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19 results on '"Lasko, B"'

1. Blood pressure-lowering effects of nifedipine/candesartan combinations in high-risk individuals: Subgroup analysis of the DISTINCT randomised trial

Author

Mancia, G, Cha, G, Gil-Extremera, B, Harvey, P, Lewin, AJ, Villa, G, Kjeldsen, SE, Agaiby, J, Aggarwal, N, Ainsworth, P, Akhras, R, Amaluan, V, Ballarin, A, Bardauskiene, L, Berra, FC, Blagden, M, Bodalia, B, Borghi, C, Bundy, C, Burgess, L, Buynak, R, Cafferata, A, Cahill, T, Capiau, L, Capuano, V, Casanova, R, Cecil, J, Chapman, J, Chilvers, M, Christensen, S, Cho, Y-H, Chung, W-B, Cipollone, F, Coca, A, Colombo, H, Contreras, EM, Crowley, D, Cusco-Prieto, B, Decarlini, F, Doh, J-H, Dzongowski, P, Dzyak, G, Ellery, A, Extremera, BG, Farias, E, Farrington, C, Fidelholtz, J, Fouche, L, Gabito, A, Gainza, M, Gani, M, Gaunt, R, Gelersztein, E, Giuliano, M, Glazunov, A, Glorioso, N, Goloschekin, B, Gumbley, M, Gupta, A, Guzman, L, Ha, J-W, Hart, R, Haworth, D, Henein, S, Henry, D, Her, S-H, Heyvaert, F, Hollanders, G, Hominal, M, Hong, B-K, Hong, T-J, Hwang, K-K, Jacovides, A, Jacqmein, J, Jeon, HK, Jones, N, Kanani, S, Kang, H, Karpenko, O, Kenton, D, Kimzey, N, Kovalenko, V, Kushnir, M, Lasko, B, Lee, KJ, Lee, N, Lewin, A, Litvak, M, Luksiene, D, Majul, C, Mannarino, E, Manuale, O, Marcadis, A, Miller, D, Mills, R, Misik, K, Mortelmans, J, O'Mahony, M, O'Mahony, W, Park, C, Pedrinelli, R, Petrulioniene, Z, Pettyjohn, F, Piskorz, D, Poss, G, Pudi, K, Pyun, WB, Raad, G, Raila, G, Ramirez Espinosa, MF, Ramlachan, P, Rhee, M, Rudenko, L, Ruiz, TS, Ryan, J, Schacter, G, Shin, J-H, Short, D, Sica, D, Sirenko, Y, Slapikas, R, Somani, R, Stanislavchuk, M, Stewart, R, Svishchenko, Y, Sychov, O, Teitelbaum, I, Tseluyko, V, Van Rensburg, DJ, Vaquer Perez, JV, Via, LM, Vico, M, Vizir, V, Vogel, D, Wellmann, H, Yoo, BS, DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, Facolta' di MEDICINA e CHIRURGIA, AREA MIN. 06 - Scienze mediche, Mancia, G, Cha, G, Gil-Extremera, B, Harvey, P, Lewin, A, Villa, G, Kjeldsen, S, Agaiby, J, Aggarwal, N, Ainsworth, P, Akhras, R, Amaluan, V, Ballarin, A, Bardauskiene, L, Berra, F, Blagden, M, Bodalia, B, Borghi, C, Bundy, C, Burgess, L, Buynak, R, Cafferata, A, Cahill, T, Capiau, L, Capuano, V, Casanova, R, Cecil, J, Chapman, J, Chilvers, M, Christensen, S, Cho, Y, Chung, W, Cipollone, F, Coca, A, Colombo, H, Contreras, E, Crowley, D, Cusco-Prieto, B, Decarlini, F, Doh, J, Dzongowski, P, Dzyak, G, Ellery, A, Extremera, B, Farias, E, Farrington, C, Fidelholtz, J, Fouche, L, Gabito, A, Gainza, M, Gani, M, Gaunt, R, Gelersztein, E, Giuliano, M, Glazunov, A, Glorioso, N, Goloschekin, B, Gumbley, M, Gupta, A, Guzman, L, Ha, J, Hart, R, Haworth, D, Henein, S, Henry, D, Her, S, Heyvaert, F, Hollanders, G, Hominal, M, Hong, B, Hong, T, Hwang, K, Jacovides, A, Jacqmein, J, Jeon, H, Jones, N, Kanani, S, Kang, H, Karpenko, O, Kenton, D, Kimzey, N, Kovalenko, V, Kushnir, M, Lasko, B, Lee, K, Lee, N, Litvak, M, Luksiene, D, Majul, C, Mannarino, E, Manuale, O, Marcadis, A, Miller, D, Mills, R, Misik, K, Mortelmans, J, O'Mahony, M, O'Mahony, W, Park, C, Pedrinelli, R, Petrulioniene, Z, Pettyjohn, F, Piskorz, D, Poss, G, Pudi, K, Pyun, W, Raad, G, Raila, G, Ramirez Espinosa, M, Ramlachan, P, Rhee, M, Rudenko, L, Ruiz, T, Ryan, J, Schacter, G, Shin, J, Short, D, Sica, D, Sirenko, Y, Slapikas, R, Somani, R, Stanislavchuk, M, Stewart, R, Svishchenko, Y, Sychov, O, Teitelbaum, I, Tseluyko, V, Van Rensburg, D, Vaquer Perez, J, Via, L, Vico, M, Vizir, V, Vogel, D, Wellmann, H, Yoo, B, Mancia, G., Cha, G., Gil-Extremera, B., Harvey, P., Lewin, A.J., Villa, G., Kjeldsen, S.E., Agaiby, J., Aggarwal, N., Ainsworth, P., Akhras, R., Amaluan, V., Ballarin, A., Bardauskiene, L., Berra, F.C., Blagden, M., Bodalia, B., Borghi, C., Bundy, C., Burgess, L., Buynak, R., Cafferata, A., Cahill, T., Capiau, L., Capuano, V., Casanova, R., Cecil, J., Chapman, J., Chilvers, M., Christensen, S., Cho, Y.-H., Chung, W.-B., Cipollone, F., Coca, A., Colombo, H., Contreras, E.M., Crowley, D., Cusco-Prieto, B., Decarlini, F., Doh, J.-H., Dzongowski, P., Dzyak, G., Ellery, A., Extremera, B.G., Farias, E., Farrington, C., Fidelholtz, J., Fouche, L., Gabito, A., Gainza, M., Gani, M., Gaunt, R., Gelersztein, E., Giuliano, M., Glazunov, A., Glorioso, N., Goloschekin, B., Gumbley, M., Gupta, A., Guzman, L., Ha, J.-W., Hart, R., Haworth, D., Henein, S., Henry, D., Her, S.-H., Heyvaert, F., Hollanders, G., Hominal, M., Hong, B.-K., Hong, T.-J., Hwang, K.-K., Jacovides, A., Jacqmein, J., Jeon, H.K., Jones, N., Kanani, S., Kang, H., Karpenko, O., Kenton, D., Kimzey, N., Kovalenko, V., Kushnir, M., Lasko, B., Lee, K.J., Lee, N., Lewin, A., Litvak, M., Luksiene, D., Majul, C., Mannarino, E., Manuale, O., Marcadis, A., Miller, D., Mills, R., Misik, K., Mortelmans, J., O'Mahony, M., O'Mahony, W., Park, C., Pedrinelli, R., Petrulioniene, Z., Pettyjohn, F., Piskorz, D., Poss, G., Pudi, K., Pyun, W.B., Raad, G., Raila, G., Ramirez Espinosa, M.F., Ramlachan, P., Rhee, M., Rudenko, L., Ruiz, T.S., Ryan, J., Schacter, G., Shin, J.-H., Short, D., Sica, D., Sirenko, Y., Slapikas, R., Somani, R., Stanislavchuk, M., Stewart, R., Svishchenko, Y., Sychov, O., Teitelbaum, I., Tseluyko, V., Van Rensburg, D.J., Vaquer Perez, J.V., Via, L.M., Vico, M., Vizir, V., Vogel, D., Wellmann, H., Yoo, B.S., DISTINCT Investigators, and [Mancia,G] Unit and Department of Clinical Medicine, University of Milano-Bicocca, IRCCS Istituto Auxologico Italiano, Milan, Italy. [Cha,G] KRK Medical Research Institute, Dallas, TX, USA. [Gil-Extremera,B] Hospital Universitario San Cecilio, Granada, Spain. [Harvey,P] Formerly in The Crouch Oak Family Practice, Addlestone, UK. [Lewin,AJ] National Research Institute, Los Angeles, CA, USA. [Villa,G] Fondazione Salvatore Maugeri—IRCCS, Pavia, Italy. [Kjeldsen,SE] Oslo University Hospital Ullevaal, University of Oslo, Oslo, Norway.

