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7. Early expansion of CD38+ICOS+ GC Tfh in draining lymph nodes during influenza vaccination immune response

Author

Law, H, Mach, M, Howe, A, Obeid, S, Milner, B, Carey, C, Elfis, M, Fsadni, B, Ognenovska, K, Phan, TG, Carey, D, Xu, Y, Venturi, V, Zaunders, J, Kelleher, AD, Munier, CML, Law, H, Mach, M, Howe, A, Obeid, S, Milner, B, Carey, C, Elfis, M, Fsadni, B, Ognenovska, K, Phan, TG, Carey, D, Xu, Y, Venturi, V, Zaunders, J, Kelleher, AD, and Munier, CML

Abstract

T follicular helper (Tfh) cells provide critical help to B cells during the germinal center (GC) reaction to facilitate generation of protective humoral immunity. Accessing the human lymph node (LN) to study the commitment of CD4 T cells to GC Tfh cell differentiation during in vivo vaccine responses is difficult. We used ultrasound guided fine needle biopsy to monitor recall responses in axillary LNs to seasonal influenza vaccination in healthy volunteers. Specific expansion of GC cell subsets occurred exclusively within draining LNs five days postvaccination. Draining LN GC Tfh and precursor-Tfh cells express higher levels of CD38, ICOS, and Ki67, indicating they were significantly more activated, motile, and proliferating, compared to contralateral LN cells. These observations provide insight into the early expansion phase of the human Tfh lineage within LNs during a vaccine induced memory response and highlights early LN immune responses may not be reflected in the periphery.

Published
2022

8. Transformational leadership and team performance in sports teams: A conditional indirect model

Author

Mach, M., Ferreira, A. I., and Abrantes, A. C. M.

Subjects
Moderated mediation, Transformational leadership, Objective sports performance, Humanidades::Outras Humanidades [Domínio/Área Científica], Organizational climate, Team cohesion, Ciências Sociais::Psicologia [Domínio/Área Científica]
Abstract

This study tests how transformational leadership fosters team performance through team cohesion and how that relationship is moderated by previous team performance and leadership consensus. We computed a moderated-mediation model based on a sample of 690 professional players in 59 top professional teams in interactive team sports leagues (basketball, handball, roller hockey, and indoor football/soccer) in Spain. Our findings suggest that transformational leadership indirectly influences objective team performance through the mediation role of team cohesion and that this indirect effect is more prominent when the level of previous performance is higher. We also found that the indirect effect of transformational leadership on team performance via cohesion is stronger in teams with higher consensus regarding their coaches' leadership. Overall, our results demonstrate the importance of integrating dispersion and contextual variables into research models, in particular, previous performance and leadership consensus. info:eu-repo/semantics/publishedVersion

Published
2022

13. Combined in Silico, Ex Vivo, and in Vivo Assessment of L-17, a Thiadiazine Derivative with Putative Neuro-and Cardioprotective and Antidepressant Effects

Author

Sarapultsev, A., Vassiliev, P., Grinchii, D., Kiss, A., Mach, M., Osacka, J., Balloova, A., Paliokha, R., Kochetkov, A., Sidorova, L., Sarapultsev, P., Chupakhin, O., Rantsev, M., Spasov, A., Dremencov, E., Sarapultsev, A., Vassiliev, P., Grinchii, D., Kiss, A., Mach, M., Osacka, J., Balloova, A., Paliokha, R., Kochetkov, A., Sidorova, L., Sarapultsev, P., Chupakhin, O., Rantsev, M., Spasov, A., and Dremencov, E.

Abstract

Depression associated with poor general medical condition, such as post-stroke (PSD) or post-myocardial infarction (PMID) depression, is characterized by resistance to classical antidepres-sants. Special treatment strategies should thus be developed for these conditions. Our study aims to investigate the mechanism of action of 2-morpholino-5-phenyl-6H-1,3,4-thiadiazine, hydrobro-mide (L-17), a recently designed thiadiazine derivative with putative neuro-and cardioprotective and antidepressant-like effects, using combined in silico (for prediction of the molecular binding mechanisms), ex vivo (for assessment of the neural excitability using c-Fos immunocytochemistry), and in vivo (for direct examination of the neuronal excitability) methodological approaches. We found that the predicted binding affinities of L-17 to serotonin (5-HT) transporter (SERT) and 5-HT3 and 5-HT1A receptors are compatible with selective 5-HT serotonin reuptake inhibitors (SSRIs) and antagonists of 5-HT3 and 5-HT1A receptors, respectively. L-17 robustly increased c-Fos immunoreac-tivity in the amygdala and decreased it in the hippocampus. L-17 dose-dependently inhibited 5-HT neurons of the dorsal raphe nucleus; this inhibition was partially reversed by the 5-HT1A antagonist WAY100135. We suggest that L-17 is a potent 5-HT reuptake inhibitor and partial antagonist of 5-HT3 and 5-HT1A receptors; the effects of L-17 on amygdaloid and hippocampal excitability might be mediated via 5-HT, and putatively mediate the antidepressant-like effects of this drug. Since L-17 also possesses neuro-and cardioprotective properties, it can be beneficial in PSD and PMID. Combined in silico predictions with ex vivo neurochemical and in vivo electrophysiological assessments might be a useful strategy for early assessment of the efficacy and neural mechanism of action of novel CNS drugs. © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

