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INTRODUCTION AND OBJECTIVES: Clinical data for older patients with advanced liver disease are limited. This post hoc analysis evaluated the efficacy and safety of terlipressin in patients aged ≥65 years with hepatorenal syndrome using data from 3 Phase III, randomized, placebo-controlled studies (OT-0401, REVERSE, CONFIRM). PATIENTS AND METHODS: The pooled population of patients aged ≥65 years (terlipressin, n = 54; placebo, n = 36) was evaluated for hepatorenal syndrome reversal-defined as a serum creatinine level ≤1.5 mg/dL (≤132.6 µmol/L) while receiving terlipressin or placebo, without renal replacement therapy, liver transplantation, or death-and the incidence of renal replacement therapy (RRT). Safety analyses included an assessment of adverse events. RESULTS: Hepatorenal syndrome reversal was almost 2-times higher in terlipressin-treated patients compared with patients who received placebo (31.5% vs 16.7%; P = 0.143). Among surviving patients, the need for RRT was significantly reduced in the terlipressin group, with an almost 3-times lower incidence of RRT versus the placebo group (Day 90: 25.0% vs 70.6%; P = 0.005). Among 23 liver-transplant-listed patients, significantly fewer patients in the terlipressin versus placebo group needed RRT by Days 30 and 60 (P = 0.027 each). Fewer patients in the terlipressin group needed RRT post-transplant (P = 0.011). More terlipressin-treated patients who were listed for and received a liver transplant were alive and RRT-free by Day 90. No new safety signals were revealed in the older subpopulation compared with previously published data. CONCLUSIONS: Terlipressin therapy may lead to clinical improvements in highly vulnerable patients aged ≥65 years with hepatorenal syndrome. CLINICAL TRIAL NUMBERS: OT-0401, NCT00089570; REVERSE, NCT01143246; CONFIRM, NCT02770716.
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Síndrome Hepatorrenal , Vasoconstritores , Humanos , Terlipressina/efeitos adversos , Vasoconstritores/efeitos adversos , Síndrome Hepatorrenal/diagnóstico , Síndrome Hepatorrenal/tratamento farmacológico , Lipressina/efeitos adversos , Albuminas/efeitos adversos , Resultado do TratamentoRESUMO
INTRODUCTION: Renal biopsy is an integral part of clinical nephrology practice that helps in the diagnosis of various renal diseases. Across the globe, it is performed by nephrologists and/or surgeons under ultrasound guidance. Lately, this novel procedure has been performed more frequently by the interventional radiologist (IR) as compared to nephrologists and surgeons. METHODS: We completed a retrospective review of 378 consecutive renal biopsies performed at our university hospital in the city center of Philadelphia, Pennsylvania, between September 2008 and June 2011 for various indications. Baseline characteristics were comparable except systolic blood pressure (SBP), prothrombin time (PT), and international normalized ratio (INR) which was higher. Hemoglobin was lower in patients who underwent biopsy by the IR compared to those who were biopsied by nephrologists and/or surgeons. RESULTS: The primary outcome showed the average number of glomeruli obtained with each biopsy was significantly lower by nephrology or surgical teams, 9.09 ± 5.17 vs. 19.17 ± 11.11 obtained by the interventional radiology team, p-value <0.0001. The number of cores obtained with each biopsy was significantly lower by nephrologist or surgeon at the bedside, 1.57 ± 1.05 vs. 2.42 ± 1.26, p-value <0.0001. The average number of attempts to obtain one core was 2.00 ± 1.10 vs. 2.60 ± 1.17 by nephrologist and surgeon vs. IR, respectively, p-value <0.0001. CONCLUSION: Our study clearly shows the superior success of renal biopsy by the IR as compared to the nephrology and surgical teams. This calls for more robust training of nephrology fellows and surgery residents to obtain the renal biopsy to prevent the loss of this unique procedure skill by non-radiology clinicians.