Subjects
Male, Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyridines::Dihydropyridines::Nifedipine [Medical Subject Headings], Phenomena and Processes::Physiological Phenomena::Body Constitution::Body Weights and Measures::Body Mass Index [Medical Subject Headings], Tetrazoles, Blood Pressure, DISTINCT study, Índice de masa corporal, 030204 cardiovascular system & hematology, Benzimidazole, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Probability::Risk::Risk Factors [Medical Subject Headings], law.invention, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Bencimidazoles, 0302 clinical medicine, Randomized controlled trial, law, Phenomena and Processes::Reproductive and Urinary Physiological Phenomena::Urinary Tract Physiological Phenomena::Glomerular Filtration Rate [Medical Subject Headings], Medicine, Tasa de filtración glomerular, 030212 general & internal medicine, Hipercolesterolemia, Tetrazole, Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 2-Ring::Benzimidazoles [Medical Subject Headings], Middle Aged, Calcium Channel Blockers, Presión sanguínea, Humanos, Antihypertensive Agent, Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Aromatic::Benzene Derivatives::Biphenyl Compounds [Medical Subject Headings], Hypertension, Diseases::Nutritional and Metabolic Diseases::Metabolic Diseases::Glucose Metabolism Disorders::Diabetes Mellitus::Diabetes Mellitus, Type 2 [Medical Subject Headings], Compuestos de bifenilo, Diabetes mellitus Tipo 2, Nifedipino, Original Article, Drug Therapy, Combination, Female, Calcium Channel Blocker, Factores de riesgo, medicine.drug, Human, medicine.medical_specialty, Combination therapy, Nifedipine, Subgroup analysis, Placebo, Nifedipine GITS, Diseases::Cardiovascular Diseases::Vascular Diseases::Hypertension [Medical Subject Headings], 03 medical and health sciences, candesartan, high blood pressure, Internal medicine, Hipertensión, Phenomena and Processes::Circulatory and Respiratory Physiological Phenomena::Cardiovascular Physiological Phenomena::Hemodynamics::Blood Pressure [Medical Subject Headings], Internal Medicine, Humans, Antihypertensive Agents, business.industry, Biphenyl Compounds, Diseases::Nutritional and Metabolic Diseases::Metabolic Diseases::Lipid Metabolism Disorders::Dyslipidemias::Hyperlipidemias::Hypercholesterolemia [Medical Subject Headings], Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Azoles::Tetrazoles [Medical Subject Headings], Candesartan, Endocrinology, Blood pressure, Benzimidazoles, business, Body mass index
Abstract

none 140 si The DISTINCT study (reDefining Intervention with Studies Testing Innovative Nifedipine GITS - Candesartan Therapy) investigated the efficacy and safety of nifedipine GITS/candesartan cilexetil combinations vs respective monotherapies and placebo in patients with hypertension. This descriptive sub-analysis examined blood pressure (BP)-lowering effects in high-risk participants, including those with renal impairment (estimated glomerular filtration rate

Published
2017

4. Cause of death and predictors of all-cause mortality in anticoagulated patients with nonvalvular atrial fibrillation: Data from ROCKET AF