Published
2021

18. Selected bisphenols and phthalates screened for estrogen and androgen disruption by in silico and in vitro methods

Author

Kandarova, H., Letasiova, S., Bachelor, M., Milasova, T., Markus, J., Ayehunie, S., Dvořáková, M., Kejlová, K., Rucki, M., Jírová, D., Indra, R., Wilhelm, M., Černá, T., Heger, Z., Dostálová, S., Adam, V., Eckschlager, T., Stiborová, M., Hraběta, J., Arlt, V.M., Schmeiser, H.H., Zdurienčíková, M., Gronesová, P., Sedlák, J., Nekvindova, J., Hyrslova Vaculova, A., Soucek, P., Anzenbacher, P., Vondracek, J., Kiss, I., Slaby, O., Kala, Z., Palicka, V., Horváthová, E., Mastihuba, V., Karnišová Potocká, E., Kis, P., Gálová, E., Ševčovičová, A., Klapáková, M., Mastihubová, M., Vondráček, J., Hýžďalová, M., Pivnička, J., Zapletal, O., Neča, J., Machala, M., Figat, R., Wójtowicz, A., Sobczak, M., Śliwińska, A., Pietrosiuk, A., Nałęcz-Jawecki, G., Košťálová, E., Nagyová, V., Kilbergerová, H., Chomová, L., Kurejová, H., Pavlikova, N., Daniel, P., Sramek, J., Jelinek, M., Halada, P., Kovar, J., Jírová, G., Vlková, A., Wittlerová, M., Kašparová, L., Chrz, J., Wittlingerová, Z., Zimová, M., Mráz, J., Hanzlíková, I., Dušková, Š., Tvrdíková, M., Chrástecká, H., Vajtrová, R., Linhart, I., Brandeburová, P., Grenčíková, A., Žabka, D., Mackuľak, T., Ryba, J., Bondarev, D., Kassa, J., Hepnarova, V., Musilek, K., Misik, J., Hatlapatkova, J., Zdarova Karasova, J., Korabecny, J., Gorecki, L., Malinak, D., Hrabinova, M., Soukup, O., Jun, D., Kuca, K., Benkova, M., Marek, J., Sleha, R., Ryskova, L., Matula, M., Tumu, H., Cuffari, B., Billack, B., Koprdová, R., Májeková, M., Kiss, A., Osacká, J., Dremencov, E., Csatlósová, K., Kokras, N., Dalla, C., Švecová, B., Mach, M., Heger, V., Viskupicova, J., Zoofishan, Z., Hunyadi, A., Horakova, L., Bogi, E., Belovicova, K., Csatlosova, K., Moravcíkova, L., Lacinova, L., Dubovicky, M., Sasváriová, M., Kaprinay, B., Salvaras, L., Belovičová, K., Bögi, E., Knézl, V., Barteková, M., Stankovičová, T., Dubovický, M., Hayes, A.W., vom Berg, C., Iskandar, A., Hoeng, J., Peitsch, MC, Dourson, M., Ambrož, M., Lněničková, K., Matoušková, P., Skálová, L., Boušová, I., Andreji, J., Dvořák, P., Anzenbacherová, E., Prokop, J., Mrkvicová, E., Pavlata, L., Zapletalová, I., Šťastník, O., Martinek, P., Kosina, P., Bögi, E, Csatlosová, K., Bernatova, I., Balis, P., Kluknavsky, M., Zemancikova, A., Torok, J., Puzserova, A., Zárybnický, T., Trnčáková, V., Šubrt, Z., Dršata, J., Brucknerová, I., Brucknerova, J., Ujházy, E., Bujňáková Mlynarčíková, A., Scsuková, S., Caloudova, H., Hodkovicova, N., Berlinska, J., Marsalek, B., Panacek, A., Svobodova, Z., Pino, M.A., Capek, J., Brychtová, V., Handl, J., Majtnerová, P., Rousar, T., Dračínská, H., Jelínková, S., Dvořák, J., Dvořáková Líšková, Z., Graňáková, P., Raisová, Stuchlíková L., Podlipná, R., Szotáková, B., Majerová, M., Hamulakova, S., Janovec, L., Čapek, J., Roušar, T., Hanousková, B., Zemanová, K., Hlávková, D., Havelková, B., Beklová, M., Hodek, P., Hucková, P., Hušková, A., Šimůnek, J., Mrázek, J., Hudeček, J., Sehonova, P., Blahova, J., Vaclavik, J., Hrabinová, M., Schmidt, M., Misík, J., Jáklová, K., Pompach, P., Takácsová, P., Vavrová, K., Kopečková, K., Kolárik, M., Jambor, T., Greifova, H., Massanyi, P., Lukac, N., Járová, K., Osičková, P., Kauerová, T., Hamadová, D., Kollár, P., Goněc, T., Kos, J., Jampílek, J., Syrovets, T., Parák, T., Suchý, P., Kobrlova, T., Janockova, J., Kubíčková, B., Rychnová, J., Dostálová, K., Vyhnalová, K., Mrázková, J., Mandys, V., Wimmerová, M., Lazová, J., Bednáriková, M., Imreová, P., Múčková, M., Lipcseyová, D., Benešová, B., Šoltésová Prnová, M., Štefek, M., Viskupičová, J., Láníčková, T., Tománková, V., Cibiček, N., Snášelová, S., Ulrichová, J., Maňáková, E., Hubičková Heringová, L., Skála, M., Skarková, V., Brynychová, V., Souček, P., Heglasová, S., Dugasová, L., Morová, M., Šimončičová, E., Senko, T., Olexová, L., Dzirbíková, Z., Kršková, L., Muckova, L., Jost, P., Pejchal, J., Nowakowska, K., Giebultowicz, J., Kamaszewski, M., Drobniewska, A., Wroczyński, P., Paprskářová, A., Kuzminová, G., Klusáková, J., Hendrych, M., Pavelka, S., Piešová, M., Račková, L., Škandík, M., Straková, Z., Bezek, Š., Jančinová, V., Raisová, L., Martínková, L., Sabolová, D., Imrichová, N., Rendošová, M., Vargová, Z., Lakatoš, B., Gulač, P., Moserová, M., Martínková, E., Frei, E., Syslová, E., Landa, P., Vaněk, T., Harant, K., Šadibolová, M., Deingruberová, K., Špičáková, A., Kraus, P., Strnad, M., Šušaníková, I., Kukurová, Ľ., Forman, V., Mučaji, P., Tvrdý, V., Karlíčková, J., Hanuščinová, L., Mladěnka, P., Ujhazy, E., Koprdova, R., Brucknerova, I., Valachová, K., Topoľská, D., Šoltés, L., Vanduchova, A., Anzenbacherova, E., Vasicek, O., Rubanova, D., Babinkova, P., Fedr, R., Svenda, J., Kubala, L., Vrba, J., Roubalova, L., Vacek, J., Storch, J., Zaltauskaite, J., Jakubynaite, A., Dikšaitytė, A., Januškaitienė, I., Sujetovienė, G., Kacienė, K., Miškelytė, D., and Juknys, R.

Subjects
L-07, L-29, L-06, L-28, L-09, L-08, Article, Abstract Book, L-03, L-25, L-02, L-24, L-05, L-27, L-04, L-26, L-21, L-20, L-01, L-23, L-22, L-18, L-17, L-19, L-30, L-14, L-13, L-16, L-15, L-10, L-32, L-31, L-12, L-11
Published
2018

36. Epidemiology of hydrogen phosphide exposures in humans reported to the Poison Center in Mainz, Germany, 1983-2003

Author

Lauterbach, Michael, Solak, E., Kaes, J., Wiechelt, J., Von Mach, M.-A., and Weilemann, L.S.

