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436 results on '"Rubio, JM"'

1. Introducing S.C.O.P.E.™ (Schizophrenia Clinical Outcome Scenarios and Patient–Provider Engagement), an Interactive Digital Platform to Educate Healthcare Professionals on Schizophrenia Care

Author

Correll CU, Rubio JM, Citrome L, Mychaskiw MA, Thompson S, Franzenburg KR, Suett M, Kotak S, and Kane JM

Subjects
long-acting injectable antipsychotic, schizophrenia, treatment, education, patient outcomes, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571, Neurology. Diseases of the nervous system, RC346-429
Abstract

Christoph U Correll,1– 4,* Jose M Rubio,1– 3,* Leslie Citrome,5,* Marko A Mychaskiw,6 Stephen Thompson,6 Kelli R Franzenburg,7 Mark Suett,8 Sameer Kotak,9 John M Kane1– 3,* 1Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA; 2Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA; 3Institute of Behavioral Science, Feinstein Institutes for Medical Research, Manhasset, NY, USA; 4Department of Child and Adolescent Psychiatry, Charité – Universitätsmedizin Berlin, Berlin, Germany; 5Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 6Global Health Economics and Outcomes Research, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA; 7Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA; 8Global Medical Affairs, Teva UK Limited, Harlow, United Kingdom; 9Yorker Health Corp., Glen Rock, NJ, USA*These authors contributed equally to this workCorrespondence: Christoph U Correll, Email ccorrell@northwell.eduAbstract: Despite evidence of benefits beyond those of oral antipsychotics, long-acting injectable antipsychotics (LAIs) are underused in schizophrenia treatment. Underuse may be partially a result of misconceptions held by some healthcare professionals (HCPs) pertaining to LAIs. A panel of four experts convened between January 2022 and May 2022 to identify these misconceptions, and example cases or scenarios were created to illustrate common clinical situations relevant to these beliefs. Ultimately, an online platform and heuristic tool, Schizophrenia Clinical Outcome Scenarios and Patient-Provider Engagement (S.C.O.P.E.™), was developed to help prescribing clinicians and other HCPs better understand common clinical dilemmas, as well as the place for LAIs in schizophrenia treatment. Three main misconceptions related to the use of LAIs to treat schizophrenia were identified and included “physicians/providers know when patients are nonadherent”, “patients do not accept/want LAI treatment”, and “LAIs are only appropriate for patients who have demonstrated nonadherence”. All misconceptions are refuted by current evidence and were used to develop clinical scenarios with questions to consider when patients present to various sites of care for treatment. These cases are presented on the S.C.O.P.E. educational platform. The platform also includes videos designed to help non-prescribing HCPs and mental health professionals address patient/caregiver concerns and to communicate LAI benefits. In addition, S.C.O.P.E. provides a section with information about each LAI that is currently FDA approved in the United States for the treatment of schizophrenia, to help familiarize HCPs with characteristics of LAIs. S.C.O.P.E. is an educational tool designed for HCPs to help improve their understanding of how to manage common clinical dilemmas in the treatment of people with schizophrenia, to clarify the role of LAIs in medication management, and to increase understanding of the characteristics of available LAIs. S.C.O.P.E. also aims to improve care in schizophrenia by facilitating increased awareness to patients and caregivers.Plain Language Summary: Schizophrenia is a serious, lifelong mental health disorder that affects about 2.8 million adults in the United States and many more worldwide. Symptoms can include hallucinations (ie, hearing “voices”), delusions (ie, convinced something is true when it is not), poor attention, lack of motivation and interest, and cognitive problems. Schizophrenia can have considerable impact on people with the disorder as well as their families, friends, and communities. There are several treatment options available for healthcare professionals (HCPs), patients, and caregivers to consider, with antipsychotic medicines being the cornerstone of the treatment for schizophrenia. Long-acting injectable antipsychotics (LAIs) have shown benefits over antipsychotics taken orally (by mouth), but are underused, and this is likely due to some common misconceptions.Four experts in schizophrenia treatment met repeatedly online to identify some of these misconceptions and created a tool to help HCPs learn about misconceptions, using example cases of patients with schizophrenia who have different types of clinical situations and concerns. On the Schizophrenia Clinical Outcome Scenarios and Patient-Provider Engagement (S.C.O.P.E.™) interactive digital platform, HCPs can choose in which type of case they are interested in and see details of the case, information they should obtain about the case, and appropriate considerations for LAI use. The tool also provides videos about communicating with patients and their families about LAIs, and information about the different LAIs currently available.The goal of providing this tool to HCPs is to improve understanding of how to treat patients with schizophrenia and the role that LAIs can play.Keywords: long-acting injectable antipsychotic, schizophrenia, treatment, education, patient outcomes

