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5. Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: The PAUSE study

Author

Mirone V, ARCANIOLO, Davide, Rivas D, Bull S, Aquilina JW, Verze P, PAUSE study team Berchart G, Hass M, Ludvik G, Aalto J, Hendolin N, Lukkarinen O, Multanen M, Nurmenniemi V, Piha J, Aheimer C, Alebrahim Dehkordy A, Andreessen R, Aust C, Baer P, Bath V, Baumgrass H, Beck C, Beecken WD, Behre H, Beitzinger M, Belusa A, Bermes UR, Berning T, Bieringer La Roche D, Blasko S, Boehmer S, Borchardt A, Boerner T, Brands F, Braun PM, Braun R, Breu D, Briken P, Brueske T, Bueker R, Buse A, Carius A, Christoph F, Cuno M, Dats E, Degen N, Denil J, Dietrichs K, Domnitz R, Dorn B, Dubiel J, Eckert R, Ehrenberg W, Eichler S, El Khadra S, Engl T, Esser O, Faragallah EA, Farahmandi R, Finke G, Fleig P, Fruehauf E, Gerhardt U, Girke CG, Glauche J, Gleissner J, Gnann R, Gralla O, Grandin A, Grewe W, Gronau E, Gruber S, Grunert S, Guelbeyaz M, Guelden H, Haendel D, Haefele J, Haghighat M, Hahne D, Haschemi Schirazi R, Hecker D, Herzig J, Hettmmer R, Hitschfeld K, Hofmann J, Hohmuth H, Hoelker D, Huebner A, Hudemann B, Hung Wehmann D, Huenninghaus K, Hueter K, Igde H, Jaeger T, Javadi P, John G, Ju M, Kaisser G, Kamann L, Kastein A, Kaup F, Kellner T, Kempe T, Kempter F, Kennerknecht M, Kirschner P, Koenig M, Konert J, Kowalik S, Krieger JU, Kruppa GL, Kube U, Kuehn F, Kuefer R, Kurt T, Kwela M, Laag R, Langen L, Lehmann J, Linder C, Loeber T, Lock UC, Loebenau M, Luberg Sievers G, Luebbe R, Lutz K, Maier S, Maletz C, Mertins B, Meschede E, Meschi MR, Miersch WD, Misera A, Muehlich S, Mueller HW, Mueller D, Muench HC, Nawka P, Othman K, Paiss T, Peter K, Peters T, Petras T, Petrischenko B, Pfund A, Plate H, Ploss HJ, Pohrt U, Pooyeh S, Potempa AJ, Pusinelli WD, Rausch U, Reinhardt F, Rengel U, Rietheimer W, Rinnab L, Rohrmann K, Romahn E, Romitan Baum R, Roessler T, Rudolph R, Rueffer J, Rug M, Rueth J, Ruettgers E, Santiago RB, Schaefer A, Schaefer T, Schaetzle P, Scheunpflug K, Schlicht J, Schmidt P, Schneider J, Schnitzler M, Schonfelder R, Schreier H, Schroeder A, Schulz FM, Schulze M, Schumann M, Seidler A, Seseke S, Siebel Eggeling G, Siebels M, Sinner B, Sippel F, Soballa M, Sommer F, Spielhaupter A, Steffen H, Steinacker M, Stiersdorfer A, Stoehr C, Sturm S, Surrey HW, Swoboda A, Szymula S, Telle J, Uththoff H, Vierneisel C, Vilmar W, Wagner M, Walhoefer F, Warnack W, Weiss J, Weizert P, Wicht A, Wieland J, Willgerodt J, Wilski B, Wilson E, Wipfler G, Wohn HG, Wolf J, Zoehrlaut B, Zuerner T, Angeletti G, Avolio A, Baldassarre R, Balercia G, Balloni F, Barba G, Bartoletti R, Basile Fasolo C, Bassi PF, Beatrici V, Bertozzi MA, Bocciardi AM, Bondavalli C, Bonini F, Bonsanto M, Branchi A, Briganti A, Calabrese M, Calafiore R, Calogero AE, Cantelmo P, Caraceni E, Carbone A, Cardella A, Carini M, Carmignani L, Carmignani G, Carrino M, Caviglia C, Cecchi M, Ceruti C, Chiovato L, Cicalese V, Colpi G, Corinti M, Cormio L, Cova G, Cozzupoli P, Ottavio G, Damiano R, De Ceglie G, De Grande G, De