Author

Pokorney, Sean D, Piccini, Jonathan P., Stevens, Susanna R., Patel, Manesh R., Pieper, Karen S., Halperin, Jonathan L., Breithardt, Günter, Singer, Daniel E., Hankey, Graeme J., Hacke, Werner, Becker, Richard C., Berkowitz, Scott D., Nessel, Christopher C., Mahaffey, Kenneth W., Fox, Keith A. A., Califf, Robert M., Anderson, J., Bedwell, N., Bilsker, M., Bruce, G., Agah, R., Desantis, M., Eisenberg, S., Flores, A., Herzog, W., Klein, S., Snyder, H., Krueger, S., Almaguer, E., Lavie, E., Lee, C., Mallis, G., Modi, M., Woodworth, G., Niazi, I., Peart, B., Sundaram, S., Snoddy, B., Sotolongo, R., Moloney, J., Vijayaraghavan, K., Whittier, F., Yellen, L., Banerjee, S., Lustgarten, D., Suresh, D., Gelernt, M., Levinson, L., Ghanekar, R., Kneller, G., Hall, C., Fadl, Y., Pirwitz, M., French, W., Mayer, N., Pugeda, J., Steel, K., Mody, F., Malik, A., Chandna, H., Go, A., Emlein, G., Bowden, W., Moscoso, R., Hodson, R., Berk, M., Pan, D., Pappas, J., Orchard, R., Lynchard, G., Vijay, N., Khan, W., El Khadra, M., Antonishen, M., Cucher, F., Staab, M., Zebrack, J., Borromeo, S., Heilman, J., Chaturvedi, S., Makam, S., Turk, S., Hyers, T., Williams, G., Labroo, A., Gill, S., Myears, D., Weinstein, J., Shanes, J., Chandrashekhar, Y., Shah, S., Reiter, W., Logemann, T., Almquist, A., Bhagwat, R., Tak, T., Shen Ling, J., Patel, P., Artis, A., Arouni, A., Lauer, M., Kinney, K., Elsen, J., Roan, P., Villafria, R., Sumpter, M., Ip, J., Welka, S., Schifferdecker, B., Sandoval, R., Speirs, S., Jones, A., Haldis, T., Kazmierski, J., Sutherland, J., Dietrich, D., Telfer, E., Berry, J., Mcelveen, A., Russell, J., Sackett, M., Antonios, N., Smith, D., Vora, K., Kirby, A., Lui, H., Mego, D., Ziada, K., Navas, J., Taussig, A., Koren, M., Vogel, C., Saba, F., Parrott, C., Schneider, R., Shirwany, A., Rubin, M., Treasure, C., Bertolet, B., Chang, M., Langberg, J., Becker, R., Cohen, Y., Mcgrew, F., White, J., Arzola, F., Zelenka, J., Tannenbaum, A., Fernandes, V., Jamnadas, P., Agamasu, J., Collins, B., Jauch, W., Sasseen, B., Hotchkiss, D., Abadier, R., Osunkoya, A., Schlau, A., Chappel, C., Foster, M., Braun, E., Mostel, E., Capo, J., Ashchi, M., Howard, V., Albirini, A., Burger, A., Rolston, D., Staniloae, C., Bacon, J., Wiseman, A., Mcgarvey, J., Sonel, A., Hamroff, G., Chang, D., Daboul, N., Broderick, G., Meholick, A., Corbelli, J., Silverman, R., Raffetto, J., Fishberg, R., Georgeson, S., Held, J., Seidner, M., Saint Jacques, H., Heitner, J., Kutalek, S., Friedlander, I., Hutchinson, B., Walia, J., Kondo, N., Smiley, N., Blitz, L., Dale, H., Sulman, S., Szulawski, I., Modares, F., Martin, R., Nahhas, A., Renzi, M., Akyea Djamson, A., Alfieri, A., Sandhu, J., Voyce, S., Amaram, S., Meyerrose, G., Shoukfeh, M., Lee, F., Villegas, B., Idowu, O., Khera, A., Sam, C., Vo, A., Lieber, I., Smith, T., Awan, N., Tsai, C., Ganim, R., Alzaghrini, G., Pitt, W., Shepherd, A., Tang, S., Stoltz, S., Nelson, W., Cox, S., Meymandi, S., Melucci, M., Thomas, G., Gogia, H., Machell, C., Chandrasekaran, S., Brown, C., Jetty, P., Miller, G., Dykstra, G., Jaffrani, N., Zakhary, B., Caruso, A., Zolty, R., Fox, D., Jacobs, G., Lebenthal, M., Mukherjee, S., Zimetbaum, P., Kingsley, J., Jones, R., Robinson, V., Kenton, D., Usedom, J., Williams, S., Snipes, C., Wilson, V., Hasty, R., Shoemaker, J., Donahue, M., Al Saghir, Y., Thomsen, E., Yarows, S., Chastain, S., Mclaughlin, P., Wakham, M., Shrestha, D., Simmons, J., Fisher, D., Seymour, Z., Frandsen, B., First, B., Sharpe, C., Popeil, L., Guthrie, R., Hunter, J., Alvarado, O., Sandberg, J., Gutman, N., Belber, A., Arkhipov, M., Ballyzek, M., Baranov, A., Barbarash, O., Barbarich, V., Belenky, D., Berkovich, O., Bokarev, I., Boyarkin, M., Vaniev, S., Volkova, E., Gratsiansky, N., Demin, A., Zadionchenko, V., Zateyshchikov, D., Zrazhevsky, K., Mazaev, V., Martynov, A., Mikhailov, S., Mkrtchian, V., Novozhenov, V., Raskina, T., Rebrov, A., Sanina, N., Simanekov, V., Sitnikova, M., Smolenskaya, O., Stryuk, R., Storozhakov, G., Tankhilevich, B., Tereschenko, S., Khokhlov, A., Khrustalev, O., Chernov, S., Shvarts, Y., Shubik, Y., Shulman, V., Yakushin, S., Bugrova, O., Ivleva, A., Libis, R., Khozyainova, N., Maslov, S., Baranova, E., Sherenkov, A., Libov, I., Lusov, V., Chumakova, G., Kuznetsov, V., Ryamzina, I., Reshetko, O., Boldueva, S., Alekseeva, N., Novikova, T., Dvornikov, V., Idrisova, E., Shostak, N., Yarokhno, N., Tebloev, K., Treshkur, T., Mazurov, V., Loktin, E., Sedavnyh, I., Alexeeva, O., Yakhontova, P., Repin, A., Izmozherova, N., Kostenko, V., Fokin, A., Ketova, G., Kouz, S., Leader, R., Ayala Paredes, F., Luton, R., Ma, P., Pandey, S., Pesant, Y., Senior, R., Vertes, G., Bell, A., Crowley, D., Vizel, S., Lasko, B., Landry, D., Berger, L., Heath, J., Bessoudo, R., Ling, M., Tellier, G., Berlingieri, J., Kafka, H., Hill, L., Mazza, G., O'Mahony, W., Chilvers, M., O'Mahony, M., Newman, D., Silagy, S., Heffernan, M., Bennett, M., Bhesania, T., Rockman, G., Ng, K., Kalra, B., Meneses, G., Liang, W., Cheung, M., Kozak, J., Pugen, G., Vavougios, J., Kates, M., Nunes Vaz, C., Jaffer, S., Orfi, J., Faiers, A., Chung, C., Felsen, S., Bergman, S., Bernstein, I., Brownscombe, L., Stockdill, J., Silver, E., Ezekiel, D., Jagan, N., Khurana, M., Reisler, H., Goldman, H., Maung, T., Wong, F., Gillis, G., Vexler, R., Goldberg, B., Luterman, M., Gould, D., Coutu, B., Ouellet, A., Macdonald, P., Jones, M., Collette, R., Chong, P., Fargher, T., St Maurice, F., Fortin, C., Chehayeb, R., Proulx, G., Roy, R., Liutkus, J., Syan, G., Rupka, D., Lichtenstein, T., Kooy, J., Papastergiou, D., Lubelsky, B., Doyle, W., Rajakumar, A., Cha, J., Choudhry, A., Bhamjee, H., Mawji, A., Durfresne, M., Constance, C., Mutrie, J., Najarali, A., Warren, R., Mucha, M., Borts, D., Nord, P., Carrier, S., Dawood, M., Sabe Affaki, G., Archibald, J., Abram, N., Teitelbaum, E., Ebrahim, I., Siebert, R., van Zyl, L., Theron, H., Lloyd, E., Sommers, R., Podgorski, G., Steingo, L., Dalby, A., Bayat, J., Herbst, L., Bester, F., Corbett, C., Bennett, J., Roodt, A., Roux, J., Abelson, M., Mohamed, Z., Nortje, H., Da Silva, A., Nikolaides, K., Liagkas, K., Papasteriadis, E., Achimastos, A., Koliopoulos, N., Trikas, A., Manolis, A., Ruiter, J., Basart, D., Crijns, H., Withagen, A., Janssen, M., Van Langeveld, R., van Gelder, I., Hamer, B., Van Der Heijden, R., Hertzeberger, D., Van Hessen, M., Pieterse, M., Groutars, R., Kuijper, A., De Ruiter, G., van Boven, A., Hoogslag, P., Kragten, H., Thijssen, H., Veldkamp, R., Scavee, C., Heidbuchel, H., Debruyne, P., Deruyter, B., El Ali, H., Goethals, M., Cytryn, R., Striekwold, H., De Wolf, L., Goethals, P., Provenier, F., Hellemans, S., Galinier, M., Coisne, D., Koenig, A., Galley, D., Destrac, S., Leduc, J., Rifai, A., Citron, B., Ellie, E., Fournier, P., Steg, G., Landel, R., Robinson, A., Ziegler, F., Boulliat, J., Zuber, M., Vida, M., Galve Basilio, E., Lopez, M., Íñiguez, C., Iglesias Alonso, L., Cavero Gibanel, M., Olivan Martinez, J., Calvo Iglesias, F., Marco Vera, P., Bruguera Cortada, J., Jaber Houbani, A., Merino, J., Olaz Preciado, F., Balaguer, J., de la Hera Galarza, J., Martinez Rubio, A., Fontcuberta, J., Sotillo Marti, J., Gonzalez Juanatey, J., Del Campo, R., Vivanco, G., Alvarez Garcia, P., Pelayo, M., Lippai, J., Zamolyi, K., Károly, T., Vertes, A., Nagy, A., Kosa, I., Janosi, A., Lupkovics, G., Kalo, E., Forster, T., Kis, E., Tenczer, J., Bereczki, D., Komoly, S., Csanyi, A., Kiss, R., Valikovics, A., Dioszeghy, P., Masini, F., Terrosu, P., Cirrincione, V., Marabotti, C., Cosmi, F., Salvioni, A., Binetti, G., Piovaccari, G., Nassiacos, D., Boriani, Giuseppe, Calvi, V., De Caterina, R., Pengo, V., Parati, G., Carolei, A., D'Angelo, A., Di Biase, M., Fattore, L., Agnelli, G., Merlini, P., Furlan, M., Rasura, M., Gandolfo, C., Ageno, W., Piovella, F., Micieli, G., Cinteza, M., Fierbinteanu, C., Natase Melicovici, D., Ionescu, D., Macarie, C., Nanea, I., Radoi, M., Tatu Chitoiu, G., Dragulescu, S., Tudose, A., Militaru, C., Bengus, C., Ungureanu, G., Tau, A., Popa, V., Pirvu, O., Bojinca, M., Sipciu, D., Popescu, M., Chiru, M., Vinereanu, D., Tudoran, M., Cojocaru, T., Vintila, M., Aron, G., Petrascu, O., Bolohan, F., Baumgartner, R., Sekoranja, L., Vojacek, J., Lacnak, B., Kellnerova, I., Dunaj, M., Cihalik, C., Janota, T., Janousek, J., Bouchal, P., Spacek, R., Choi Siruckova, J., Heinc, P., Vojtisek, P., Pirchala, M., Malecha, J., Padour, F., Linhart, A., Mandysova, E., Jandik, J., Zidkova, E., Sipula, D., Ostadal, P., Polasek, R., Stransky, V., Marcinek, G., Rysava, D., Osmancik, P., Huber, K., Drexel, H., Brainin, M., Eichinger Hasenauer, S., Lang, W., Pilger, E., Moriarty, A., Hudson, I., Tang, K., Cleland, J., Macwalter, R., Cooke, J., Mcinnes, G., Durairaj, R., Macleod, M., Murdoch, D., Kadr, H., Lip, G., Andrews, R., Hunt, B., Jackson, P., Roffe, C., Syed, H., Bath, P., Coyle, J., Kelly, D., Stender, S., Torppedersen, C., Tuxen, C., Jensen, G., Melchior, T., Klarlund, K., Dahlstrom, C., Nielsen, T., Nielsen, E., Bronnum Schou, J., Sykulski, R., Blomstrom, P., Lindholm, C., Wallen, T., Nilsson, C., Bertholds, E., Carlsater, J., Sirnes, P., Elle, S., Risberg, K., Furuseth, K., Skag, A., Hoivik, H., Landmark, N., Kjaernli, T., Berg Johansen, J., Gradek, G., Drzewiecki, A., Pluta, W., Szwed, H., Trusz Gluza, M., Ogorek, M., Loboz Grudzien, K., Ruszkowski, P., Sciborski, R., Kopaczewski, J., Jaworska, K., Kubica, J., Opolski, G., Hoffman, A., Krzciuk, M., Sinkiewicz, W., Piotrowski, W., Kolodziej, P., Goszczynska, M., Rynkiewicz, A., Chojnowska, L., Lewczuk, J., Biedrzycka, M., Piepiorka, M., Kowal, J., Karczmarczyk, A., Pruszczyk, P., Tendera, M., Gaciong, Z., Krzeminska Pakula, M., Kornacewicz Jach, Z., Kania, G., Brachmann, J., Lawall, H., Guelker, H., Spitzer, S., Moebiuswinkler, S., Dempfle, C., Bode, C., Darius, H., Genth Zotz, S., Sommer, S., Roehnisch, J., Strasser, R., Daenschel, W., Schwencke, C., vom Dahl, J., Meuser, M., Behrens Spandau, S., Behrens Humbold, S., Muegge, A., Schoen, N., Grooterhorst, P., Ebert, H., Kraemer, A., Kohler, B., Taggeselle, J., Claus, G., Sarnighausen, H., Al Zoebi, A., Schroeder, T., Weissbrodt, M., Lange, R., Gabelmann, M., Kaeaeb, S., Doerr, M., Boscher, D., Bosch, R., Sonntag, F., Bauknecht, C., Omran, H., Leicht, M., Veltkamp, R., Hohensee, H., Dieckmann, H., Winkelmann, B., Bernhardt, P., Schnabel, A., Kadel, C., Proskynitopoulos, N., Seidl, K., Schellong, S., Rios, C., Guevara, C., Coloma, R., Torrejon, H., Parra Galvan, J., Drago Silva, J., Gallegos, J., Mendoza, A., Negron, S., Watanabe, L., Medina, F., Virgen Carrilo, L., Alvarez Lopez, H., Rodriguez, I., Leiva Pons, J., Baños Velasco, A., Villarreal Careaga, J., De los Rios, M., Alcocer Gamba, M., Llamas Esperon, G., Villeda, E., Ahuad Guerrero, A., Alvariqueta, A., Amuchastegui, M., Bluguermann, J., Caime, G., Cuneo, C., Gabito, A., Garcia Brasca, D., Hominal, M., Jure, H., Luquez, H., Montana, O., Piskorz, D., Listorti, S., Serra, J., Sessa, H., Varini, S., Vita, N., Aiub, J., Mackinnon, I., Chekherdemian, S., Castagnino, J., Cimbaro Canella, J., Sgammini, H., Escudero, A., Albina, G., Rapallo, C., Balparda, C., Chahin, M., Fuentealba, V., Riccitelli, M., Casabe, J., Lobo Marquez, L., Kevorkian, R., Cuadrado, J., Dran, R., Muntaner, J., Gonzalez, M., Cartasegna, L., Hasbani, E., Hrabar, A., Sanchez, A., Vogel, D., Hershson, A., Avezum, A., Jaber, J., Ernesto Leaes, P., Bozza, A., Lorga Filho, A., Pimentel Filho, P., Moura Jorge, J., Maia, L., Manenti, E., D'Aurea Mora, R., de Souza Neto, J., Precoma, D., Rabelo, A., Rocha, J., Rossi, P., Kerr Saraiva, J., Zimerman, L., Bodanese, L., Figueiredo, E., de Souza, W. Sebba Barroso, Braga, J., Alessi, S., Gomes, M., Silva, R., Teixeira, M., Costa, F., Motta, M., Sobral Filho, D., Reis, G., Garbelini, B., Zimmermann, S., Pereira Barretto, A., Dohmann, H., Barreto Filho, J., Ghorayeb, N., Borelli, F., Rossi dos Santos, F., Lopes Prudente, M., Vejar, M., Lanas, F., Del Pino, R., Potthoff, S., Charme, G., Aguirre, A., Saldana, A., Garces, E., Bunster, L., Figueroa, H., Olivares, C., Raffo, C., Vergara, E., Sepulveda, P., Jano, G., Morales Alvarado, J., Suarez, R., Urina, M., Perez, G., Quintero, A., Pava, L., Botero Lopez, R., Luengas, C., Hernandez, E., Sanchez, D., Poveda, C., Coronel, J., Beltran, R., Jaramillo, C., Pardo, J., Ponte Negretti, C., Isea, J., Vergara, G., Morr, I., Sim, K., Wan Ahmad, W., Yusof, Z., Rosman, A., Basri, H., Thompson, P., Jeffery, P., Purnell, I., Roberts Thomson, P., Heddle, W., Waites, J., Walters, D., Amerena, J., Challa, P., Karrasch, J., Lowy, A., Fitzpatrick, D., Parsons, M., Phan, T., Bladin, C., Donnan, G., Aroney, G., Gerraty, R., Anderson, C., Blombery, P., Martin, P., Tissa Wijeratne, K., Cross, D., Crimmins, D., Packham, D., Jackson, D., Chua, W., Merino, R., Magno, M., Tirador, L., Batalla, E., Manalo, C., Uy, N., Ebo, G., Reyes, E., Bernan, A., Richards, M., Hart, H., Mann, S., Fisher, R., Stewart, R., Wilkins, G., Barber, A., Tan, R., Ong, H., Singh, R., Sukonthasarn, A., Tanomsup, S., Krittayaphong, R., Piamsomboon, C., Piyayotai, D., Sunsaneewitayakul, B., Baek, S., Seo, H., Rim, S., Kim, C., Kim, K., Ryu, K., Jo, S., Tahk, S., Lee, H., Kim, Y., Shin, D., Choi, Y., Chung, N., Namgung, J., Hong, T., Shin, W., Jin, S., Yan, X., Fu, G., Lu, G., Yang, K., Xu, D., Chen, J., Liu, J., Wu, S., Song, J., Liao, Y., Xu, B., Li, Z., Ma, S., Yin, Y., Zhao, Y., Hu, D., Ma, C., Ma, J., Sun, J., Li, H., Hong, X., Yu, B., Lu, Q., Yang, J., Wu, Z., Li, Y., Huang, Y., Wang, Y., Liu, M., Cheng, Y., Yang, T., Chen, K., Wang, H., Yuan, Z., Wang, J., Zeng, Z., Chen, Y., Yavuzgil, O., Kozan, O., Etemoglu, M., Diker, E., Belgi, A., Ceyhan, C., Cin, V., Yilmaz, O., Ata, N., Altunkeser, B., Agacdiken Agir, A., Karadede, A., Topsakal, R., Gulati, R., Madhavan, A., Jain, S., Oomman, A., Janorkar, S., Kumar, P., Madhukar Naik, A., Thacker, H., Rajasekhar, V., Reddy, R., Keshavamurthy, C., Jain, P., Gowdappa, B., Gadkari, M., Abhyankar, A., Ramesh Babu, B., Vydianathan, P., Sinha, S., Garg, N., Rao, S., Gautam, P., Chockalingam, K., Kumbla, M., Panwar, R., Banker, D., Kaste, M., Jäkälä, P., Roine, R., Mihov, A., Raev, D., Yordanova, V., Dimitrova, S., Benov, H., Tsanova, V., Kyolean, M., Marchev, S., Stoikov, A., Zdravkov, N., Ramshev, K., Krastev, A., Stamenova, P., Angelova, I., Pencheva, G., Grigorova, V., Petrauskiene, B., Skripkauskiene, I., Raugaliene, R., Norkiene, S., Mazutavicius, R., Kavoliuniene, A., Aidietiene, S., Aganauskiene, J., Dailydkiene, A., Marcinkeviciene, J., Grigoniene, L., Anusauskiene, J., Kavaliauskiene, R., Lizogub, V., Rudenko, L., Tseluyko, V., Voronkov, L., Sychov, O., Svyshchenko, Y., Sirenko, Y., Serkova, V., Seredyuk, N., Pertseva, T., Netyazhenko, V., Lishnevska, V., Kupchynska, O., Koval, O., Koshukova, G., Karpenko, O., Grishyna, O., Faynyk, A., Dzyak, G., Dyadyk, O., Yena, L., Volkov, V., Rudyk, I., Kopytsya, M., Kononenko, L., Amosova, K., Zhurba, S., Kazimirko, V., Iuzkiv, I., Shershnyova, O., Khomazyuk, T., Batushkin, V., Vykhovanyuk, I., Popik, G., Skrebkov, V., Skurtov, A., Mishchenko, T., Lytvynenko, N., Sokolova, L., Vatutin, M., Shved, M., Rebrov, B., Kadina, L., Vajda, M., Ursol, G., Zheleznyy, V., Vysochanska, T., Gozhenko, A., Fan, K., Ho, D., Tse, H., Yu, C., Wong, L., Yeh, H., Pai, P., Hsieh, I., Huang, C., Hsieh, Y., Yin, W., Tsai, L., Huang, T., Chen, C., Chiang, F., Ueng, K., Charng, M., Marmor, A., Katz, A., Butnaru, A., Lewis, B., Eldar, M., Rosenhack, S., Elias, N., Koifman, B., Shochat, M., Swissa, M., Zimlichman, R., Bental, T., Weiss, A., Ganam, R., Elias, M., Nseir, W., Oliven, A., Brenner, B., Dayan, M., Pokorney, S, Piccini, J, Stevens, S, Patel, M, Pieper, K, Halperin, J, Breithardt, G, Singer, D, Hankey, G, Hacke, W, Becker, R, Berkowitz, S, Nessel, C, Mahaffey, K, Fox, K, Califf, R, Parati, G, Neurologian yksikkö, and Clinicum

