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Myung Gyoon Lee - One of the best experts on this subject based on the ideXlab platform.

  • gastrointestinal First Pass Effect of yja 20379 8 a new reversible proton pump inhibitor in rats
    Journal of Pharmacy and Pharmacology, 2010
    Co-Authors: Jonghan Kim, Kye S Han, Eun Jeong Kim, Man S Chang, Myung Gyoon Lee
    Abstract:

    Since low bioavailability of YJA-20379-8 (3-butyryl-4-[5-R-(a)-methylbenzylamino]-8ethoxy-1,7-naphthyridine), a new reversible proton pump inhibitor, has been reported after oral administration of the drug to rats, the First-Pass organ of the drug was investigated in rats. YJA-20379-8, 50 mg kg ˇ1 , was infused over 1 min via the jugular vein (na 5) or the portal vein (na 5), or was instilled directly into the stomach (na 5) or the duodenum (na 5). After intravenous or intraportal infusion of the drug, the total body clearance of YJA20379-8 (181 and 19 7m L min ˇ1 kg ˇ1 based on plasma data) was considerably lower than the reported cardiac output (296 mL min ˇ1 kg ˇ1 based on blood data) in rats. This data indicated that the First-Pass Effect of YJA-20379-8 by the lung and heart was negligible. The areas under the plasma concentration‐time curve from time zero to time infinity (AUC) after intravenous or intraportal administration of YJA-20379-8 (2760 and 2540mg min mL ˇ1 ) were not significantly different, indicating that the hepatic First-Pass Effect of the drug was also negligible in rats. After intragastric or intraduodenal instillation of YJA-20379-8, the extent of absolute oral bioavailability was 182 and 338%, respectively. Based on gastrointestinal recovery studies, approximately 865 and 912% of YJA-20379-8 was absorbed from rat gastrointestinal tract after intragastric or intraduodenal instillation, respectively. The data indicated that gastrointestinal and intestinal First-Pass Effects of YJA-20379-8 were approximately 68% (865‐182) and 57% (912‐338), respectively. The AUC 0‐2 4 h values of YJA-20379-8 were significantly different between intragastric and intraduodenal instillation, indicating that the gastric First-Pass Effect of the drug was approximately 10% in rats. Therefore, it could be concluded that the low F value of YJA-20379-8 after oral administration of the drug could be due to a considerable (approx. 60%) intestinal FirstPass Effect in rats.

  • pharmacokinetics of amitriptyline and one of its metabolites nortriptyline in rats little contribution of considerable hepatic First Pass Effect to low bioavailability of amitriptyline due to great intestinal First Pass Effect
    Journal of Pharmaceutical Sciences, 2009
    Co-Authors: Soo K. Bae, Yoon Gyoon Kim, Kyung Yang, Dipendra K Aryal, Myung Gyoon Lee
    Abstract:

    Pharmacokinetics of amitriptyline and nortriptyline were evaluated after intravenous (2.5-10 mg/kg) and oral (10-100 mg/kg) administration of amitriptyline to rats. The hepatic, gastric, and intestinal First-Pass Effects of amitriptyline were also measured at a dose of 10 mg/kg. The areas under the plasma concentration-time curve (AUCs) of amitriptyline were dose-proportional following both intravenous and oral administration. After oral administration of amitriptyline, approximately 1.50% of the dose was not absorbed, the extent of absolute oral bioavalability (F) was approximately 6.30%, and the hepatic and intestinal First-Pass Effects of amitriptyline were approximately 9% and 87% of the oral dose, respectively. Although the hepatic First-Pass Effect was 78.9% after absorption into the portal vein, the value was only 9% of the oral dose due to considerable intestinal First-Pass Effect in rats. The low F of amitriptyline in rats was primarily attributable to considerable intestinal First-Pass Effect. This study proves the little contribution of considerable hepatic First-Pass Effect to low F of amitriptyline due to great intestinal First-Pass Effect in rats. The lower F value of amitriptyline in rats than that in humans (46 +/- 48%) was due to grater metabolism of amitriptyline in rats' liver and/or small intestine.

  • pharmacokinetics of l fmaus a new antiviral agent after intravenous and oral administration to rats contribution of gastrointestinal First Pass Effect to low bioavailability
    Biopharmaceutics & Drug Disposition, 2007
    Co-Authors: Hye Jin Chung, Joo Hoon Lee, Sung J Woo, Hee K Park, Chang H Koo, Myung Gyoon Lee
    Abstract:

    The pharmacokinetics of L-FMAUS after intravenous and oral administration (20, 50 and 100 mg/kg) to rats, gastrointestinal First-Pass Effect of L-FMAUS (50 mg/kg) in rats, in vitro stability of L-FMAUS, blood partition of L-FMAUS between plasma and blood cells of rat blood, and protein binding of L-FMAUS to 4% human serum albumin were evaluated. L-FMAUS is being evaluated in a preclinical study as a novel antiviral agent. Although the dose-normalized AUC values of L-FMAUS were not significantly different among the three doses after intravenous and oral administration, no trend was apparent between the dose and dose-normalized AUC. After oral administration of L-FMAUS (50 mg/kg), approximately 2.37% of the oral dose was not absorbed, and the extent of absolute oral bioavailability (F) was approximately 11.5%. The gastrointestinal First-Pass Effect was approximately 85% of the oral dose. The First-Pass Effects of L-FMAUS in the lung, heart and liver were almost negligible, if any, in rats. Hence, the small F of L-FMAUS in rats was mainly due to the considerable gastrointestinal First-Pass Effect. L-FMAUS was stable in rat gastric juices. The plasma-to-blood cells partition ratio of L-FMAUS was 2.17 in rat blood. The plasma protein binding of L-FMAUS in rats was 98.6%. Copyright © 2007 John Wiley & Sons, Ltd.