Subjects
Toxicology -- Research, Environmental issues, Health, Pharmaceuticals and cosmetics industries
Abstract

Background. Poisonings with rodenticides containing hydrogen phosphide-releasing compounds may lead to deleterious organ dysfunction and death. Since data of hydrogen phosphide poisonings is limited to case reports/series, this study was intended to elucidate hydrogen phosphide poisonings based on a 20-year data collection. Methods. Explorative data analysis of the Poison Center Mainz database looking for route of exposure, symptoms, and severity using the Poisoning Severity Score. Results. From 1983-2003, 188 hydrogen phosphide poisonings were reported. Sixty-five percent of these were unintentional residential, 28% attempts to commit suicide (intentional), 5% occupational, and 2% undetermined. In the majority of intentional poisonings the poison was ingested, whereas in unintentional poisoning of adults inhalation exposure dominated, caused by inappropriate self-protection from the released hydrogen phosphide gas during usage. Frequently observed symptoms in unintentional poisonings were nausea, vomiting, pain, coughing, and dizziness with no further worsening of symptoms. In intentional poisonings frequent symptoms were vomiting, somnolence, seizures, coma, and shock with two initially fatal poisonings. Follow-up on these cases showed a significant worsening of symptoms and a two-fold increase in fatal poisonings. Conclusion. Route of exposure, severity of symptoms, and the necessary treatment differs substantially between unintentional and intentional poisonings. In this study, two initially symptomatic intentional poisonings were later reported fatal. Careful monitoring is recommended in symptomatic intentional poisonings. Keywords Hydrogen phosphide poisoning; Phosphine; Explorative data analysis; Intent; Age group, INTRODUCTION Rodenticides containing hydrogen phosphide-releasing compounds are readily available for public use. Hydrogen phosphide (phosphine) is produced by the action of water on the mainly used aluminium, calcium, or zinc [...]

Published
2005

37. Experiences of a poison center network with renal insufficiency in acetaminophen overdose: an analysis of 17 cases

Author

von Mach, M.-A., Hermanns-Clausen, M., Koch, I., Hengstler, J.G., Lauterbach, M., Kaes, J., and Weilemann, L.S.

Subjects
Acetaminophen -- Dosage and administration, Acute renal failure -- Risk factors, Acute renal failure -- Diagnosis, Acute renal failure -- Drug therapy, Environmental issues, Health, Pharmaceuticals and cosmetics industries
Abstract

Objective. Renal insufficiency is less common than liver failure in acetaminophen overdose but renal tubular damage occurs even in the absence of hepatotoxicity. Data published on this topic are rare consisting mostly of case reports or reports in a small number of patients. Presently, a larger number of patients with renal insufficiency associated with acetaminophen overdose should be analyzed using a multicenter approach. Study Design. Retrospective analysis of patients with acetaminophen-related nephrotoxicity reported to a poison center network from 1995 to 2003. Renal insufficiency was defined as elevated serum creatinine of more than double of the normal range (>2.4 mg/ dL 212 [micro]mol/L). Patients were classified into 4 groups (A: creatinine 2.4-5.0 mg/dL, B: creatinine >5.0 mg/dL requiring no dialysis, C: creatinine >5.0 mg/dL requiring dialysis, D: creatinine >5.0 mg/dL with fatal outcome). Results. Seventeen patients were included (8 female, 9 male, average age 31.7 [+ or -] 21.1 yrs) with 6 patients in group A (B: 7, C: 2, D: 2). In 5 patients renal insufficiency occurred without elevation of liver enzymes. Regarding possible risk factors 5 patients concomitantly ingested nephrotoxic substances, 4 presented with dehydration due to vomiting, 4 with chronic excessive dosing (overdose) of acetaminophen, 3 showed pre-existing renal insufficiency, 2 pre-existing liver disease and 2 died with multiple organ failure. Conclusions. Renal insufficiency in acetaminophen overdose mostly resolved without dialysis and occurred isolated without hepatotoxicity in less than one-third of the investigated patients. Conditions which might play a role as influencing factors for renal complications included concomitant ingestion of nephrotoxic drugs, dehydration, chronic excessive dosing (overdose) of acetaminophen, preexisting renal or liver disease and multiple organ failure. Renal function should be monitored in acetaminophen overdose particularly in patients showing the latter comorbidity. Keywords Acetaminophen; Overdose; Renal insufficiency, INTRODUCTION Acute renal failure requiring dialysis occurred in approximately 1% of unselected patients arriving at the hospital with acetaminophen overdose before effective antidotes were developed in 1973 (1-3). Recently, acetaminophen-related [...]

Published
2005

38. Empagliflozin and Kidney Function Decline in Patients with Type 2 Diabetes: A Slope Analysis from the EMPA-REG OUTCOME Trial

