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  • SAGE Publications  (4)
  • 1
    Online Resource
    Online Resource
    Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2
    SAGE Publications ; 2020
    In:  International Journal of Stroke Vol. 15, No. 6 ( 2020-08), p. 638-649
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 15, No. 6 ( 2020-08), p. 638-649
    Abstract: Treatment of individuals with asymptomatic carotid artery stenosis is still handled controversially. Recommendations for treatment of asymptomatic carotid stenosis with carotid endarterectomy (CEA) are based on trials having recruited patients more than 15 years ago. Registry data indicate that advances in best medical treatment (BMT) may lead to a markedly decreasing risk of stroke in asymptomatic carotid stenosis. The aim of the SPACE-2 trial (ISRCTN78592017) was to compare the stroke preventive effects of BMT alone with that of BMT in combination with CEA or carotid artery stenting (CAS), respectively, in patients with asymptomatic carotid artery stenosis of ≥70% European Carotid Surgery Trial (ECST) criteria. Methods SPACE-2 is a randomized, controlled, multicenter, open study. A major secondary endpoint was the cumulative rate of any stroke (ischemic or hemorrhagic) or death from any cause within 30 days plus an ipsilateral ischemic stroke within one year of follow-up. Safety was assessed as the rate of any stroke and death from any cause within 30 days after CEA or CAS. Protocol changes had to be implemented. The results on the one-year period after treatment are reported. Findings It was planned to enroll 3550 patients. Due to low recruitment, the enrollment of patients was stopped prematurely after randomization of 513 patients in 36 centers to CEA (n = 203), CAS (n = 197), or BMT (n = 113). The one-year rate of the major secondary endpoint did not significantly differ between groups (CEA 2.5%, CAS 3.0%, BMT 0.9%; p = 0.530) as well as rates of any stroke (CEA 3.9%, CAS 4.1%, BMT 0.9%; p = 0.256) and all-cause mortality (CEA 2.5%, CAS 1.0%, BMT 3.5%; p = 0.304). About half of all strokes occurred in the peri-interventional period. Higher albeit statistically non-significant rates of restenosis occurred in the stenting group (CEA 2.0% vs. CAS 5.6%; p = 0.068) without evidence of increased stroke rates. Interpretation The low sample size of this prematurely stopped trial of 513 patients implies that its power is not sufficient to show that CEA or CAS is superior to a modern medical therapy (BMT) in the primary prevention of ischemic stroke in patients with an asymptomatic carotid stenosis up to one year after treatment. Also, no evidence for differences in safety between CAS and CEA during the first year after treatment could be derived. Follow-up will be performed up to five years. Data may be used for pooled analysis with ongoing trials.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493019833017
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2211666-7
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  • 2
    Online Resource
    Online Resource
    Variability in Retronasal Odor Identification Among Patients With Chronic Rhinosinusitis
    SAGE Publications ; 2018
    In:  American Journal of Rhinology & Allergy Vol. 32, No. 5 ( 2018-09), p. 424-431
    Details
    In: American Journal of Rhinology & Allergy, SAGE Publications, Vol. 32, No. 5 ( 2018-09), p. 424-431
    Abstract: Retronasal olfaction is important in flavor detection and enjoyment. The ability to identify specific individual retronasal odors may play a role in quality of life for patients with chronic rhinosinusitis (CRS). Objective To identify patterns and improve understanding of retronasal identification of individual odors in CRS patients. Methods Patients diagnosed with CRS underwent retronasal and orthonasal (Sniffin’ Sticks) olfactory testing and taste testing (taste strips). Retronasal identification was tested with presentation of flavored powders on the posterior tongue. Retronasal identification for individual odors was compared with results of orthonasal and taste testing. Results Seventy participants were evaluated. Retronasal identification correlated with orthonasal identification and discrimination for most individual odors. Among all patients, cinnamon and apple were identified better retronasally and banana better orthonasally ( P  〈  .05). Anosmics identified retronasal orange, cinnamon, mushroom, coffee, smoked ham, peach, ginger, grape, and cheese more than would be expected by chance for a forced-choice paradigm with 3 distractor items ( P  〈  .05), and this was independent of objective taste function for most odors. Conclusion Retronasal and orthonasal identification of most odors correlate in CRS patients; however, patients with anosmia can still identify certain retronasal odors more often than expected. These odors do not appear to stimulate gustatory pathways and may involve trigeminal stimulation. Understanding preserved retronasal neural stimuli may allow providers to improve eating-related quality of life in these patients.