  • dose independent pharmacokinetics of clindamycin after intravenous and oral administration to rats contribution of gastric First Pass Effect to low bioavailability
    International Journal of Pharmaceutics, 2007
    Co-Authors: Si H Yang, Myung Gyoon Lee
    Abstract:

    Purpose. To evaluate the pharmacokinetics of telithromycin after intravenous and oral administration and to find the reason for incomplete F value (First Pass- Effect) after intravenous, intraportal, intragastric, and intraduodenal administration to rats. Methods. Telithromycin was administered intravenously or orally at doses of 20, 50, and 100 mg/kg to rats. And hepatic, gastric, and intestinal First-Pass Effects of telithromycin were also measured after intravenous, intraportal, intragastric, and intraduodenal administration at a dose of 50 mg/kg to rats. Results. The dose-normalized AUC values of telithromycin were dose- dependent (increased with increasing doses) after both intravenous and oral dose ranges studied, possibly due to saturable metabolism of telithromycin. After oral administration (50 mg/kg), approximately 4.06% of oral dose was not absorbed, F was approximately 27.5%, and the intestinal First-Pass Effect was approximately 63.4% of oral dose. The First-Pass Effects of telithromycin in the lung, heart, stomach, and liver were almost negligible, if any, in rats. Conclusions. The low F of telithromycin at a dose of 50 mg/kg was mainly due to considerable intestinal First-Pass Effect, approximately 63.4% of oral dose, in rats.

  • pharmacokinetics of da 6034 an agent for inflammatory bowel disease in rats and dogs contribution of intestinal First Pass Effect to low bioavailability in rats
    European Journal of Pharmaceutical Sciences, 2006
    Co-Authors: Hye Jin Chung, Jong W Kwon, Young Hee Choi, Hye Duck Choi, Ji M Jang, Hyun J Shim, Moohi Yoo, Myung Gyoon Lee
    Abstract:

    Abstract The pharmacokinetics of DA-6034 in rats and dogs and First-Pass Effect in rats were examined. After intravenous administration, the dose-normalized AUC 0–∞ values at 25 and 50 mg/kg were significantly smaller than that at 10 mg/kg. This could be due to significantly slower Cl r values than that at 10 mg/kg, possibly due to saturated renal secretion at doses of 25 and 50 mg/kg. After oral administration, the dose-normalized AUC 0–12 h values at 50 and 100 mg/kg were significantly smaller than that at 25 mg/kg, possibly due to poor water solubility of the drug. The low F -value (approximately 0.136%) of DA-6034 at a dose of 50 mg/kg in rats could be due to considerable intestinal First-Pass Effect (approximately 69% of oral dose) and unabsorbed fraction from the gastrointestinal tract (approximately 30.5%). The Effect of cola beverage, cimetidine, or omeprazole on the AUC 0–24 h of DA-6034 was almost negligible in rats. Pharmacokinetic parameters of DA-6034 after intravenous and oral administration at various doses were dose-independent in dogs. DA-6034 was not accumulated in rats and dogs after consecutive 7 and 28 days oral administration, respectively. The stability, blood partition, and protein binding of DA-6034 were also discussed.

Raul G Nogueira - One of the best experts on this subject based on the ideXlab platform.

  • First Pass Effect in patients with large vessel occlusion strokes undergoing neurothrombectomy insights from the trevo retriever registry
    Journal of NeuroInterventional Surgery, 2021
    Co-Authors: Ashutosh P Jadhav, Shashvat M Desai, Rishi Gupta, Joey English, Diogo C Haussen, Ronald F Budzik, Blaise Baxter, B Bartolini, Antonin Krajina, Raul G Nogueira
    Abstract:

    Background First Pass Effect (FPE), defined as near-total/total reperfusion of the territory (modified Thrombolysis in Cerebral Infarction (mTICI) 2c/3) of the occluded artery after a single thrombectomy attempt (single Pass), has been associated with superior safety and efficacy outcomes than in patients not experiencing FPE. Objective To characterize the clinical features, incidence, and predictors of FPE in the anterior and posterior circulation among patients enrolled in the Trevo Registry. Methods Data were analyzed from the Trevo Retriever Registry. Univariate and multivariable analyses were used to assess the relationship of patient (demographics, clinical, occlusion location, collateral grade, Alberta Stroke Program Early CT Score (ASPECTS)) and device/technique characteristics with FPE (mTICI 2c/3 after single Pass). Results FPE was achieved in 27.8% (378/1358) of patients undergoing anterior large vessel occlusion (LVO) thrombectomy. Multivariable regression analysis identified American Society of Interventional and Therapeutic Neuroradiology (ASITN) levels 2–4, higher ASPECTS, and presence of atrial fibrillation as independent predictors of FPE in anterior LVO thrombectomy. Rates of modified Rankin Scale (mRS) score 0–2 at 90 days were higher (63.9% vs 53.5%, p Conclusion Twenty-eight percent of patients undergoing anterior LVO thrombectomy and 24% of patients undergoing basilar artery occlusion thrombectomy experience FPE. Independent predictors of FPE in anterior circulation LVO thrombectomy include higher ASITN levels, higher ASPECTS, and the presence of atrial fibrillation.

  • e 018 a novel 8fr aspiration catheter significantly increases the First Pass Effect in comparison with industry standard 6fr devices in an in vitro human vasculature model
    Journal of NeuroInterventional Surgery, 2020
    Co-Authors: Sean Fitzgerald, D Ryan, L Mullins, John Thornton, Raul G Nogueira
    Abstract:

    Introduction/Purpose Achieving complete reperfusion from a single mechanical thrombectomy attempt, termed First Pass Effect (FPE), is associated with significantly improved outcomes. Increasing the lumen of aspiration catheters to 6Fr has previously been shown to increase the reperfusion rates in comparison to smaller lumen catheters. We evaluated the performance of a novel large bore (0.088’’ ID) 8Fr aspiration catheter (Millipede 088, Perfuze Ltd.) and compared its performance against current industry standard 6Fr aspiration catheters (ACE68, Penumbra and SOFIA Plus, Microvention) in an in-vitro human vasculature model. Methods Following National University of Ireland Research Ethics committee approval human whole blood and platelet donations were obtained from the Irish Blood Transfusion Service. Three clot analogue phenotypes representative of clots retrieved from patients were created; Red Blood Cell-Rich, Mixed and Fibrin/Platelet-Rich. Histopathological analysis was performed using Martius Scarlet Blue (MSB) staining to confirm clot composition. The in-vitro model comprised a peristaltic pump, aortic arch and circle of Willis. Flow rates and pressure were controlled to replicate in-vivo conditions. Clot analogues of each phenotype were inserted into the ICA and lodged under pulsatile flow. Clot volume was optimized to mimic the clinical scenario; 10 mm clots reliably lead to a Distal M1+MCA Bifurcation Occlusion and 20 mm clots reliably lead to an ICA-T + Proximal M1 occlusion covering both the Posterior Communicating Artery and Anterior Cerebral Artery. Five replicates of each test were performed. Endpoints were FPE and Second Pass Reperfusion Success (>90% Retrieved). Results Histological composition was confirmed as RBC-Rich (RBCs:92.9%, WBCs:0.1%, Fibrin/Platelets:7.0%), Mixed (RBCs:79.7%, WBCs:0.3%, Fibrin/Platelets:20.0%) and Fibrin/Platelet-Rich (RBCs:51.8%, WBCs:0.3%, Fibrin/Platelets:47.9%). The 8Fr (Millipede 088) catheter performed better for each clot phenotype and in both occlusion locations (ICA-T & M1) compared to the 6Fr (0.068’’ & 0.070’’ ID) devices. In 10 mm M1+Bifurcation occlusions the 8Fr catheter achieved 100% FPE compared to an average of 40% in 6Fr devices (p>0.001*). In longer 20 mm ICA-T+Proximal M1 occlusions the Millipede 088 achieved 100% removal success within two Passes in each clot phenotype compared to an average of 27% in the 6Fr devices (p>0.001*). Conclusions A novel 8Fr aspiration catheter demonstrates superiority over 6Fr aspiration catheters for each clot phenotype at the most common sites of occlusion in an in-vitro model. Disclosures S. Fitzgerald: 1; C; Perfuze Ltd. D. Ryan: None. L. Mullins: 4; C; Perfuze Ltd. 5; C; Perfuze Ltd. J. Thornton: 2; C; Perfuze Ltd. 4; C; Perfuze Ltd. R. Nogueira: 2; C; Perfuze Ltd. 4; C; Perfuze Ltd.

  • abstract tp18 First Pass Effect may reduce the impact of delays to treatment in endovascular thrombectomy analysis of the stratis registry
    Stroke, 2020
    Co-Authors: Nathan W Manning, Raul G Nogueira, David S Liebeskind, Ameer E Hassan, Ashutosh P Jadhav, Nils Mueller, Dileep R Yavagal, Jason Wenderoth, Andrew Cheung, Osama O Zaidat
    Abstract:

    Introduction: First-Pass reperfusion Effect (FPE) appears superior to multiple device Passes in achieving good functional recovery in endovascular thrombectomy (EVT). It is unclear if this represen...

  • o 001 predictors of the First Pass Effect with neurothrombectomy for acute ischemic stroke
    Journal of NeuroInterventional Surgery, 2019
    Co-Authors: A Jadhav, Raul G Nogueira, O Zaidat, Shashvat M Desai, Nils Muellerkronast, Tudor G Jovin, David S Liebeskind
    Abstract:

    Introduction Achieving complete revascularization after a single attempt with mechanical thrombectomy (First Pass Effect, FPE) in the setting of an acute ischemic stroke due to large vessel occlusion (LVO) is associated with significantly higher rates of a good clinical outcome. We aim to identify predictors of FPE in a large real word registry of patients undergoing thrombectomy. Methods Data were analyzed from the STRATIS registry -- a prospective, nonrandomized study of patients undergoing neurothrombectomy with the Solitaire device. A total of 984 patients treated at 55 sites were analyzed. Univariate and multivariable logistic regression was used to assess the relationship between patient characteristics (demographics, clinical, occlusion location, collateral grade) and procedural features with FPE. Complete data was only available for 930 patients. Results First Pass Effect was achieved in 40% (ns=372) of patients. Patients in the FPE group were older (69 ±15 vs 67 ±15 years, p=0.02) and had less internal carotid artery (ICA) occlusions (17% vs 28%, p=0.001). While rates of symptomatic intracranial hemorrhage (0.6% vs 2.2%, p=0.13) were comparable, rates of mRS 0–2 at 90 days were higher (66% vs 49%, p≤0.001) and mortality at 90 days (12% vs 19%, p=0.008) were lower in the FPE group compared to the non-FPE group. Multivariable regression analysis identified absence of ICA occlusion (p=0.01), the use of a balloon guided-catheter (p=0.001) and better collateral grade (p≤0.001), as independent predictors of FPE. Conclusion Non-ICA site of occlusion, the use of a balloon-guided catheter and better collateral grade are independent predictors of FPE. Further understanding of these factors may influence choice of thrombectomy device and technique. Disclosures A. Jadhav: None. O. Zaidat: None. S. Desai: None. R. Nogueira: None. N. Mueller-Kronast: None. T. Jovin: None. D. Liebeskind: None.

  • p 007 First Pass Effect analysis using the trevo stent retriever acute stroke track registry
    Journal of NeuroInterventional Surgery, 2019
    Co-Authors: Maxim Mokin, Raul G Nogueira, Alicia C Castonguay, Joey English, Christopher T Primiani, Diogo C Haussen, Sudhakar R Satti, Jennifer Chen, Hamed Farid, Candace Borders
    Abstract:

    Background and objective The First Pass Effect (FPE) has become a novel measure for neurointerventionalists, achieving a complete recanalization with a single thrombectomy device Pass, which has been shown to be associated with higher rates of good clinical outcomes. We describe and expand the FPE to one of a large US post-marketing registry (TRACK, Trevo Stent-Retriever Acute Stroke) to elucidate the Effect of a single device Pass and clinical outcome. Methods TRACK was a core-laboratory adjudicated multicenter registry of 634 patients from 23 centers aimed to evaluate the use of the Trevo device in everyday clinical practice. The TRACK registry was utilized to identify an FPE subgroup (n=140). Baseline features including demographics and clinical data were compared with the non-FPE patients (n=469). Clinical outcome measures included modified Rankin Scale score (mRS) at 30 and 90 days, National Institutes of Health Stroke Scale (NIHSS) score, symptomatic intracranial hemorrhage (sICH), and mortality. FPE was defined as a single Pass/use of a device with TICI 2c/3 recanalization, and no use of rescue therapy. Results 609 patients were included in the FPE (140/609, 23%) vs non-FPE (469/609, 77%) subgroup analysis from the TRACK registry. There was no association between patient demographics and FPE group, including age (p=0.36), sex (p=0.50), race (p=0.49), location of occlusion (p=0.26), baseline NIHSS (p=0.61) past medical history including hypertension (p=0.57), atrial fibrillation (p=0.55), diabetes mellitus (p=0.74), hyperlipidemia (p=0.28), coronary artery disease (p=0.27), or history of smoking (p=0.12). The non-FPE group was associated with higher use of intraarterial tPA (FPE: 11% vs non-FPE: 23%). The onset to puncture time in minutes was not significantly different between groups (p=0.31); however, the total procedural time, total fluoroscopic time, and puncture to reperfusion time had significantly shorter mean time in FPE group (p Conclusion The achievement of complete revascularization from a single Trevo Stent-Retriever device Pass is associated with higher rates of good clinical outcomes. Additionally, FPE in our subgroup registry analysis was associated with shorter procedural times, lower NIHSS at discharge, and significantly lower rates of EDT. Our analysis was not able to identify any patient demographics that would be associated to achieve First Pass Effect. Further research is warranted to confirm findings and identify additional factors achieving good clinical outcome after thrombectomy. Disclosures M. Mokin: 2; C; Claret Medical, Nogueira-Stryker Neurovascular (Trevo-2 Trial Principal Investigator; DAWN Trial Principal Investigator, TREVO Registry Steering Committee), Medtronic (SWIFT Trial Steering Committee; SWIFT-Prime Trial Steering Committee ; STAR Trial Angiographic Core Lab), Penumbra (3D Separator Trial Executive Committee), Neuravi (ARISE-2 Steering Committee), Genentech (Physician Advisory Board), Allm Inc (Physician Advisory Board). C. Primiani: None. A. Castonguay: None. R. Nogueira: None. D. Haussen: None. J. English: None. S. Satti: 2; C; Stryker Neurovascular. J. Chen: None. H. Farid: None. C. Borders: None. E. Veznedaroglu: None. M. Binning: None. A. Puri: None. N. Vora: None. R. Budzik: None. G. Dabus: None. I. Linfante: 2; C; Metronic, Stryker, Penumbra, and Cordis. V. Janardhan: None. A. Alshekhlee: None. M. Abraham: None. R. Edgell: None. M. Taqi: None. R. El Khoury: None. A. Majjhoo: None. M. Kabbani: None. M. Froehler: None. I. Finch: None. S. Ansari: None. R. Novakovic: None. T. Nguyen: None. O. Zaidat: 6; C; overall PI for TRACK, Arise II, Co-PI Therapy Trial, Steering committee STRATIS registry.

Osama O Zaidat - One of the best experts on this subject based on the ideXlab platform.

  • abstract tp18 First Pass Effect may reduce the impact of delays to treatment in endovascular thrombectomy analysis of the stratis registry
    Stroke, 2020
    Co-Authors: Nathan W Manning, Raul G Nogueira, David S Liebeskind, Ameer E Hassan, Ashutosh P Jadhav, Nils Mueller, Dileep R Yavagal, Jason Wenderoth, Andrew Cheung, Osama O Zaidat
    Abstract:

    Introduction: First-Pass reperfusion Effect (FPE) appears superior to multiple device Passes in achieving good functional recovery in endovascular thrombectomy (EVT). It is unclear if this represen...

  • p 015 long term economic impact of the First Pass Effect fpe in the treatment of stroke with the embotrap ii device in arise ii
    Journal of NeuroInterventional Surgery, 2019
    Co-Authors: Osama O Zaidat, Albert J Yoo, J L Saver, Heinrich Mattle, Hormozd Bozorgchami, Ana Paula Narata, M Ribo, Concetta Crivera, Heather L Cameron, Tommy Andersson
    Abstract:

    Introduction The First Pass Effect (FPE) is the ability to restore near or complete revascularization (modified Thrombolysis in Cerebral Ischemia [mTICI] ≥2c) of acutely blocked cerebral arteries in a single thrombectomy device Pass. FPE has been shown to be an independent predictor of good functional outcomes (modified Rankin Scale [mRS] ≤2), a goal of stroke therapy that impacts healthcare costs, and is associated with reduced 90-day mortality and fewer adverse events. A separate analysis of ARISE-II data showed that the FPE was associated with reduced procedural and in-patient healthcare resource use (length of stay, days in the intensive care unit, standard bed days, and devices used) and accompanying short-term costs; however, the long-term economic impact of achieving the FPE has not been assessed. Methodology Data were obtained from a single-arm, prospective, multicenter study assessing the EMBOTRAP II device, ARISE-II (n=227). Patients who did not achieve complete revascularization were excluded. Among those who achieved complete revascularization (mTICI≥2c), the proportion of patients achieving each mRS score was assessed, stratified by the FPE status. Long-term costs per mRS score, obtained from a 2015 U.S. cost-Effectiveness analysis that projected annual post-hospitalization inpatient/outpatient and nursing home costs using data from the National Death Index and Centers for Medicare and Medicaid Services (CMS), were applied to all patients. Post-hospitalization costs, in 2018 USD, were then compared between patients that did or did not achieve the FPE and incremental differences were calculated for a 1-year time horizon. Results In ARISE-II, 76% of patients (n=172) achieved complete revascularization; among these patients, 53% achieved the FPE. A significantly higher percentage of patients that achieved the FPE had good functional outcomes vs. those that did not achieve the FPE (80.5% vs. 61.0%, p=0.006). Estimated annual post-hospitalization costs were lower among patients that achieved FPE vs. those that did not achieve FPE, leading to estimated per-patient cost-savings of $3,876 (table 1). In the absence of cost data reported in ARISE-II, costs for healthcare resource use were obtained from the literature, which may not be generalizable across settings and is a limitation of this analysis. Additionally, the cost-Effectiveness analysis used to inform the long-term costs per mRS score did not report costs for death (i.e., mRS 6), which had a lower incidence among patients who achieved the FPE vs. those who did not achieve the FPE (5.75% vs. 14.29%). Conclusion Among patients with final complete reperfusion (mTICI≥2c), achieving FPE may lead to long-term per-patient cost-savings of $3,876 in the First year due to improved functional outcomes. Disclosures O. Zaidat: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech, Tesla Clinical Trial. 2; C; Cerenovus, Stryker, Medtronic, Penumbra. J. Saver: 2; C; Cerenovus, Stryker, Medtronic, Rapid Medical. H. Mattle: 1; C; Neuravi/Cerenovus. 2; C; Neuravi/Cerenovus. 3; C; Neuravi/Cerenovus. M. Ribo: 1; C; Stryker, Medtronic. 2; C; Cerenovus, Stryker, Medtronic, Anaconda Biomed. 4; C; Anaconda Biomed. A. Narata: None. A. Yoo: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Cerenovus, Genentech, Zoll Circulation. 4; C; Insera Therapeutics. H. Bozorgchami: 2; C; Cerenovus, Stryker, Coherex. C. Crivera: 4; C; Johnson & Johnson. 5; C; Johnson & Johnson. H. Cameron: 2; C; Employee of Cornerstone Research Group, contracted by Cerenovus. T. Andersson: 2; C; Cerenovus, Anaconda, Medtronic, Ablynx, Amnis Therapeutics, Rapid Medical.

