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1.
Int J Cardiol ; 397: 131613, 2024 Feb 15.
Article in English | MEDLINE | ID: mdl-38030039

ABSTRACT

BACKGROUND: Heart failure is a major cause of morbidity and mortality among older adults. Sacubitril-Valsartan (Sac/Val) has been shown to improve patients' outcomes; however, its safety profile among older adults has not been adequately examined. We therefore aimed to examine its safety profile among this population. METHODS: We conducted a retrospective pharmacovigilance study utilizing the FDA's database of safety reports (FAERS). We employed disproportionality analysis comparing Sac/Val to angiotensin receptor blockers (ARBs). We aim to evaluate the reporting of pre-defined adverse events associated with Sac/Val (hypotension, acute kidney injury (AKI), hyperkalemia and angioedema) in two age groups: adults (< 75 years) and older adults (≥ 75). For each subgroup, we calculated reporting odds ratio (ROR) and compared them by calculating P for interaction. RESULTS: The FAERS database encompassed 18,432 unique reports of Sac/Val. Of them, 12,630 (68.5%) subjects were adults (< 75 years), and 5802 (31.5%) were older adults (≥ 75 years), with a median age (IQR) of 68 (59-77). When compared to ARBs, Sac/Val was associated with higher reporting of hypotension, lower reporting of acute kidney injury (AKI) and hyperkalemia, and similar reporting of angioedema. Notably, we did not observe a significant interaction between the age subgroups and the risk estimates (AKI: Pinteraction = 0.72, hyperkalemia: Pinteraction = 0.94, hypotension: Pinteraction = 0.31, and angioedema: Pinteraction = 0.61). CONCLUSIONS: In this postmarking study, none of the prespecified adverse events was reported more frequently in older adults. These findings provide reassurance for safety use of Sac/Val in older adults.


Subject(s)
Acute Kidney Injury , Angioedema , Heart Failure , Hyperkalemia , Hypotension , Humans , Aged , Retrospective Studies , Tetrazoles/adverse effects , Angiotensin Receptor Antagonists/adverse effects , Pharmacovigilance , Hyperkalemia/chemically induced , Hyperkalemia/diagnosis , Hyperkalemia/epidemiology , Angiotensin-Converting Enzyme Inhibitors , Valsartan/adverse effects , Aminobutyrates/adverse effects , Biphenyl Compounds/adverse effects , Heart Failure/epidemiology , Heart Failure/chemically induced , Drug Combinations , Hypotension/chemically induced , Hypotension/diagnosis , Hypotension/epidemiology , Angioedema/chemically induced , Angioedema/diagnosis , Angioedema/epidemiology , Acute Kidney Injury/chemically induced , Acute Kidney Injury/diagnosis , Acute Kidney Injury/epidemiology , Stroke Volume
2.
J Investig Med ; 69(8): 1404-1410, 2021 12.
Article in English | MEDLINE | ID: mdl-34353884

ABSTRACT

Direct oral anticoagulants (DOACs) have become the treatment of choice in thromboembolism prophylaxis for non-valvular atrial fibrillation, surpassing warfarin. While interruption of DOAC therapy for various reasons is a common eventuality, the body of data from real-world clinical practice on the implications of such interruptions in different clinical settings is still limited. We assessed complication rates from DOAC (apixaban, rivaroxaban, dabigatran) interruption compared with warfarin in hospitalized patients. We performed a retrospective cohort analysis of electronic records of patients hospitalized in Rabin Medical Center between 2010 and 2017. Incidents of anticoagulation interruptions for various reasons (including unintended interruptions) were collected. DOAC-treated patients were excluded if they reported non-compliance, and warfarin-treated patients were excluded if their international normalized ratio measurement on admission was subtherapeutic. Outcomes included ischemic stroke, systemic thromboembolism, myocardial infarction, and all-cause mortality within 90 days of anticoagulation interruption. The median CHA2DS2-VASc score was 5.0 (IQR 4.0-6.0) in both treatment groups. The associated risk of stroke, thromboembolic complications, myocardial infarction, and all-cause mortality after interruption of anticoagulation was not significantly different between the 2 treatment groups. Selective comparison of patients who were well balanced on warfarin before treatment interruption to DOAC-treated patients did not significantly influence the outcomes. This study did not find a significant difference in the complication rate after interruption of DOAC therapy compared with interruption of warfarin therapy in hospitalized patients with a high risk of thromboembolism.


Subject(s)
Atrial Fibrillation , Myocardial Infarction , Stroke , Thromboembolism , Administration, Oral , Anticoagulants/adverse effects , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Cohort Studies , Hemorrhage/drug therapy , Humans , Retrospective Studies , Stroke/drug therapy , Thromboembolism/drug therapy , Thromboembolism/prevention & control , Warfarin/adverse effects
3.
Am J Hum Genet ; 72(3): 739-48, 2003 Mar.
Article in English | MEDLINE | ID: mdl-12574987

ABSTRACT

The genomic evolution and causes of phenotypic variation among humans and great apes remain largely unknown, although the phylogenetic relationships among them have been extensively explored. Previous studies that focus on differences at the amino acid and nucleotide sequence levels have revealed a high degree of similarity between humans and chimpanzees, suggesting that other types of genomic change may have contributed to the relatively large phenotypic differences between them. For example, the activity of long interspersed element 1 (LINE-1) retrotransposons may impose significant changes on genomic structure and function and, consequently, on phenotype. Here we investigate the relative rates of LINE-1 amplification in the lineages leading to humans, bonobos (Pan paniscus), and chimpanzees (P. troglodytes). Our data indicate that LINE-1 insertions have accumulated at significantly greater rates in bonobos and chimpanzees than in humans, provide insights into the timing of major LINE-1 amplification events during great ape evolution, and identify a Pan-specific LINE-1 subfamily.


Subject(s)
Long Interspersed Nucleotide Elements/genetics , Pan troglodytes/genetics , Animals , Base Sequence , Chromosome Mapping , Gene Amplification , Humans , Molecular Sequence Data , Phylogeny , Species Specificity
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