Author

Wanner, Christoph, Heerspink, Hiddo J. L., Zinman, Bernard, Inzucchi, Silvio E., Koitka-Weber, Audrey, Mattheus, Michaela, Hantel, Stefan, Woerle, Hans-Juergen, Broedl, Uli C., von Eynatten, Maximilian, Groop, Per-Henrik, Aizenberg, D., Ulla, M., Waitman, J., De Loredo, L., Farias, J., Fideleff, H., Lagrutta, M., Maldonado, N., Colombo, H., Ferre Pacora, F., Wasserman, A., Maffei, L., Lehman, R., Selvanayagam, J., d'Emden, M., Fasching, P., Paulweber, B., Toplak, H., Luger, A., Drexel, H., Prager, R., Schnack, C., Schernthaner, G., Fliesser-Goerzer, E., Kaser, S., Scheen, A., Van Gaal, Luc, Hollanders, G., Kockaerts, Y., Capiau, L., Chachati, A., Persu, A., Hermans, M., Vantroyen, D., Vercammen, C., Van de Borne, P., Mathieu, C., Benhalima, Katrien, Lienart, F., Mortelmans, J., Strivay, M., Vereecken, G., Keymeulen, B., Lamkanfi, F., Chacra, A., Eliaschewitz, F., Zanella, M., Faludi, A., Bertolami, M., Hayashida, C., Nunes Salles, J., Monte, O., Dinato, M., Manenti, E., Rassi, N., Halpern, A., Lima Filho, M., Ayoub, J., Felicio, J., Borges, J., Gross, J., Sgarbi, J., Betti, R., Tiburcio, A., Purisch, S., Schmid, H., Takahashi, M., Castro, M., Rea, R., Hissa, M., Geloneze Neto, B., Saraiva, J., Henein, S., Lochnan, H., Imran, S. A., Clayton, D., Bayly, K., Berlingieri, J., Boucher, P., Chan, Y., Gupta, M., Chehayeb, R., Ouellett, A., Ur, E., Woo, V., Zinman, B., St Amour, E., Terront Lozano, M., Yupanqui Lozno, H., Urina, M., Lopez Jaramillo, P., Jaramillo, N., Sanchez, G., Perez, G., Tusek, S., Mirosevic, G., Goldoni, V., Jurisic-Erzen, D., Balasko, A., Balic, S., Drvodelic-Sunic, E., Varzic, S. Canecki, Machkova, M., Weiner, P., Lastuvka, J., Olsovsky, J., Krarup, T., Ridderstrale, M., Tarnow, L., Boesgaard, T. Wellov, Lihn, A. Saetre, Christensen, P., Juhl, H., Urhammer, S., Lund, P., Adojaan, B., Jakovlev, U., Lanno, R., Lubi, M., Marandi, T., Gouet, D., Courreges, J., Zaoui, P., Choukroun, G., Petit, C., Formagne, L., Estour, B., Mabire, P., Daugenet, C., Lemarie, B., Clavel, S., Aure, P., Remaud, P., Halimi, J., Hadjadj, S., Couffinhal, T., Glonti, S., Metreveli, D., Lominadze, Z., Giorgadze, E., Burtchuladze, T., Javashvili, L., Kurashvili, G., Kurashvili, R., Virsaladze, D., Nadareishvili, L., Khomasuridze, A., Cahill, T., Green, F., MacRury, S., Waldron, M., Middleton, A., McKnight, J., Pearson, E., Butler, M., Choksi, M., Caldwell, I., Farmer, I., Wyatt, N., Patrick, J., O'Brien, I., Devers, M., Bousboulas, S., Pappas, S., Piaditis, G., Vryonidou, A., Tentolouris, N., Karamitsos, K., Manes, C., Benroubi, M., Avramidis, I., Ozaki, R., Tan, K., Siu, S., Tsang, C., Dudas, M., Nagy, K., Salamon, C., Ip, T., Geroo, L., Patkay, J., Tabak, A., Juhasz, F., Szentpeteri, I., Tamas, G., Ghaisas, N., Bantwal, G., Mohan, V., Gupta, J., Sadhu, N., Kulkarni, A., Garg, N., Reddy, S., Deshpande, N., Gutlapalli, K., Pillai, M., Premchand, R., Badgandi, M., Jain, S., Aravind, S., Shamanna, P., Pandey, A., Gupta, S., Pramono, B., Saksono, H. Dante, Agung, P., Wahono, S. Djoko, Suastika, K., Tanggo, Y., Juwana, Y., Siswanto, B., Adawi, F., Efrati, S., Mazen, E., Bashkin, A., Herskovits, T., Jaffe, A., Schiff, E., Wainstein, J., Taddei, S., Aiello, A., Arca, M., Calabro, P., Cignarelli, M., Fioretto, P., Reggiani, G. Marchesini, Gnasso, A., Marchionni, N., Marsilii, A., Bucci, M., Mezzetti, A., Pozzilli, P., Colivicchi, F., Santini, M., Moro, E., Toscano, V., Fucili, A., Semplicini, A., Monno, S., Furui, K., Higashiue, S., Hiramatsu, N., Kawamitsu, K., Takenaka, T., Takahashi, H., Hojo, F., Onishi, Y., Izumino, K., Okubo, M., Wakida, Y., Kondo, Y., Hieshima, K., Jinnouchi, H., Suzuki, A., Ito, M., Park, S., Kim, Y., Hong, T., Park, H., Gwon, H., Kim, H., Kang, K., Jeong, M., Seung, K., Lim, D., Rha, S., Tahk, S., Yang, J., Yoon, J., Shin, M., Kim, D., Jeong, J., Ahmad, N. Nik, Mustafa, N., Mohamed, W. Wan, Fung, Y., Ghani, R. Abdul, Chandramouli, A., Chee, K., Kadir, K. Abdul, Ling, K., Abu Hassan, M., Foo, S., Lee, S., Garcia Hernandez, P., Aguilar-Salinas, C., Vidrio Velazquez, M., Flores, F., Alpizar Salazar, M., Micher Escalante, D., Garcia Soria, M., Cardona Munoz, E., Storms, G., Schaper, N., Kooy, A., Krekels, M., van Bemmel, T., Verhoeven, R., Mulder, H., Oldenburg-Ligtenberg, P., Gonkel, F., de Jong, A., van Soest, J., Viergever, P., Mevissen, H., Lochorn, G., Zwiers, G., Hoogslag, P., Ronner, E., Nierop, P., Al-Windy, N., Kragten, J., Dekelver, P., Benatar, J., Krebs, J., Scott, R., Heggen, E., Berz, A., Fossum, C., Hurtig, U., Langslet, G., Baranowski, M., Sparby, J., Karlsson, T., Karlsson, Thomas, Delgado Torres, C., Rodriguez Escudero, A., Lisson, R., Allemant Maldonado, A., Gallardo Rojas, W., Gonzales Bravo, L., Lema Osores, J., Farfan, J., Zapata, L., Godoy Junchaya, J., Roldan Concha, Y., Urquiaga Calderon, J., Sy, R., Tan, G., Aquitania, G., De Los Santos, G., Panelo, A., Roderos, O., Rosales, R., Toledo, R., Liwag, A., Ramoncito, H., Skokowska, E., Krzyzagorska, E., Ogorek, M., Wojnowski, L., Spyra, J., Konieczny, M., Piesiewicz, W., Kus, W., Ocicka-Kozakiewicz, A., Orlowska-Kunikowska, E., Zmuda, W., Duarte, S., Leitao, A., Monteiro, P., Rita, H., Salgado, V., Pinto, L., Queiros, J., Teixeira, J., Rogado, C., Duarte, R., Sobral do Rosario, F., Silva, A., Andrade, L., Velez, M., Brazao, M., Istratoaie, O., Lichiardopol, R., Catrinoiu, D., Militaru, C., Zetu, C., Barbonta, D., Cosma, D., Crisan, C., Pop, L., Esip, V., Khetagurova, F., Petrov, A., Arutyunov, G., Boyarkin, M., Agafyina, A., Vorokhobina, N., Petunina, N., Libov, I., Zalevskaya, A., Nikolaev, K., Barbarash, O., Potemkin, V., Bystrova, A., Krasilnikova, E., Barbarich, V., Chumakova, G., Tarasov, N., Meleshkevich, T., Zateyshchikov, D., Lantseva, O., Belenkiy, D., Obrezan, A., Rossolko, L., Fillipova, E., Yakhontova, P., Khokhlov, A., Tan, R., Sum, C., Chang, H., Distiller, L., Pretorius, M., Nortje, H., Mitha, E., Burgess, L., Blignaut, S., Venter, T., Moodley, R., Lombaard, J., Govind, U., Naidoo, V., Mookadam, M., Engelbrecht, J., Omar, M., Jurgens, J., Podgorski, G., Vawda, H., Naidoo, D., Emanuel, S., Roodt, A., Amod, A., Van Zyl, L., Segura, J., Brito, M., Fernandez-Cruz, A., Artola, S., Iglesias, R., Toural, E., Garcia-Ortiz, L., Saban, J., Mesa, J., Vidal, J., Linares, J., del Canizo, F., Rigla, M., Suarez, C., Llorente, I., Moreno, B., Antoli, A., Gomez Peralta, F., Iglesias, M., Pereg, V., de Teresa, L., Camafort, M., Trescoli, C., Satarasinghe, R., Somasundaram, N., Siyambalapitiya, S., Antonypillai, C., Bulugahapitiya, D., Medagama, U., Huang, C., Lu, Y., Hwang, J., Chiang, C., Wen, M., Chen, J., Lai, W., Chang, K., Wang, J., Yeh, H., Kriangsak, P., Deerochanawong, C., Suwanwalaikorn, S., Mangklabruks, A., Kaewsuwanna, P., Piyayotai, D., Iabluchanskyi, M., Samoylov, O., Godlevska, O., Kovalyova, O., Voloshyna, O., Tseluyko, V., Zotov, S., Vykhovanyuk, I., Dulgeroff, A., Mayfield, R., Zaniewski-Singh, M., Ullal, J., Aloi, J., De La Rosa, R., Mosely, J., Wittmer, B., Aronoff, S., Rosenfeld, J., Seidner, M., Warren, M., Fishman, N., Weiss, R., Arif, A., Sandberg, M., Lewis, D., Ball, E., Graf, R., Breton, C., Tamayo, R., Richards, R., Cefalu, W., Uwaifo, G., Zayour, D., Hoffman, J., Fitz-Patrick, D., Khan, B., Blaze, K., Bressler, P., Halpern, S., Chappell, D., Bergenstal, R., Cuddihy, R., Matfin, G., Freedman, Z., Gonzalez-Campoy, J., Lerman, S., Rendell, M., Sitar, S., Reeves, M., Howard, T., Soufer, J., Miranda-Palma, B., Laliotis, A., Shomali, M., Teltser, M., Hurley, D., Morawski, E., Cherlin, R., Houchin, V., Welch, M., Goytia-Leos, D., Syed, M., Kowaloff, E., Weinrauch, L., Peniston, J., Brockmyre, A., First, B., Feld, L., Huffman, D., Nassim, O., Gottschlich, G., Patel, A., Knopke, C., Hernandez, M., Diaz, J., Giugliano, G., Nicasio, J., Eagerton, D., Huntley, R., Reed, J., Magee, M., Hippert, R., Sofley, C., Alzohaili, O., Levins, P., Anspach, R., Shah, S., Brusco, O., Naidu, J., Lindenbaum, J., Jacks, R., Hammond, G., Arena, C., Saxman, K., Mach, M., Kerstein, H., Kereiakes, D., Wahlen, J., Wehmeier, K., Chaykin, L., Rothman, J., Fogelfeld, L., Stroger, John H., Bittar, N., Rosenstock, J., Kayne, D., Navarro, J., Colfer, H., Mokshagundam, S., Shandilya, L., Connery, L., Wysham, C., Dela Llana, A., Jardula, M., MacAdams, M., Flippo, G., Heurich, E., Curtis, C., Sanders, D., Rawls, R., Velazquez, F., Osea, E., Mahood, K., Feldman, G., Eder, F., Riley, E., Fowler, W., Jain, M., Shepard, M., Schear, M., Barker, B., Strout, C., Obiekwe, O., Shanik, M., Green, C., Blakney, E., Roberson, K., Bretton, E., Pish, R., Kaveh, K., Maynard, B., Barager, W., Soldyshev, R., Austin, B., Parmar, P., Simpson, R., Chauhan, A., Kasper, J., Burr, R., Patel, N., Mariano, H., Pluto, T., Bratcher, C., Juarez, M., Levinson, L., Awad, A., Longshaw, K., Hoffman, K., Richwine, R., Molter, D., Boscia, J., Kowalyk, S., Lemis, P., Liss, J., Orr, R., Riser, J., Wood, J., Ubani, A., Paine, W., Hassani, F., Miranda, F., Hansen, V., Hansen, Val R., Farris, N., Bowden, R., Ajani, D., Maw, K., Andersen, J., Bergman, B., Dunmyer, S., Brandon, D., Anderson, M., Bononi, P., Prawer, J., Seidman, B., Cruz, H., Wilks, K., DiSanto, L., Buynak, R., Christensen, T., Denker, P., Koppel, W., Stedman, M., Lewy-Alterbaum, L., Karim, S., Shapiro, J., Gardner, T., Oskin, T., Gabra, N., Malano, J., Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Groningen Kidney Center (GKC), Methods in Medicines evaluation & Outcomes research (M2O), and EMPA-REG OUTCOME Investigators