  • e 101 economic impact of the First Pass Effect fpe in the treatment of stroke with the embotrap ii device in arise ii
    Journal of NeuroInterventional Surgery, 2019
    Co-Authors: Osama O Zaidat, Albert J Yoo, J L Saver, Heinrich Mattle, Hormozd Bozorgchami, Ana Paula Narata, M Ribo, Concetta Crivera, Heather L Cameron, Tommy Andersson
    Abstract:

    Introduction The First Pass Effect (FPE), a measure of thrombectomy device’s ability to restore near or complete revascularization (modified Thrombolysis in Cerebral Ischemia [mTICI] ≥2c) in a single Pass, may be considered as a benchmark for thrombectomy devices in the treatment of acute ischemic stroke. While the FPE has been shown to be an independent predictor of good functional outcomes (modified Rankin Scale [mRS] ≤2) and is associated with reduced 90-day mortality, the economic impact of achieving the FPE has not been assessed. Methodology Data were obtained from the EMBOTRAP II device, ARISE-II (n=227) study. FPE was defined as complete revascularization (mTICI ≥2c) after the First Pass of the EMBOTRAP II device. Patients who did not achieve complete revascularization within the ARISE-II population were excluded from the analysis. Healthcare resources included total hospital length of stay (LOS), days in the intensive care unit (ICU), standard bed days, and procedural device use (stent retrievers and aspiration devices). Costs from the literature, in 2018 USD, were applied to healthcare resources. Results In ARISE-II, 76% of patients (n=172) achieved complete revascularization; among these patients, 53% achieved the FPE. Among patients that achieved complete revascularization, baseline characteristics were well-balanced between patients that did or did not achieve the FPE. A significantly higher percentage of patients that achieved the FPE had good functional outcomes vs. those that did not achieve the FPE (80.5% vs. 61.0%, p=0.006). Healthcare resource use was lower among patients that achieved the FPE. While patients that achieved the FPE required only a single EMBOTRAP II device, 35% of the patients that did not achieve the FPE required both the EMBOTRAP II device and an additional device to achieve complete revascularization. Patients that achieved the FPE had a significantly shorter LOS (6.1 vs. 9.5 days, p=0.004) and fewer days spent in a standard bed (3.1 vs. 6.1, p=0.004) vs. those that did not achieve the FPE. Overall, the reduction in healthcare resource use associated with achieving the FPE led to estimated per-patient cost-savings of $6,355 (table 1). In the absence of cost data reported in ARISE-II, costs for healthcare resource use were obtained from the literature, which may not be generalizable across settings and is a limitation of this analysis. Additionally, this analysis did not include all components of health resource use that may impact costs (e.g., procedure time, surgical evacuation for symptomatic intracranial hemorrhage [sICH]). Conclusion Among patients with final complete reperfusion (mTICI≥2c), achieving the FPE may lead to per-patient cost-savings of $6,355 due to reductions in procedural and in-patient healthcare resource use. Disclosure O. Zaidat: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Stryker, Cerenovus, Penumbra, Medtronic. J. Saver: 2; C; Cerenovus, Stryker, Medtronic, Rapid Medical. 4; C; Rapid Medical. 5; C; University of California. H. Mattle: 1; C; Neuravi/Cerenovus. 2; C; Neuravi/Cerenovus. 3; C; Neuravi/Cerenovus. H. Bozorgchami: 2; C; Cerenovus, Stryker, Coherex. A. Narata: None. A. Yoo: 1; C; Cerenovus, Stryker, Medtronic, Penumbra, Genentech. 2; C; Cerenovus, Genentech, Zoll Circulation. 4; C; Insera Therapeutics. M. Ribo: 1; C; Stryker, Medtronic. 2; C; Cerenovus, Stryker, Medtronic, Anaconda Biomed. 4; C; Anaconda Biomed. C. Crivera: 4; C; Johnson & Johnson. 5; C; Johnson & Johnson. H. Cameron: 5; C; Cornerstone Research Group, contracted by Cerenovus. T. Andersson: 2; C; Cerenovus, Anaconda, Medtronic, Rapid Medical, Ablynx, Amnis Therapeutics.

  • First Pass Effect a new measure for stroke thrombectomy devices
    Stroke, 2018
    Co-Authors: Osama O Zaidat, Nils Muellerkronast, Alicia C Castonguay, Rishi Gupta, Joey English, Italo Linfante, Guilherme Dabus, C Martin, W Holloway, Tim W Malisch
    Abstract:

    Background and Purpose—In acute ischemic stroke, fast and complete recanalization of the occluded vessel is associated with improved outcomes. We describe a novel measure for newer generation devic...

Myung Gull Lee - One of the best experts on this subject based on the ideXlab platform.