Published
2024

2. An Overview of the Management of Mansonellosis

Author

Ta-Tang TH, Luz SL, Crainey JL, and Rubio JM

Subjects
mansonellosis, mansonella perstans, mansonella ozzardi, mansonella streptocerca, wolbachia, doxycycline, Arctic medicine. Tropical medicine, RC955-962
Abstract

Thuy-Huong Ta-Tang,1 Sergio LB Luz,2 James L Crainey,2 José M Rubio3 1Malaria and NTDs Laboratory, National Centre of Tropical Medicine, Instituto de Salud Carlos III, Madrid, Spain; 2Laboratório de Ecologia de Doenças Transmissíveis na Amazônia, Instituto Leônidas e Maria Deane, Fundação Oswaldo Cruz, Manaus, Amazonas State, Brazil; 3Malaria & Emerging Parasitic Diseases Laboratory, National Microbiology Center, Instituto de Salud Carlos III, Madrid, SpainCorrespondence: José M RubioMalaria & Emerging Parasitic Diseases Laboratory, National Microbiology Center, Instituto de Salud Carlos III, Cra. Majadahonda-Pozuelo Km 2,5, Majadahonda, Madrid, 28220, SpainTel +34918223420Fax +34915097034Email jmrubio@isciii.esJames L CraineyLaboratório de Ecologia de Doenças Transmissíveis na Amazônia, Instituto Leônidas e Maria Deane, Fundação Oswaldo Cruz, 476 Rua Terezina, Adrianópolis, Manaus, Amazonas State, CEP 69057-070, BrazilEmail james.lee@fiocruz.brAbstract: Mansonellosis is caused by three filarial parasite species from the genus Mansonella that commonly produce chronic human microfilaraemias: M. ozzardi, M. perstans and M. streptocerca. The disease is widespread in Africa, the Caribbean and South and Central America, and although it is typically asymptomatic it has been associated with mild pathologies including leg-chills, joint-pains, headaches, fevers, and corneal lesions. No robust mansonellosis disease burden estimates have yet been made and the impact the disease has on blood bank stocks and the monitoring of other filarial diseases is not thought to be of sufficient public health importance to justify dedicated disease management interventions. Mansonellosis´s Ceratopogonidae and Simuliidae vectors are not targeted by other control programmes and because of their small size and out-door biting habits are unlikely to be affected by interventions targeting other disease vectors like mosquitoes. The ivermectin and mebendazole-based mass drug administration (iMDA and mMDA) treatment regimens deployed by the WHO´s Elimination of Neglected Tropical Diseases (ESPEN) programme and its forerunners have, however, likely impacted significantly on the mansonellosis disease burden, principally by reducing the transmission of M. streptocerca in Africa. The increasingly popular plan of using iMDA to control malaria could also affect M. ozzardi parasite prevalence and transmission in Latin America in the future. However, a potentially far greater mansonellosis disease burden impact is likely to come from short-course curative anti-Wolbachia therapeutics, which are presently being developed for onchocerciasis and lymphatic filariasis treatment. Even if the WHO´s ESPEN programme does not choose to deploy these drugs in MDA interventions, they have the potential to dramatically increase the financial and logistical feasibility of effective mansonellosis management. There is, thus, now a fresh and urgent need to better characterise the disease burden and eco-epidemiology of mansonellosis so that effective management programmes can be designed, advocated for and implemented.Keywords: Mansonellosis, Mansonella perstans, Mansonella ozzardi, Mansonella streptocerca, Wolbachia, doxycycline

Published
2021

4. Mansonellosis: current perspectives

Author

Ta-Tang TH, Crainey JL, Post RJ, Luz SLB, and Rubio JM

Subjects
Mansonellosis, filariasis, M. perstans, M. ozzardi, M. streptocerca, neglected disease., Arctic medicine. Tropical medicine, RC955-962
Abstract

