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2. Maraviroc Pharmacokinetics in HIV-1–Infected Pregnant Women

Author

Colbers, Angela, Best, Brookie, Schalkwijk, Stein, Wang, Jiajia, Stek, Alice, Tenorio, Carmen Hidalgo, Hawkins, David, Taylor, Graham, Kreitchmann, Regis, Burchett, Sandra, Haberl, Annette, Kabeya, Kabamba, van Kasteren, Marjo, Smith, Elizabeth, Capparelli, Edmund, Burger, David, Mirochnick, Mark, Team, for the PANNA Network and the IMPAACT 1026 Study, van der Ende, ME, Erasmus, MC, van der Ven, AJAM, Nellen, J, Moltó, J, Nicastri, E, Giaquinto, C, Gingelmaier, A, Lyons, F, Lambert, J, Wyen, C, Faetkenheuer, G, Rockstroh, JK, Schwarze-Zander, C, Sadiq, S Tariq, Gilleece, Y, Wood, C, Buschur, Shelley, Jackson, Chivon, Paul, Mary, Florez, Claudia, Bryan, Patricia, Stone, Monica, Katz, Mindy, Auguste, Raphaelle, Wiznia, Andrew, Bruder, Karen L, Lewis, Gail, Casey, Denise, Losso, Marcelo H, Ivalo, Silvina A, Hakim, Alejandro, Deveikis, Audra, Batra, Jagmohan, Alvarez, Janielle Jackson, Knapp, Katherine M, Sublette, Nina, Wride, Thomas, Febo, Irma L, Santos, Ruth, and Tamayo, Vivian

Subjects
Medical Microbiology, Reproductive Medicine, Biomedical and Clinical Sciences, HIV/AIDS, Infectious Diseases, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Reproductive health and childbirth, Infection, Adult, Anti-HIV Agents, Blood Chemical Analysis, Cyclohexanes, Europe, Female, HIV Infections, Humans, Maraviroc, Pregnancy, Pregnancy Complications, Infectious, Triazoles, United States, Young Adult, MTCT, pharmacokinetics, pregnancy, HIV, maraviroc, PANNA Network and the IMPAACT 1026 Study Team, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

ObjectiveTo describe the pharmacokinetics of maraviroc in human immunodeficiency virus (HIV)-infected women during pregnancy and post partum.MethodsHIV-infected pregnant women receiving maraviroc as part of clinical care had intensive steady-state 12-hour pharmacokinetic profiles performed during the third trimester and ≥2 weeks after delivery. Cord blood samples and matching maternal blood samples were taken at delivery. The data were collected in 2 studies: P1026 (United States) and PANNA (Europe). Pharmacokinetic parameters were calculated.ResultsEighteen women were included in the analysis. Most women (12; 67%) received 150 mg of maraviroc twice daily with a protease inhibitor, 2 (11%) received 300 mg twice daily without a protease inhibitor, and 4 (22%) had an alternative regimen. The geometric mean ratios for third-trimester versus postpartum maraviroc were 0.72 (90% confidence interval, .60-.88) for the area under the curve over a dosing interval (AUCtau) and 0.70 (0.58-0.85) for the maximum maraviroc concentration. Only 1 patient showed a trough concentration (Ctrough) below the suggested target of 50 ng/mL, both during pregnancy and post partum. The median ratio of maraviroc cord blood to maternal blood was 0.33 (range, 0.03-0.56). The viral load close to delivery was

Published
2015

5. Sensitivity of PM10 oxidative potential to aerosol chemical composition at a Mediterranean urban site: ascorbic acid versus dithiothreitol measurements.

Author

Clemente, Á., Gil-Moltó, J., Yubero, E., Juárez, N., Nicolás, J. F., Crespo, J., and Galindo, N.

Abstract

The oxidative potential (OP) of PM10 daily samples collected at a traffic site in southeastern Spain during summer and winter was assessed by two acellular assays: the ascorbic acid (AA) and dithiothreitol (DTT) methods. Although PM10 levels were similar during both periods, OP values (expressed in nmol min−1 m−3) showed a defined seasonal trend. The AA activity was higher in summer than in winter, whereas the DTT reactivity exhibited an opposite seasonal pattern. Both assays were sensitive to different PM10 components, as shown by the results of the linear correlation analysis. Moreover, the relationship between OP values and PM10 chemical species was not the same during summer and winter, indicating that particle toxicity is associated with different sources during the warm and cold seasons. When OP values were expressed on a mass basis (nmol min−1 µg−1), lower correlation coefficients with PM10 chemical species were generally obtained compared to volume-normalized activities. These outcomes suggest that only some specific components have a significant intrinsic oxidative potential. [ABSTRACT FROM AUTHOR]

Published
2023
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6. Simplification to dual therapy (atazanavir/ritonavir + lamivudine) versus standard triple therapy [atazanavir/ritonavir + two nucleos(t)ides] in virologically stable patients on antiretroviral therapy: 96 week results from an open-label, non-inferiority, randomized clinical trial (SALT study)

