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10. Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects

Author

James, Wp, Caterson, Id, Coutinho, W, Finer, N, VAN GAAL LF, Maggioni, Ap, TORP-PEDERSEN, C, Sharma, Am, Shepherd, Gm, Rode, Ra, Renz, Cl, Van Gaal LF, Torp-Pedersen, C, Pepine, C, Pocock, S, Drexler, H, Swedberg, K, Sleight, P, Armstrong, P, Kerr, D, Dagenais, G, Brophy, J, Avezum, A, Bogaty, P, Fabbri, G, Galli, M, Hildebrandt, P, Mann, J, Ostergren, J, Sherman, D, Zannad, F, Colquhoun, D, Hollanders, G, e Forti A, Costa, Cifkova, R, Toubro, S, Ziegler, O, Scherbaum, Wa, Jordan, J, Halmy, L, Ferrannini, E, Santini, F, Gonzalez, C, Narkiewicz, K, Hancu, N, Payer, J, Pascual, J, Wilding, J, Campbell, L, Carey, D, Gerstman, M, Karrasch, J, Lefkovits, J, Marks, J, Marks, S, Moses, R, Phillips, P, Proietto, J, Roberts, D, Roberts-Thomson, P, Shaw, J, Simpson, R, Singh, B, Singleton Jeffries, W, Stuckey, B, Boland, J, Brohet, C, Coucke, F, Dendale, P, Jouret, G, Kolanowski, J, Kutnowski, M, Martens, F, Muls, E, Peiffer, F, Penninckx, H, Scheen, A, Schoors, D, Vaerenberg, M, Van Cleemput, J, Van Crombrugge, P, Van Kuyk, M, Verhaegen, A, Wollaert, B, de Albuquerque DC, Appolinario, J, de Godoy Matos AF, Gross, Jl, Halpern, A, Kerr Saraiva JF, Milagres, R, Repetto, G, Suplicy, Hl, Zanella, Mt, Bednarova, J, Cepelak, V, Cerny, P, Hainer, V, Havranek, P, Homza, M, Jansa, P, Karlicek, M, Kolesar, J, Kotik, I, Kucera, D, Kuchar, J, Kunc, M, Kvapil, M, Linhart, A, Machova, V, Matuska, J, Oral, I, Pavlas, J, Pesatova, S, Povolny, J, Semrad, B, Smetana, K, Soucek, M, Svacina, S, Tesinsky, P, Urbanek, R, Wasserburger, B, Zachoval, R, Zahumensky, E, Zidkova, E, Astrup, A, Dominguez, H, Faber, J, Hilderbrant, P, Kober, L, Perrild, H, Richelsen, B, Sogaard, P, Svendsen, Ol, Urhammer, S, Archambeaud, F, Basdevant, A, Borys, Jm, Bringer, J, Brunetiere, C, Charpentier, G, Cocaul-André, M, Dabadie, H, Dubreuil, A, Estour, B, Gautier, Jf, Gibault, T, Halimi, S, Hespel, Jp, Issa Sayegh, M, Krempf, M, Laville, M, Lecerf, Jm, Louvet, Jp, Penfornis, A, Ritz, P, Schlienger, Jl, Schmitt, B, Valensi, P, Baar, M, Beermann, J, Bock, M, Boenner, G, Dammann, Hg, Diehm, C, Ditschuneit, H, Gadow, J, Gehlhar, S, Gessner, S, Guthersohn, A, Hamann, A, Hanefeld, M, Hasenfuss, G, Herzner, A, Heun, Kc, Heufelder, Ae, Hohensee, H, Jacob, S, Krings, P, Krätzig, B, Krosse, B, Lehmann, Rt, Mindt-Prüfert, S, Maisch, B, Pfeiffer, Af, Richard, F, Rose, B, Schmidt, E, Scholze, J, Schreckenberg, A, Stuebler, P, Walter, J, Wirth, A, Wunderlich, J, Abraham, G, Altorjay, A, Augusztin, G, Csaszar, A, Czuriga, I, Dinnyes, J, Gero, L, Gyimesi, A, Janosi, A, Kovacs, I, Liziczai, I, Majtenyi, A, Medvegy, M, Nadhazi, Z, Pados, G, Polak, G, Ronaszeki, A, Sido, Z, Simon, K, Anzà, C, Bevilacqua, M, Bosello, O, Chiariello, M, Cordera, R, Ferrari, E, Frittitta, L, Giorgino, R, Liuzzi, A, Malinverni, C, Di Mario, U, Melchionda, N, Occhi, G, Perticone, F, Pinchera, A, Pinelli, G, Rovera, G, Santeusanio, F, Urbinati, S, Alpizar-Salazar, M, Carrillo-Ortega, E, Fanghanel