Subjects
Male, Time Factors, medicine.medical_treatment, Administration, Oral, Comorbidity, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, THERAPY, Sudden Cardiac Death, 3124 Neurology and psychiatry, Sudden cardiac death, 0302 clinical medicine, Rivaroxaban, Risk Factors, Cause of Death, Atrial Fibrillation, 80 and over, Medicine, Arrhythmia and Electrophysiology, atrial fibrillation, 030212 general & internal medicine, Stroke, Cause of death, Original Research, CATHETER ABLATION, Aged, 80 and over, DABIGATRAN, Age Factors, Atrial fibrillation, 3. Good health, Intention to Treat Analysis, Treatment Outcome, Mortality, Warfarin, Aged, Anticoagulants, Double-Blind Method, Drug Administration Schedule, Factor Xa Inhibitors, Female, Humans, Multivariate Analysis, Proportional Hazards Models, Risk Assessment, Sex Factors, Cardiology and Cardiovascular Medicine, Administration, medicine.drug, Oral, medicine.medical_specialty, Catheter ablation, Dabigatran, 03 medical and health sciences, RISK-FACTOR, Intensive care medicine, METAANALYSIS, Ischemic Stroke, Intracranial Hemorrhage, Heart Failure, CONGESTIVE-HEART-FAILURE, business.industry, EFFICACY, medicine.disease, warfarin, Emergency medicine, FOLLOW-UP, business
Abstract