Author

Perez-Molina, J. A., Rubio, R., Rivero, A., Pasquau, J., Suárez-Lozano, I., Riera, M., Estébanez, M., Palacios, R., Sanz-Moreno, J., Troya, J., Mariño, A., Antela, A., Navarro, J., Esteban, H., Moreno, S., Andrade, J. D. Pedreira, Iglesias, M. A. Castro, Mena, A., López, S., Vázquez, P., Esteban, H., Sánchez, S., Caínzos, T., Muñoz, J., Ferrero, O. L., Zulibarria, Z. Zubero, Ibarra, S., Jáuregui, J. M. Santamaría, Artexe, J. Baraitzxaburu, Olalla, J., De Arco, A., De la Torre, J., Prada, J. L., Téllez, M. J., Vergas, J., Estada, V., Quero, J. Hernández, Monje, A. Peña, Parra, J., Martínez, M., Muñoz, L., Sánchez, V., Arias, E. Losada, Martínez, A. Prieto, Loyarte, J. A. Iribarren, Ibarguren, M., Galparsoro, H. Azkune, Odriozola, M. J. Bistinduy, de Barrón, X. C. Ortiz, Sánchez, M. A. Goenaga, De Miguel, M. A. Von Wichmann, Tomé, L. Pascual, Camino, X., Ena, J., Pascuau, F., Amador, C., Benito, C., Barrufet, P., Force, L., Bejarano, G., Pedrol, P. Domingo, Gutierren, M., Mateo, G., Terrón, A., Marín, D., Bancalero, P., Cosín, J., Berenguer, J., Miralles, P., Sánchez, M., López, J. C., Ramírez, M., Cuellar, I., Carrero, A., Portilla, J., Boix, V., Merino, E., Reus, S., Giner, L., Pampliega, M., Gutierrez, F., Conto, M. Masía, Rincón, J. M. Ramos, Urrea, S. Padilla, García, C. Robledano, Picó, J. M. Fajarso, Muñoz, M. D. Merino, Marcos, F. J. Martínez, Gómez, F. J. Rodríguez, Rayan, P., Solís, J., Palomero, N., Clotet, B., Chamorro, A., Puigmal, E. Negredo, Echevarría, P., Bonjoch, A., Moltó, J., Puig, J., Blanco, M. A. Ribas, Marinescu, C., Crespo, M., Navarro, J., Asensi, V., Sanchez, J. A. Cartón, Pulido, F., Matarraz, M., Lagarde, M., Bisbal, O., Portillo, A., Arribas, J. R., Bernardino, I., Zamora, F. J., Montes, M. L., González, J. J., Pérez, I., Castro, J., De Miguel, J., Arranz, A., Casas, E., Dronda, F., Moreno, S., Fortún, J., Pérez-Elías, M. J., Navas, E., Quereda, C., Rodríguez-Sagrado, M. A., Jurado, R., García, M., Camacho, A., De la Torre, J., Tapia, A., Hidalgo, C., López, M. A., Martínez, R., García, C., Santos, J., Márquez, M., Ruiz, J., Nuño, E., Oteo, J. A., Blanco, J. R., Sanz, M., Ibarra, V., Metola, L., Pérez, L., Miralles, C., Ocampo, A., Rodríguez, A., and Warncke, F.

Published
2017
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14. The Effect of Pregnancy on the Pharmacokinetics of Total and Unbound Dolutegravir and Its Main Metabolite in Women Living With Human Immunodeficiency Virus

Author

Bollen, P.D.J., Freriksen, J.J.M., Konopnicki, D., Weizsäcker, K., Hidalgo Tenorio, C., Moltó, J., Taylor, G., Alba-Alejandre, I., Crevel, R. van, Colbers, A., Burger, D.M., Bollen, P.D.J., Freriksen, J.J.M., Konopnicki, D., Weizsäcker, K., Hidalgo Tenorio, C., Moltó, J., Taylor, G., Alba-Alejandre, I., Crevel, R. van, Colbers, A., and Burger, D.M.

Abstract

Item does not contain fulltext, BACKGROUND: Pharmacokinetic and efficacy data on dolutegravir in pregnant women living with human immunodeficiency virus (HIV) are still limited but needed to support its use as one of the preferred antiretroviral agents. METHODS: Within the multicenter Pharmacokinetics of ANtiretroviral agents in HIV-infected pregNAnt women (PANNA) study, pregnant women living with HIV and using dolutegravir once daily (50 mg, with food) underwent 24-hour pharmacokinetic profiling in their third trimester and postpartum. Dolutegravir exposure in the third trimester was considered adequate if geometric mean unbound, pharmacologically active, minimal plasma concentrations (Cmin, unbound) and ≥90% of individual Cmin, unbound levels were >0.85 µg/L, the proposed 90% inhibitory concentration for unbound dolutegravir. Geometric mean ratios (GMRs) with 90% confidence intervals (CIs) for comparison of total and unbound pharmacokinetic parameters in the third trimester and postpartum were calculated, including the metabolic ratio for dolutegravir-glucuronide. Safety and virological data were collected. RESULTS: Seventeen women (76% black) were enrolled (25 evaluable pharmacokinetic profiles; 15 in the third trimester, 10 in postpartum). In the third trimester, geometric mean (coefficient of variation, %) Cmin, unbound was 2.87 (87) µg/L and 93% of individual Cmin, unbound levels were >0.85 µg/L. The GMR (90% CI) in the third trimester vs postpartum was 0.86 (.68-1.10) for area under the curve (AUC0-24h), and for Cmax, 0.93 (.77-1.13). GMR (90% CI) for the trough concentrations was 0.71 (.49-1.02), based on total dolutegravir concentrations. Four serious adverse events were reported, unlikely related to dolutegravir. The HIV polymerase chain reaction test was negative in 14/17 infants (result unknown for 3 infants). CONCLUSIONS: Pharmacokinetic changes for dolutegravir in late pregnancy are not clinically relevant and support the use of dolutegravir 50 mg once daily with food in pregnancy. C

Published
2021

15. Early virological failure with cabotegravir/rilpivirine.

Author

Bailón, L, Sábato, S, Coll, J, Santos, J R, Miranda, C, Puig, T, D´Avolio, A, Paredes, R, Moltó, J, and Negredo, E

Subjects
HIV infections
Abstract

This article discusses a case of virological failure in a person with HIV who was switched to long-acting therapy with cabotegravir and rilpivirine. The patient experienced an increase in viral load after starting the new treatment, despite having no prior exposure to certain medications or previous treatment interruptions. The article suggests that factors such as HIV subtype, preexisting resistance mutations, and low drug concentrations may contribute to virological failure with this therapy. The case highlights the importance of close monitoring and further research in this area. [Extracted from the article]

Published
2024
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17. The Oasis Papers 2 : Proceedings of the Second International Conference of the Dakhleh Oasis Project

Author

Wiseman, Marcia F., Edited by, Parr, Bruce E., Production Editor, Aufderheide, Arthur C., Bagnall, Roger S., Blondaux, Laurence, Cartmell, Larry, Churcher, Charles S., Dupras, Tosha L., Fairgrieve, Scott I., Evensen, Norman, Frizano, Jacqueline, Gardner, Iain, Giegengack, Robert, Hawkins, Alicia L., Kleindienst, Maxine R., König, Christiane, McDonald, Mary M. A., Mills, Anthony J., Molto, J. Eldon, Nicoll, Kathleen A., Schwarcz, Henry P., Shaw, Roberta, Sheldrick, Peter, Szkudlarek, Robert, Thanheiser, Ursula, Thompson, Jennifer L., Wiseman, Marcia F., Zlonis, Michael, Wiseman, Marcia F., Parr, Bruce E., Aufderheide, Arthur C., Bagnall, Roger S., Blondaux, Laurence, Cartmell, Larry, Churcher, Charles S., Dupras, Tosha L., Fairgrieve, Scott I., Evensen, Norman, Frizano, Jacqueline, Gardner, Iain, Giegengack, Robert, Hawkins, Alicia L., Kleindienst, Maxine R., König, Christiane, McDonald, Mary M. A., Mills, Anthony J., Molto, J. Eldon, Nicoll, Kathleen A., Schwarcz, Henry P., Shaw, Roberta, Sheldrick, Peter, Szkudlarek, Robert, Thanheiser, Ursula, Thompson, Jennifer L., Wiseman, Marcia F., and Zlonis, Michael