Lisa A, DE SIO, Marco, De Stefani S, Dehò F, Delsignore A, Di Filippo A, Di Lena S, Di Trapani D, Diambrini M, Drei GN, Fabbri A, Fasolis G, Ferone D, Ferrari G, Foresta C, Francavilla S, Gadda F, Galantini A, Galì A, Gentile V, Giammusso B, Giannubilo W, Granata A, Grasso M, Iafrate M, Ilacqua N, Isidori A, Italiano E, Jallous HA, Jannini E, La Pera G, Laganà F, Lauretti S, Leonardi R, Liguori G, Loiero G, Lombardi G, Lombardo F, Lusenti C, Maffucci A, Maggi M, Maio G, Mammana G, Manieri C, Marzotto Caotorta M, Mastroeni F, Mazzilli F, Mazzone L, Minervini M, Mirone VG, Montorsi F, Morelli G, Morrone G, Nicita G, Nicola M, Palmiotto F, Paradiso M, Paulis G, Pavone C, Pescatori ES, Petterle V, Piazza N, Pittaluga P, Piubello G, Polito M, Ponchietti R, Porena M, Rago R, Risi O, Roggia A, Salzano L, Sanseverino R, SASSO, Ferdinando Carlo, Savoca G, Scarano P, Schips L, Serao A, Sforza A, Sidari V, Silvani M, Sinisi A, Sorrentino F, Spera E, Strada G, Tenaglia R, Terrone C, Titta M, Tracia A, Turchi P, Ughi G, Vecchio D, Veneziano IA, Vicini P, Vita A, Vitti P, Volpi R, Zago T, Zenico T, Zito AR, Apolinario M, Carvalho AP, Corte Real J, Matos Cabeca J, Mendes Leal A, Monteiro Pereira N, Palma dos Reis J, Patricio A, Prisco R, Rocha Mendes J, Santos A, Vieira R, Abad Gairín C, Abascal García JM, Adot Zurbano JM, Álvarez de la Red PL, Al Wattar W, Antón Saiz C, Aranda Doncel N, Arrosagaray PM, Arteaga Serrano F, Barberán Soriano J, Bataller Perello V, Beltrán Persiva J, Benejam Gual J, Blanco Díez A, Blasco Casares FJ, Blasco Villalonga M, Blázquez Izquierdo J, Boladeras Sabater J, Borrás JJ, Bouchi Bakrim AR, Bucar Terrades S, Burgués Gasión JP, Busto Castañón L, Caballero JM, Cabello Santamaría F, Cabreja López E, Carrasco Aznar JC, Casasola Chamorro J, Castellanos González L, Cimadevila García A, Closas Capdevila M, Concepción Masip T, Conde C, Conde Santos G, Cortada i. Robert J, Cos Calvet JM, Crespi Martínez F, Cruz N, De la Rosa Khermann M, Delgado Martín JA, Devesa Mújica M, Doganis Peppas C, Domínguez Freire F, Donderis Guastavino C, Duarte Vázquez JJ, El Khoury Yacob R, Escobal Tamayo V, Farré Martí JM, Fernández Fernández A, Fernández Lozano A, Fernández Viñas JA, Fiter Gómez L, Fleitas Asencio E, Frago Valls SM, Galiana Álvarez A, García Bayo I, García Contreras J, García Cruz E, García de Jalón Martín A, García Giralda L, García Marco MA, García Navas R, García Reboll L, Garrido Insúa S, Giner Santamaría C, Gómez Berjón F, Gómez Gil E, Gómez Lanza E, Gómez Pérez L, Gómez Rodríguez A, González Sala JL, González Sala MJ, Gonzalvo Ybarra A, Guerrero Martínez V, Gutiérrez González MA, Gutierrez Mínguez E, Hidalgo Arroyo J, Hmeidan M, Idígora i. Planas X, Jara Rascón J, Jiménez Verdejo J, Lledó García E, Lliteras Arañi M, López Almansa M, López Palacios MÁ, López Tello J, Lorenzo Gómez MF, Luque Gálvez P, Luque López AJ, Mallafré Sala JM, Martí Cebrián JM, Martín Clos J, Martín Huescar A, Martín Morales A, Martín Rodríguez A, Martínez Rodríguez R, Martínez Salamanca JI, Mascarós Balaguer E, Mejide