Subjects
Male, Placebo-controlled study, PROGRESSION, Type 2 diabetes, 030204 cardiovascular system & hematology, PLACEBO-CONTROLLED TRIAL, GLOMERULAR-FILTRATION-RATE, HYPERFILTRATION, law.invention, ESTABLISHED CARDIOVASCULAR-DISEASE, Cohort Studies, MELLITUS, 0302 clinical medicine, Randomized controlled trial, Glucosides, law, Medicine, Diabetic Nephropathies, GFR DECLINE, General Medicine, Middle Aged, Nephrology, diabetes mellitus, randomized controlled trials, Disease Progression, Female, Glomerular Filtration Rate, medicine.medical_specialty, Urology, Renal function, 030209 endocrinology & metabolism, Placebo, 03 medical and health sciences, Double-Blind Method, Clinical Research, Diabetes mellitus, BASE-LINE CHARACTERISTICS, END-POINTS, Empagliflozin, Humans, Benzhydryl Compounds, Sodium-Glucose Transporter 2 Inhibitors, Aged, COTRANSPORTER 2 INHIBITION, Models, Statistical, Dose-Response Relationship, Drug, business.industry, chronic kidney disease, medicine.disease, Confidence interval, Diabetes Mellitus, Type 2, Human medicine, business
Abstract

BACKGROUND: Empagliflozin slowed the progression of CKD in patients with type 2 diabetes and cardiovascular disease in the EMPA-REG OUTCOME Trial. In a prespecified statistical approach, we assessed treatment differences in kidney function by analyzing slopes of eGFR changes.METHODS: Participants (n=7020) were randomized (1:1:1) to empagliflozin 10 mg/d, empagliflozin 25 mg/d, or placebo added to standard of care. We calculated eGFR slopes using random-intercept/random-coefficient models for prespecified study periods: treatment initiation (baseline to week 4), chronic maintenance treatment (week 4 to last value on treatment), and post-treatment (last value on treatment to follow-up).RESULTS: Compared with placebo, empagliflozin was associated with uniform shifts in individual eGFR slopes across all periods. On treatment initiation, adjusted mean slope (eGFR change per week, ml/min per 1.73 m2) decreased with empagliflozin (-0.77; 95% confidence interval, -0.83 to -0.71; placebo: 0.01; 95% confidence interval, -0.08 to 0.10; PCONCLUSIONS: The hemodynamic effects of empagliflozin, associated with reduction in intraglomerular pressure, may contribute to long-term preservation of kidney function.