Published
2016

20. Condylomata, cytological abnormalities and human papillomavirus infection in the anal canal in HIV-infected men

Author

Darwich, L, Cañadas, M P, Videla, S, Coll, J, Piñol, M, Cobarsi, P, Molina-López, R A, Vela, S, García-Cuyás, F, Llatjos, M, Sirera, G, Clotet, B, Fernández, I., Castella, E., LLatjós, M., Bonjoch, A., Echevarría, P., Jabaloyas, M., Jou, A., Llibre, J. M., Moltó, J., Negredo, E., Pérez-Alvarez, N., Rey-Joly, C., Romeu, J., Santos, J. R., Tural, C., Alcalde, C., Guerola, R., Salas, A., Castilla, I., Cirigliano, V., Ejarque, M., López, E., Ordóñez, E., and Rueda, L.

Published
2012
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27. Therapeutic vaccine in chronically Hiv-1-infected patients

Author

Jong, W. (Wesley) de, Leal, L. (Lorna), Buyze, J. (Jozefien), Pannus, P. (Pieter), Guardo, A. (Alberto), Salgado, M. (Maria), Mothe, B. (Beatriz), Moltó, J. (José), Moron-Lopez, S. (Sara), Gálvez, C. (Cristina), Florence, E. (Eric), Vanham, G. (Guido), Gorp, E.C.M. (Eric) van, Brander, C. (Christian), Allard, S.D., Thielemans, K. (Kris), Martinez-Picado, J. (Javier), Plana, M. (Montserrat), García, F. (Felipe), Gruters, R.A. (Rob), Jong, W. (Wesley) de, Leal, L. (Lorna), Buyze, J. (Jozefien), Pannus, P. (Pieter), Guardo, A. (Alberto), Salgado, M. (Maria), Mothe, B. (Beatriz), Moltó, J. (José), Moron-Lopez, S. (Sara), Gálvez, C. (Cristina), Florence, E. (Eric), Vanham, G. (Guido), Gorp, E.C.M. (Eric) van, Brander, C. (Christian), Allard, S.D., Thielemans, K. (Kris), Martinez-Picado, J. (Javier), Plana, M. (Montserrat), García, F. (Felipe), and Gruters, R.A. (Rob)

Abstract

Therapeutic vaccinations aim to re-educate human immunodeficiency virus (HIV)-1specific immune responses to achieve durable control of HIV-1 replication in virally suppressed infected individuals after antiretroviral therapy (ART) is interrupted. In a double blinded, placebocontrolled phase IIa multicenter study, we investigated the safety and immunogenicity of intranodal administration of the HIVACAT T cell Immunogen (HTI)-TriMix vaccine. It consists of naked mRNA based on cytotoxic T lymphocyte (CTL) targets of subdominant and conserved HIV-1 regions (HTI), in combination with mRNAs encoding constitutively active TLR4, the ligand for CD40 and CD70 as adjuvants (TriMix). We recruited HIV-1-infected individuals under stable ART. Study-arms HTI-TriMix, TriMix or Water for Injection were assigned in an 8:3:3 ratio. Participants received three vaccinations at weeks 0, 2, and 4 in an inguinal lymph node. Two weeks after the last vaccination, immunogenicity was evaluated using ELISpot assay. ART was interrupted at week 6 to study the effect of the vaccine on viral rebound. The vaccine was considered safe and well tolerated. Eighteen percent (n = 37) of the AEs were considered definitely related to the study product (grade 1 or 2). Three SAEs occurred: two were unrelated to the study product, and one was possibly related to ART interruption (ATI). ELISpot assays to detect T cell responses using peptides covering the HTI sequence showed no significant differences in immunogenicity between groups. There were no significant differences in viral load rebound dynamics after ATI between groups. The vaccine was safe and well tolerated. We were not able to demonstrate immunogenic effects of the vaccine.

Published
2019
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31. Thermal and non-thermal preservation techniques of tiger nuts\textquoteright beverage \textquotedbllefthorchata de chufa\textquotedblright. Implications for food safety, nutritional and quality properties

Author

Roselló-Soto, E., Poojary, M. M., Barba, Francisco J., Koubaa, Mohamed, Lorenzo, José Manuel, Mañes, J., Moltó, J. C., Faculty of Pharmacy, Preventive Medicine & Public Health, Food Science, Toxicology & Forensic Medicine Department, University of Valencia, School of Science and Technology [Camerino], Università degli Studi di Camerino (UNICAM), University of Copenhagen = Københavns Universitet (KU), ESCOM, Transformation Intégrée de la Matière Renouvelable (TIMR), Université de Technologie de Compiègne (UTC), Department of Chemistry & QOPNA, and Universidade de Aveiro

Subjects
[SDE.IE]Environmental Sciences/Environmental Engineering, [SPI.GPROC]Engineering Sciences [physics]/Chemical and Process Engineering
Published
2018

32. Effect of atorvastatin in elderly patients with a recent stroke or transient ischemic attack

Author

Chaturvedi, S, Zivin, J, Breazna, A, Amarenco, P, Callahan, A, Goldstein, LB, Hennerici, M, Sillesen, H, Rudolph, A, Welch, MA, SPARCL Investigators, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Shuaib A, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Stipal R, Vaclavik D, Boysen G, Klingenberg H, Iversen, Sillesen H, Hillbom M, Kaste M, Numminen H, Pilke A, Salmivaara A, Sivenius J, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Bogdahn U, Diener HC, Dichgans M, Glahn J, Haberl R, Harms L, Hennerici MG, Knecht S, Kroczek G, Lichy C, Sander D, Schneider D, Kazis A, Karageorgiou C, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Scott R, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rodriguez F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Bogousslavsky J, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Altafullah I, Benavente O, Book D, Broderick J, Callahan A. 3rd, Calder C, Carlini W, Chaturvedi S, Chippendale T, Clark W, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Graham G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hendin D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., FERRARESE, CARLO, Chaturvedi, S, Zivin, J, Breazna, A, Amarenco, P, Callahan, A, Goldstein, L, Hennerici, M, Sillesen, H, Rudolph, A, Welch, M, Sparcl, I, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Shuaib, A, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Stipal, R, Vaclavik, D, Boysen, G, Klingenberg, H, Iversen, Hillbom, M, Kaste, M, Numminen, H, Pilke, A, Salmivaara, A, Sivenius, J, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Bogdahn, U, Diener, H, Dichgans, M, Glahn, J, Haberl, R, Harms, L, Knecht, S, Kroczek, G, Lichy, C, Sander, D, Schneider, D, Kazis, A, Karageorgiou, C, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Scott, R, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rodriguez, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Bogousslavsky, J, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Macwalter, R, Sharma, A, Shetty, H, Albers, G, Altafullah, I, Benavente, O, Book, D, Broderick, J, Callahan A., 3, Calder, C, Carlini, W, Chippendale, T, Clark, W, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Graham, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hendin, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Lamonte, M, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, and De Bastos, M