Manresa R, Molero Rodríguez F, Molina Carranza A, Moncada Iribarren I, Montagud Moncho JB, Montesino Semper M, Mosteiro Ponce JA, Mouaffak Tatari N, Navarro Gil JM, Novás Castro S, Ortiz del Corral ML, Ortiz Gamiz A, Osca García JM, Padilla León M, Palomino García A, Pascual Mateo C, Peinado Ibarra F, Pérez Mestre M, Portillo Martín JA, Poyato Galán JM, Prats de Puig J, Prieto Castro R, Puigvert Martínez A, Quintana de la Rosa JL, Ramada Benlloch FJ, Reyes Martínez F, Rigabert M, Ríos Espuny AF, Robles Iniesta A, Rodrigo Aliaga M, Rodríguez Alba JL, Rodríguez Bethencourt F, Rodríguez Jiménez FJ, Rodríguez Leal DA, Rodríguez Rubio F, Rodríguez Tolrá J, Rodríguez Vallejo JM, Romero Otero J, Roselló Barbará M, Rubio Briones J, Ruíz Moriana O, Sampol Company J, San Martín Blanco C, Sánchez Encinas M, Sánchez Sánchez F, Sancho Serrano C, Santandreu Puifros J, Santisteban González M, Santos Ascarza Tabares JL, Sanz Lahoz I, Sapiña Ortola F, Sarquella Geli J, Segarra Tomás J, Soler Fernández J, Tato Rodríguez J, Tesedo Cubedo J, Traid Sender V, Valbuena Álvarez R, Valverde Rubio JM, Varela Salgado M, Vargas Rugeles M, Vilches Cocovi E, Virto Bajo FJ, Andius P, Anker Hansen O, Arver S, Bosson P, Brattberg A, Grenabo L, Hanning J, Hassler L, Paradis AÅ, Wang E., Mirone, Vincenzo, Arcaniolo, Davide, David, Riva, Scott, Bull, Joseph W., Aquilina, Verze, Paolo, Mirone, V, Arcaniolo, D, Rivas, D, Bull, S, Aquilina, JW, Verze, P, Pavone, C, Aquilina, Jw, PAUSE study team Berchart, G, Hass, M, Ludvik, G, Aalto, J, Hendolin, N, Lukkarinen, O, Multanen, M, Nurmenniemi, V, Piha, J, Aheimer, C, Alebrahim Dehkordy, A, Andreessen, R, Aust, C, Baer, P, Bath, V, Baumgrass, H, Beck, C, Beecken, Wd, Behre, H, Beitzinger, M, Belusa, A, Bermes, Ur, Berning, T, Bieringer La Roche, D, Blasko, S, Boehmer, S, Borchardt, A, Boerner, T, Brands, F, Braun, Pm, Braun, R, Breu, D, Briken, P, Brueske, T, Bueker, R, Buse, A, Carius, A, Christoph, F, Cuno, M, Dats, E, Degen, N, Denil, J, Dietrichs, K, Domnitz, R, Dorn, B, Dubiel, J, Eckert, R, Ehrenberg, W, Eichler, S, El Khadra, S, Engl, T, Esser, O, Faragallah, Ea, Farahmandi, R, Finke, G, Fleig, P, Fruehauf, E, Gerhardt, U, Girke, Cg, Glauche, J, Gleissner, J, Gnann, R, Gralla, O, Grandin, A, Grewe, W, Gronau, E, Gruber, S, Grunert, S, Guelbeyaz, M, Guelden, H, Haendel, D, Haefele, J, Haghighat, M, Hahne, D, Haschemi Schirazi, R, Hecker, D, Herzig, J, Hettmmer, R, Hitschfeld, K, Hofmann, J, Hohmuth, H, Hoelker, D, Huebner, A, Hudemann, B, Hung Wehmann, D, Huenninghaus, K, Hueter, K, Igde, H, Jaeger, T, Javadi, P, John, G, Ju, M, Kaisser, G, Kamann, L, Kastein, A, Kaup, F, Kellner, T, Kempe, T, Kempter, F, Kennerknecht, M, Kirschner, P, Koenig, M, Konert, J, Kowalik, S, Krieger, Ju, Kruppa, Gl, Kube, U, Kuehn, F, Kuefer, R, Kurt, T, Kwela, M, Laag, R, Langen, L, Lehmann, J, Linder, C, Loeber, T, Lock, Uc, Loebenau, M, Luberg