Thuy-Huong Ta-Tang,1 James L Crainey,2 Rory J Post,3,4 Sergio LB Luz,2 José M Rubio1 1Malaria and Emerging Parasitic Diseases Laboratory, National Microbiology Center, Instituto de Salud Carlos III, Majadahonda, Spain; 2Laboratory of Infectious Disease Ecology in the Amazon, Oswaldo Cruz Foundation, Instituto Leônidas e Maria Deane, Manaus, Brazil; 3School of Natural Sciences and Psychology, John Moores University, Liverpool, 4Department of Disease Control, Faculty of Infectious Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK Abstract: Mansonellosis is a filarial disease caused by three species of filarial (nematode) parasites (Mansonella perstans, Mansonella streptocerca, and Mansonella ozzardi) that use humans as their main definitive hosts. These parasites are transmitted from person to person by bloodsucking females from two families of flies (Diptera). Biting midges (Ceratopogonidae) transmit all three species of Mansonella, but blackflies (Simuliidae) are also known to play a role in the transmission of M. ozzardi in parts of Latin America. M. perstans and M. streptocerca are endemic in western, eastern, and central Africa, and M. perstans is also present in the neotropical region from equatorial Brazil to the Caribbean coast. M. ozzardi has a patchy distribution in Latin America and the Caribbean. Mansonellosis infections are thought to have little pathogenicity and to be almost always asymptomatic, but occasionally causing itching, joint pains, enlarged lymph glands, and vague abdominal symptoms. In Brazil, M. ozzardi infections are also associated with corneal lesions. Diagnosis is usually performed by detecting microfilariae in peripheral blood or skin without any periodicity. There is no standard treatment at present for mansonellosis. The combination therapy of diethylcarbamazine plus mebendazole for M. perstans microfilaremia is presently one of the most widely used, but the use of ivermectin has also been proven to be very effective against microfilariae. Recently, doxycycline has shown excellent efficacy and safety when used as an antimicrobial against endosymbiotic Wolbachia bacteria harbored by some strains of M. perstans and M. ozzardi. Diethylcarbamazine and ivermectin have been used effectively to treat M. streptocerca infection. There are at present no estimates of the disease burden caused by mansonellosis, and thus its importance to many global health professionals and policy makers is presently limited to how it can interfere with diagnostic tools used in modern filarial disease control and elimination programs aimed at other species of filariae. Keywords: mansonellosis, filariasis, M. perstans, M. ozzardi, M. streptocerca, neglected disease

Published
2018

5. Azimuthal anisotropy of photon and charged particle emissionin 208Pb + 208Pb collisions at 158 ̇ A GeV/c

Author

Aggarwal, MM, Ahammed, Z, Angelis, ALS, Antonenko, V, Arefiev, V, Astakhov, V, Avdeitchikov, V, Awes, TC, Baba, PVKS, Badyal, SK, Bathe, S, Batiounia, B, Bernier, T, Bhatia, VS, Blume, C, Bucher, D, Büsching, H, Carlén, L, Chattopadhyay, S, Decowski, MP, Delagrange, H, Donni, P, Dutta Majumdar, MR, Dubey, AK, El Chenawi, K, Enosawa, K, Fokin, S, Frolov, V, Ganti, MS, Garpman, S, Gavrishchuk, O, Geurts, FJM, Ghosh, TK, Glasow, R, Gupta, R, Guskov, B, Gustafsson, HA, Gutbrod, HH, Hrivnacova, I, Ippolitov, M, Kalechofsky, H, Kamermans, R, Karadjev, K, Karpio, K, Kolb, BW, Kosarev, I, Koutcheryaev, I, Kugler, A, Kulinich, P, Kurata, M, Lebedev, A, Löhner, H, Luquin, L, Mahapatra, DP, Manko, V, Martin, M, Martínez, G, Maximov, A, Miake, Y, Mishra, GC, Mohanty, B, Mora, MJ, Morrison, D, Moukhanova, T, Mukhopadhyay, DS, Naef, H, Nandi, BK, Nayak, SK, Nayak, TK, Nianine, A, Nikitine, V, Nikolaev, S, Nilsson, P, Nishimura, S, Nomokonov, P, Nystrand, J, Oskarsson, A, Otterlund, I, Peitzmann, T, Peressounko, D, Petracek, V, Phatak, SC, Pinganaud, W, Plasil, F, Purschke, ML, Rak, J, Raniwala, R, Raniwala, S, Rao, NK, Retiere, F, Reygers, K, Roland, G, Rosselet, L, Roufanov, I, Roy, C, Rubio, JM, Sambyal, SS, Santo, R, Sato, S, and Schlagheck, H

Subjects
Nuclear & Particles Physics, Quantum Physics, Atomic, Molecular, Nuclear, Particle and Plasma Physics, Atomic, Molecular, Nuclear, Particle and Plasma Physics
Abstract

The azimuthal distributions of photons and charged particles with respect to the event plane are investigated as a function of centrality in 208Pb + 208Pb collisions at 158 · A GeV/c in the WA98 experiment at the CERN SPS. The anisotropy of the azimuthal distributions is characterized using a Fourier analysis. For both the photon and charged particle distributions the first two Fourier coefficients are observed to decrease with increasing centrality. The observed anisotropies of the photon distributions compare well with the expectations from the charged particle measurements for all centralities. © Springer-Verlag / Società di Fisica 2005.