Subjects
Male, medicine.medical_specialty, Atorvastatin, medicine.medical_treatment, Coronary Disease, Pyrrole, Revascularization, Risk Assessment, Cohort Studies, Coronary artery disease, Internal medicine, Anticholesteremic Agent, Myocardial Revascularization, medicine, Clinical endpoint, Humans, Pyrroles, Age Factor, cardiovascular diseases, Stroke, Aged, Cerebral infarction, business.industry, Anticholesteremic Agents, Hazard ratio, Age Factors, Cholesterol, LDL, Middle Aged, medicine.disease, Surgery, Heptanoic Acid, Heptanoic Acids, Ischemic Attack, Transient, Cohort, Cardiology, Female, Hydroxymethylglutaryl-CoA Reductase Inhibitor, Neurology (clinical), Hydroxymethylglutaryl-CoA Reductase Inhibitors, Cohort Studie, business, Human, medicine.drug
Abstract

BACKGROUND: It is unclear whether patients age 65 years and over with a recent stroke or TIA benefit from statin treatment to a similar degree as younger patients. METHODS: The 4,731 patient cohort in the SPARCL study was divided into an elderly group (65 and over) and a younger group. The primary endpoint (fatal or nonfatal stroke) and secondary endpoints were analyzed, with calculation of the hazard ratio (HR) and p values from a Cox regression model. RESULTS: There were 2,249 patients in the elderly group and 2,482 in the younger group. The baseline LDL (133 mg/dL) and total cholesterol were comparable in the two groups. The elderly and younger groups had a 61.4 mg/dL and 58.7 mg/dL decrease in mean LDL during the trial. The primary endpoint was reduced by 26% in younger patients (HR 0.74, 0.57-0.96, p = 0.02) and by 10% in elderly subjects (HR 0.90, 0.73-1.11, p = 0.33). A test of heterogeneity for a treatment-age interaction was not significant (p = 0.52). The risk of stroke or TIA (HR 0.79, p = 0.01), major coronary events (HR 0.68, p = 0.035), any coronary heart disease event (HR 0.61, p = 0.0006), and revascularization procedures (HR 0.55, p = 0.0005) was reduced in the elderly group. CONCLUSIONS: There was no heterogeneity in the stroke reduction seen with atorvastatin in the elderly and younger groups. Cardiac events and revascularization procedures were also lower in both the elderly and younger subgroups treated with atorvastatin. These results support the use of atorvastatin in elderly patients with recent stroke or TIA.

Published
2008

33. The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women

Author

Colbers, Ap, Hawkins, Da, Gingelmaier, A, Kabeya, K, Rockstroh, Jk, Wyen, C, Weizsäcker, K, Sadiq, St, Ivanovic, J, Giaquinto, Carlo, Taylor, Gp, Moltó, J, Burger, Dm, and Panna, Network

Subjects
Adult, medicine.medical_specialty, Anti-HIV Agents, Pregnancy Trimester, Third, Immunology, Organophosphonates, HIV Infections, Emtricitabine, Deoxycytidine, Young Adult, Pharmacokinetics, Acquired immunodeficiency syndrome (AIDS), Pregnancy, medicine, Humans, Immunology and Allergy, Pregnancy Complications, Infectious, Tenofovir, Nucleoside analogue, business.industry, Obstetrics, Adenine, Poverty-related infectious diseases [N4i 3], Area under the curve, Gestational age, Viral Load, Fetal Blood, medicine.disease, Infectious Disease Transmission, Vertical, Confidence interval, Surgery, Europe, Infectious Diseases, HIV-1, Female, Poverty-related infectious diseases Infectious diseases and international health [N4i 3], business, Viral load, medicine.drug
Abstract

Contains fulltext : 117827.pdf (Publisher’s version ) (Closed access) OBJECTIVE:: To describe the pharmacokinetics of tenofovir and emtricitabine in the third trimester of pregnant HIV-infected women and at postpartum. DESIGN:: A nonrandomized, open-label, multicentre phase IV study in HIV-infected pregnant women recruited from HIV treatment centres in Europe. METHODS:: HIV-infected pregnant women treated with the nucleotide/nucleoside analogue reverse transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate (TDF 300 mg; equivalent to 245 mg tenofovir disoproxil) and/or emtricitabine (FTC 200 mg) were included in the study. Twenty-four-hour pharmacokinetic curves were recorded in the third trimester (preferably week 33) and postpartum (preferably week 4-6). Collection of a cord blood sample and maternal sample at delivery was optional. Pharmacokinetic parameters were calculated using WinNonlin software version 5.3. Statistical analysis was conducted using SPSS version 16.0. RESULTS:: Thirty-four women were included in the analysis. Geometric mean ratios of third trimester vs. postpartum [90% confidence interval (CI)] were 0.77 (0.71-0.83) for TDF area under the curve (AUC0-24 h); 0.81 (0.68-0.96) for TDF Cmax and 0.79 (0.70-0.90) for TDF C24 h and 0.75 (0.68-0.82) for FTC AUC0-24 h; and 0.87 (0.77-0.99) for FTC Cmax and 0.77 (0.52-1.12) for FTC C24 h. The viral load close to delivery was less than 200 copies/ml in all but one patient, the average gestational age at delivery was 38 weeks. All children were tested HIV-negative and no congenital abnormalities were reported. CONCLUSION:: Although pharmacokinetic exposure of the NRTIs TDF and FTC during pregnancy is approximately 25% lower, this was not associated with virological failure in this study and did not result in mother-to-child transmission.

Published
2013

35. P-glycoprotein (ABCB1) activity decreases raltegravir disposition in primary CD4+P-gphigh cells and correlates with HIV-1 viral load

Author

Minuesa G, Arimany-Nardi C, Itziar Erkizia, Cedeño S, Moltó J, Clotet B, Pastor-Anglada M, and Martinez-Picado J

Subjects
virus diseases
Abstract

To evaluate the role of P-glycoprotein (P-gp) and multidrug-resistant-protein 1 (MRP1) on raltegravir intracellular drug disposition in CD4+ T cells, investigate the effect of HIV-1 infection on P-gp expression and correlate HIV-1 viraemia with P-gp activity in primary CD4+ T cell subsets.