Published
2018

42. Impact of asphyxia on red blood cell folate concentration levels in newborns

Author

Revakova T, Dubovicky M, Eduard Ujházy, Mach M, Ingrid Brucknerová, and A Vasilenkova

Subjects
Male, Economics and Econometrics, Erythrocytes, medicine.medical_treatment, Physiology, Gestational Age, Folic Acid, Sex Factors, Materials Chemistry, Media Technology, medicine, Humans, Caesarean section, Prospective Studies, Prospective cohort study, Asphyxia, Asphyxia Neonatorum, business.industry, Infant, Newborn, Gestational age, Forestry, Fetal Blood, medicine.disease, Perinatal asphyxia, Red Blood Cell Folate, Red blood cell, medicine.anatomical_structure, Anesthesia, Female, medicine.symptom, business
Abstract

OBJECTIVES To determine whether red blood cell (RBC) folate concentration levels are correlated with the occurrence of neonatal asphyxia and to study the effects of gestational age, gender, and mode of delivery on RBC folate concentration levels in newborns. BACKGROUND Asphyxia is one of the frequent causes of morbidity and mortality of newborns. Severe perinatal asphyxia can arise due to many factors. METHODS In a prospective study, the RBC folate concentrations were determined on day 1 of life in the whole group (n=181) of full-term (n=121) and preterm (n=60) newborns. Immunochemical analysis for the determination of folate in erythrocytes was performed. RESULTS RBC folate concentration levels in asphyxiated newborns (n=16) were significantly decreased (median 974 ng/ml; p=0.023) in comparison with healthy newborns. On the other hand, the RBC folate concentration levels were significantly increased in preterm newborns (median 1,212 ng/ml; p=0.01) in comparison with full-term newborns (median 1,098 ng/ml). Higher RBC folate concentration levels were found in newborns which had been delivered by Caesarean section (median 1,188 ng/ml; p=0.02) compared to those born vaginally (median 1,098 ng/ml). CONCLUSION Our results confirmed a significant decrease in RBC folate concentration in asphyxiated newborns on their first day of life (Fig. 4, Ref. 36).