Published
2005

11. Impact of ABVD chemotherapy on ovarian reserve after fertility preservation in reproductive-aged women with Hodgkin lymphoma

Author

Policiano C, Subirá J, Aguilar A, Monzó S, Iniesta I, and Rubio Rubio JM

Subjects
endocrine system, endocrine system diseases, Ovarian reserve, ABVD, Anti-Mullerian hormone, Fertility preservation, Hodgkin lymphoma
Abstract

Research question How is ovarian reserve affected by chemotherapy in patients with Hodgkin lymphoma (HL) who undergo fertility preservation (FP)? Methods A retrospective study was conducted by reviewing medical records of 105 HL patients referred to the FP unit before starting adriamycin, bleomycin, vinblastine, and dacarbazine (ABVD) chemotherapy. Ovarian reserve was evaluated before chemotherapy and at the last follow-up using anti-Mullerian hormone (AMH) and antral follicle count (AFC) measurements. The decrease in AMH was compared with that expected from normograms. AMH was compared between patients who underwent cryopreservation of ovarian tissue and those who underwent cryopreservation of mature oocytes. Results After ABVD, 15% of patients required hematopoietic stem cell transplantation. At a median follow-up of 33 months, the median decrease in AMH was 0.88 ng/mL, which was significantly greater than that of the general population of this age group (p < 0.001). Of the 82 women who only had ABVD, 38 underwent FP by cryopreservation of mature oocytes and 44 underwent cryopreservation of the ovarian cortex. There was no significant difference in AMH or AFC at the last follow-up between FP techniques. Conclusion Although ABVD is considered to be of low gonadotoxic risk, the decrease in AMH was greater than expected for patients' age, and 15% of patients needed more aggressive therapy during follow-up. Type of FP was not associated with decline in ovarian reserve. Reproductive-aged women with HL should have the opportunity for FP counseling before starting treatment.

Published
2020

13. Multiplicity distributions and charged-neutral fluctuations

Author

Nayak, Tapan K, Aggarwal, MM, Agnihotri, A, Ahammed, Z, Angelis, ALS, Antonenko, V, Arefiev, V, Astakhov, V, Avdeitchikov, V, Awes, TC, Baba, PVKS, Badyal, SK, Baldine, A, Barabach, L, Barlag, C, Bathe, S, Batiounia, B, Bernier, T, Bhalla, KB, Bhatia, VS, Blume, C, Bock, R, Bohne, E-M, Bucher, D, Buijs, A, Buis, E-J, Büsching, H, Carlen, L, Chalyshev, V, Chattopadhyay, S, Chenawi, KE, Cherbatchev, R, Chujo, T, Claussen, A, Das, AC, Decowski, MP, Djordjadze, V, Donni, P, Doubovik, I, Dubey, AK, Dutta Majumdar, MR, Eliseev, S, Enosawa, K, Feldmann, H, Foka, P, Fokin, S, Frolov, V, Ganti, MS, Garpman, S, Gavrishchuk, O, Geurts, FJM, Ghosh, TK, Glasow, R, Gupta, SK, Guskov, B, Gustafsson, HA, Gutbrod, HH, Higuchi, R, Hrivanacova, I, Ippolitov, M, Kalechofsky, H, Kamermans, R, Kampert, K-H, Karadjev, K, Karpio, K, Kato, S, Kees, S, Kim, H, Kolb, BW, Kosarev, I, Koutcheryaev, I, Kugler, A, Kulinich, P, Kumar, V, Kurata, M, Kurita, K, Kuzmin, N, Langbein, I, Lebedev, A, Lee, YY, Löhner, H, Mahapatra, DP, Manko, V, Martin, M, Maximov, A, Mehdiyev, R, Mgebrichvili, G, Miake, Y, Mikhalev, D, Mishra, GC, Miyamoto, Y, Mohanty, B, Morrison, D, Mukhopadhyay, DS, Myalkovski, V, Naef, H, Nandi, BK, Nayak, SK, Nayak, TK, Neumaier, S, Nianine, A, Nikitine, V, Nikolaev, S, Nishimura, S, Nomokov, P, Nystrand, J, Obenshain, FE, Oskarsson, A, Otterlund, I, Pachr, M, Parfenov, A, Pavliouk, S, Peitzmann, T, Petracek, V, Plasil, F, Purschke, ML, Raeven, B, Rak, J, Raniwala, R, Raniwala, S, Ramamurthy, VS, Rao, NK, Retiere, F, Reygers, K, Roland, G, Rosselet, L, Roufanov, I, Rubio, JM, Sambyal, SS, Santo, R, Sato, S, Schlagheck, H, Schmidt, H-R, Shabratova, G, Sibiriak, I, Siemiarczuk, T, Sinha, BC, Slavine, N, Söderström, K, Solomey, N, Sood, G, Sørensen, SP, Stankus, P, Stefanek, G, Steinberg, P, Stenlund, E, Stüken, D, Sumbera, M, Svensson, T, Trivedi, MD, Tsvetkov, A, Twenhöfel, C, Tykarski, L, Urbahn, J, Eijndhoven, NV, Heeringen, WHV, Nieuwenhuizen, GJV, Vinogradov, A, Viyogi, YP, Vodopianov, A, Vörös, S, Vos, MA, Wyslouch, B, Yagi, K, Yokota, Y, and Young, GR