  • gastrointestinal First Pass Effect of furosemide in rats
    Journal of Pharmacy and Pharmacology, 2010
    Co-Authors: Eun Jung Kim, Kye S Han, Myung Gull Lee
    Abstract:

    The First-Pass Effect of furosemide was investigated in rats. Furosemide intravenous solution (20 mg kg -1 Lasix), was administered via the jugular vein and the portal vein, orally, and instilled directly into the duodenum of rats. The First-Pass Effects of furosemide by lung, heart, and liver seemed to be negligible in rats. The absolute bioavailability of furosemide was 28.9 and 48.3% after oral and intraduodenal administration, respectively. Based on the gastrointestinal (GI) recovery study, 68.3 and 69.5% of furosemide were found to have disappeared mainly due to absorption and/or metabolism from rat GI tract after oral and intraduodenal administration, respectively. The results indicate that gastrointestinal and intestinal First-Pass Effects of furosemide were approximately 40% (68.3-28.9%) and 20% (69.5-48.3%) of the dose, respectively.

  • dose dependent pharmacokinetics of telithromycin after intravenous and oral administration to rats contribution of intestinal First Pass Effect to low bioavailability
    Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, 2007
    Co-Authors: Joo Hyun Lee, Myung Gull Lee
    Abstract:

    PURPOSE To evaluate the pharmacokinetics of telithromycin after intravenous and oral administration and to find the reason for incomplete F value (First Pass-Effect) after intravenous, intraportal, intragastric, and intraduodenal administration to rats. METHODS Telithromycin was administered intravenously or orally at doses of 20, 50, and 100 mg/kg to rats. And hepatic, gastric, and intestinal First-Pass Effects of telithromycin were also measured after intravenous, intraportal, intragastric, and intraduodenal administration at a dose of 50 mg/kg to rats. RESULTS The dose-normalized AUC values of telithromycin were dose-dependent (increased with increasing doses) after both intravenous and oral dose ranges studied, possibly due to saturable metabolism of telithromycin. After oral administration (50 mg/kg), approximately 4.06% of oral dose was not absorbed, F was approximately 27.5%, and the intestinal First-Pass Effect was approximately 63.4% of oral dose. The First-Pass Effects of telithromycin in the lung, heart, stomach, and liver were almost negligible, if any, in rats. CONCLUSIONS The low F of telithromycin at a dose of 50 mg/kg was mainly due to considerable intestinal First-Pass Effect, approximately 63.4% of oral dose, in rats.

  • pharmacokinetics of da 7867 a new oxazolidinone after intravenous or oral administration to rats intestinal First Pass Effect
    Antimicrobial Agents and Chemotherapy, 2004
    Co-Authors: Soo K. Bae, Eun Jeong Kim, Wonsuk Chung, Jae K Rhee, Jong W Kwon, Won B Kim, Myung Gull Lee
    Abstract:

    Pharmacokinetic parameters of DA-7867 were dose independent after both intravenous administration and oral administration (at doses of 1 to 20 mg/kg of body weight) to rats. After oral administration of DA-7867 to rats at a dose of 10 mg/kg, approximately 8.27% of oral dose was not absorbed from the gastrointestinal tract, F was 70.8%, and approximately 21.8% of the oral dose was eliminated by the intestine (intestinal First-Pass Effect).

  • dose independent pharmacokinetics of a new reversible proton pump inhibitor kr 60436 after intravenous and oral administration to rats gastrointestinal First Pass Effect
    Journal of Pharmaceutical Sciences, 2003
    Co-Authors: Soo K. Bae, Yoon Gyoon Kim, Eun Jung Kim, Dong H Lee, Hong Lim, Sunok Kim, Myung Gull Lee
    Abstract:

    ABSTRACT: Dose-independent pharmacokinetic parameters of KR-60436, a new proton pump inhibitor, were evaluated after intravenous (iv; 5, 10, and 20 mg/kg) and oral (20, 50, and 100 mg/kg) administration to rats. The hepatic, gastric, and intestinal First-Pass Effects were also measured after iv, intraportal (ip), intragastric (ig), and intraduodenal (id) administrations to rats of a dose of 20 mg/kg. The areas under the plasma concentration–time curve from time to zero to time infinity (AUCs) were independent of iv and oral dose ranges studied; the dose-normalized AUCs were 83.0–104 μg · min/mL (based on 5 mg/kg) and 78.4–96.8 μg · min/mL (based on 20 mg/kg) for iv and oral administration, respectively. After an oral administration at a dose of 20 mg/kg, ∼3% of the oral dose was not absorbed, and the extent of absolute oral bioavaliability ( F ) was estimated to be 18.8%. The AUCs of KR-60436 after ig and id administration at a dose of 20 mg/kg were significantly smaller (82.4 and 57.5% decrease, respectively) than that after an ip administration at a dose of 20 mg/kg, suggesting that gastrointestinal First-Pass Effect of KR-60436 was ∼80% of oral dose in rats (the gastric First-Pass Effect was ∼25%). After an ip administration at a dose of 20 mg/kg, the AUC was 77.6% of an iv administration, suggesting that hepatic First-Pass Effect was ∼22% of KR-60436 absorbed into the portal vein. Note that the value of 22% was equivalent to ∼4% of the oral dose. Because only 17% of oral dose was absorbed into the portal vein, the low F of KR-60436 in rats was mainly due to considerable gastrointestinal First-Pass Effect, which was ∼80% (the gastric First-Pass Effect was ∼25%) of oral dose. © 2003 Wiley-Liss, Inc. and the American Pharmacists Association

  • Pharmacokinetics of ipriflavone, an isoflavone derivative, after intravenous and oral administration to rats hepatic and intestinal First-Pass Effects.
    Life sciences, 2002
    Co-Authors: So Hee Kim, Myung Gull Lee
    Abstract:

    Pharmacokinetic parameters of ipriflavone were evaluated after intravenous administration of spray-dried ipriflavone with polyvinylpyrrolidone, SIP (5, 10, 20, and 40 mg/kg as ipriflavone) and oral administration of SIP (50, 100, and 200 mg/kg as ipriflavone) to rats. The hepatic, gastric, and intestinal First-Pass Effects of ipriflavone were also measured after intravenous, intraportal, intraduodenal, and oral administration of SIP (20 or 50 mg/kg as ipriflavone) to rats. After intravenous and oral administration, the pharmacokinetic parameters of ipriflavone were dose-independent. The extent of absolute oral bioavailability (F) was also independent of oral doses; the mean F value was approximately 24%. Considering the amount of unchanged ipriflavone recovered from 24-hr gastrointestinal tract (the mean value was approximately 12%), the low F values could be due to the hepatic, gastric, and/or intestinal First-Pass Effects. Based on total body clearance (CL) data of ipriflavone after intravenous administration, the First-Pass Effect in the heart and lung could be almost negligible, if any, in rats. Approximately 30% of ipriflavone absorbed into the portal vein was eliminated by liver (hepatic First-Pass Effect) based on intravenous and intraportal administration of SIP. The area under the plasma concentration-time curve from time zero to time infinity (AUC) values after oral administration and intraduodenal instillation of SIP, 50 mg/kg as ipriflavone, were not significantly different, but the values were significantly smaller (129 and 116 μg ml/min) than that after intraportal administration of SIP, 20 mg/kg as ipriflavone (513 μg ml/min based on 50 mg/kg), indicating that gastric First-Pass Effect of ipriflavone was negligible, but intestinal First-Pass Effect was considerable in rats. Therefore, the low F value of ipriflavone after oral administration to rats was mainly due to intestinal First-Pass Effect. The hepatic First-Pass Effect and incomplete absorption of ipriflavone from rat gastrointestinal tract could also contributed to the low F in rats.

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  • First Pass Effect in patients with large vessel occlusion strokes undergoing neurothrombectomy insights from the trevo retriever registry
    Journal of NeuroInterventional Surgery, 2021
    Co-Authors: Ashutosh P Jadhav, Shashvat M Desai, Rishi Gupta, Joey English, Diogo C Haussen, Ronald F Budzik, Blaise Baxter, B Bartolini, Antonin Krajina, Raul G Nogueira
    Abstract:

    Background First Pass Effect (FPE), defined as near-total/total reperfusion of the territory (modified Thrombolysis in Cerebral Infarction (mTICI) 2c/3) of the occluded artery after a single thrombectomy attempt (single Pass), has been associated with superior safety and efficacy outcomes than in patients not experiencing FPE. Objective To characterize the clinical features, incidence, and predictors of FPE in the anterior and posterior circulation among patients enrolled in the Trevo Registry. Methods Data were analyzed from the Trevo Retriever Registry. Univariate and multivariable analyses were used to assess the relationship of patient (demographics, clinical, occlusion location, collateral grade, Alberta Stroke Program Early CT Score (ASPECTS)) and device/technique characteristics with FPE (mTICI 2c/3 after single Pass). Results FPE was achieved in 27.8% (378/1358) of patients undergoing anterior large vessel occlusion (LVO) thrombectomy. Multivariable regression analysis identified American Society of Interventional and Therapeutic Neuroradiology (ASITN) levels 2–4, higher ASPECTS, and presence of atrial fibrillation as independent predictors of FPE in anterior LVO thrombectomy. Rates of modified Rankin Scale (mRS) score 0–2 at 90 days were higher (63.9% vs 53.5%, p Conclusion Twenty-eight percent of patients undergoing anterior LVO thrombectomy and 24% of patients undergoing basilar artery occlusion thrombectomy experience FPE. Independent predictors of FPE in anterior circulation LVO thrombectomy include higher ASITN levels, higher ASPECTS, and the presence of atrial fibrillation.

  • p 007 First Pass Effect analysis using the trevo stent retriever acute stroke track registry
    Journal of NeuroInterventional Surgery, 2019
    Co-Authors: Maxim Mokin, Raul G Nogueira, Alicia C Castonguay, Joey English, Christopher T Primiani, Diogo C Haussen, Sudhakar R Satti, Jennifer Chen, Hamed Farid, Candace Borders
    Abstract:

    Background and objective The First Pass Effect (FPE) has become a novel measure for neurointerventionalists, achieving a complete recanalization with a single thrombectomy device Pass, which has been shown to be associated with higher rates of good clinical outcomes. We describe and expand the FPE to one of a large US post-marketing registry (TRACK, Trevo Stent-Retriever Acute Stroke) to elucidate the Effect of a single device Pass and clinical outcome. Methods TRACK was a core-laboratory adjudicated multicenter registry of 634 patients from 23 centers aimed to evaluate the use of the Trevo device in everyday clinical practice. The TRACK registry was utilized to identify an FPE subgroup (n=140). Baseline features including demographics and clinical data were compared with the non-FPE patients (n=469). Clinical outcome measures included modified Rankin Scale score (mRS) at 30 and 90 days, National Institutes of Health Stroke Scale (NIHSS) score, symptomatic intracranial hemorrhage (sICH), and mortality. FPE was defined as a single Pass/use of a device with TICI 2c/3 recanalization, and no use of rescue therapy. Results 609 patients were included in the FPE (140/609, 23%) vs non-FPE (469/609, 77%) subgroup analysis from the TRACK registry. There was no association between patient demographics and FPE group, including age (p=0.36), sex (p=0.50), race (p=0.49), location of occlusion (p=0.26), baseline NIHSS (p=0.61) past medical history including hypertension (p=0.57), atrial fibrillation (p=0.55), diabetes mellitus (p=0.74), hyperlipidemia (p=0.28), coronary artery disease (p=0.27), or history of smoking (p=0.12). The non-FPE group was associated with higher use of intraarterial tPA (FPE: 11% vs non-FPE: 23%). The onset to puncture time in minutes was not significantly different between groups (p=0.31); however, the total procedural time, total fluoroscopic time, and puncture to reperfusion time had significantly shorter mean time in FPE group (p Conclusion The achievement of complete revascularization from a single Trevo Stent-Retriever device Pass is associated with higher rates of good clinical outcomes. Additionally, FPE in our subgroup registry analysis was associated with shorter procedural times, lower NIHSS at discharge, and significantly lower rates of EDT. Our analysis was not able to identify any patient demographics that would be associated to achieve First Pass Effect. Further research is warranted to confirm findings and identify additional factors achieving good clinical outcome after thrombectomy. Disclosures M. Mokin: 2; C; Claret Medical, Nogueira-Stryker Neurovascular (Trevo-2 Trial Principal Investigator; DAWN Trial Principal Investigator, TREVO Registry Steering Committee), Medtronic (SWIFT Trial Steering Committee; SWIFT-Prime Trial Steering Committee ; STAR Trial Angiographic Core Lab), Penumbra (3D Separator Trial Executive Committee), Neuravi (ARISE-2 Steering Committee), Genentech (Physician Advisory Board), Allm Inc (Physician Advisory Board). C. Primiani: None. A. Castonguay: None. R. Nogueira: None. D. Haussen: None. J. English: None. S. Satti: 2; C; Stryker Neurovascular. J. Chen: None. H. Farid: None. C. Borders: None. E. Veznedaroglu: None. M. Binning: None. A. Puri: None. N. Vora: None. R. Budzik: None. G. Dabus: None. I. Linfante: 2; C; Metronic, Stryker, Penumbra, and Cordis. V. Janardhan: None. A. Alshekhlee: None. M. Abraham: None. R. Edgell: None. M. Taqi: None. R. El Khoury: None. A. Majjhoo: None. M. Kabbani: None. M. Froehler: None. I. Finch: None. S. Ansari: None. R. Novakovic: None. T. Nguyen: None. O. Zaidat: 6; C; overall PI for TRACK, Arise II, Co-PI Therapy Trial, Steering committee STRATIS registry.

