scholarly journals Risk Factors for Major Adverse Cardiovascular Events in Phase III and Long‐Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis

2019 ◽  
Vol 71 (9) ◽  
pp. 1450-1459 ◽  
Author(s):  
Christina Charles‐Schoeman ◽  
Ryan DeMasi ◽  
Hernan Valdez ◽  
Koshika Soma ◽  
Lie‐Ju Hwang ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Risk Factors ◽  
Cardiovascular Events ◽  
Phase Iii ◽  
Major Adverse Cardiovascular Events

scholarly journals Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database

2021 ◽  
pp. annrheumdis-2021-221276
Author(s):  
Peter C Taylor ◽  
Tsutomu Takeuchi ◽  
Gerd R Burmester ◽  
Patrick Durez ◽  
Josef S Smolen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Kinase Inhibitor ◽  
Incidence Rates ◽  
Janus Kinase ◽  
Phase Iii ◽  
Major Adverse Cardiovascular Events ◽  
Integrated Analysis ◽  
Link Type ◽  
Serious Infections

ObjectiveTo report long-term safety from the completed extension trial of baricitinib, an oral selective Janus kinase inhibitor, in patients with active rheumatoid arthritis (RA).MethodsTreatment-emergent adverse events are summarised from an integrated database (9 phase III/II/Ib and 1 long-term extension) of patients who received any baricitinib dose (All-bari-RA). Standardised incidence ratio (SIR) for malignancy (excluding non-melanoma skin cancer (NMSC)) and standardised mortality ratio (SMR) were estimated. Additional analysis was done in a subset of patients who had ever taken 2 mg or 4 mg baricitinib.Results3770 patients received baricitinib (14 744 patient-years of exposure (PYE)). All-bari-RA incidence rates (IRs) per 100 patient-years at risk were 2.6, 3.0 and 0.5 for serious infections, herpes zoster and major adverse cardiovascular events (MACE), respectively. In patients aged ≥50 with ≥1 cardiovascular risk factor, the IR for MACE was 0.77 (95% CI 0.56 to 1.04). The IR for malignancy (excluding NMSC) during the first 48 weeks was 0.6 and remained stable thereafter (IR 1.0). The SIR for malignancies excluding NMSC was 1.07 (95% CI 0.90 to 1.26) and the SMR was 0.74 (95% CI 0.59 to 0.92). All-bari-RA IRs for deep vein thrombosis (DVT)/pulmonary embolism (PE), DVT and PE were 0.5 (95% CI 0.38 to 0.61), 0.4 (95% CI 0.26 to 0.45) and 0.3 (95% CI 0.18 to 0.35), respectively. No clear dose differences were noted for exposure-adjusted IRs (per 100 PYE) for deaths, serious infections, DVT/PE and MACE.ConclusionsIn this integrated analysis including long-term data of baricitinib from 3770 patients (median 4.6 years, up to 9.3 years) with active RA, baricitinib maintained a similar safety profile to earlier analyses. No new safety signals were identified.Trial registration numberNCT01185353, NCT00902486, NCT01469013, NCT01710358, NCT02265705, NCT01721044, NCT01721057, NCT01711359 and NCT01885078.

scholarly journals POS1015 ANTI-TNF DRUGS AND CARDIOVASCULAR EVENTS IN PATIENTS WITH SPONDYLOARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 775.2-776
Author(s):  
C. W. S. Chan ◽  
P. H. LI ◽  
C. S. Lau ◽  
H. Y. Chung
Keyword(s):  
Risk Factors ◽  
Psoriatic Arthritis ◽  
Cardiovascular Events ◽  
Clinical Information ◽  
Incidence Rates ◽  
Major Adverse Cardiovascular Events ◽  
Cross Sectional ◽  
Cerebrovascular Events ◽  
Cardiovascular Morbidity And Mortality

