)

Ist Teil von

• Circulation (New York, N.Y.), 2020-11, Vol.142 (Suppl_3 Suppl 3), p.A16427-A16427

Ort / Verlag

by the American College of Cardiology Foundation and the American Heart Association, Inc

Erscheinungsjahr

2020

Link zum Volltext

Quelle

Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals

Beschreibungen/Notizen

• IntroductionThe risk of major atherosclerotic CV events increases with age, as do comorbidities, polypharmacy, and greater vulnerability to adverse drug reactions/events, posing challenges in the treatment of dyslipidemia. Three Phase III placebo-controlled trials evaluated the efficacy and safety of inclisiran according to age.ObjectiveTo assess the efficacy and safety of inclisiran in patients across age categories.MethodsPatients were categorized according to age<65 years (not old), ≥65 and <75 years (old), or ≥75 years (very old). The co-primary endpoints were percentage change in LDL-C from baseline to Day 510 and time-adjusted percentage change from baseline after Day 90 up to Day 540. Efficacy and safety parameters were assessed over 18 months.ResultsOf a total 3660 patients, 1737 [47.5%] were not old, 1431 [39.1%] were old, and 492 [13.4%] were very old. At baseline, the prevalence of comorbidities increased with age (not old, old, very old)stage 3 CKD (8.4%, 19.9%, 31.2%), hypertension (72.9%, 85.2%, 88.1%) and diabetes mellitus (32.2%, 40.0%, 38.0%), respectively. The placebo-corrected percentage change in LDL-C with inclisiran was similar across all agesfrom baseline to Day 510 [–51.3% (not old), –49.9% (old), –51.0% (very old); P<0.0001 for all] and time-adjusted from baseline to Day 90 up to Day 540 [–49.6% (not old), –51.5% (old), –50.8% (very old); P<0.0001 for all]. Overall AE and SAE rates increased with age and were similar between both treatment arms in all groups, except for injection-site reactions that were higher with inclisiran vs placebo across all ages, and were more frequent in not old patients. CK levels >5x ULN were more frequently elevated in the not old category (Table).ConclusionInclisiran lowered LDL-C similarly across all ages with an acceptable safety profile. Inclisiran added to maximally tolerated statin therapy could be a safe option for older patients with ASCVD who need more intensive lipid-lowering treatment.