Archives

  • 2026-07
  • 2026-06
  • 2026-05
  • 2026-04
  • 2026-03
  • 2026-02
  • 2026-01
  • 2025-12
  • 2025-11
  • 2025-10
  • 2025-09
  • 2025-03
  • 2025-02
  • 2025-01
  • 2024-12
  • 2024-11
  • 2024-10
  • 2024-09
  • 2024-08
  • 2024-07
  • 2024-06
  • 2024-05
  • 2024-04
  • 2024-03
  • 2024-02
  • 2024-01
  • 2023-12
  • 2023-11
  • 2023-10
  • 2023-09
  • 2023-08
  • 2023-06
  • 2023-05
  • 2023-04
  • 2023-03
  • 2023-02
  • 2023-01
  • 2022-12
  • 2022-11
  • 2022-10
  • 2022-09
  • 2022-08
  • 2022-07
  • 2022-06
  • 2022-05
  • 2022-04
  • 2022-03
  • 2022-02
  • 2022-01
  • 2021-12
  • 2021-11
  • 2021-10
  • 2021-09
  • 2021-08
  • 2021-07
  • 2021-06
  • 2021-05
  • 2021-04
  • 2021-03
  • 2021-02
  • 2021-01
  • 2020-12
  • 2020-11
  • 2020-10
  • 2020-09
  • 2020-08
  • 2020-07
  • 2020-06
  • 2020-05
  • 2020-04
  • 2020-03
  • 2020-02
  • 2020-01
  • 2019-12
  • 2019-11
  • 2019-10
  • 2019-09
  • 2019-08
  • 2019-07
  • 2019-06
  • 2019-05
  • 2019-04
  • 2018-11
  • 2018-10
  • 2018-07

    • In this issue of Proietti and

    2018-10-23

    In this brucine issue of , Proietti and colleagues () analyzed pooled datasets (n=3646) from SPORTIF III and V trials of warfarin-treated patients dependent on renal function. Diminished creatinine clearance (<60ml/min) was reported in 952 (26%) patients. Overall, the time in therapeutic range (TTR) was higher in patients with normal renal function compared to those with RI (p<0.001). By logistic regression, chronic atrial fibrillation and male gender were associated with TTR>70%, whilst diabetes mellitus, aspirin use and RI were inversely associated with TTR>70%. On Cox analysis, RI was an independent predictor for stroke (p=0.006) and death (p<0.001); while TTR>70% was independently associated with a lower risk of stroke (p=0.024), death (p=0.001) and major bleeding (p=0.001). The combined SPORTIF warfarin data suggest that RI is highly prevalent among patients with atrial fibrillation, being a risk factor for stroke and death. Adjusting for RI, good quality anticoagulation control (TTR>70%) was an independent predictor for lower risks of stroke, death and major bleeding. There are few important considerations yielded from these latest elegant data. Importantly, patients with even mild RI experience much more frequent vascular thrombotic events than patients with normal kidney function. The index data are in full agreement that despite huge differences among the trials with regard to exclusions, baseline characteristics, randomization or enrollment patterns, and length of follow up, RI patients have consistently higher risks to experience primary vascular endpoint event despite even a very liberal eGRF or creatinine clearance of <60ml/min cut-off to triage RI cohorts. Also, the RI patients experience much more frequent bleeding events, especially those with non-adjusted TTR. These two disturbing findings raise obvious concerns that we may consider OAC dose/regimen downgrades in such patients, the strategy which is currently not recommended by the regulatory agencies. The problem is that RI patients constitute no >10–15% of the entire trial pool generating woefully small dataset(s) for each particular OAC. Dichotomizing patients further into severe, mild, or moderate RI, make such groups very small, usually in double-digit numbers hence preventing quality analyses. These circumstances allow the regulatory authorities to ignore such obvious shortcomings, or/and demand unbiased risk assessment in RI patients receiving OAC. Indeed, the fact that patients exhibited such poor outcomes in RI, () we should consider the advantage of non-Vitamin K antagonist oral anticoagulants (NOACs) over warfarin. Indeed, there is some evidence () that NOACs may be superior to warfarin causing less bleeding complications. However, all OAC mega trials suffer from massive double-digit incomplete follow-up rates, challenging the quality of the analyzed datasets (). Overall, the current knowledge suggests no single superior OAC choice with regard to their safety and efficacy in patients with RI (). Further comparative randomized studies of different OACs in patients with moderate and severe RI are urgently needed. Disclosure
    Background In this issue of EBioMedicine, Roerecke and Colleagues report that, in Japan, alcohol consumption as low as <20g daily was associated with significant protection from incident and prevalent fatty liver; however, no such association was found in countries other than Japan (Roerecke et al., 2016). This systematic review is based on the analysis of 18 articles (11 of which are from Japan) which recruited, overall, 99,370 participants, 25,662 of whom had steatosis.
    Steatosis Steatosis defines fatty changes either in >5% of hepatocytes based on histological analysis or >5.6% based on findings from proton magnetic resonance spectroscopy (EASL-EAS-EASO, 2016). Often, steatosis is diagnosed with ultrasonography both in clinical practice and in the research arena (Ballestri et al., 2015, 2016a). A large variety of causes, notably including alcohol consumption, may eventually be conducive to accumulation of intrahepatic fat (EASL-EAS-EASO, 2016). In recent years nonalcoholic fatty liver disease (NAFLD) has reached massive proportions worldwide and has an epidemic diffusion in certain high-risk groups. However, the rationale for distinguishing alcoholic from nonalcoholic fatty liver disease has been questioned based on shared clinico-pathological commonalities (Völzke, 2012).