Background:Cardiovascular (CVS) diseases are the leading cause of death worldwide and patients with rheumatic diseases have an increased CVS risk including stroke and myocardial infarction (MI) (1-3). CVS risk factors and CVS events are common in SpA (4). Delineating the CVS risk and the association with medications in patients with SpA would be useful.Objectives:The objective of this study was to delineate the CVS risk and the association with medications in patients with SpA.Methods:Patients with SpA and patients with non-specific back pain (NSBP) were identified in rheumatology and orthopedics clinics respectively. Clinical information and CVS events were retrieved. Incidence rates were calculated. Association analysis was performed to determine the CVS risk of SpA and other modifiable risk factors.Results:A total of 5046 patients (SpA 2616 and NSBP 2430) were included from eight centers. Over 56 484 person-years of follow-up, 160 strokes, 84 MI and 262 major adverse cardiovascular events (MACE) were identified. Hypercholesterolemia was more prevalent in SpA (SpA 34.2%, NSBP 28.7%, P<0.01). Crude incidence rates of stroke and MI were higher in SpA patients. SpA was associated with a higher risk of MACE (HR 1.66, 95%CI 1.22-2.27, P<0.01) and cerebrovascular events (HR 1.42, 95%CI 1.01-2.00, p=0.04). The use of anti-tumor necrosis factor (TNF) drugs was associated with a reduced risk of MACE (HR 0.37, 95%CI 0.17-0.80, P=0.01) and cerebrovascular events (HR 0.21, 95%CI 0.06-0.78, P=0.02).Conclusion:SpA is an independent CVS risk factor. Anti-TNF drugs were associated with a reduced CVS risk in these patients.References:[1]Crowson CS, Liao KP, Davis JM, 3rd, Solomon DH, Matteson EL, Knutson KL, et al. Rheumatoid arthritis and cardiovascular disease. Am Heart J. 2013;166(4):622-8 e1.[2]Verhoeven F, Prati C, Demougeot C, Wendling D. Cardiovascular risk in psoriatic arthritis, a narrative review. Joint Bone Spine. 2020;87(5):413-8.[3]Liew JW, Ramiro S, Gensler LS. Cardiovascular morbidity and mortality in ankylosing spondylitis and psoriatic arthritis. Best Pract Res Clin Rheumatol. 2018;32(3):369-89.[4]Molto A, Etcheto A, van der Heijde D, Landewe R, van den Bosch F, Bautista Molano W, et al. Prevalence of comorbidities and evaluation of their screening in spondyloarthritis: results of the international cross-sectional ASAS-COMOSPA study. Ann Rheum Dis. 2016;75(6):1016-23.Disclosure of Interests:None declared.

scholarly journals Risk factors for major adverse cardiovascular events after the first acute coronary syndrome

2021 ◽  
Vol 53 (1) ◽  
pp. 817-823
Author(s):  
Marjo Okkonen ◽  
Aki S. Havulinna ◽  
Olavi Ukkola ◽  
Heikki Huikuri ◽  
Arto Pietilä ◽  
...  
Keyword(s):  
Risk Factors ◽  
Acute Coronary Syndrome ◽  
Cardiovascular Events ◽  
Major Adverse Cardiovascular Events ◽  
Coronary Syndrome

P6424The association between long-term beta-blocker use and outcome in a contemporary large-scale cohort of patients with acute myocardial infarction

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C X Song ◽  
R Fu ◽  
J G Yang ◽  
K F Dou ◽  
Y J Yang
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Beta Blocker ◽  
Cardiovascular Events ◽  
Beta Blockers ◽  
Left Ventricular Ejection ◽  
Major Adverse Cardiovascular Events ◽  
Baseline Characteristics

Abstract Background Controversy exists regarding the use of beta-blockers (BBs) among patients with acute myocardial infarction (AMI) in contemporary reperfusion era. Previous studies predominantly focused on beta-blockers prescribed at discharge, and the effect of long-term adherence to beta-blocker on major adverse cardiovascular events (MACE) remains unclear. Objective To explore the association between long-term beta-blocker use patterns and MACE among contemporary AMI patients. Methods We enrolled 7860 patients with AMI, who were discharged alive and prescribed with BBs based on CAMI registry from January 2013 to September 2014. Patients were divided into two groups according to BBs use pattern: Always users group (n=4476) were defined as patients reporting BBs use at both 6- and 12-month follow-up; Inconsistent users group were defined as patients reporting at least once not using BBs at 6- or 12-month follow-up. Primary outcome was defined as MACE at 24-month follow-up, including all-cause death, non-fatal MI and repeat-revascularization. Multivariable cox proportional hazards regression model was used to assess the association between BBs and MACE. Results Baseline characteristics are shown in table 1. At 2-year follow-up, 518 patients in inconsistent users group (15.6%) and 548 patients in always users group (12.3%) had MACE. After multivariable adjustment, inconsistent use of BBs was associated with higher risk of MACE (HR: 1.323, 95% CI: 1.171–1.493, p<0.001). Table 1 Baseline characteristics Variable Always user (N=4476) Inconsistent user (N=3384) P value Age (years) 60.6±12.0 61.2±12.2 <0.001 Male 3381 (75.7%) 2461 (74.3%) 0.084 Diabetes 892 (20.0%) 610 (18.4%) 0.003 Hypertension 2372 (53.2%) 1543 (46.6%) <0.001 Dyslipidemia 244 (5.5%) 126 (3.8%) <0.001 Prior myocardial infarction 351 (7.9%) 232 (7.0%) <0.001 Heart failure 88 (2.0%) 63 (1.9%) <0.001 Chronic obstructive pulmonary disease 66 (1.5%) 60 (1.8%) <0.001 Current smoker 2054 (46.1%) 1579 (47.8%) 0.179 Left ventricular ejection fraction (%) 53.7±11.48 54.0±10.9 <0.001 Major Adverse Cardiovascular Events 548 (12.3%) 518 (15.6%) <0.001 Conclusions Our results showed consistent BBs use was associated with reduced risk of MACE among patients with AMI managed by contemporary treatment. Acknowledgement/Funding CAMS Innovation Fund for Medical Sciences (CIFMS) (2016-I2M-1-009)

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