Published
2016

37. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women

Author

Colbers, A, Best, B, Schalkwijk, S, Wang, J, Stek, A, Hidalgo Tenorio, C, Hawkins, D, Taylor, G, Kreitchmann, R, Burchett, S, Haberl, A, Kabeya, K, Van Kasteren, M, Smith, E, Capparelli, E, Burger, D, Mirochnick, M, Van Der Ende, ME, Erasmus, M, Van Der Ven, AJAM, Nellen, J, Moltó, J, Nicastri, E, Giaquinto, C, Gingelmaier, A, Lyons, F, Lambert, J, Wyen, C, Faetkenheuer, G, Rockstroh, JK, Schwarze-Zander, C, Sadiq, ST, Gilleece, Y, Wood, C, Buschur, S, Jackson, C, Paul, M, Florez, C, Bryan, P, Stone, M, Katz, M, Auguste, R, Wiznia, A, Bruder, KL, Lewis, G, Casey, D, Losso, MH, Ivalo, SA, Hakim, A, Deveikis, A, Batra, J, Alvarez, JJ, Knapp, KM, Sublette, N, Wride, T, Febo, IL, Santos, R, and Tamayo, V

Abstract

© The Author 2015. Published by Oxford University Press on behalf of the Infectious. Objective.To describe the pharmacokinetics of maraviroc in human immunodeficiency virus (HIV)-infected women during pregnancy and post partum. Methods.HIV-infected pregnant women receiving maraviroc as part of clinical care had intensive steady-state 12-hour pharmacokinetic profiles performed during the third trimester and ≥2 weeks after delivery. Cord blood samples and matching maternal blood samples were taken at delivery. The data were collected in 2 studies: P1026 (United States) and PANNA (Europe). Pharmacokinetic parameters were calculated. Results.Eighteen women were included in the analysis. Most women (12; 67%) received 150 mg of maraviroc twice daily with a protease inhibitor, 2 (11%) received 300 mg twice daily without a protease inhibitor, and 4 (22%) had an alternative regimen. The geometric mean ratios for third-trimester versus postpartum maraviroc were 0.72 (90% confidence interval,. 60-.88) for the area under the curve over a dosing interval (AUCtau) and 0.70 (0.58-0.85) for the maximum maraviroc concentration. Only 1 patient showed a trough concentration (Ctrough) below the suggested target of 50 ng/mL, both during pregnancy and post partum. The median ratio of maraviroc cord blood to maternal blood was 0.33 (range, 0.03-0.56). The viral load close to delivery was

Published
2015

38. Effect of atorvastatin in elderly patients with a recent stroke or transient ischemic attack

Author

Chaturvedi, S, Zivin, J, Breazna, A, Amarenco, P, Callahan, A, Goldstein, L, Hennerici, M, Sillesen, H, Rudolph, A, Welch, M, Sparcl, I, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Shuaib, A, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Stipal, R, Vaclavik, D, Boysen, G, Klingenberg, H, Iversen, Hillbom, M, Kaste, M, Numminen, H, Pilke, A, Salmivaara, A, Sivenius, J, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Bogdahn, U, Diener, H, Dichgans, M, Glahn, J, Haberl, R, Harms, L, Knecht, S, Kroczek, G, Lichy, C, Sander, D, Schneider, D, Kazis, A, Karageorgiou, C, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Scott, R, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rodriguez, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Bogousslavsky, J, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Macwalter, R, Sharma, A, Shetty, H, Albers, G, Altafullah, I, Benavente, O, Book, D, Broderick, J, Callahan A., 3, Calder, C, Carlini, W, Chippendale, T, Clark, W, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Graham, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hendin, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Lamonte, M, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, De Bastos, M, Goldstein, LB, Welch, MA, SPARCL Investigators, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Shuaib A, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Stipal R, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Kaste M, Numminen H, Pilke A, Salmivaara A, Sivenius J, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Bogdahn U, Diener HC, Dichgans M, Glahn J, Haberl R, Harms L, Hennerici MG, Knecht S, Kroczek G, Lichy C, Sander D, Schneider D, Kazis A, Karageorgiou C, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Scott R, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rodriguez F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Bogousslavsky J, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Altafullah I, Benavente O, Book D, Broderick J, Callahan A. 3rd, Calder C, Carlini W, Chaturvedi S, Chippendale T, Clark W, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Graham G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hendin D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., FERRARESE, CARLO, Chaturvedi, S, Zivin, J, Breazna, A, Amarenco, P, Callahan, A, Goldstein, L, Hennerici, M, Sillesen, H, Rudolph, A, Welch, M, Sparcl, I, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Shuaib, A, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Stipal, R, Vaclavik, D, Boysen, G, Klingenberg, H, Iversen, Hillbom, M, Kaste, M, Numminen, H, Pilke, A, Salmivaara, A, Sivenius, J, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Bogdahn, U, Diener, H, Dichgans, M, Glahn, J, Haberl, R, Harms, L, Knecht, S, Kroczek, G, Lichy, C, Sander, D, Schneider, D, Kazis, A, Karageorgiou, C, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Scott, R, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rodriguez, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Bogousslavsky, J, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Macwalter, R, Sharma, A, Shetty, H, Albers, G, Altafullah, I, Benavente, O, Book, D, Broderick, J, Callahan A., 3, Calder, C, Carlini, W, Chippendale, T, Clark, W, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Graham, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hendin, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Lamonte, M, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, De Bastos, M, Goldstein, LB, Welch, MA, SPARCL Investigators, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Shuaib A, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Stipal R, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Kaste M, Numminen H, Pilke A, Salmivaara A, Sivenius J, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Bogdahn U, Diener HC, Dichgans M, Glahn J, Haberl R, Harms L, Hennerici MG, Knecht S, Kroczek G, Lichy C, Sander D, Schneider D, Kazis A, Karageorgiou C, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Scott R, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rodriguez F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Bogousslavsky J, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Altafullah I, Benavente O, Book D, Broderick J, Callahan A. 3rd, Calder C, Carlini W, Chaturvedi S, Chippendale T, Clark W, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Graham G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hendin D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., and FERRARESE, CARLO