    Type of Medium: Online Resource
    ISSN: 1945-8924 , 1945-8932
    URL: Article
    DOI: 10.1177/1945892418793540
    RVK:
    XA 20278
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
    detail.hit.zdb_id: 2554548-6
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  • 3
    Online Resource
    Online Resource
    Changes of Gut Barrier Function During Anesthesia and Cardiac Surgery
    SAGE Publications ; 2001
    In:  Angiology Vol. 52, No. 7 ( 2001-07), p. 477-482
    Details
    In: Angiology, SAGE Publications, Vol. 52, No. 7 ( 2001-07), p. 477-482
    Abstract: The aim of this clinical study was to investigate the time sequence between intraoperative and postoperative endotoxemia, changes in intramucosal pH I , mediator release, and acute phase proteins and their relationship to postoperative infections. In 60 patients (median age 61 [33-72] years, male/female: 50/10) plasma levels of endotoxin, endotoxin neutralizing capacity (ENC), leukotriene-C 4 (LTC 4 ), 6-ketoprostaglandin-F-1α (PGF), thromboxane-B 2 (TxB 2 ), inter leukin-6 (IL-6), and C-reactive protein (CRP) were measured before, during, and after cardiac surgery. The intraluminal pH I of the stomach was assessed as a marker of splanchnic blood circulation. Patients were divided in one group with postoperative infections (group A, n=8) and another groups without infections (group B, n = 52). Among all measured parameters, endotoxin plasma levels showed the most rapid changes. A significant increase of endotoxin plasma levels and a decrease in ENC appeared after the induction of anesthesia, culminating in a peak after reperfusion. Endotoxin showed a significantly higher increase in group A (14fold) compared to group B (sixfold, p 〈 0.001 ), whereas ENC decreased by eightfold in both groups. The parameters of the arachidonic cascade increased and pH I decreased, however, there were no significant differences between both groups. The latest increase was observed for the acute phase proteins IL-6 and CRP. IL-6 levels peaked 6 hours postoperatively with a 20fold (group B) and 30fold (group A) increase (p 〈 0.001 vs baseline; no differences between groups), whereas CRP rose at the first postoperative day with a 21fold (group B) and 25fold (group A) increase at day 2 (p 〈 0.001 vs baseline, no difference between groups). Differences between both groups appeared at the second postoperative day for IL-6 (median values group A/B: 421/219 pg/mL; p 〈 0.05) and at the fifth postoperative day for CRP (median values group A/B: 321/81 mg/L; p 〈 0.05). In conclusion, endotoxin seems to be the earliest trigger of the mediator cascade in acute phase response and may indicate infections in the postoperative course.
    Type of Medium: Online Resource
    ISSN: 0003-3197 , 1940-1574
    URL: Article
    DOI: 10.1177/000331970105200706
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2001
    detail.hit.zdb_id: 2065911-8
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  • 4
    Online Resource
    Online Resource
    In Vitro Metabolite Formation in Human Hepatocytes and Cardiomyocytes and Metabolism and Tissue Distribution in Monkeys of the 2′-C-Methylguanosine Prodrug BMS-986094 : Potential Role in Clinical Cardiovascular Toxicity
    SAGE Publications ; 2017
    In:  International Journal of Toxicology Vol. 36, No. 1 ( 2017-01), p. 35-49
    Details
    In: International Journal of Toxicology, SAGE Publications, Vol. 36, No. 1 ( 2017-01), p. 35-49
    Abstract: BMS-986094, a 2′-C-methylguanosine prodrug for the treatment of chronic hepatitis C virus infection, was withdrawn from phase 2 clinical trials because of unexpected cardiac and renal toxicities. To better understand these toxicities, the in vitro metabolism of BMS-986094 in human hepatocytes (HHs) and human cardiomyocytes (HCMs) and the measurement of BMS-986094 and selected metabolites in monkey plasma and tissues were assessed. BMS-986094 was extensively metabolized by HHs and HCMs, resulting in more efficient formation and accumulation of the active triphosphorylated metabolite, INX-09114, and less efficient efflux of metabolites in HCMs. The predominant metabolism pathway (hydrolysis) in HHs and HCMs was not associated with the formation of reactive metabolites or oxidative stress. In cynomolgus monkeys dosed with BMS-986094 of 15 or 30 mg/kg/d for 3 weeks, the nucleoside metabolite M2 was the major plasma analyte (66%-68% of the combined area under the curve). INX-09114 was the highest drug-related species in the heart and kidney (2,610-4,280 ng/mL [males]; ∼2-420× the concentration of other analytes). Other analytes increased dose dependently, with BMS-986094 highest in diaphragm (≤4,400 ng/mL) followed by M2 in liver and kidney (≤1,360 ng/mL), and M7 and M8 in other tissues (≤124 ng/mL). Three weeks after the last dose, INX-09114 remained high in the heart and kidney (≤1,870 ng/mL), with low M2 (≤37 ng/mL) in plasma and tissues. Persistent high concentrations of INX-09114 in the heart and kidney appeared to correlate with toxicities in these tissues in monkeys.
    Type of Medium: Online Resource
    ISSN: 1091-5818 , 1092-874X
    URL: Article
    DOI: 10.1177/1091581816683642
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
    detail.hit.zdb_id: 1500682-7
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