Background Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions. Methods and Results In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose‐adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all‐cause mortality in the 14 171 participants in the intention‐to‐treat population. The median age was 73 years, and the mean CHADS 2 score was 3.5. Over 1.9 years of median follow‐up, 1214 (8.6%) patients died. Kaplan–Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all‐cause mortality was observed between the rivaroxaban and warfarin arms ( P =0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33–1.70, P CI 1.51–1.90, P Conclusions In a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas Clinical Trial Registration URL : https://www.clinicaltrials.gov/ . Unique identifier: NCT 00403767.

Published
2016
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5. Cost of detecting malignant lesions by endoscopy in 2741 primary care dyspeptic patients without alarm symptoms

Author

VAKIL N, TALLEY N, VAN ZANTEN SV, FLOOK N, PERSSON T, BJÖRCK E, LIND T, BOLLING STERNEVALD E, STARS I. STUDY GROUP: BAI JC, SEGAL E, DI RISIO C, PEDRANA R, RAINOLDI J, MILUTIN M, PALAZZO F, MACKEN E, BAETENS P, D'HAENS G, CABOOTER M, MARTINET JP, DELWAIDE J, PIESSEVAUX H, BUSET M, JANSSENS J, VERGAUWE P, POLLET S, QUILICI F, RODRIGUEZ TN, DA SILVA EP, NADER F, LUIZ JORGE J, ACHILLES P, CORRÊA BL, GUEDES J, CLARK D, PLOURDE, DESAI M, MORGAN EP, GRAY J, COHEN A, REDDY S, JOBIN G, SADOWSKI D, KELLY A, MORGAN D, ING G, LIANG W, TYTUS R, TEITELBAUM I, LASKO B, KASSNER R, CARLSON B, O'KEEFE D, SOMANI R, GREENSPOON A, FAIERS A, BANKS M, JARDINE F, WOODLAND R, LUCES K, COX R, ROLFE A, FAY D, AKHRAS D, MAZZA G, KIILERICH S, BYTZER P, HENDEL L, ERIKSEN J, THORDAL C, VADSTRUP S, FLY G, GOLDFAIN D, COULANJON G, LEOTHAUD G, DELETTE O, MATHONIERE O, ZRIHEN D, LEMAITRE JP, PEIGNOT JF, BARBERIS A, TORDJMAN G, GOMPEL M, GRANDGUILLAUME J, MARCIANO P, LE TEXIER A, BOYE A, TONDUT A, SCHEER J, SCHMIDT W, KÖLLING W, REGLING S, ALASMAR D, BECKER TESCH A, LEHMANN R, SCHIRRMEISTER G, SPEETZEN G, STAHL HD, ROITENBERG A, KITIS GE, KARAMANOLIS D, TRIANTAFILLOU G, TZIVRAS M, AVGERINOS A, BJÖRNSSON ORVAR K, KRISTJÁNSDÓTTIR, BIRGISSON, VALDIMARSSON, BJÖRNSSON S, SPISNI R, SCARPULLA G, MINOLI G, DELLA BIANCA G, BIANCO MA, PISTOIA MA, VAIRA D, LONGHINI A, CESTARI R, JOMAAS H, JOHANSEN Y, LIER J, LØLAND O, SKJEGSTAD E, JØRUM IM, FONNELØP H, WANGESTAD M, TOMASSEN ST, NORDSTRAND A, HERTZENBERG AB, SAEBØ L, MANSILLA TINOCO R, NORHEIM PD, SOLNØR L, LUNDBY B, TOMALA T, SANAKER H, FAUSKE J, OSHAUG M, LINDSTRØM M, RUDNEVA E, HANSEN AN, SKAG A, WERNER EL, AHLQVIST JO, BØ PE, KJØRLAUG K, EIKELAND T, HATLEBREKKE T, OLSEN K, TUDOR N, DOBRU D, REDIS R, COMAN F, BALADAS H, FOCK KW, HO LK, LIM CC, GROBLER S, ALLY R, ABOO N, VAN RENSBURG C, MOHAME H, SCHNEIDER H, PRINS M, MOOLA S, BEKKER J, ABAD A, MEARIN MANRIQUE F, DOMINGUEZ E, HERRERIAS GUTIÉRREZ JM, DIAZ RUBIO M, WEDÉN M, EDIN R, UNG KA, TOTH E, JOHNSSON F, STUBBERÖD A, TOUR R, FALK A, HULTBER C, LARNEFELDT H, LÖNNEBORG L, ERICSSON M, KNUTSSON AC, FRÖBERG L, LARSSON A, TRACZ S, HOLLENBERG S, WIDE S, POLHEM B, PAULSSON L, GRIMFORS S, ROOS H, SKALENU JO, WEBER KB, STANGHELLINI, VINCENZO, VAKIL N, TALLEY N, VAN ZANTEN SV, FLOOK N, PERSSON T, BJÖRCK E, LIND T, BOLLING-STERNEVALD E, STARS I STUDY GROUP: BAI JC, SEGAL E, DI RISIO C, PEDRANA R, RAINOLDI J, MILUTIN M, PALAZZO F, MACKEN E, BAETENS P, D'HAENS G, CABOOTER M, MARTINET JP, DELWAIDE J, PIESSEVAUX H, BUSET M, JANSSENS J, VERGAUWE P, POLLET S, QUILICI F, RODRIGUEZ TN, DA SILVA EP, NADER F, LUIZ JORGE J, ACHILLES P, CORRÊA BL, GUEDES J, CLARK D, PLOURDE, DESAI M, MORGAN EP, GRAY J, COHEN A, REDDY S, JOBIN G, SADOWSKI D, KELLY A, MORGAN D, ING G, LIANG W, TYTUS R, TEITELBAUM I, LASKO B, KASSNER R, CARLSON B, O'KEEFE D, SOMANI R, GREENSPOON A, FAIERS A, BANKS M, JARDINE F, WOODLAND R, LUCES K, COX R, ROLFE A, FAY D, AKHRAS D, MAZZA G, KIILERICH S, BYTZER P, HENDEL L, ERIKSEN J, THORDAL C, VADSTRUP S, FLY G, GOLDFAIN D, COULANJON G, LEOTHAUD G, DELETTE O, MATHONIERE O, ZRIHEN D, LEMAITRE JP, PEIGNOT JF, BARBERIS A, TORDJMAN G, GOMPEL M, GRANDGUILLAUME J, MARCIANO P, LE TEXIER A, BOYE A, TONDUT A, SCHEER J, SCHMIDT W, KÖLLING W, REGLING S, ALASMAR D, BECKER-TESCH A, LEHMANN R, SCHIRRMEISTER G, SPEETZEN G, STAHL HD, ROITENBERG A, KITIS GE, KARAMANOLIS D, TRIANTAFILLOU G, TZIVRAS M, AVGERINOS A, BJÖRNSSON ORVAR K, KRISTJÁNSDÓTTIR, BIRGISSON, VALDIMARSSON, BJÖRNSSON S, STANGHELLINI V, SPISNI R, SCARPULLA G, MINOLI G, DELLA BIANCA G, BIANCO MA, PISTOIA MA, VAIRA D, LONGHINI A, CESTARI R, JOMAAS H, JOHANSEN Y, LIER J, LØLAND O, SKJEGSTAD E, JØRUM IM, FONNELØP H, WANGESTAD M, TOMASSEN ST, NORDSTRAND A, HERTZENBERG AB, SAEBØ L, MANSILLA-TINOCO R, NORHEIM PD, SOLNØR L, LUNDBY B, TOMALA T, SANAKER H, FAUSKE J, OSHAUG M, LINDSTRØM M, RUDNEVA E, HANSEN AN, SKAG A, WERNER EL, AHLQVIST JO, BØ PE, KJØRLAUG K, EIKELAND T, HATLEBREKKE T, OLSEN K, TUDOR N, DOBRU D, REDIS R, COMAN F, BALADAS H, FOCK KW, HO LK, LIM CC, GROBLER S, ALLY R, ABOO N, VAN RENSBURG C, MOHAME H, SCHNEIDER H, PRINS M, MOOLA S, BEKKER J, ABAD A, MEARIN MANRIQUE F, DOMINGUEZ E, HERRERIAS GUTIÉRREZ JM, DIAZ RUBIO M, WEDÉN M, EDIN R, UNG KA, TOTH E, JOHNSSON F, STUBBERÖD A, TOUR R, FALK A, HULTBER C, LARNEFELDT H, LÖNNEBORG L, ERICSSON M, KNUTSSON AC, FRÖBERG L, LARSSON A, TRACZ S, HOLLENBERG S, WIDE S, POLHEM B, PAULSSON L, GRIMFORS S, ROOS H, SKALENU JO, and WEBER KB