Abstract

BACKGROUND: It is unclear whether patients age 65 years and over with a recent stroke or TIA benefit from statin treatment to a similar degree as younger patients. METHODS: The 4,731 patient cohort in the SPARCL study was divided into an elderly group (65 and over) and a younger group. The primary endpoint (fatal or nonfatal stroke) and secondary endpoints were analyzed, with calculation of the hazard ratio (HR) and p values from a Cox regression model. RESULTS: There were 2,249 patients in the elderly group and 2,482 in the younger group. The baseline LDL (133 mg/dL) and total cholesterol were comparable in the two groups. The elderly and younger groups had a 61.4 mg/dL and 58.7 mg/dL decrease in mean LDL during the trial. The primary endpoint was reduced by 26% in younger patients (HR 0.74, 0.57-0.96, p = 0.02) and by 10% in elderly subjects (HR 0.90, 0.73-1.11, p = 0.33). A test of heterogeneity for a treatment-age interaction was not significant (p = 0.52). The risk of stroke or TIA (HR 0.79, p = 0.01), major coronary events (HR 0.68, p = 0.035), any coronary heart disease event (HR 0.61, p = 0.0006), and revascularization procedures (HR 0.55, p = 0.0005) was reduced in the elderly group. CONCLUSIONS: There was no heterogeneity in the stroke reduction seen with atorvastatin in the elderly and younger groups. Cardiac events and revascularization procedures were also lower in both the elderly and younger subgroups treated with atorvastatin. These results support the use of atorvastatin in elderly patients with recent stroke or TIA.

Published
2009

39. Etravirine pharmacokinetics in HIV-infected pregnant women

Author

Mulligan, N. (Nikki), Schalkwijk, S. (Stein), Best, B.M. (Brookie M.), Colbers, A. (Angela), Wang, J. (Jiajia), Capparelli, E.V. (Edmund V.), Moltó, J. (José), Stek, A.M. (Alice M.), Taylor, G. (Graham), Smith, E. (Elizabeth), Tenorio, C.H. (Carmen Hidalgo), Chakhtoura, N. (Nahida), Kasteren, M.E.E. (Marjo) van, Fletcher, C.V. (Courtney V.), Mirochnick, M. (Mark), Burger, D.M. (David), Antinori, A. (Andrea), Ende, I.E. (Ineke) van der, Faetkenheuer, G. (Gerd), Giaquinto, C. (Carlo), Gilleece, Y. (Yvonne), Gingelmaier, A. (Andrea), Haberl, A. (Annette), Hawkins, D. (David), Ivanovic, J. (Jelena), Kabeya, K. (Kabamba), Lambert, J. (Julien), Lyons, F. (Fyona), Nellen, J.F.J.B. (Jeannine), Nicastri, E. (Emanuelle), Rockstroh, J. (Jürgen), Schwarze-zander, C., Ruiter, A. (Annemiek de), Sadiq, T. (Tariq), Ven, A. (André van der), Weizsäcker, K. (Katharina), Wood, C. (Chris), Wyen, C. (Christoph), Mulligan, N. (Nikki), Schalkwijk, S. (Stein), Best, B.M. (Brookie M.), Colbers, A. (Angela), Wang, J. (Jiajia), Capparelli, E.V. (Edmund V.), Moltó, J. (José), Stek, A.M. (Alice M.), Taylor, G. (Graham), Smith, E. (Elizabeth), Tenorio, C.H. (Carmen Hidalgo), Chakhtoura, N. (Nahida), Kasteren, M.E.E. (Marjo) van, Fletcher, C.V. (Courtney V.), Mirochnick, M. (Mark), Burger, D.M. (David), Antinori, A. (Andrea), Ende, I.E. (Ineke) van der, Faetkenheuer, G. (Gerd), Giaquinto, C. (Carlo), Gilleece, Y. (Yvonne), Gingelmaier, A. (Andrea), Haberl, A. (Annette), Hawkins, D. (David), Ivanovic, J. (Jelena), Kabeya, K. (Kabamba), Lambert, J. (Julien), Lyons, F. (Fyona), Nellen, J.F.J.B. (Jeannine), Nicastri, E. (Emanuelle), Rockstroh, J. (Jürgen), Schwarze-zander, C., Ruiter, A. (Annemiek de), Sadiq, T. (Tariq), Ven, A. (André van der), Weizsäcker, K. (Katharina), Wood, C. (Chris), and Wyen, C. (Christoph)

Abstract

__Background__ The study goal was to describe etravirine pharmacokinetics during pregnancy and postpartum in HIV-infected women. __Methods__ IMPAACT P1026s and PANNA are on-going, non-randomized, open-label, parallel-group, multi-center phase-IV prospective studies in HIV-infected pregnant women. Intensive steady-state 12-h pharmacokinetic profiles were performed from 2nd trimester through postpartum. Etravirine was measured at two labs using validated ultra performance liquid chromatography (detection limits: 0.020 and 0.026 mcg/mL). __Results__ Fifteen women took etravirine 200 mg twice-daily. Etravirine AUC0-12 was higher in the 3rd trimester compared to paired postpartum data by 34% (median 8.3 vs. 5.3 mcg*h/mL, p = 0.068). Etravirine apparent oral clearance was significantly lower in the 3rd trimester of pregnancy compared to paired postpartum data by 52% (median 24 vs. 38 L/h, p = 0.025). The median ratio of cord blood to maternal plasma concentration at delivery was 0.52 (range: 0.19-4.25) and no perinatal transmission occurred. __Conclusion__ Etravirine apparent oral clearance is reduced and exposure increased during the third trimester of pregnancy. Based on prior dose-ranging and safety data, no dose adjustment is necessary for maternal health but the effects of etravirine in utero are unknown. Maternal health and infant outcomes should be closely monitored until further infant safety data are available. __Clinical Trial registration:__ The IMPAACT protocol P1026s and PANNA study are registered at ClinicalTrials.gov under NCT00042289 and NCT00825929.