Published
2001
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16. Regression of a giant pseudopolyp in a patient with colonic Crohn's disease after therapy with infliximab

Author

Sánchez Melgarejo JF, Navarro B, Rubio JM, Bastida G, and Nos P

Abstract

Giant inflammatory pseudopolyps ( 15 mm) are an uncommon complication of inflammatory bowel disease (IBD) and a differential diagnosis with adenomas and carcinomas is challenging. Although usually asymptomatic, they may result in intestinal obstruction or intussusception due to their size. The standard management involves lesion biopsies and endoscopic excision for selected cases; surgery is usually reserved for size-associated complications or an uncertain pathology. We report the case of a 43-year-old female patient with Crohn's disease (CD) in clinical remission, with no specific treatment at the time. A giant pseudopolyp of 40-mm was found during a screening colonoscopy. Therapy was initiated with infliximab and azathioprine in an attempt to reduce the size of the polyp and allow an endoscopic resection. Additional colonoscopies were performed following induction doses at weeks 0, 2, and 6, which revealed a reduced lesion size. Mucosal resection was attempted but failed due to severe fibrosis, which prevented base injections from lifting up the polyp. However, a follow-up colonoscopy three months later showed that the lesion had completely disappeared. The evidence in the literature regarding giant pseudopolyp management is scarce, but reports indicate that they rarely disappear with medical therapy alone and usually require surgery or endoscopic resection.

Published
2019

18. 4CPS-034 Use of ustekinumab in refractory patients of psoriasis

Author

Gil-Sierra, MD, primary, Rios-Sanchez, E, additional, Briceño-Casado, MDP, additional, Fenix-Caballero, S, additional, Martinez-Diaz, C, additional, Palomo-Palomo, C, additional, Alegre-Del Rey, EJ, additional, Diaz-Navarro, J, additional, Lopez-Vallejo, JF, additional, Camean-Castillo, M, additional, and Borrero-Rubio, JM, additional

Published
2019
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21. 2SPD-010 Indirect comparison of pembrolizumab plus chemotherapy versus pembrolizumab in lung cancer

Author

Gil-Sierra, MD, primary, Fenix-Caballero, S, additional, Sanchez-Hidalgo, M, additional, Alarcon de la Lastra Romero, C, additional, Briceño-Casado, MDP, additional, Rios-Sanchez, E, additional, Diaz-Navarro, J, additional, Martinez-Diaz, C, additional, Camean-Castillo, M, additional, Borrero-Rubio, JM, additional, and Alegre-Del Rey, E, additional

Published
2019
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22. 4CPS-181 Effectiveness and safety of omalizumab in chronic idiopathic urticaria

Author

Briceño Casado, MDP, primary, Gil-Sierra, MD, additional, Rios-Sanchez, E, additional, Fenix-Caballero, S, additional, Camean-Castillo, M, additional, Garciadeparedes-Esteban, JC, additional, Martinez-Diaz, C, additional, Diaz-Navarro, J, additional, Alegre-Del Rey, EJ, additional, Salmeron-Navas, FJ, additional, and Borrero-Rubio, JM, additional

Published
2019
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23. 2SPD-009 Analysis of olaparib and talazoparib as possible therapeutic alternatives in advanced breast cancer and a germline BRCA mutation

Author

Camean-Castillo, M, primary, Fenix-Caballero, S, additional, Gil-Sierra, MD, additional, Briceño-Casado, MP, additional, Salmeron-Navas, FJ, additional, Alegre del Rey, EJ, additional, Rios-Sanchez, E, additional, Diaz-Navarro, J, additional, Martinez-Diaz, C, additional, and Borrero-Rubio, JM, additional