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Esophageal Neoplasms, MEDLINE, Primary care, ALARM, Young Adult, Stomach Neoplasms, Occult malignancy, Medicine, Humans, Stomach Ulcer, Young adult, Dyspepsia, Aged, Gastrointestinal Neoplasms, Hepatology, medicine.diagnostic_test, Primary Health Care, business.industry, General surgery, Gastroenterology, Age Factors, Endoscopy, Middle Aged, Surgery, Duodenal Ulcer, Gastroesophageal Reflux, Female, business
Abstract

BACKGROUND & AIMS: Current guidelines recommend empirical, noninvasive approaches to manage dyspeptic patients without alarm symptoms, but concerns about missed lesions persist; the cost savings afforded by noninvasive approaches must be weighed against treatment delays. We investigated the prevalence of malignancies and other serious abnormalities in patients with dyspepsia and the cost of detecting these by endoscopy. METHODS: We studied 2741 primary-care outpatients, 18-70 years in age, who met Rome II criteria for dyspepsia. Patients with alarm features (dysphagia, bleeding, weight loss, etc) were excluded. All patients underwent endoscopy. The cost and diagnostic yield of an early endoscopy strategy in all patients were compared with those of endoscopy limited to age-defined cohorts. Costs were calculated for a low, intermediate, and high cost environment. RESULTS: Endoscopies detected abnormalities in 635 patients (23%). The most common findings were reflux esophagitis with erosions (15%), gastric ulcers (2.7%), and duodenal ulcers (2.3%). The prevalence of upper gastrointestinal malignancy was 0.22%. If all dyspeptic patients 50 years or older underwent endoscopy, 1 esophageal cancer and no gastric cancers would have been missed. If the age threshold for endoscopy were set at 50 years, at a cost of $500/endoscopy, it would cost $82,900 (95% CI, $35,714-$250,000) to detect each case of cancer. CONCLUSIONS: Primary care dyspeptic patients without alarm symptoms rarely have serious underlying conditions at endoscopy. The costs associated with diagnosing an occult malignancy are large, but an age cut-off of 50 years for early endoscopy provides the best assurance that an occult malignancy will not be missed.

Published
2009

7. Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized, placebo-controlled study in patients with acute low back pain.

Author

Lasko B, Levitt RJ, Rainsford KD, Bouchard S, Rozova A, and Robertson S

Abstract

Abstract Objective: Combinations of oral analgesics may offer several potential benefits compared with an individual agent. The objective of this study was to investigate the efficacy and safety of an extended-release, twice-daily fixed combination of 75 mg tramadol/650 mg paracetamol (DDS-06C) in the treatment of moderate-to-severe pain, using acute low back pain as a model. Research design and methods: In this phase III study, 277 patients with moderate-to-severe acute low back pain were randomized to 1-2 tablets of DDS-06C or placebo every 10-12 h for 2.5 days during the double-blind phase. Following the double-blind phase, patients had the option to continue for a 2.5-day open-label phase. Clinical trial registration: Clinicaltrials.gov (Identifier: NCT00643383) Main outcome measures: The primary end point was the sum of pain intensity differences (SPID) over the 50-h double-blind phase (SPID50). Secondary end points included total pain relief score over the 50-h double-blind phase (TOTPAR50), patient's global impression of medication, and SPID over the first 4 h. Results: A statistically significant (p = 0.038) greater decrease in pain intensity was observed in the DDS-06C group (median SPID50: -6.0) versus placebo (median SPID50: -4.0). Greater pain relief was also observed in patients randomized to DDS-06C: the median TOTPAR50 was 13.0 for the DDS-06C group and 11.0 for placebo (p = 0.026). DDS-06C demonstrated statistically significant superior efficacy compared with placebo for the majority of the other secondary end points. Overall, 38% of patients treated with DDS-06C experienced at least one adverse event; the intensity was mild-to-moderate in 81% of cases. The most commonly reported adverse events (>5% of patients receiving DDS-06C) were nausea, dizziness, vomiting, and somnolence. Conclusions: Using acute low back pain, a model with a high degree of heterogeneity and intrinsic variability, DDS-06C was superior to placebo on measures of pain intensity and relief, and was well-tolerated. [ABSTRACT FROM AUTHOR]

Published
2012
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8. Rapid immunization against H5N1: a randomized trial evaluating homologous and cross-reactive immune responses to AS03(A)-adjuvanted vaccination in adults.

Author

Lasko B, Reich D, Madan A, Roman F, Li P, Vaughn D, Lasko, Benjamin, Reich, Dennis, Madan, Anuradha, Roman, François, Li, Ping, and Vaughn, David

Abstract

Background: Accelerated immunization schedules may help gain early control of influenza pandemics. We investigated different schedules of an AS03(A)-adjuvanted H5N1 vaccine.Methods: This phase II, open-label, 6-month study randomized participants (aged 18-64 years) to 2 vaccine doses administered 21 (standard schedule), 14, or 7 days apart, or on the same day. Coprimary end points were that the lower limit of the 98.75% confidence interval 14 days after the last dose must be (1) >40% for seroconversion rate (SCR) (Center for Biologics Evaluation and Research [CBER] criterion) and (2) >50% for seroprotection rate (SPR) (attainment rate for reciprocal hemagglutination inhibition titers ≥40, protocol-defined criterion) for the vaccine homologous strain (A/Indonesia/5/2005). European Committee for Human Medicinal Products (CHMP) immunogenicity criteria were also evaluated.Results: Coprimary end points were achieved (lower 98.75% confidence intervals exceeded defined values). Titers were highest with the standard schedule. Nevertheless, CBER SCR, protocol-defined SPR, and CHMP criteria were met with all schedules for the A/Indonesia/5/2005 strain. There were no significant differences between age groups (18-40 vs 41-64 years). Immune response was robust against drift variants A/turkey/Turkey/1/2005 and A/Vietnam/1194/2004.Conclusions: The AS03(A)-adjuvanted H5N1 vaccine in accelerated schedules offers a robust immune response against vaccine homologous and drift variant strains, allowing consideration of compressed vaccination intervals.Clinical Trials Registration: NCT00695669. [ABSTRACT FROM AUTHOR]

Published
2011
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9. A Randomized, Placebo-Controlled Phase 3 Trial (Study SB-767905/012) of Alvimopan for Opioid-Induced Bowel Dysfunction in Patients With Non-Cancer Pain.