Published
2016
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40. Relative effects of statin therapy on stroke and cardiovascular events in men and women: Secondary analysis of the stroke prevention by aggressive reduction in cholesterol levels (SPARCL) study

Author

Goldstein, L, Amarenco, P, Lamonte, M, Gilbert, S, Messig, M, Callahan, A, Hennerici, M, Sillesen, H, Welch, K, Sparcl, I, Bogousslavsky, J, Zivin, J, Clark, W, Dávalos, A, Kaste, M, Leiter, L, Altafullah, I, Graham, G, Glahn, J, Jiménez Hernández, D, Macwalter, R, Scott, R, Shuaib, A, Sivenius, J, Stipal, R, Hart, R, Marsh, J, Norrving, B, Pocock, S, Sacco, R, Easton, J, Brown, M, Nagy, Z, Whisnant, J, O'Neill, B, Kleber, F, Lablanche, J, Welty, F, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Vaclavik, D, Boysen, G, Klingenberg, H, Hillbom, M, Numminen, H, Pilke, A, Salmivaara, A, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rubio, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Sharma, A, Shetty, H, Albers, G, Benavente, O, Book, D, Broderick, J, Calder, C, Carlini, W, Chaturvedi, S, Chippendale, T, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hess, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, De Bastos, M, Goldstein, LB, Welch, KMA, SPARCL investigators, Bogousslavsky J, Goldstein LB, Zivin J, Clark W, Dávalos A, Kaste M, Leiter L, Altafullah I, Graham G, Glahn J, Jiménez Hernández D, MacWalter R, Scott R, Shuaib A, Sivenius J, Stipal R, Hart R, Marsh J, Norrving B, Pocock S, Sacco R, Easton J, Brown M, Nagy Z, Whisnant J, O'Neill B, Kleber F, LaBlanche JM, Welty F, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Numminen H, Pilke A, Salmivaara A, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rubio F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Benavente O, Book D, Broderick J, Calder C, Carlini W, Chaturvedi S, Chippendale T, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hess D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., FERRARESE, CARLO, Goldstein, L, Amarenco, P, Lamonte, M, Gilbert, S, Messig, M, Callahan, A, Hennerici, M, Sillesen, H, Welch, K, Sparcl, I, Bogousslavsky, J, Zivin, J, Clark, W, Dávalos, A, Kaste, M, Leiter, L, Altafullah, I, Graham, G, Glahn, J, Jiménez Hernández, D, Macwalter, R, Scott, R, Shuaib, A, Sivenius, J, Stipal, R, Hart, R, Marsh, J, Norrving, B, Pocock, S, Sacco, R, Easton, J, Brown, M, Nagy, Z, Whisnant, J, O'Neill, B, Kleber, F, Lablanche, J, Welty, F, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Vaclavik, D, Boysen, G, Klingenberg, H, Hillbom, M, Numminen, H, Pilke, A, Salmivaara, A, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rubio, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Sharma, A, Shetty, H, Albers, G, Benavente, O, Book, D, Broderick, J, Calder, C, Carlini, W, Chaturvedi, S, Chippendale, T, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hess, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, De Bastos, M, Goldstein, LB, Welch, KMA, SPARCL investigators, Bogousslavsky J, Goldstein LB, Zivin J, Clark W, Dávalos A, Kaste M, Leiter L, Altafullah I, Graham G, Glahn J, Jiménez Hernández D, MacWalter R, Scott R, Shuaib A, Sivenius J, Stipal R, Hart R, Marsh J, Norrving B, Pocock S, Sacco R, Easton J, Brown M, Nagy Z, Whisnant J, O'Neill B, Kleber F, LaBlanche JM, Welty F, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Numminen H, Pilke A, Salmivaara A, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rubio F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Benavente O, Book D, Broderick J, Calder C, Carlini W, Chaturvedi S, Chippendale T, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hess D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., and FERRARESE, CARLO

Abstract

BACKGROUND AND PURPOSE: In SPARCL, treatment with atorvastatin 80 mg daily reduced stroke risk in patients with recent stroke or TIA and no known coronary heart disease by 16% versus placebo over 4.9 years of follow-up. The purpose of this secondary analysis was to determine whether men and women similarly benefited from randomization to statin treatment. METHODS: The effect of sex on treatment-related reductions in stroke and other cardiovascular outcomes were analyzed with Cox regression modeling testing for sex by treatment interactions. RESULTS: Women (n=1908) constituted 40% of the SPARCL study population. At baseline, men (n=2823) were younger (62.0+/-0.21 versus 63.9+/-0.27 years), had lower systolic BPs (138.1+/-0.35 versus 139.5+/-0.47 mm Hg), higher diastolic BPs (82.2+/-0.20 versus 81.0+/-0.25 mm Hg), more frequently had a history of smoking (73% versus 38%), and had lower total cholesterol (207.0+/-0.54 versus 218.9+/-0.67 mg/dL) and LDL-C levels (132+/-0.45 versus 134+/-0.57 mg/dL) than women. Use of antithrombotics and antihypertensives were similar. After prespecified adjustment for region, entry event, time since event, and age, there were no sex by treatment interactions for the combined risk of nonfatal and fatal stroke (treatment Hazard Ratio, HR=0.84, 95% CI 0.68, 1.02 in men versus HR=0.84, 95% CI 0.63, 1.11 in women; treatment x sex interaction P=0.99), major cardiac events (HR=0.61, 95% CI 0.42, 0.87 in men versus HR=0.76, 95% CI 0.48, 1.21 in women; P=0.45), major cardiovascular events (HR=0.78, 95% CI 0.65, 0.93 in men versus HR=0.84, 95% CI 0.65, 1.07 in women; P=0.63), revascularization procedures (HR=0.50, 95% CI 0.37, 0.67 in men versus HR=0.76, 95% CI 0.46, 1.24 in women; P=0.17), or any CHD event (HR=0.54, 95% CI 0.41, 0.72 in men versus 0.67 95% CI 0.46, 0.98 in women; P=0.40). CONCLUSIONS: Stroke and other cardiovascular events are similarly reduced with atorvastatin 80 mg/d in men and women with recent stroke or TIA.

Published
2008

41. Relative effects of statin therapy on stroke and cardiovascular events in men and women: secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Study

Author

Goldstein, LB, Amarenco, P, Lamonte, M, Gilbert, S, Messig, M, Callahan, A, Hennerici, M, Sillesen, H, Welch, KMA, SPARCL investigators, Bogousslavsky J, Goldstein LB, Zivin J, Clark W, Dávalos A, Kaste M, Leiter L, Altafullah I, Graham G, Glahn J, Jiménez Hernández D, MacWalter R, Scott R, Shuaib A, Sivenius J, Stipal R, Hart R, Marsh J, Norrving B, Pocock S, Sacco R, Easton J, Brown M, Nagy Z, Whisnant J, O'Neill B, Kleber F, LaBlanche JM, Welty F, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Numminen H, Pilke A, Salmivaara A, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rubio F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Benavente O, Book D, Broderick J, Calder C, Carlini W, Chaturvedi S, Chippendale T, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hess D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., FERRARESE, CARLO, Goldstein, L, Amarenco, P, Lamonte, M, Gilbert, S, Messig, M, Callahan, A, Hennerici, M, Sillesen, H, Welch, K, Sparcl, I, Bogousslavsky, J, Zivin, J, Clark, W, Dávalos, A, Kaste, M, Leiter, L, Altafullah, I, Graham, G, Glahn, J, Jiménez Hernández, D, Macwalter, R, Scott, R, Shuaib, A, Sivenius, J, Stipal, R, Hart, R, Marsh, J, Norrving, B, Pocock, S, Sacco, R, Easton, J, Brown, M, Nagy, Z, Whisnant, J, O'Neill, B, Kleber, F, Lablanche, J, Welty, F, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Vaclavik, D, Boysen, G, Klingenberg, H, Hillbom, M, Numminen, H, Pilke, A, Salmivaara, A, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rubio, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Sharma, A, Shetty, H, Albers, G, Benavente, O, Book, D, Broderick, J, Calder, C, Carlini, W, Chaturvedi, S, Chippendale, T, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hess, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, and De Bastos, M