Published
2019
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24. 2SPD-011 Network meta-analysis of first-line antiangiogenic drugs in advanced renal cell carcinoma

Author

Gil-Sierra, MD, primary, Gimeno-Ballester, V, additional, Briceño-Casado, MDP, additional, Sanchez-Hidalgo, M, additional, Alarcon de la Lastra-Romero, C, additional, Fenix-Caballero, S, additional, Rios-Sanchez, E, additional, Diaz-Navarro, J, additional, Martinez-Diaz, C, additional, Borrero-Rubio, JM, additional, and Alegre-Del Rey, EJ, additional

Published
2019
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26. 4CPS-085 Stewardships of hepatitis c virus patients in prisons

Author

Gil-Sierra, MD, primary, Tellez-Perez, F, additional, Rios-Sanchez, E, additional, Briceño-Casado, MDP, additional, Fenix-Caballero, S, additional, Martinez-Diaz, C, additional, Alegre-Del Rey, EJ, additional, Palomo-Palomo, C, additional, Diaz-Navarro, J, additional, Lopez-Vallejo, JF, additional, and Borrero-Rubio, JM, additional

Published
2019
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28. 2SPD-002 Comparative efficacy of dimethylfumarate and other treatments for moderate-to-severe chronic plaque psoriasis

Author

Palomo-Palomo, C, primary, Rios-Sanchez, E, additional, Fenix-Caballero, S, additional, Gandara-Ladrondeguevara, MJ, additional, Gil-Sierra, MD, additional, Briceño-Casado, MP, additional, Salmeron-Navas, FJ, additional, Alegre-Del Rey, EJ, additional, Martinez-Diaz, C, additional, Diaz-Navarro, J, additional, and Borrero-Rubio, JM, additional

Published
2019
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30. 4CPS-150 Use of adalimumab for hidradenitis suppurativa

Author

Gil-Sierra, MD, primary, Garciadeparedes-Esteban, JC, additional, Rios-Sanchez, E, additional, Briceño-Casado, MDP, additional, Palomo-Palomo, C, additional, Diaz-Navarro, J, additional, Rey, EJ Alegre-Del, additional, Martinez-Diaz, C, additional, Lopez-Vallejo, JF, additional, and Borrero-Rubio, JM, additional

Published
2018
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32. 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

33. CP-140 Analysis of distribution and acceptability of pharmaceutical interventions after implantation of the electronic assisted prescription

Author

Gil-Sierra, MD, primary, Diaz-Navarro, J, additional, Camean-Castillo, M, additional, Fenix-Caballero, S, additional, GarciadeParedes-Esteban, JC, additional, Blanco-Castaño, MA, additional, Gandara-LadrondeGuevara, MJ, additional, Martinez-Diaz, C, additional, Borrero-Rubio, JM, additional, and Rey, EJ Alegre-Del, additional

Published
2017
Full Text
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36. Single Site Laparoscopy for Fertility Preservation: A Cohort Study

Author

Núñez Valera MJ, Padilla Iserte P, Higueras García G, Herraiz S, Rubio JM, Romeu Villarroya M, Pellicer A, and Díaz-García C

Subjects
Oophorectomy, Ovary, Cosmesis, Laparoscopy, Fertility preservation
Abstract

Study Objective: To compare operative and postoperative results of ovarian cortex retrieval by conventional laparoscopy (1cm umbilical site and 3 accessory 5-mm-reusable working ports) (HASS) versus single site laparoscopy (SSL). Design: Prospective cohort study. Setting: Fertility Preservation Programme at La Fe University Hospital-University of Valencia, Valencia, Spain, 2011 to 2012. Fertility Preservation Programme at La Fe University Hospital of Valencia, Valencia, Spain. Patients: Twenty-one patients with cancer (breast cancer: n = 17; Hodgkin's lymphoma: n = 3; and non-Hodgkin's lymphoma: n = 1). Intervention: Ovarian cortex retrieval either by conventional laparoscopy using an umbilical Hasson port and 3 accessory ports (HASS group: n = 11) or by SSL (SSL group: n = 10). Measurements and Main Results: Operative length, blood loss, postoperative pain (visual analog scale for pain at 6, 24, and 48 hours), need of additional analgesia, quality of life (European Quality of Life-5 Dimensions), cosmesis of the scar, and patient's self-perception were assessed at 24 and 48 hours and 3 months after surgery. Baseline characteristics were similar between groups. Estimated blood loss, operative length, and postoperative pain did not differ between groups. The start of chemotherapy was not delayed in either group, and cosmesis and image self-perception were also similar. Conclusion: The SSL approach can be considered a safe option compared with the classic multisite approach. (C) 2015 AAGL. All rights reserved.