  • First Pass Effect a new measure for stroke thrombectomy devices
    Stroke, 2018
    Co-Authors: Osama O Zaidat, Nils Muellerkronast, Alicia C Castonguay, Rishi Gupta, Joey English, Italo Linfante, Guilherme Dabus, C Martin, W Holloway, Tim W Malisch
    Abstract:

    Background and Purpose—In acute ischemic stroke, fast and complete recanalization of the occluded vessel is associated with improved outcomes. We describe a novel measure for newer generation devic...

  • o 004 the First Pass Effect a new measure for stroke thrombectomy devices
    Journal of NeuroInterventional Surgery, 2015
    Co-Authors: O Zaidat, Nils Muellerkronast, Alicia C Castonguay, Rishi Gupta, C Sun, Coleman O Martin, William E Holloway, Joey English, Italo Linfante, Guilherme Dabus
    Abstract:

    Background Advances in acute ischemic stroke mechanical thrombectomy devices have led to increased expectations of their safety and efficacy results. Objective To describe a new measure for the newer generation stroke thrombectomy devices, the First Pass Effect (FPE), defined as achieving thrombolysis in cerebral ischemia (TICI) score of 3 from the First Pass, without the use of rescue therapy. In addition, a second objective was to assess if achieving TICI2b only with FP (FPE-TICI2b only) yielded similar results as FPE-TICI3 or non-FPE-TICI3 or non-FPE-TICI2b. The influence of FPE on clinical outcome, and its frequency and predictors was evaluated in the North American Solitaire Acute stroke (NASA) registry. Methods The FPE group was identified from the NASA multicenter registry database. Baseline features and clinical outcomeswere compared between the FPE group and the rest of the cohort. Subsequently, two multivariate analyzes were performed to identify if FPE is an independent predictor of clinical outcome and to identify the predictors of FPE. Furthermore, we assessed the difference between FPE and achieving other revascularization grades such as non-FPE-TICI3, FPE-TICI2b, and non-FPE-TICI2b scores. Clinical outcomes were mRS0–2 at 90 days, NIH stroke severity scale, mortality, and symptomatic intracranial hemorrhage (sICH). Results A total of 354 patients from 24 US centers were included in the NASA registry. The FPE was achieved in 89/354 (25.1%). Baseline demographics were comparable between FPE and the rest of the cohort, except that the FPE population had less octogenarians (34.6% vs. 65.4%), more woman (60.7% vs. 47.2%), and more Caucasians (83% vs. 71.2%). Baseline NIHSS and time from onset to groin puncture did not differ among the two groups. Angiographic features demonstrated more MCA occlusion (64% vs. 52.7%) and less ICA occlusion (10.1% vs. 27.7%) in the FPE group. Technical factors associated with FPE were limited to BGC use (64.8% vs. 36.8%), with no difference with use of IV-tPA, IA-tPA, or General Anesthesia. Multivariate analysis demonstrated use of BGC, no ICA occlusion, MCA occlusion, female gender, and white race as independent  predictors of FPE. Clinical outcome measured with mRS 0–2 at 90 days was seen in 61.3%, 52.4%, 44.7%, and 39.1% with FPE-TICI3, FPE-TICI 2b, non-FPE-TICI3, and non-FPE-TICI2b, respectively. sICH was seen less frequently in FPE (5.6%,11.6%, 9.6%, and 12.9% in FPE-TICI3, FPE-TICI2b, non-FPE-TICI3,and non-FPE-TICI2b, respectively). Ninety days mortality was 16.3%, 31.0%, 27.7%, and 29.7% with FPE-TICI3, FPE-TICI2b, non-FPE-TICI3, and non-FPE-TICI2b, respectively. Conclusions The First Pass Effect was seen in 25.1% of NASA post-marketing registry patients and is the most powerful predictor of clinical outcome with best safety results. FPE is more commonly seen in white patients, MCA occlusion, and balloon guide catheter use; however, ICA terminus occlusion seems to be resistant to FPE. The FPE may also be related to gender, race, and age. Further research is needed to better understand the FPE and to guide future technical advances. Disclosures O. Zaidat: 1; C; Covidien, Stryker. 2; C; Covidien, Stryker. A. Castonguay: None. R. Gupta: None. C. Sun: None. C. Martin: None. W. Holloway: None. N. Mueller-Kronast: None. J. English: None. I. Linfante: None. G. Dabus: None. T. Malisch: None. F. Marden: None. H. Bozorgchami: None. A. Xavier: None. A. Rai: None. M. Froehler: None. A. Badruddin: None. T. Nguyen: None. M. Taqi: None. M. Abraham: None. V. Janardhan: None. H. Shaltoni: None. R. Novakovic: None. A. Yoo: None. A. Abou-Chebl: None. P. Chen: None. G. Britz: None. R. Kaushal: None. A. Nanda: None. R. Nogueira: None.