Published
2015

43. Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk

Author

Zinman, Bernard, Inzucchi, Silvio E., Lachin, John M., Wanner, Christoph, Fitchett, David, Kohler, Sven, Mattheus, Michaela, Biomath, Dipl, Woerle, Hans J., Broedl, Uli C., Johansen, Odd Erik, Albers, Gregory W., Diener, Hans Christoph, Aizenberg, D., Ulla, M., Waitman, J., De Loredo, L., Farias, J., Fideleff, H., Lagrutta, M., Maldonado, N., Colombo, H., Ferre Pacora, F., Wasserman, A., Maffei, L., Lehman, R., Selvanayagam, J., d'Emden, M., Fasching, P., Paulweber, B., Toplak, H., Luger, A., Drexel, H., Prager, R., Schnack, C., Schernthaner, G., Fliesser-Goerzer, E., Kaser, S., Scheen, A., Van Gaal, L., Hollanders, G., Kockaerts, Y., Capiau, L., Chachati, A., Persu, A., Hermans, M., Vantroyen, D., Vercammen, C., Van de Borne, P., Mathieu, C., Benhalima, K., Lienart, F., Mortelmans, J., Strivay, M., Vereecken, G., Keymeulen, B., Lamkanfi, F., Chacra, A., Eliaschewitz, F., Zanella, M., Faludi, A., Bertolami, M., Hayashida, C., Nunes Salles, J., Monte, O., Dinato, M., Manenti, E., Rassi, N., Halpern, A., Lima Filho, M., Ayoub, J., Felicio, J., Borges, J., Gross, J., Sgarbi, J., Betti, R., Tiburcio, A., Purisch, S., Schmid, H., Takahashi, M., Castro, M., Rea, R., Hissa, M., Geloneze Neto, B., Saraiva, J., Henein, S., Lochnan, H., Imran, S. A., Clayton, D., Bayly, K., Berlingieri, J., Boucher, P., Chan, Y., Gupta, M., Chehayeb, R., Ouellett, A., Ur, E., Woo, V., Zinman, B., St Amour, E., Terront Lozano, M., Yupanqui Lozno, H., Urina, M., Lopez Jaramillo, P., Jaramillo, N., Sanchez, G., Perez, G., Tusek, S., Mirosevic, G., Goldoni, V., Jurisic-Erzen, D., Balasko, A., Balic, S., Drvodelic-Sunic, E., Varzic, S. Canecki, Machkova, M., Weiner, P., Lastuvka, J., Olsovsky, J., Krarup, T., Ridderstrale, M., Tarnow, L., Boesgaard, T. Wellov, Lihn, A. Saetre, Christensen, P., Juhl, H., Urhammer, S., Lund, P., Adojaan, B., Jakovlev, U., Lanno, R., Lubi, M., Marandi, T., Gouet, D., Courreges, J., Zaoui, P., Choukroun, G., Petit, C., Formagne, L., Estour, B., Mabire, P., Daugenet, C., Lemarie, B., Clavel, S., Aure, P., Remaud, P., Halimi, J., Hadjadj, S., Couffinhal, T., Glonti, S., Metreveli, D., Lominadze, Z., Giorgadze, E., Burtchuladze, T., Javashvili, L., Kurashvili, G., Kurashvili, R., Virsaladze, D., Nadareishvili, L., Khomasuridze, A., Cahill, T., Green, F., MacRury, S., Waldron, M., Middleton, A., McKnight, J., Pearson, E., Butler, M., Choksi, M., Caldwell, I., Farmer, I., Wyatt, N., Patrick, J., O'Brien, I., Devers, M., Bousboulas, S., Pappas, S., Piaditis, G., Vryonidou, A., Tentolouris, N., Karamitsos, K., Manes, C., Benroubi, M., Avramidis, I., Ozaki, R., Tan, K., Siu, S., Tsang, C., Dudas, M., Nagy, K., Salamon, C., Ip, T., Geroo, L., Patkay, J., Tabak, A., Juhasz, F., Szentpeteri, I., Tamas, G., Ghaisas, N., Bantwal, G., Mohan, V., Gupta, J., Sadhu, N., Kulkarni, A., Garg, N., Reddy, S., Deshpande, N., Gutlapalli, K., Pillai, M., Premchand, R., Badgandi, M., Jain, S., Aravind, S., Shamanna, P., Pandey, A., Gupta, S., Pramono, B., Saksono, H. Dante, Agung, P., Wahono, S. Djoko, Suastika, K., Tanggo, Y., Juwana, Y., Siswanto, B., Adawi, F., Efrati, S., Mazen, E., Bashkin, A., Herskovits, T., Jaffe, A., Schiff, E., Wainstein, J., Taddei, S., Aiello, A., Arca, M., Calabro, P., Cignarelli, M., Fioretto, P., Reggiani, G. Marchesini, Gnasso, A., Marchionni, N., Marsilii, A., Bucci, M., Mezzetti, A., Pozzilli, P., Colivicchi, F., Santini, M., Moro, E., Toscano, V., Fucili, A., Semplicini, A., Monno, S., Furui, K., Higashiue, S., Hiramatsu, N., Kawamitsu, K., Takenaka, T., Takahashi, H., Hojo, F., Onishi, Y., Izumino, K., Okubo, M., Wakida, Y., Kondo, Y., Hieshima, K., Jinnouchi, H., Suzuki, A., Ito, M., Park, S., Kim, Y., Hong, T., Park, H., Gwon, H., Kim, H., Kang, K., Jeong, M., Seung, K., Lim, D., Rha, S., Tahk, S., Yang, J., Yoon, J., Shin, M., Kim, D., Jeong, J., Ahmad, N. Nik, Mustafa, N., Mohamed, W. Wan, Fung, Y., Ghani, R. Abdul, Chandramouli, A., Chee, K., Kadir, K. Abdul, Ling, K., Abu Hassan, M., Foo, S., Lee, S., Garcia Hernandez, P., Aguilar-Salinas, C., Vidrio Velazquez, M., Flores, F., Alpizar Salazar, M., Micher Escalante, D., Garcia Soria, M., Cardona Munoz, E., Storms, G., Schaper, N., Kooy, A., Krekels, M., van Bemmel, T., Verhoeven, R., Mulder, H., Oldenburg-Ligtenberg, P., Gonkel, F., de Jong, A., van Soest, J., Viergever, P., Mevissen, H., Lochorn, G., Zwiers, G., Hoogslag, P., Ronner, E., Nierop, P., Al-Windy, N., Kragten, J., Dekelver, P., Benatar, J., Krebs, J., Scott, R., Heggen, E., Berz, A., Fossum, C., Hurtig, U., Langslet, G., Baranowski, M., Sparby, J., Karlsson, T., Karlsson, Thomas, Delgado Torres, C., Rodriguez Escudero, A., Lisson, R., Allemant Maldonado, A., Gallardo Rojas, W., Gonzales Bravo, L., Lema Osores, J., Farfan, J., Zapata, L., Godoy Junchaya, J., Roldan Concha, Y., Urquiaga Calderon, J., Sy, R., Tan, G., Aquitania, G., De Los Santos, G., Panelo, A., Roderos, O., Rosales, R., Toledo, R., Liwag, A., Ramoncito, H., Skokowska, E., Krzyzagorska, E., Ogorek, M., Wojnowski, L., Spyra, J., Konieczny, M., Piesiewicz, W., Kus, W., Ocicka-Kozakiewicz, A., Orlowska-Kunikowska, E., Zmuda, W., Duarte, S., Leitao, A., Monteiro, P., Rita, H., Salgado, V., Pinto, L., Queiros, J., Teixeira, J., Rogado, C., Duarte, R., Sobral do Rosario, F., Silva, A., Andrade, L., Velez, M., Brazao, M., Istratoaie, O., Lichiardopol, R., Catrinoiu, D., Militaru, C., Zetu, C., Barbonta, D., Cosma, D., Crisan, C., Pop, L., Esip, V., Khetagurova, F., Petrov, A., Arutyunov, G., Boyarkin, M., Agafyina, A., Vorokhobina, N., Petunina, N., Libov, I., Zalevskaya, A., Nikolaev, K., Barbarash, O., Potemkin, V., Bystrova, A., Krasilnikova, E., Barbarich, V., Chumakova, G., Tarasov, N., Meleshkevich, T., Zateyshchikov, D., Lantseva, O., Belenkiy, D., Obrezan, A., Rossolko, L., Fillipova, E., Yakhontova, P., Khokhlov, A., Tan, R., Sum, C., Chang, H., Distiller, L., Pretorius, M., Nortje, H., Mitha, E., Burgess, L., Blignaut, S., Venter, T., Moodley, R., Lombaard, J., Govind, U., Naidoo, V., Mookadam, M., Engelbrecht, J., Omar, M., Jurgens, J., Podgorski, G., Vawda, H., Naidoo, D., Emanuel, S., Roodt, A., Amod, A., Van Zyl, L., Segura, J., Brito, M., Fernandez-Cruz, A., Artola, S., Iglesias, R., Toural, E., Garcia-Ortiz, L., Saban, J., Mesa, J., Vidal, J., Linares, J., del Canizo, F., Rigla, M., Suarez, C., Llorente, I., Moreno, B., Antoli, A., Gomez Peralta, F., Iglesias, M., Pereg, V., de Teresa, L., Camafort, M., Trescoli, C., Satarasinghe, R., Somasundaram, N., Siyambalapitiya, S., Antonypillai, C., Bulugahapitiya, D., Medagama, U., Huang, C., Lu, Y., Hwang, J., Chiang, C., Wen, M., Chen, J., Lai, W., Chang, K., Wang, J., Yeh, H., Kriangsak, P., Deerochanawong, C., Suwanwalaikorn, S., Mangklabruks, A., Kaewsuwanna, P., Piyayotai, D., Iabluchanskyi, M., Samoylov, O., Godlevska, O., Kovalyova, O., Voloshyna, O., Tseluyko, V., Zotov, S., Vykhovanyuk, I., Dulgeroff, A., Mayfield, R., Zaniewski-Singh, M., Ullal, J., Aloi, J., De La Rosa, R., Mosely, J., Wittmer, B., Aronoff, S., Rosenfeld, J., Seidner, M., Warren, M., Fishman, N., Weiss, R., Arif, A., Sandberg, M., Lewis, D., Ball, E., Graf, R., Breton, C., Tamayo, R., Richards, R., Cefalu, W., Uwaifo, G., Zayour, D., Hoffman, J., Fitz-Patrick, D., Khan, B., Blaze, K., Bressler, P., Halpern, S., Chappell, D., Bergenstal, R., Cuddihy, R., Matfin, G., Freedman, Z., Gonzalez-Campoy, J., Lerman, S., Rendell, M., Sitar, S., Reeves, M., Howard, T., Soufer, J., Miranda-Palma, B., Laliotis, A., Shomali, M., Teltser, M., Hurley, D., Morawski, E., Cherlin, R., Houchin, V., Welch, M., Goytia-Leos, D., Syed, M., Kowaloff, E., Weinrauch, L., Peniston, J., Brockmyre, A., First, B., Feld, L., Huffman, D., Nassim, O., Gottschlich, G., Patel, A., Knopke, C., Hernandez, M., Diaz, J., Giugliano, G., Nicasio, J., Eagerton, D., Huntley, R., Reed, J., III, Magee, M., Hippert, R., Sofley, C., Jr., Alzohaili, O., Levins, P., Anspach, R., Shah, S., Brusco, O., Naidu, J., Lindenbaum, J., Jacks, R., Hammond, G., Arena, C., Saxman, K., Mach, M., Kerstein, H., Kereiakes, D., Wahlen, J., Wehmeier, K., Chaykin, L., Rothman, J., Fogelfeld, L., Stroger, John H., Jr., Bittar, N., Rosenstock, J., Kayne, D., Navarro, J., Colfer, H., Mokshagundam, S., Shandilya, L., Connery, L., Wysham, C., Dela Llana, A., Jardula, M., MacAdams, M., Flippo, G., Heurich, E., Curtis, C., Sanders, D., Rawls, R., Velazquez, F., Osea, E., Mahood, K., Feldman, G., Eder, F., Riley, E., Fowler, W., Jain, M., Shepard, M., Schear, M., Barker, B., Strout, C., Obiekwe, O., Shanik, M., Green, C., Blakney, E., Roberson, K., Bretton, E., Pish, R., Kaveh, K., Maynard, B., Barager, W., Soldyshev, R., Austin, B., Parmar, P., Simpson, R., Chauhan, A., Kasper, J., Burr, R., Patel, N., Mariano, H., Pluto, T., Bratcher, C., Juarez, M., Levinson, L., Awad, A., Longshaw, K., Hoffman, K., Richwine, R., Molter, D., Boscia, J., III, Kowalyk, S., Lemis, P., Liss, J., Orr, R., Riser, J., Wood, J., Ubani, A., Paine, W., Hassani, F., Miranda, F., Hansen, V., Hansen, Val R., Farris, N., Bowden, R., Ajani, D., Maw, K., Andersen, J., Bergman, B., Dunmyer, S., Brandon, D., Anderson, M., Bononi, P., Prawer, J., Seidman, B., Cruz, H., Wilks, K., DiSanto, L., Buynak, R., Christensen, T., Denker, P., Koppel, W., Stedman, M., Lewy-Alterbaum, L., Karim, S., Shapiro, J., Gardner, T., Oskin, T., Gabra, N., Malano, J., and EMPA REG OUTCOME Investigators