Sievers, G, Luebbe, R, Lutz, K, Maier, S, Maletz, C, Mertins, B, Meschede, E, Meschi, Mr, Miersch, Wd, Misera, A, Muehlich, S, Mueller, Hw, Mueller, D, Muench, Hc, Nawka, P, Othman, K, Paiss, T, Peter, K, Peters, T, Petras, T, Petrischenko, B, Pfund, A, Plate, H, Ploss, Hj, Pohrt, U, Pooyeh, S, Potempa, Aj, Pusinelli, Wd, Rausch, U, Reinhardt, F, Rengel, U, Rietheimer, W, Rinnab, L, Rohrmann, K, Romahn, E, Romitan Baum, R, Roessler, T, Rudolph, R, Rueffer, J, Rug, M, Rueth, J, Ruettgers, E, Santiago, Rb, Schaefer, A, Schaefer, T, Schaetzle, P, Scheunpflug, K, Schlicht, J, Schmidt, P, Schneider, J, Schnitzler, M, Schonfelder, R, Schreier, H, Schroeder, A, Schulz, Fm, Schulze, M, Schumann, M, Seidler, A, Seseke, S, Siebel Eggeling, G, Siebels, M, Sinner, B, Sippel, F, Soballa, M, Sommer, F, Spielhaupter, A, Steffen, H, Steinacker, M, Stiersdorfer, A, Stoehr, C, Sturm, S, Surrey, Hw, Swoboda, A, Szymula, S, Telle, J, Uththoff, H, Vierneisel, C, Vilmar, W, Wagner, M, Walhoefer, F, Warnack, W, Weiss, J, Weizert, P, Wicht, A, Wieland, J, Willgerodt, J, Wilski, B, Wilson, E, Wipfler, G, Wohn, Hg, Wolf, J, Zoehrlaut, B, Zuerner, T, Angeletti, G, Avolio, A, Baldassarre, R, Balercia, G, Balloni, F, Barba, G, Bartoletti, R, Basile Fasolo, C, Bassi, Pf, Beatrici, V, Bertozzi, Ma, Bocciardi, Am, Bondavalli, C, Bonini, F, Bonsanto, M, Branchi, A, Briganti, A, Calabrese, M, Calafiore, R, Calogero, Ae, Cantelmo, P, Caraceni, E, Carbone, A, Cardella, A, Carini, M, Carmignani, L, Carmignani, G, Carrino, M, Caviglia, C, Cecchi, M, Ceruti, C, Chiovato, L, Cicalese, V, Colpi, G, Corinti, M, Cormio, L, Cova, G, Cozzupoli, P, Ottavio, G, Damiano, R, De Ceglie, G, De Grande, G, De Lisa, A, DE SIO, Marco, De Stefani, S, Dehò, F, Delsignore, A, Di Filippo, A, Di Lena, S, Di Trapani, D, Diambrini, M, Drei, Gn, Fabbri, A, Fasolis, G, Ferone, D, Ferrari, G, Foresta, C, Francavilla, S, Gadda, F, Galantini, A, Galì, A, Gentile, V, Giammusso, B, Giannubilo, W, Granata, A, Grasso, M, Iafrate, M, Ilacqua, N, Isidori, A, Italiano, E, Jallous, Ha, Jannini, E, La Pera, G, Laganà, F, Lauretti, S, Leonardi, R, Liguori, G, Loiero, G, Lombardi, G, Lombardo, F, Lusenti, C, Maffucci, A, Maggi, M, Maio, G, Mammana, G, Manieri, C, Marzotto Caotorta, M, Mastroeni, F, Mazzilli, F, Mazzone, L, Minervini, M, Mirone, Vg, Montorsi, F, Morelli, G, Morrone, G, Nicita, G, Nicola, M, Palmiotto, F, Paradiso, M, Paulis, G, Pescatori, E, Petterle, V, Piazza, N, Pittaluga, P, Piubello, G, Polito, M, Ponchietti, R, Porena, M, Rago, R, Risi, O, Roggia, A, Salzano, L, Sanseverino, R, Sasso, Ferdinando Carlo, Savoca, G, Scarano, P, Schips, L, Serao, A, Sforza, A, Sidari, V, Silvani, M, Sinisi, A, Sorrentino, F, Spera, E, Strada, G, Tenaglia, R, Terrone, C, Titta, M, Tracia, A, Turchi, P, Ughi, G, Vecchio, D, Veneziano, Ia, Vicini, P, Vita, A, Vitti, P, Volpi, R, Zago, T, Zenico, T, Zito, Ar, Apolinario, M, Carvalho, Ap, Corte Real, J, Matos Cabeca, J, Mendes Leal, A, Monteiro Pereira, N, Palma dos Reis, J, Patricio, A, Prisco, R, Rocha Mendes, J, Santos, A, Vieira, R, Abad Gairín, C, Abascal García, Jm, Adot Zurbano, Jm, Álvarez de la Red, Pl, Al Wattar, W, Antón Saiz, C, Aranda Doncel, N, Arrosagaray, Pm, Arteaga Serrano, F, Barberán