Author

Jansen JP, Lorch D, Langan J, Lasko B, Hermanns K, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, and Mortensen ER

Abstract

Gastrointestinal (GI) side effects are common with opioid medication, and constipation affects ~40% of patients. Such symptoms considerably impair patients' quality of life. Alvimopan is an orally administered, systemically available, peripherally acting mu-opioid receptor (PAM-OR) antagonist approved in the US for short-term, in-hospital management of postoperative ileus in patients undergoing bowel resection. This double-blind, placebo-controlled trial was conducted as part of a recently discontinued clinical program, in which alvimopan was being developed for opioid-induced constipation (OIC). Patients (N = 518) receiving opioids for non-cancer pain were randomized to receive alvimopan .5 mg once daily, alvimopan .5 mg twice daily, or placebo for 12 weeks. The primary efficacy endpoint was the proportion of patients experiencing >=3 spontaneous bowel movements (SBMs; bowel movements with no laxative use in the previous 24 hours) per week over the treatment period and an average increase from baseline of >=1 SBM per week. A significantly greater proportion of patients in the alvimopan .5 mg twice-daily group met the primary endpoint compared with placebo (72% versus 48%, P < .001). Treatment with alvimopan twice daily improved a number of other symptoms compared with placebo and reduced the requirement for rescue laxative use. The opioid-induced bowel dysfunction Symptoms Improvement Scale (SIS) responder rate was 40.4% in the alvimopan .5 mg twice daily group, versus 18.6% with placebo (P < .001). In general, alvimopan .5 mg once daily produced qualitatively similar but numerically smaller responses than twice-daily treatment. Active treatment did not increase the requirement for opioid medication or increase average pain intensity scores. Over the 12-week treatment period, alvimopan appeared to be well tolerated. PERSPECTIVE: These results demonstrate the potential for a PAM-OR antagonist to improve the symptoms of OIC without antagonizing opioid analgesia. [ABSTRACT FROM AUTHOR]

Published
2011

13. A nasally administered trivalent inactivated influenza vaccine is well tolerated, stimulates both mucosal and systemic immunity, and potentially protects against influenza illness

Author

Langley, J.M., Aoki, F., Ward, B.J., McGeer, A., Angel, J.B., Stiver, G., Gorfinkel, I., Shu, D., White, L., Lasko, B., Dzongowski, P., Papp, K., Alexander, M., Boivin, G., and Fries, L.

Subjects
*INFLUENZA vaccines, *DRUG administration, *DRUG tolerance, *MEMBRANE proteins, *VIRAL proteins, *INTRANASAL medication, *RANDOMIZED controlled trials, *DRUG efficacy
Abstract

Abstract: A randomized placebo-controlled double-blind trial of a nasally administered inactivated trivalent influenza vaccine formulated with partially purified meningococcal outer membrane proteins (OMP-TIV) was conducted in 1349 healthy adults aged 18–64 years. Subjects received either vaccine containing 15μg of haemagglutinin (HA) of each of three influenza strains for the 2003–2004 season on days 0 and 14, or 30μg on day 0 and saline placebo on day 14, or placebo on days 0 and 14. Vaccination was well tolerated, with similar reactogenicity as placebo. Compared to placebo, statistically significant increases in mean serum haemagglutinin inhibition reciprocal titers and salivary secretory IgA to all 3 antigens were seen on day 28 for both vaccine dose groups. The incidence of culture-positive influenza and fever >37.8°C and cough and one or more of sore throat, runny nose or nasal congestion, muscle or joint ache, headache, fatigue, or chills or culture positive influenza and at least two of these symptoms was low (16/1349; 1.2%). In the intent-to-immunize population too few febrile culture-confirmed illness events (n =4) occurred to perform analysis. Fever occurred infrequently, even in the presence of positive cultures and disabling multi-symptom disease. In participants receiving all doses of either vaccine regimen the incidence of culture-confirmed influenza with respiratory symptoms and with or without fever was 0.77% (7/904) vs. 2.03% (9/443) in placebo recipients (p =0.045, Fisher''s exact test; relative risk reduction 62%), despite circulation of a drift variant A/H3N2 that was poorly matched to vaccine. An OMP-TIV vaccine was well tolerated and reduced risk of symptomatic culture confirmed influenza. Vaccine efficacy will need to be validated in a season with a higher attack rate. [Copyright &y& Elsevier]

Published
2011
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14. Effects of taspoglutide on glycemic control and body weight in obese patients with type 2 diabetes (T-emerge 7 study).

Author

Hollander P, Lasko B, Barnett AH, Bengus M, Kanitra L, Pi-Sunyer FX, and Balena R

Subjects
Adolescent, Adult, Aged, Anti-Obesity Agents therapeutic use, Body Mass Index, Diabetes Mellitus, Type 2 complications, Diabetes Mellitus, Type 2 drug therapy, Double-Blind Method, Fasting, Female, Glycated Hemoglobin analysis, Glycated Hemoglobin metabolism, Humans, Hypoglycemic Agents therapeutic use, Male, Metformin therapeutic use, Middle Aged, Obesity complications, Young Adult, Blood Glucose analysis, Obesity drug therapy, Peptides therapeutic use, Weight Loss drug effects
Abstract

Objective: Therapies that lower blood glucose and provide weight loss may provide meaningful benefits for obese patients with type 2 diabetes mellitus (T2DM). This study assessed the efficacy of taspoglutide compared with placebo on glycemic control and weight in obese patients with T2DM inadequately controlled with metformin monotherapy., Design and Methods: In a 24-week, randomized, double-blind, placebo-controlled, multicenter trial, obese adults with T2DM were randomized (1:1) to weekly subcutaneous taspoglutide 20 mg (10 mg for first 4 weeks) (n = 154) or placebo (n = 151) for 24 weeks. Efficacy measures included hemoglobin A1c (HbA1c) levels, body weight, percentage of patients achieving HbA1c ≤6.5 and ≤7.0%, and fasting plasma glucose (FPG). Adverse events (AEs) were assessed., Results: Mean baseline HbA1c was 7.55% and mean baseline BMI was 36.7 kg/m(2) . HbA1c reductions from baseline were significantly greater with taspoglutide than placebo (least square mean [LSMean], -0.81% vs. -0.09%; P < 0.0001). Weight loss at week 24 was significantly greater with taspoglutide than placebo (LSMean, -3.16 vs. -1.85 kg; P < 0.01). In the taspoglutide and placebo groups, target HbA1c levels (≤6.5%) were achieved by 49 and 16% of patients, respectively, while 72 and 36% achieved HbA1c levels ≤7%. Decreases in FPG were significantly greater with taspoglutide than placebo (-23.59 vs. 0.09 mg/dl; P < 0.0001). Nausea and vomiting were the most common AEs associated with taspoglutide, but tended to be transient and generally mild or moderate., Conclusions: In obese patients with T2DM, once-weekly taspoglutide provided the combined benefits of glycemic control and weight loss., (Copyright © 2012 The Obesity Society.)

Published
2013
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15. Force and movement of non-osseointegrated implants: an in vitro study.

Author

Flanagan D, Ilies H, Lasko B, and Stack J

Subjects
Animals, Biomechanical Phenomena, Bite Force, Cattle, Imaging, Three-Dimensional, Materials Testing instrumentation, Materials Testing methods, Mechanical Phenomena, Movement, Osseointegration, Signal Processing, Computer-Assisted, Stress, Mechanical, Transducers, Dental Implants, Mandible pathology
Abstract

Dental implants have enabled a dramatic increase in the quality of life for many partially edentulous and edentulous patents. Immediate loading of newly placed dental implants is a recent advancement that attempts to meet patient demand. However, immediate loading of a just placed implant may induce implant failure to osseointegrate. Some patients can generate a biting force that can reach approximately 1300 Newtons (N) in the posterior jaws. The magnitude of bite force that would cause failure of osseointegration of newly placed implants is currently unknown. It has been proposed that osseointegration would fail if an implant is luxated in bone more than 50 to 150 microns. Fibrous tissue, not bone, would form. This study investigated the quantity of various off-axial forces required to move a nonosseointegrated 4.3 x 13 mm implant 50 microns. The previously published pilot study for this study found that the amount of horizontal force required to displace an implant 50 microns was approximately 150 N. This study found that the force needed to move the implants 100 microns at a horizontal approach, 0 degrees, averaged 50 N, with a range of 23-79 N; at 22 degrees, averaged 52 N, with a range of 27-70 N; and at 60 degrees averaged 87 N, with a range of 33-105 N.

Published
2009
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16. Alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist for the treatment of opioid-induced bowel dysfunction: results from a randomized, double-blind, placebo-controlled, dose-finding study in subjects taking opioids for chronic non-cancer pain.