Salmon, G, Laviada-Molina, Ha, Madero, Ma, Rodriguez, G, Saldate, C, Sanchez-Castillo, Cp, Violante, Rm, Wacher, N, Zayas-Jaime, Fj, Zuniga-Guajardo, S, Adamiec, R, Banasiak, W, Chrusciel, P, Derlaga, B, Gebala, A, Gessek, J, Janik, K, Janion, M, Kalina, Z, Kozlowski, A, Kusnierz, B, Majcher, Z, Miekus, P, Niegowska, J, Okopien, B, Ostrowska, L, Pasowicz, M, Piepiorka, M, Pluta, W, Polaszewska-Muszynska, M, Ponikowski, P, Pupek-Musialik, D, Sawicki, A, Sobocik, H, Stankiewicz, A, Szpajer, M, Trojnar, R, Tykarski, A, Wrabec, K, Wyrzkowski, B, Zahorska-Markiewicz, B, Zalewski, M, Carrageta, M, Mendes Pedro MM, Parente Martins LM, dos Santos, L, Babes, A, Creteanu, G, Dan, Ga, Dragulescu, Si, Graur, M, Tirgoviste, Ci, Morosanu, M, Mota, M, Paveliu, Fs, Radoi, M, Ranetti, A, Totoian, I, Andre, I, Bugan, V, Cencarik, J, Csala, L, Farsky, S, Gonsorcik, J, Kamensky, G, Kmec, J, Krahulec, B, Kurian, R, Macek, V, Majercak, I, Micko, K, Mokan, M, Riecansky, I, Sojka, G, Uhliar, R, Urgeova, L, Vancik, J, Baro, Fm, Barrios Merino, A, Borras, Jl, Caixas, A, Cuatrecasas Cambra, G, Dominguez Escribano JR, Duran Garcia, S, Escobar-Jimenez, L, Esteva de Antonio, I, Formiguera Sala, X, Garcia-Luna, Pp, Garcia Robles, R, Gonzalez Albarran, O, Hernandez-Mijares, A, Martin Hidalgo, A, Masmiquel Comas, L, Morales Perez, F, Moreno Esteban, B, Pascual Izuel JM, Redon Mas, J, Ricart, W, Rubio, Ma, Ruilope, Lm, Salas-Salvado, J, Terroba Larumbe, M, Tinahones, F, de la Torre Casares ML, Vidal Cortada, J, Zuniga-Perez Lemaur, M, Abdulhakim, Ee, Adler, A, Barnett, Ah, Bodmer, C, Campbell, Iw, Chowdhury, T, Cleland, J, Cook, Rc, Dinneen, S, Donnachie, H, Haslam, Dw, Hillis, Gs, Horne, M, Howarth, Dj, Hughes, E, Jackson, S, Jones, Sc, Jones, Th, Kumar, S, Lean, M, Maroni, J, Mcinnes, G, Middleton, A, Morris, A, Newcombe, G, O'Kane, Kp, Pavel, Ic, Pawa, R, Perry, C, Pitts, C, Raja, A, Reckless, J, Robinson, J, Sarmiento, R, Soo, Sc, Taylor, S, Thomas, Ho, Thomson, Ma, and Wilkins, M.

Subjects
Male, medicine.medical_specialty, Myocardial Infarction, Blood Pressure, Kaplan-Meier Estimate, Type 2 diabetes, Klinikai orvostudományok, Placebo, law.invention, Double-Blind Method, Randomized controlled trial, Weight loss, law, Internal medicine, Appetite Depressants, medicine, Humans, Obesity, Myocardial infarction, Stroke, Aged, business.industry, Hazard ratio, Orvostudományok, General Medicine, Middle Aged, Overweight, medicine.disease, Surgery, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Cardiology, Female, Human medicine, medicine.symptom, business, Cyclobutanes, Sibutramine, medicine.drug
Abstract

Background The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established. Methods We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death). Results The mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P=0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P=0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P=0.03). The rates of cardiovascular death and death from any cause were not increased. Conclusions Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; ClinicalTrials.gov number, NCT00234832.)