Soriano, J, Bataller Perello, V, Beltrán Persiva, J, Benejam Gual, J, Blanco Díez, A, Blasco Casares, Fj, Blasco Villalonga, M, Blázquez Izquierdo, J, Boladeras Sabater, J, Borrás, Jj, Bouchi Bakrim, Ar, Bucar Terrades, S, Burgués Gasión, Jp, Busto Castañón, L, Caballero, Jm, Cabello Santamaría, F, Cabreja López, E, Carrasco Aznar, Jc, Casasola Chamorro, J, Castellanos González, L, Cimadevila García, A, Closas Capdevila, M, Concepción Masip, T, Conde, C, Conde Santos, G, Cortada i., Robert J, Cos Calvet, Jm, Crespi Martínez, F, Cruz, N, De la Rosa Khermann, M, Delgado Martín, Ja, Devesa Mújica, M, Doganis Peppas, C, Domínguez Freire, F, Donderis Guastavino, C, Duarte Vázquez, Jj, El Khoury Yacob, R, Escobal Tamayo, V, Farré Martí, Jm, Fernández Fernández, A, Fernández Lozano, A, Fernández Viñas, Ja, Fiter Gómez, L, Fleitas Asencio, E, Frago Valls, Sm, Galiana Álvarez, A, García Bayo, I, García Contreras, J, García Cruz, E, García de Jalón Martín, A, García Giralda, L, García Marco, Ma, García Navas, R, García Reboll, L, Garrido Insúa, S, Giner Santamaría, C, Gómez Berjón, F, Gómez Gil, E, Gómez Lanza, E, Gómez Pérez, L, Gómez Rodríguez, A, González Sala, Jl, González Sala, Mj, Gonzalvo Ybarra, A, Guerrero Martínez, V, Gutiérrez González, Ma, Gutierrez Mínguez, E, Hidalgo Arroyo, J, Hmeidan, M, Idígora i., Planas X, Jara Rascón, J, Jiménez Verdejo, J, Lledó García, E, Lliteras Arañi, M, López Almansa, M, López Palacios, Má, López Tello, J, Lorenzo Gómez, Mf, Luque Gálvez, P, Luque López, Aj, Mallafré Sala, Jm, Martí Cebrián, Jm, Martín Clos, J, Martín Huescar, A, Martín Morales, A, Martín Rodríguez, A, Martínez Rodríguez, R, Martínez Salamanca, Ji, Mascarós Balaguer, E, Mejide Manresa, R, Molero Rodríguez, F, Molina Carranza, A, Moncada Iribarren, I, Montagud Moncho, Jb, Montesino Semper, M, Mosteiro Ponce, Ja, Mouaffak Tatari, N, Navarro Gil, Jm, Novás Castro, S, Ortiz del Corral, Ml, Ortiz Gamiz, A, Osca García, Jm, Padilla León, M, Palomino García, A, Pascual Mateo, C, Peinado Ibarra, F, Pérez Mestre, M, Portillo Martín, Ja, Poyato Galán, Jm, Prats de Puig, J, Prieto Castro, R, Puigvert Martínez, A, Quintana de la Rosa, Jl, Ramada Benlloch, Fj, Reyes Martínez, F, Rigabert, M, Ríos Espuny, Af, Robles Iniesta, A, Rodrigo Aliaga, M, Rodríguez Alba, Jl, Rodríguez Bethencourt, F, Rodríguez Jiménez, Fj, Rodríguez Leal, Da, Rodríguez Rubio, F, Rodríguez Tolrá, J, Rodríguez Vallejo, Jm, Romero Otero, J, Roselló Barbará, M, Rubio Briones, J, Ruíz Moriana, O, Sampol Company, J, San Martín Blanco, C, Sánchez Encinas, M, Sánchez Sánchez, F, Sancho Serrano, C, Santandreu Puifros, J, Santisteban González, M, Santos Ascarza Tabares, Jl, Sanz Lahoz, I, Sapiña Ortola, F, Sarquella Geli, J, Segarra Tomás, J, Soler Fernández, J, Tato Rodríguez, J, Tesedo Cubedo, J, Traid Sender, V, Valbuena Álvarez, R, Valverde Rubio, Jm, Varela Salgado, M, Vargas Rugeles, M, Vilches Cocovi, E, Virto Bajo, Fj, Andius, P, Anker Hansen, O, Arver, S, Bosson, P, Brattberg, A, Grenabo, L, Hanning, J, Hassler, L, Paradis, Aå, and Wang, E.

