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Efficacy of vonoprazan against bleeding from endoscopic submucosal dissection-induced gastric ulcers under antithrombotic medication: A cross-design synthesis of randomized and observational studies.
Hidaka, Y, Imai, T, Inaba, T, Kagawa, T, Omae, K, Tanaka, S
PloS one. 2021;(12):e0261703
Abstract
Vonoprazan, a potassium-competitive acid blocker, is expected to be superior to proton pump inhibitors (PPIs) in preventing post-endoscopic submucosal dissection (ESD)-induced gastric bleeding. However, the results of randomized controlled trials (RCTs) and observational studies on the efficacy of vonoprazan have been inconsistent. This study aimed to evaluate the effectiveness of vonoprazan in antithrombotic drug users, a population that has been excluded from RCTs. Treatment effects were assessed using cross-design synthesis, which can be adjusted for differences in study design and patient characteristics. We used data from an RCT in Japan (70 patients in the vonoprazan group and 69 in the PPI group) and an observational study (408 patients in the vonoprazan group and 870 in the PPI group). After matching, among the antithrombotic drug users in the observational study, post-ESD bleeding was noted in 8 out of 86 patients in the vonoprazan group and 18 out of 86 patients in the PPI group. After pooling the data from the RCT and observational study, the risk difference for antithrombotic drug users was -14.6% (95% CI: -22.0 to -7.2). CDS analysis suggested that vonoprazan is more effective than PPIs in preventing post-ESD bleeding among patients administered antithrombotic medications.
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Effect of Vonoprazan on Delayed Bleeding after Endoscopic Submucosal Dissection for Gastric Neoplasia among Antithrombotic Drug Users: A Single-Center, Single-Arm Prospective Observational Case Control Study.
Yamamoto, S, Takayama, H, Shimodate, Y, Takezawa, R, Nishimura, N, Doi, A, Mouri, H, Matsueda, K, Mizuno, M, Okada, H
Acta medica Okayama. 2020;(3):245-250
Abstract
Antithrombotic therapy is a major risk factor for delayed bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasia. A potassium-competitive acid blocker, vonoprazan, is expected to prevent delayed bleeding better than conventional proton pomp inhibitors (PPIs), but the evidence is controversial. We sought to clarify the efficacy of vonoprazan for prevention of delayed bleeding after gastric ESD in patients under antithrombotic therapy. We prospectively registered 50 patients who underwent gastric ESD while receiving antithrombotic therapy and vonoprazan in our institution between October 2017 and September 2018. The incidence of delayed bleeding was compared with that in a historical control group of 116 patients treated with conventional PPI. We also evaluated risk factors associated with delayed bleeding. Delayed bleeding was observed in 8 of 50 patients (16.0%), which was not dissimilar from the incidence in the historical control group (12.1%) (p=0.49). In the univariate analysis, age (> 70 years) (p=0.034), multiple antithrombotic drug use (p<0.01), procedure time (> 200 min) (p=0.038) and tumor size (> 40 mm) (p<0.01) were associated with delayed bleeding after gastric ESD, but vonoprazan was not (p=0.49). Vonoprazan may not be more effective than conventional PPIs in preventing delayed bleeding after gastric ESD in patients receiving antithrombotic therapy.
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Practice variation in the re-initiation of dofetilide: An observational study.
Turagam, MK, Afzal, MR, Reddy, M, Pillarisetti, J, Lavu, M, Atkins, D, Jeffrey, C, Christensen, K, Pimentel, R, Dendi, R, et al
International journal of cardiology. 2017;:221-225
Abstract
BACKGROUND Dofetilide is a class III antiarrhythmic drug that has been reported to be safe and efficacious in the treatment of atrial dysrhythmias with a known initial risk of QT prolongation and torsades de pointes (TdP). As a result, the Federal Drug Administration (FDA) mandated in-hospital dofetilide initiation and adherence to a common dosing protocol. However, there is a lack of clarity on how to manage dofetilide re-initiation. METHODS An observational survey was performed including 347 cardiologists in the United States and worldwide to evaluate the deviations from approved manufacturer's protocol during dofetilide initiation and re-initiation among practicing cardiologists. RESULTS Most practicing cardiologists were cautious about outpatient dofetilide use and adhered to the manufacturer's in-patient dofetilide protocol during de-novo initiation and reported low incidence of TdP in clinical practice. There were substantial differences among practicing cardiologists with deviation from the manufacturer's protocol during re-initiation of dofetilide. About 21% cardiologists always admitted patients to the hospital while 37% admitted patients <10% of the time for dofetilide re-initiation. Only 4% reported major adverse events with outpatient dofetilide re-initiation. There was also wide variation regarding monitoring of electrolytes and QT interval as an outpatient with dofetilide. CONCLUSION There is significant practice pattern variation in the use of dofetilide for the management of AF. This degree of variation noted is concerning and is a reflection of the current lack of substantial clinical evidence in the re-initiation dofetilide protocol to help direct the provider.
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Temporal trends in the use of high-dose potent statins following acute coronary syndrome in Israel.
Elis, A, Pereg, D, Dicker, D, Gevrielov-Yusim, N, Goldenberg, I, Matetzky, S, Kopel, E, Klempfner, R
Cardiology. 2014;(3):266-72
Abstract
OBJECTIVES This study aimed to evaluate factors associated with the prescription of high-dose potent statin (HDPS) therapy following hospitalization for acute coronary events. STUDY DESIGN Sub-analysis was made using the data of 3,525 patients enrolled in the 2008 and 2010 Acute Coronary Syndrome Israeli Surveys (ACSIS). METHODS Analyses were carried out to identify demographic and clinical factors associated with the prescription of HDPS therapy (atorvastatin 40-80 mg/day or rosuvastatin 20-40 mg/day) at discharge compared with the prescription of lower-dose statins. RESULTS Among the study patients, 1,387 (39%) were discharged on HDPS, 1,860 (53%) with lower-dose statin regimens and 278 (8%) with no recommendation for statin therapy. Multivariate logistic regression analysis showed that pre-admission usage of HDPS and participation in the more recent (2010) ACSIS survey were independently associated with a higher likelihood of HDPS prescription at discharge from the index event (odds ratio, OR, 21.07, p < 0.001, and 5.61, p < 0.001, respectively), whereas factors independently associated with a lack of HDPS prescription included age >75 years (OR 0.76, p = 0.03), low-density lipoprotein-cholesterol levels <100 mg/dl on admission (OR 0.67, p < 0.001) and a history of heart failure prior to the index hospitalization (OR 0.54, p = 0.0018). The 30-day compliance with the HDPS regimen was 98%. CONCLUSIONS The findings show increased use of HDPS therapy in acute coronary syndrome (ACS) patients, although this mode of medical therapy is still underutilized in the important subset of high-risk ACS patients.