Published
2015

37. Antral Follicle Priming Before Intracytoplasmic Sperm Injection in Previously Diagnosed Low Responders: A Randomized Controlled Trial (FOLLPRIM)

Author

Escriva AM, Diaz-Garcia C, Monterde M, Rubio JM, and Pellicer A

Subjects
LUTEAL ESTRADIOL PRETREATMENT, AGONIST PROTOCOL, POOR-RESPONDERS, GONADOTROPIN STIMULATION, CONTROLLED OVARIAN HYPERSTIMULATION, STIMULATING-HORMONE RECEPTOR, LUTEINIZING-GRANULOSA-CELLS, IN-VITRO FERTILIZATION, TRANSDERMAL TESTOSTERONE, GENE-EXPRESSION
Abstract

Context: A low response to controlled ovarian hyperstimulation implies a reduced number of embryos and impaired pregnancy rate. Follicular priming with steroids before controlled ovarian hyperstimulation has been suggested to improve the subsequent ovarian response. Objective: Thepurposeofthisstudywastodeterminethebestfollicularprimingprotocolinlowresponders and to investigate the intrafollicular mechanisms triggered by steroid hormone priming. Design: This was a single-center, randomized, parallel, open-label, controlled trial, in two phases. Setting: The setting was a university-based in vitro fertilization unit. Patients: Potential low responders (n = 99) underwent a first intracytoplasmic sperm injection cycle. Confirmed low responders (n = 66) were randomized to different priming protocols before a new intracytoplasmic sperm injection. Interventions: Randomized patients underwent one of the following priming strategies: transdermal testosterone (20 mu g/kg/d), transdermal estradiol (200 mu g/d), orcombinedestrogensandoral contraceptive pills (30 mu g of ethinyl estradiol plus 150 mu g of desogestrel administered during the luteal phase of two consecutive cycles) and 4 mg/d of estradiol valerate during the follicular phase between them. Main Outcomes Measures: Metaphase II (MII) oocytes were retrieved. Gene expression levels in the granulosa cells of steroidogenesis enzymes and FSH, LH, and androgen receptors were measured. Results: The number of retrieved MII oocytes did not differ between the interventional groups (testosterone, 2.2 +/- 2.0; estrogen, 2.7 +/- 1.7; and combined estrogens and oral contraceptive pills, 2.0 +/- 1.3; not significant). Compared with those in nonprimed cycles, estradiol pretreatment yielded more MII oocytes (primed, 2.7 +/- 1.7; nonprimed, 1.6 +/- 1.2; P = .029) although the clinical pregnancy rate was higher in patients treated with testosterone (P = .003). Testosterone pretreatment increased androgen receptor expression (P = .028) compared with that for the previous cycle without priming. Conclusions: The results of the present trial do not support the superiority of one priming strategy over the others.

Published
2015

38. PS-062 Desensitisation protocol for cabazitaxel: A case report

Author

Garciadeparedes-esteban, JC, primary, Fenix-Caballero, S, additional, Martinez-Diaz, C, additional, Fernandez-Anguita, MJ, additional, Camean-Castillo, M, additional, Gil-Sierra, MD, additional, Borrero-Rubio, JM, additional, Diaz-Navarro, J, additional, Rios-Sanchez, E, additional, and Rey, E Alegre-del, additional

Published
2016
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39. DI-063 Survival benefit with vemurafenib in ‘braf’ mutation positive melanoma: Area under the curve based reanalysis

Author

Fenix-Caballero, S, primary, Diaz-Navarro, J, additional, Camean-Castillo, M, additional, Rey, EJ Alegre-del, additional, Palomo-Palomo, C, additional, Blanco-Castaño, MA, additional, Borrero-Rubio, JM, additional, Gandara-LadronDeGuevara, MJ, additional, GarciaDeParedes-Esteban, JC, additional, and Gil-Sierra, D, additional

Published
2016
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40. PKP-019 Pharmacological interactions registered with the use of new direct acting antiviral agents for treatment of hepatitis C virus: Abstract PKP-019 Table 1

Author

de Guevara, MJ Gándara Ladrón, primary, Palomo, C Palomo, additional, Sánchez, E Ríos, additional, de Paredes Esteban, JC García, additional, Castillo, M Cameán, additional, Castaño, MA Blanco, additional, Caballero, S Fénix, additional, Navarro, J Díaz, additional, Díaz, C Martínez, additional, and Rubio, JM Borrero, additional