Subjects
Adult, Complementary Therapies, Male, medicine.medical_specialty, Benzylamines, Adolescent, Nausea, Urology, Naphthalenes, Dapoxetine Safety Cardiovascular events Syncope, Syncope, Cardiovascular events, Young Adult, Internal medicine, Premature ejaculation, medicine, 80 and over, Dapoxetine, Safety, Aged, Aged, 80 and over, Humans, Middle Aged, Premature Ejaculation, Prospective Studies, Serotonin Uptake Inhibitors, Adverse effect, Prospective cohort study, Sertraline, business.industry, Settore MED/24 - UROLOGIA, Incidence (epidemiology), syncope, Anesthesia, Observational study, medicine.symptom, business, Selective Serotonin Reuptake Inhibitors, medicine.drug, Cardiovascular events, Dapoxetine, Safety, Syncope
Abstract

Background Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor and the first drug approved for the on-demand treatment of premature ejaculation (PE). Its safety was established in a thorough clinical development program. Objective To characterize the safety profile of dapoxetine in PE treatment and to report the incidence, severity, and type of adverse events. Design, setting, and participants We conducted a 12-wk, open-label, observational study with a 4-wk, postobservational contact. A total of 10 028 patients were enrolled, with 6712 patients (67.6%) treated with dapoxetine 30–60mg (group A)and 3316 (32.4%) treated with alternative care/nondapoxetine (group B). Interventions Treatment with dapoxetine or alternative care/nondapoxetine. Outcome measurements and statistical analysis Treatment-emergent adverse events (TEAEs) and concomitant therapy use during the 12-wk observational and the postobservational period were reported. Results and limitations The mean age for all patients was 40.5 yr. In group A, 93.0% of the patients were initially prescribed dapoxetine 30mg. Treatment options for group B patients included clomipramine, paroxetine, fluoxetine, sertraline, topical drugs, condoms, and behavioral counseling. Both treatment regimens were well tolerated. TEAEs were reported by 12.0% and 8.9% of group A and group B, respectively, with the highest incidence observed in patients aged >65 yr for group A (21.4%) and 30–39 yr (9.8%) for group B. The most commonly reported TEAEs were nausea, headache, and vertigo, with a higher incidence in group A (3.1%, 2.6%, and 1.0%, respectively) than in group B (oral drugs: 2.3%, 1.3%, and 0.9%, respectively). There were no cases of syncope in group A and one case in group B. A major limitation is that this was a nonrandomized, open-label, short-term study lacking efficacy data. Conclusions The results of this postmarketing observational study demonstrated that dapoxetine for treatment of PE has a good safety profile and low prevalence of TEAEs. Syncope and major cardiovascular adverse events were not reported. The high level of adherence by healthcare providers to the contraindications, special warnings, and precautions for dapoxetine minimizes the risk for its use in routine clinical practice. The current risk minimization measures for its identified and potential risks are effective.

Published
2014

7. Infektionen Frühgeborener und unreifer Neugeborener mit koagulasenegativen Staphylokokken

Author

Steinacker, M. (Marion), Peters, G. (Georg), and Universitäts- und Landesbibliothek Münster

Subjects
Medicine and health, ddc:610, Staphylokokken, koagulasenegativ, Speziesdifferenzierung, Antibiogramm, Neugeborene, Sepsis
Abstract

Bei 69 Neugeborenen mit V.a. Sepsis wurden von verschiedenen Körperstellen koagulasenegative Staphylokokken isoliert. Bei der Speziesdifferenzierung dominierte S.epidermidis, gefolgt von S.haemolyticus und S.hominis. Alle Stämme waren sensibel für Vancomycin, 76% waren resistent gegen Ampicillin und 39,7% gegen Oxacillin. Bei der Schleimtestung waren 60,3% stark, 14,1% schwach und 25,6% nicht adhärent. Bei 17 Kindern wurden aus mindestens zwei Proben CNS einer Spezies isoliert. Mit diesen wurden eine Typisierung nach Antibiogramm, eine Plasmid- und eine Proteinprofilanalyse durchgeführt. Bei 6 Kindern waren die Ergebnisse bei mindestens zwei Stämmen nahezu identisch. So konnte der Rückschluss auf eine klonale Identität gezogen werden und die isolierten CNS als wahrscheinliche Sepsiserreger verantwortlich gemacht werden. Alle Kinder überlebten die septischen Perioden unter antibiotischer Therapie. Im Labor waren eine Erhöhung der I/T-Proportion und eine Thrombopenie am verlässlichsten.

Published
2004

19. Predicting chemotherapy-induced thrombotoxicity by NARX neural networks and transfer learning.

Author

Steinacker M, Kheifetz Y, and Scholz M

Subjects
Humans, Lymphoma, Non-Hodgkin drug therapy, Antineoplastic Agents adverse effects, Thrombosis chemically induced, Female, Neural Networks, Computer, Thrombocytopenia chemically induced
Abstract