Subjects
riesgo, compuestos de bencidrilo, type 2 diabetes mellitus, Original Contributions, humanos, Medizin, 030204 cardiovascular system & hematology, blood pressure, cardiovascular diseases, hematocrit, stroke, 0302 clinical medicine, Glucosides, glucósidos, 030212 general & internal medicine, Myocardial infarction, Stroke, mediana edad, anciano, OUTCOMES, Hazard ratio, Middle Aged, ISCHEMIC-STROKE, Anesthesia, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Cardiology, TRIAL, Cardiology and Cardiovascular Medicine, Life Sciences & Biomedicine, Risk, medicine.medical_specialty, Clinical Sciences, enfermedades cardiovasculares, Clinical Neurology, Placebo, 03 medical and health sciences, Outcome Assessment (Health Care), Internal medicine, medicine, Empagliflozin, Diabetes Mellitus, Humans, Hypoglycemic Agents, accidente cerebrovascular, Benzhydryl Compounds, METAANALYSIS, Aged, Advanced and Specialized Nursing, Science & Technology, business.industry, MORTALITY, Type 2 Diabetes Mellitus, medicine.disease, Confidence interval, Blood pressure, hipoglicemiantes, Peripheral Vascular Disease, evaluación de resultados (asistencia sanitaria), Cardiovascular System & Cardiology, Neurology (clinical), Neurosciences & Neurology, business, FOLLOW-UP
Abstract

Supplemental Digital Content is available in the text., Background and Purpose— In the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients), empagliflozin added to standard of care in patients with type 2 diabetes mellitus and high cardiovascular risk reduced the risk of 3-point major adverse cardiovascular events, driven by a reduction in cardiovascular mortality, with no significant difference between empagliflozin and placebo in risk of myocardial infarction or stroke. In a modified intent-to-treat analysis, the hazard ratio for stroke was 1.18 (95% confidence interval, 0.89–1.56; P=0.26). We further investigated cerebrovascular events. Methods— Patients were randomized to empagliflozin 10 mg, empagliflozin 25 mg, or placebo; 7020 patients were treated. Median observation time was 3.1 years. Results— The numeric difference in stroke between empagliflozin and placebo in the modified intent-to-treat analysis was primarily because of 18 patients in the empagliflozin group with a first event >90 days after last intake of study drug (versus 3 on placebo). In a sensitivity analysis based on events during treatment or ≤90 days after last dose of drug, the hazard ratio for stroke with empagliflozin versus placebo was 1.08 (95% confidence interval, 0.81–1.45; P=0.60). There were no differences in risk of recurrent, fatal, or disabling strokes, or transient ischemic attack, with empagliflozin versus placebo. Patients with the largest increases in hematocrit or largest decreases in systolic blood pressure did not have an increased risk of stroke. Conclusions— In patients with type 2 diabetes mellitus and high cardiovascular risk, there was no significant difference in the risk of cerebrovascular events with empagliflozin versus placebo. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01131676.

Published
2017

50. Human Monoclonal Antibodies Neutralizing Cytomegalovirus (CMV) for Prophylaxis of CMV Disease: Report of a Phase I Trial in Bone Marrow Transplant Recipients

Author

Aulitzky, W. E., Schulz, T. F., Tilg, H., Niederwieser,, D., Larcher, K., Ostberg, L., Scriba, M., Martindale,, J., Stern, A. C., Grass, P., Mach, M., Dierich,, M. P., Huber, C., Aulitzky, W. E., Schulz, T. F., Tilg, H., Niederwieser,, D., Larcher, K., Ostberg, L., Scriba, M., Martindale,, J., Stern, A. C., Grass, P., Mach, M., Dierich,, M. P., and Huber, C.

Abstract

The safety and pharmacokinetics of the two neutralizing human IgG1 monoclonal antibodies to cytomegalovirus (CMV) SDZ89-104 and 89-109 in bonemarrowtransplant (BM1)recipients was assessed in an open phase I trial. Thirteen patients, 8 seropositive and 5 seronegative for CMV, were treated with allogeneic or autologous bone marrow transplantation. SDZ 89-104 was given to 5 and SDZ 89-109 to 8 patients. Patients were divided into high-and low-dose groups. A fixed prestudy dose of 0.1 mg/kg was given 4 days before BMT. On days 3, 17, 31,45, 59, and 73, patients were treated with either 0.5 or 2 mg/kg of the respective antibody. Results indicate that doses of 2 mg/kg of SDZ 89-104 or SDZ 89-109 in alternating weeks can be safely administered to BMT patients. Serum trough levels measured by antiidiotype ELISA were ∼10 µg/ml after administration of 0.5 mg/kg and ∼50 µg/ml after treatment with 2 mg/kg of SDZ 89-104 or SDZ 89-109. High serum levels defined by antiidiotype ELISA techniques closely paralleled increased neutralizing activity. Serum half-lives calculatedfrom these data were ∼6 days

Published
2017

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