Subjects
Male, Atorvastatin, Blood Pressure, Sex Factor, Pyrrole, Triglyceride, law.invention, Randomized controlled trial, law, Stroke, Sex Characteristics, Middle Aged, Heptanoic Acid, Cholesterol, Treatment Outcome, Data Interpretation, Statistical, Hypertension, Population study, Female, Cardiology and Cardiovascular Medicine, Human, medicine.drug, medicine.medical_specialty, Randomization, Logistic Model, Reproducibility of Result, Placebo, Sex Factors, Internal medicine, medicine, Humans, Pyrroles, Triglycerides, Advanced and Specialized Nursing, Apolipoprotein A-I, Proportional hazards model, business.industry, Reproducibility of Results, Sex Characteristic, medicine.disease, Surgery, Blood pressure, Logistic Models, Heptanoic Acids, Hydroxymethylglutaryl-CoA Reductase Inhibitor, Neurology (clinical), Hydroxymethylglutaryl-CoA Reductase Inhibitors, business
Abstract

Background and Purpose— In SPARCL, treatment with atorvastatin 80 mg daily reduced stroke risk in patients with recent stroke or TIA and no known coronary heart disease by 16% versus placebo over 4.9 years of follow-up. The purpose of this secondary analysis was to determine whether men and women similarly benefited from randomization to statin treatment. Methods— The effect of sex on treatment-related reductions in stroke and other cardiovascular outcomes were analyzed with Cox regression modeling testing for sex by treatment interactions. Results— Women (n=1908) constituted 40% of the SPARCL study population. At baseline, men (n=2823) were younger (62.0±0.21versus 63.9±0.27 years), had lower systolic BPs (138.1±0.35 versus 139.5±0.47 mm Hg), higher diastolic BPs (82.2±0.20 versus 81.0±0.25 mm Hg), more frequently had a history of smoking (73% versus 38%), and had lower total cholesterol (207.0±0.54 versus 218.9±0.67 mg/dL) and LDL-C levels (132±0.45 versus 134±0.57 mg/dL) than women. Use of antithrombotics and antihypertensives were similar. After prespecified adjustment for region, entry event, time since event, and age, there were no sex by treatment interactions for the combined risk of nonfatal and fatal stroke (treatment Hazard Ratio, HR=0.84, 95% CI 0.68, 1.02 in men versus HR=0.84, 95% CI 0.63, 1.11 in women; treatment×sex interaction P =0.99), major cardiac events (HR=0.61, 95% CI 0.42, 0.87 in men versus HR=0.76, 95% CI 0.48, 1.21 in women; P =0.45), major cardiovascular events (HR=0.78, 95% CI 0.65, 0.93 in men versus HR=0.84, 95% CI 0.65, 1.07 in women; P =0.63), revascularization procedures (HR=0.50, 95% CI 0.37, 0.67 in men versus HR=0.76, 95% CI 0.46, 1.24 in women; P =0.17), or any CHD event (HR=0.54, 95% CI 0.41, 0.72 in men versus 0.67 95% CI 0.46, 0.98 in women; P =0.40). Conclusion— Stroke and other cardiovascular events are similarly reduced with atorvastatin 80 mg/d in men and women with recent stroke or TIA.

Published
2008

42. Switching from tipranavir (TPV) 500/ritonavir (RTV) 200 mg to TPV 500/RTV 100 mg in treatment‐experienced patients (pts) with HIV RNA <50 copies/mL

Author

Casado, Jl, Domingo, P, Rubio, R, Antela, A, Lopez?Ruz, Ma, Castro, A, Portilla, J, Ribera, E, Podzamczer, D, Oteo, Ja, Galindo, J, Otero, S, Lozano, F, Estrada, V, Moltó, J, and Moreno, S

Subjects
Ritonavir -- Testing -- Dosage and administration, HIV infection -- Drug therapy, Health
Abstract

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK, Background The administration of 200 mg of RTV to boost TPV plasma levels is associated with poor tolerance and toxicity. Some studies have shown that 100 mg of RTV could [...]

Published
2010
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44. Factors affecting the presence of ochratoxin A in wines.

Author

Blesa, J., Soriano, J., Moltó, J., Mañes, J., Soriano, J M, Moltó, J C, and Mañes, J

Subjects
OCHRATOXINS, WINES, MYCOTOXINS, ASPERGILLUS, PENICILLIUM, BEVERAGES, VITICULTURE
Abstract

Ochratoxin A (OTA) are synthesized mainly by different species of Aspergillus and Penicillium being its human toxicological effects reflected in different countries due to the consumption of different foods and beverages such as red, white, rose, and special wines. This review presents an overview of the direct (meteorological conditions, grape cultivation, and wine-making techniques) and indirect (latitude, year of production, use of pesticides, presence of spoilage microorganisms, conditions of storage of the harvested grapes, type of maceration, and conditions of fermentation), factors affecting the presence of OTA in wines. [ABSTRACT FROM AUTHOR]

Published
2006
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45. Herb-drug interaction between Echinacea purpurea and darunavir/ritonavir in HIV-infected patients

Author

Moltó, J, Valle, M, Miranda, C, Cedeño, S, Negredo, E, Barbanoj, Mj, and Clotet, B

Subjects
Herb-drug interactions -- Analysis, Darunavir -- Dosage and administration, HIV patients -- Care and treatment, HIV infection -- Risk factors -- Prevention, Echinacea -- Identification and classification -- Usage -- Health aspects, Health
Abstract

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK, Purpose of the study To investigate the potential of a commonly used botanical supplement, Echinacea purpurea, to interact with the boosted protease inhibitor darunavir/ritonavir. Methods Open‐label, fixed‐sequence study in 15 [...]

Published
2010
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