Background: Thrombocytopenia is a common side effect of cytotoxic chemotherapies, which is often dose-limiting. Predicting an individual's risk is of high clinical importance, as otherwise, a small subgroup of patients limits dosages for the overall population for safety reasons., Methods: We aim to predict individual platelet dynamics using non-linear auto-regressive networks with exogenous inputs (NARX). We consider different architectures of the NARX networks, namely feed-forward networks (FNN) and gated recurrent units (GRU). To cope with the relative sparsity of individual patient data, we employ transfer learning (TL) approaches based on a semi-mechanistic model of hematotoxicity. We use a large data set of patients with high-grade non-Hodgkin's lymphoma to learn the respective models on an individual scale and to compare prediction performances with that of the semi-mechanistic model., Results: Of the examined network models, the NARX with GRU architecture performs best. In comparison to the semi-mechanistic model, the network model can result in a substantial improvement of prediction accuracy for patients with irregular dynamics, given well-spaced measurements. TL improves individual prediction performances., Conclusion: NARX networks can be utilized to predict an individual's thrombotoxic response to cytotoxic chemotherapy treatment. For reasonable model learning, we recommend at least three well-spaced measurements per cycle: at baseline, during the nadir phase and during the recovery phase. We aim at generalizing our approach to other treatment scenarios and blood lineages in the future., (© 2024. The Author(s).)

Published
2024
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20. Individual modelling of haematotoxicity with NARX neural networks: A knowledge transfer approach.

Author

Steinacker M, Kheifetz Y, and Scholz M

Abstract

Cytotoxic cancer therapy often results in dose-limiting haematotoxic side effects. Predicting an individual's risk is a major objective in precision medicine of cancer treatment. In this regard, patient heterogeneity presents a significant challenge. In this paper, we explore the use of hypothesis-free machine learning models based on recurrent nonlinear auto-regressive networks with exogenous inputs (NARX) as an approach to achieve this goal. Also, we propose a knowledge transfer approach to ameliorate the issue of sparse individual data, which typically hampers learning of individual networks. We demonstrate the feasibility of our approach based on a virtual patient population generated using a semi-mechanistic model of haematopoiesis and imposing different cytotoxic therapy scenarios on it. Employing different techniques of model optimisation, we derive robust and parsimonious individual networks with good generalisation performances. Moreover, we analyse in detail possible factors influencing the generalisation performance. Results suggest that our transfer learning approach using NARX networks can provide robust predictions of individual patient's response to treatment. As a practical perspective, we apply our approach to individual time series data of two patients with non-Hodgkin's lymphoma., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: M. Scholz received funding from Pfizer Inc. for a project not related to this research., (© 2023 The Authors.)

Published
2023
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21. Isolation, Biosynthesis and Chemical Modifications of Rubterolones A-F: Rare Tropolone Alkaloids from Actinomadura sp. 5-2.

Author

Guo H, Benndorf R, Leichnitz D, Klassen JL, Vollmers J, Görls H, Steinacker M, Weigel C, Dahse HM, Kaster AK, de Beer ZW, Poulsen M, and Beemelmanns C

Subjects
Actinomycetales classification, Actinomycetales genetics, Alkaloids chemistry, Alkaloids isolation & purification, Alkaloids pharmacology, Animals, Biosynthetic Pathways genetics, Chromatography, High Pressure Liquid, Crystallography, X-Ray, Intestines microbiology, Isoptera microbiology, Magnetic Resonance Spectroscopy, Mass Spectrometry, Molecular Conformation, Multigene Family, Phylogeny, Whole Genome Sequencing, Actinomycetales chemistry, Alkaloids biosynthesis, Tropolone chemistry
Abstract

The discovery of six new, highly substituted tropolone alkaloids, rubterolones A-F, from Actinomadura sp. 5-2, isolated from the gut of the fungus-growing termite Macrotermes natalensis is reported. Rubterolones were identified by using fungus-bacteria challenge assays and a HRMS-based dereplication strategy, and characterised by NMR and HRMS analyses and by X-ray crystallography. Feeding experiments and subsequent chemical derivatisation led to a first library of rubterolone derivatives (A-L). Genome sequencing and comparative analyses revealed their putative biosynthetic pathway, which was supported by feeding experiments. This study highlights how gut microbes can present a prolific source of secondary metabolites., (© 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Published
2017
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