Published
2016
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41. CP-234 Antimicrobial stewardships: Semi-automatic validation tool for antimicrobial prescribing based on real time antibiograms

Author

Diaz-Navarro, J, primary, Fenix-Caballero, S, additional, Gil-Sierra, D, additional, Palomo-Palomo, C, additional, GarciaDeParedes-Esteban, JC, additional, Camean-Castillo M, M, additional, Blanco-Castaño, MA, additional, Gandara-LadronDeGuevara, MJ, additional, Freyre-Carrillo, C, additional, and Borrero-Rubio, JM, additional

Published
2016
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50. One-, two-, and three-particle distributions from 158A GeV/c central Pb+Pb collisions

Author

Aggarwal, M M, Angelis, A L S, Antonenko, V, Arefiev, V, Astakhov, V, Avdeitchikov, V, Awes, TC, Baba, P V K S, Badyal, K, Bathe, S, Batiounia, B, Bernier, T, Bhalla, KB, Bhatia, VS, Blume, C, Bucher, D, Busching, H, Carlen, L, Chattopadhyay, S, Decowski, MP, Delagrange, H, Donni, P, Majumdar, MRD, El Chenawi, K, Enosawa, K, Fokin, S, Frolov, V, Ganti, MS, Garpman, S, Gavrishchuk, O, Geurts, FJM, Ghosh, T K, Glasow, R, Guskov, B, Gustafsson, H.A., Gutbrod, HH, Hrivnacova, I., Ippolitov, M, Kalechofsky, H, Kamermans, R, Karadjev, K, Karpio, K, Kolb, BW, Kosarev, I., Koutcheryaev, I., Kugler, A, Kulinich, P, Kurata, M, Lebedev, A, Lohner, H, Mahapatra, DP, Manko, V., Martin, M, Martinez, G, Maximov, A, Miake, Y, Mishra, GC, Mohanty, B, Mora, MJ, Morrison, D, Mukhanova, T, Mukhopadhyay, DS, Naef, H, Nandi, BK, Nayak, SK, Nayak, TK, Nianine, A, Nikitine, V, Nikolaev, S, Nilsson, P, Nishimura, S, Nomokonov, P, Nystrand, J, Oskarsson, A, Otterlund, I., Peitzmann, T, Peressounko, D, Petracek, V., Plasil, F, Purschke, ML, Rak, J, Raniwala, R, Raniwala, S, Rao, NK, Reygers, K, Roland, G, Rosselet, L, Roufanov, I, Rubio, JM, Sambyal, SS, Santo, R, Sato, S, Schlagheck, H, Schutz, Y, Shabratova, G, Shah, TH, Sibiriak, I., Siemiarczuk, T, Silvermyr, D, Sinha, BC, Slavine, N, Soderstrom, K, Sood, G, Sorensen, SP, Stankus, P, Stefanek, G, Steinberg, P, Stenlund, E, Sumbera, M, Svensson, T, Tsvetkov, A., Tykarski, L, v d Pijll, EC, v Eijndhoven, N, v Nieuwenhuizen, GJ, Vinogradov, A, Viyogi, YP, Vodopianov, A, Voros, S, Wyslouch, B, Young, GR, and Research unit Nuclear & Hadron Physics

Subjects
TWISS CORRELATION RADII, Nuclear Theory, 3-PION INTERFEROMETRY, MULTISTEP AVALANCHE CHAMBER, PHASE-SPACE DENSITY, NUCLEAR COLLISIONS, HEAVY-ION COLLISIONS, 2-PION CORRELATIONS, PERFORMANCE, Nuclear Experiment, PLUS PB COLLISIONS, PION INTERFEROMETRY
Abstract

Several hadronic observables have been studied in central 158A GeV Pb+Pb collisions using data measured by the WA98 experiment at CERN: single pi(-) and K- production, as well as two- and three-pion interferometry. The Wiedemann-Heinz hydrodynamical model has been fitted to the pion spectrum, giving an estimate of the temperature and transverse flow velocity. Bose-Einstein correlations between two identified pi(-) have been analyzed as a function of k(T), using two different parametrizations. The results indicate that the source does not have a strictly boost invariant expansion or spend time in a long-lived intermediate phase. A comparison between data and a hydrodynamical based simulation shows very good agreement for the radii parameters as a function of k(T). The pion phase-space density at freeze-out has been measured, and agrees well with the Tomasik-Heinz model. A large pion chemical potential close to the condensation limit of m(pi) seems to be excluded. The three-pion Bose-Einstein interferometry shows a substantial contribution of the genuine three-pion correlation, but not quite as large as expected for a fully chaotic and symmetric source.

Published
2003

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