Author

Webster L, Jansen JP, Peppin J, Lasko B, Irving G, Morlion B, Snidow J, Pierce A, Mortensen E, Kleoudis C, and Carter E

Subjects
Adult, Colic chemically induced, Colic physiopathology, Constipation physiopathology, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Enteric Nervous System drug effects, Enteric Nervous System metabolism, Enteric Nervous System physiopathology, Female, Gastrointestinal Motility drug effects, Gastrointestinal Motility physiology, Humans, Intestines drug effects, Intestines innervation, Intestines physiopathology, Male, Middle Aged, Narcotic Antagonists administration & dosage, Narcotic Antagonists adverse effects, Pain drug therapy, Piperidines adverse effects, Placebos, Receptors, Opioid, mu metabolism, Risk Assessment, Treatment Outcome, Analgesics, Opioid adverse effects, Analgesics, Opioid antagonists & inhibitors, Constipation chemically induced, Constipation drug therapy, Piperidines administration & dosage, Receptors, Opioid, mu antagonists & inhibitors
Abstract

Our objective was to investigate the efficacy and safety of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, in subjects with non-cancer pain and opioid-induced bowel dysfunction (OBD), and to identify at least one treatment regimen that improves OBD. Following a 2-week baseline period, 522 subjects reporting <3 spontaneous bowel movements (SBMs)/week (with >or=25% accompanied by a sensation of incomplete evacuation, straining, or lumpy hard stools), requiring analgesia equivalent to >or=30 mg oral morphine/day were randomized to alvimopan 0.5mg twice daily (BID), 1mg once daily (QD), 1mg BID, or placebo for 6 weeks. Compared with placebo, there was a statistically and clinically significant increase in mean weekly SBM frequency over the initial 3 weeks of treatment (primary endpoint) with alvimopan 0.5mg BID (+1.71 mean SBMs/week), alvimopan 1mg QD (+1.64) and alvimopan 1mg BID (+2.52); P<0.001 for all comparisons. Increased SBM frequency and additional treatment effects, including improvements in symptoms such as straining, stool consistency, incomplete evacuation, abdominal bloating/discomfort, and decreased appetite, were sustained over 6 weeks. The most frequently reported adverse events were abdominal pain, nausea, and diarrhea, occurring more frequently in the higher dosage groups. The alvimopan 0.5mg BID regimen demonstrated the best benefit-to-risk profile for managing OBD with alvimopan in this study population, with a side effect profile similar to that of placebo. There was no evidence of opioid analgesia antagonism. Competitive peripheral antagonism of opioids with alvimopan can restore GI function and relieve OBD without compromising analgesia.

Published
2008
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17. Efficacy and tolerability of telithromycin for 5 or 10 days vs amoxicillin/clavulanic acid for 10 days in acute maxillary sinusitis.

Author

Luterman M, Tellier G, Lasko B, and Leroy B

Subjects
Adolescent, Adult, Aged, Amoxicillin-Potassium Clavulanate Combination adverse effects, Anti-Bacterial Agents adverse effects, Double-Blind Method, Drug Therapy, Combination adverse effects, Female, Humans, Male, Middle Aged, Treatment Outcome, Amoxicillin-Potassium Clavulanate Combination administration & dosage, Anti-Bacterial Agents administration & dosage, Drug Therapy, Combination administration & dosage, Ketolides, Macrolides, Maxillary Sinusitis drug therapy
Abstract

Telithromycin (HMR 3647) is a new ketolide antimicrobial that was developed for the treatment of community-acquired respiratory tract injections. We conducted a randomized, double-blind, multicenter study to compare the clinical efficacy and safety of oral telithromycin, at 800 mg once daily for 5 or 10 days, with that of amoxicillin/clavulanic acid, at 500/125 mg three times daily for 10 days, in adults with acute maxillary sinusitis (AMS). A total of 754 patients with AMS of less than 28 days' duration were randomized to receive either telithromycin for 5 days followed by placebo for 5 days, telithromycin for 10 days, or amoxicillin/clavulanic acid for 10 days. Clinical outcome was assessed at a test-of-cure (TOC) visit between days 17 and 24 and at a late post-therapy visit between days 31 and 45. Analysis of clinical outcome on a per-protocol basis (n = 434) demonstrated therapeutic equivalence among the three regimens at the TOC visit; in each treatment group, the clinical cure rate was approximately 75%. Only a few patients (3 to 5 in each group) had relapsed by the late post-therapy follow-up visit. Telithromycin was generally safe and well tolerated. The most common adverse events were mild or moderate gastrointestinal effects, which occurred with similar frequency in all three groups. We conclude that 5 or 10 days of telithromycin at 800 mg once daily is as effective clinically and as well tolerated as 10 days of treatment with amoxicillin/clavulanic acid. Telithromycin, therefore, appears to be a valuable option for the treatment of AMS.

Published
2003

18. Canadian valsartan study in patients with mild-to-moderate hypertension.

Author

Lasko BH, Laplante A, Hébert D, and Bonnefis-Boyer S

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Angiotensin Receptor Antagonists, Antihypertensive Agents standards, Antihypertensive Agents toxicity, Blood Pressure drug effects, Blood Pressure Monitoring, Ambulatory, Canada, Chronotherapy, Female, Humans, Hypertension complications, Male, Middle Aged, Prospective Studies, Racial Groups, Sex Factors, Single-Blind Method, Tetrazoles standards, Tetrazoles toxicity, Valine analogs & derivatives, Valine standards, Valine toxicity, Valsartan, Antihypertensive Agents administration & dosage, Hypertension drug therapy, Tetrazoles administration & dosage, Valine administration & dosage
Abstract

Objective: This study was designed mainly to establish the rates of response to valsartan 80mg once daily (qd) and to valsartan 160mg qd given to non-responders to 80mg qd, as well as to determine the safety of valsartan and the blood pressure control achieved using valsartan over a period of 24 h or more, using ambulatory blood pressure monitoring (ABPM) devices., Methods: This was a single-blind, single-arm, multicenter study involving 256 out-patients with mild-to-moderate essential hypertension. After previous antihypertensive treatments had been 'washed out', the patients were entered into a 2-week placebo run-in period to confirm the diagnosis of mild-to-moderate hypertension. Patients who, at the end of the placebo run-in period, had a mean sitting diastolic blood pressure of between 95 and 115mmHg inclusive received valsartan 80mg qd for 4 weeks. Non-responders (those not demonstrating a diastolic blood pressure of less than 90mmHg or a decrease in diastolic blood pressure of 10mmHg or more compared with baseline) received valsartan 160mg qd for another 4 weeks. In selected centers, patients who agreed also had their blood pressure monitored for 24 h, provided their blood pressure was shown to be controlled. Of these patients, half skipped one dose of valsartan and were monitored for an additional 24h period., Results: The rate of response to valsartan 80mg was 45.4%, and of those not responding to this dose, 36.3% responded to valsartan 160mg. The response rate to one or other dose was 63.2%. The ambulatory blood pressure data support a consistent reduction of blood pressure with valsartan over a 24h period and for up to 32 h after dosing in those who missed a dose. The overall incidence of adverse experiences per person-year, treatment related or otherwise, was 6.3 and 10.6 for the valsartan and placebo study periods respectively., Conclusion: Antihypertensive treatment with valsartan for 8 weeks produced a significant decrease in diastolic blood pressure in hypertensive patients. In addition, the drug may be safely administered, and the results of 24 h/48 h ambulatory monitoring demonstrate that valsartan is a true once-a-day antihypertensive.

Published
2001
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19. Efficacy and safety of oral levofloxacin compared with clarithromycin in the treatment of acute sinusitis in adults: a multicentre, double-blind, randomized study. The Canadian Sinusitis Study Group.

Author

Lasko B, Lau CY, Saint-Pierre C, Reddington JL, Martel A, and Anstey RJ

Subjects
Acute Disease, Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents adverse effects, Anti-Infective Agents adverse effects, Clarithromycin adverse effects, Double-Blind Method, Female, Humans, Male, Middle Aged, Ofloxacin adverse effects, Sinusitis physiopathology, Treatment Outcome, Anti-Bacterial Agents administration & dosage, Anti-Infective Agents administration & dosage, Clarithromycin administration & dosage, Levofloxacin, Ofloxacin administration & dosage, Sinusitis drug therapy
Abstract

Adult patients with acute sinusitis (n = 236) were randomized in a double-blind study to levofloxacin 500 mg orally once daily (n = 119) or clarithromycin 500 mg orally twice daily (n = 117) for 10-14 days. Between 2 and 5 days after therapy participants were evaluated as cured (no symptoms), improved (symptoms improved, no further therapy required), or failed (further therapy required). Clinical response rates (cured plus improved) for clinically evaluable patients were 93.9% for levofloxacin (n = 98) and 93.5% for clarithromycin (n = 93). The proportion of patients evaluated as cured was higher in the levofloxacin (40.8%) than in the clarithromycin arm (29.0%) and individual symptoms showed higher rates of resolution. Of patients receiving levofloxacin and clarithromycin, 22.5% and 39.3%, respectively, experienced adverse events related or possibly related to the study therapy. This study showed that, in the treatment of acute sinusitis, daily levofloxacin therapy is as effective as twice-daily clarithromycin therapy with more complete clearing of symptoms and a more tolerable side-effect profile.

Published
1998
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