Published
2010
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11. Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus

Author

Scirica, B, Bhatt, D, Braunwald, E, Steg, P, Davidson, J, Hirshberg, B, Ohman, P, Frederich, R, Wiviott, S, Hoffman, E, Cavender, M, Udell, J, Desai, N, Mosenzon, O, Mcguire, D, Ray, K, Leiter, L, Raz, I, Abrahamsen, T, Grossman, M, Morin, S, Im, K, Gabovitch, D, Pricken, A, Buskila, A, Stahre, C, Price, D, Billing-Clason, S, Sabel, K, Monyak, J, Sjostrand, M, Wei, C, Lu, J, Miller, E, Raichlen, J, Fitt, S, Iqbal, N, Donovan, M, Aguilar-Salinas, C, Alvarsson, M, Amerena, J, Ardissino, D, Averkov, O, Avogaro, A, Barnett, A, Bretzel, R, Chiang, C, Codoceo, V, Corbalan, R, Dalby, A, Darius, H, Deerochanawong, C, Dellborg, M, Eliaschewitz, F, Garcia-Castillo, A, Gomis, R, Henry, P, Hoekstra, J, Jermendy, G, Kastelein, J, Keech, A, Kiss, R, Krempf, M, Laakso, M, Leitersdorf, E, Lewis, B, Litwak, L, Lopez-Sendon, J, Ma, R, Medina, F, Moses, R, Nicolau, J, Opolski, G, Ophuis, T, Paolasso, E, Ruda, M, Kumar, K, Shestakova, M, Sheu, W, Smahelova, A, Bhupathiraju, B, Spinar, J, Sritata, P, Strojeck, K, Villena-Chavez, J, Jia, W, Huo, Y, Lowe, C, Awtry, E, Berger, C, Desai, A, Gelfand, E, Leeman, D, Link, M, Ruberg, F, Vita, J, Rost, N, Silverman, S, Greenberger, N, Lerch, M, Gersh, B, Nesto, R, Del Prato, S, Tuomilehto, J, Kelsey, S, Alvarisqueta, A, Cuadrado, J, Rista, L, Hermida, S, Baccaro, C, Luquez, C, Lagrutta, M, Maffei, L, Bartolacci, I, Montana, O, Cutuli, H, Berli, M, Lorenzatti, A, Frechtel, G, La Greca, R, Fretes, O, Diaz, M, Papini, N, Farias, E, Issa, C, Elbert, A, Lehman, R, Arya, M, Singh, B, Colquhoun, D, Jayasinghe, R, de Looze, F, Blombery, P, Ward, G, Szto, G, Abhayaratna, W, Borges, J, Russo, L, Felicio, J, Santos, F, Guimaraes, F, Castro, M, Rossi, P, Armaganijan, D, Leaes, P, Bandeira, F, Franken, M, Rassi, N, Rea, R, Zanella, M, Amodeo, C, Cesar, L, Betti, R, Chacra, A, Schmid, H, Bell, A, Syan, G, Zadra, R, Conter, H, Dumas, R, Borts, D, Dattani, I, Poirier, P, Cha, J, Dzongowski, P, Labonte, R, St Pierre, B, Gaudet, D, Kouz, S, Lamy, A, Tishler, S, Chehayeb, R, Bedard, J, Hramiak, I, Teitelbaum, I, Fortin, C, Woo, V, Conway, J, Mehta, P, Robinson, S, Sussex, B, Chiasson, J, Muirhead, N, Bose, S, Ouellet, A, Yale, J, Bhargava, R, Lau, D, Tobe, S, Perron, P, Sigalas, J, Bilodeau, L, Tytus, R, Achyuthan, G, Pearce, M, Steele, A, Bailey, G, Ma, P, St-Maurice, F, Rupka, D, Houlden, R, Bailey, A, Rewa, G, Sohal, P, Ting, R, Prieto, J, Rodriguez, M, Godoy, G, Larenas, G, Pincetti, C, Cobos, L, Saavedra, V, Varleta, P, Lucero, F, Kuzmanic, O, Acevedo, M, Aguirre, M, Florenzano, F, Ma, J, Bao, Y, Jiang, M, Xu, W, Shi, Y, Zheng, M, Li, Y, Dong, Y, Zhao, W, Sun, M, Lei, M, Wang, J, Pistek, Z, Rihacek, I, Kucera, D, Brada, M, Naplava, R, Karasova, J, Vlasicova, H, Skopecek, J, Spinarova, L, Raclavska, L, Sarbochova, R, Okenka, L, Racicka, E, Urbancova, K, Oznerova, M, Lorenc, Z, Wasserburger, B, Zahumensky, E, Grunfeldova, H, Hradec, J, Lukac, M, Svacina, S, Podzimek, J, Hemzsky, L, Mikulkova, I, Pavlickova, J, Brychta, T, Chochola, J, Couffinhal, T, Elbaz, M, Petit, C, Faller, B, Marechaud, R, Moulin, P, Fendri, S, Nazeyrollas, P, Wendisch, U, Busch, K, Klausmann, G, Duengen, H, Appel, K, Toursarkissian, N, Jung, T, Ott, P, Schenkenberger, I, Kuesters, D, Landers, B, Nischik, R, Fischer, H, Tschoepe, D, Paschen, B, Krause, K, Derwahl, K, Wenzl-Bauer, V, Hamann, A, Strotmann, H, Milek, K, Mueller, S, Chu, D, Tan, K, Kung, K, Tsang, C, Tomlinson, B, Koranyi, L, Kerenyi, Z, Benczur, B, Illyes, L, Hidvegi, T, Somogyi, A, Valco, J, Ferenczi, S, Rapi, J, Voros, P, Winkler, G, Sydo, T, Hetey, M, Simon, K, Penzes, J, Kempler, P, Bako, B, Lengyel, Z, Witmann, I, Dudas, M, Vandorfi, G, Takacs, J, Matoltsy, A, Ladanyi, E, Gyimesi, A, Sadikot, S, Parikh, K, Jain, S, Yajnik, C, Sosale, A, Shamanna, P, Srikanta, S, Shah, S, Srinivas, A, Banker, D, Shah, P, Sharda, A, Makkar, B, Rais, N, Mardikar, H, Mishra, A, Bhupati, S, Menon, J, Sathe, S, Gupta, R, Sharma, V, Darawsha, M, Herskovits, T, Hamoud, S, Nikolsky, E, Adawi, F, Zimlichman, R, Tsalihin, D, Wainstein, J, Klainman, E, Mosseri, M, Yerushalmi, Y, Karnieli, E, Knobler, H, Benchetrit, S, Tsur, A, Yagil, Y, Atar, S, Beberashvili, I, Fuchs, S, Stern, N, Pollak, A, Chajek-Shaul, T, Rozenman, Y, Biton, A, Bramucci, E, Fiscella, A, Grassia, V, Piatti, P, De Cosmo, S, Di Lorenzo, L, Merlini, P, Mannucci, E, Frontoni, S, Trevisan, R, Zenari, L, Lambiase, C, Salvioni, A, Silvestri, O, Ambrosio, G, Di Bartolo, P, Fattore, L, Presbitero, P, Calabrese, M, Evola, R, Gamba, M, Ibarra, M, Munoz, E, Sanchez, D, Herrera, C, Rios, J, Llamas, E, Esperon, G, Cantu, E, Fragoso, J, Gonzalez, J, Martinez, G, Padilla, F, Mier, G, Marmolejo, D, Ruiz, J, Portilla, N, Rosas, E, Machado, G, Ramos, J, Briones, I, van Hessen, M, Strikwerda, S, The, S, Kooy, A, Ronner, E, Nierop, P, Remmen, J, Groenemeijer, B, Hamer, B, Basart, D, van Lennep, H, Nieuwdorp, M, van Dijk, M, Kentgens, S, van Kempen, W, Hoogendijk, J, Spiering, W, Voors-Pette, C, Kose, V, de Waard, D, Gonkel, F, Kaasjager, H, Lingan, G, Agous, I, Kruik, H, Imholz, B, Pieterse, M, Manrique, H, Villena, J, Leon, L, Kundert, K, Minchola, J, Pinto, M, Heredia, J, Rodriguez, A, Guerreros, C, Berrospi, P, Zubiate, C, Allemant, A, Arbanil, H, Ponciano, W, Calderon, J, Lisson, R, Segura, L, Sidorowicz-Bialynicka, A, Sciborski, R, Fares, I, Mader, P, Skierkowska, J, Stasinska, T, Pomiecko, W, Skorski, M, Krzyzagorska, E, Polaszewska-Muszynska, M, Sowinski, D, Strojek, K, Rosinska-Migda, J, Romanczuk, P, Golebiowski, G, Kubica, J, Mazurek, T, Wojnowski, L, Pasternak, D, Stachlewski, P, Trzepla, E, Bogdanowicz, G, Uzunow, A, Potakowska, I, Miszczyszyn, Z, Waszyrowski, T, Smolenskaya, O, Lukyanov, Y, Vorokhobina, N, Khalimov, Y, Orlikova, O, Rebrov, A, Kukharchuk, V, Boldueva, S, Arkhipov, M, Zhelninova, T, Pavlysh, E, Antsiferov, M, Panov, A, Pavlova, M, Shustov, S, Demchenko, E, Galyavich, A, Malakhina, E, Semenova, O, Kobalava, Z, Kotova, S, Gavrisheva, I, Oschepkova, E, Karpov, Y, Sidorenko, B, Kislyak, O, Ametov, A, Dreval, A, Grineva, E, Mkrtumyan, A, Tyurina, T, Sazonova, O, Bonnici, F, Ranjith, N, Burgess, L, Nortje, H, Distiller, L, Mitha, I, Moore, R, Conradie, M, Horak, A, Pillay, S, Wellmann, H, Berg, E, Pillai, P, Padayachee, T, Corbett, C, Makan, H, Wing, J, Vawda, Z, Ebrahim, I, Mitha, E, Bhorat, A, Fernandez, J, Munoz, C, Cortada, J, Conde, A, Calvo, C, Extremera, B, Delgado, E, Masmiquel, L, Puig, J, Parreno, L, Mauricio, D, Redon, J, Brito, M, Lopez, C, de la Morera, J, Linderfalk, C, Larnefeldt, H, Olsson, A, Lonneborg, L, Ekelund, M, Samad, B, Borgencrantz, B, Nilsson, J, Berglund, O, Svensson, M, Mooe, T, Curiac, D, Albin, J, Angesjo, E, Lannemyr, O, Chen, J, Tien, K, Ueng, K, Lai, W, Yin, W, Hung, Y, Shyu, K, Hou, J, Lam, H, Laothavorn, P, Kuanprasert, S, Khovidhunkit, W, Benjasuratwong, Y, Chotinaiwattarakul, C, Mamanasiri, S, Suraamornkul, S, Pratipanawatr, T, Nitiyanant, W, Heller, S, Pieters, R, Strang, C, Bodalia, B, Middleton, A, Hall, T, Chapman, G, Calvert, J, Reed, R, Tam, D, Butcher, G, Jones, N, Takhar, A, Turner, W, Mcnally, D, Corey, O, Chapman, J, Mohr, S, Edwards, S, Ocampo, A, Kandath, D, Aude, Y, Ervin, W, Savin, V, Anderson, R, Littlefield, R, Oberoi, M, Platt, G, Yazdani, S, Mangoo-Karim, R, Walder, J, Gogia, H, Chandrashekhar, Y, Boccalandro, F, Rogers, W, Bilazarian, S, Zieve, F, Siage, Y, O'Connor, T, Mudaliar, S, Nikas, A, Giusti, R, Glover, R, Chilka, S, French, W, Roth, E, Singh, N, Christofferson, R, Stich, M, Dagogo-Jack, S, Allison, J, Zengotita, G, Ison, R, Iteld, B, Sulistio, M, Gonzalez, E, Gorman, T, Hage-Korban, E, Reddy, R, Byars, W, Antonishen, M, Benjamin, S, First, B, Rosado, J, Bruschetta, H, Poling, T, Rosendorff, C, Kerstein, H, Saba, F, Willis, J, Adams, K, Vazquez, E, Ellison, H, Kahn, B, Kereiakes, D, Powell, S, Raskin, P, Smith, K, Varma, S, Whittier, F, Casanova, R, Isserman, S, Kaye, W, Mcguinn, W, Bartkowiak, A, Dworkin, L, Labrador, C, Podlecki, D, Popovtzer, M, Aronoff, S, Ballantyne, C, Ortiz, E, Mora, A, Pitts, T, Reinhardt, S, Soucie, G, Wainwright, W, Henson, B, Sklaver, N, Arakaki, R, Brown, J, Chalavarya, G, Chochinov, R, Dixon, T, Kutner, M, Perlman, R, Raisinghani, A, Salacata, A, Awasty, V, Elinoff, V, George, W, LaRochelle-Gryseels, A, Mercado, A, Miller, G, Qureshi, M, Steljes, A, Wefald, F, Wilson, J, Chinn, J, Chuang, R, Comulada-Rivera, A, Hartman, I, Narayan, P, Pacheco, T, Weiss, R, Beavins, J, Creevy, J, Hamroff, G, Hodson, R, Kosinski, E, Krichmar, P, Patel, R, Schneider, R, Shapiro, J, Sharp, D, Speer, J, Stegemoller, R, Waxman, F, Chang, F, Braun, E, Eder, F, Minor, S, Albert, M, Carr, K, Diaczok, B, Gastman, I, Gupta, V, Longshaw, K, Gonzalez-Campoy, J, Raikhel, M, Thomas, J, Wood, K, Diab, I, Furda, J, Gelernt, M, Halter, M, House, B, Kaster, S, Raad, G, Stamatin, R, Barker, B, Blonder, R, Bloomberg, R, Calderon, R, Carrol, A, Comerota, A, Feinglos, M, Henderson, D, Kastelic, R, Stonesifer, L, Talano, J, Lee, P, Brosseau, J, Clark, W, Cohen, E, 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Pratt, S, Richwine, R, Ruiz-Rivera, L, Turner, J, Wood, J, Zigrang, W, Baquerizo, H, Colon, C, Demattia, J, Desai, V, Fitz-Patrick, D, Goral, S, Odhav, A, Prentiss, A, Ruff, C, Wu, W, Wyne, K, Abbott, L, Applegate, R, Cabral, J, Kotha, P, Ortega, P, Simmons, D, Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I, Desai N, Abrahamsen T, Grossman M, Morin S, Im K, Hoffman E, Gabovitch D, Pricken A, Buskila A, Stahre C, Price D, Billing-Clason S, Sabel K, Monyak J, Sjostrand M, Wei C, Lu J, Miller E, Raichlen J, Fitt S, Iqbal N, Donovan M, Davidson JA, Aguilar-Salinas C, Alvarsson M, Amerena J, Ardissino D, Averkov O, Avogaro A, Barnett A, Bretzel R, Chiang CE, Codoceo V, Corbalan R, Dalby A, Darius H, Deerochanawong C, Dellborg M, Eliaschewitz F, Garcia-Castillo A, Gomis R, Henry P, Hoekstra J, Jermendy G, Kastelein J, Keech A, Kiss R, Krempf M, 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Ebrahim I, Mitha E, Bhorat A, Fernandez JC, Munoz C, Cortada JB, Conde AC, Calvo C, Extremera BG, Delgado E, Masmiquel L, Puig JG, Parreno LD, Mauricio D, Redon J, Brito M, Lopez C, de la Morera JS, Linderfalk C, Larnefeldt H, Olsson A, Lonneborg L, Ekelund M, Samad B, Borgencrantz B, Nilsson J, Berglund O, Svensson M, Mooe T, Curiac D, Albin J, Angesjo E, Lannemyr O, Chiang C, Sheu W, Chen J, Tien K, Ueng K, Lai W, Yin W, Hung Y, Shyu K, Hou J, Lam H, Laothavorn P, Kuanprasert S, Khovidhunkit W, Benjasuratwong Y, Chotinaiwattarakul C, Mamanasiri S, Suraamornkul S, Pratipanawatr T, Nitiyanant W, Heller S, Ray K, Pieters R, Strang C, Bodalia B, Middleton A, Hall T, Chapman G, Calvert J, Reed R, Tam D, Butcher G, Jones N, Takhar A, Turner W, McNally D, Corey O, Chapman J, Mohr S, Edwards S, Bhatt D, Ocampo A, Kandath D, Aude Y, Ervin W, Savin V, Anderson R, Littlefield R, Oberoi M, Platt GE, Yazdani S, Mangoo-Karim R, Walder J, Gogia H, Chandrashekhar Y, Boccalandro F, Rogers W, 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Blumenthal S, Cash A, Eisner G, Gutmann J, Hagan M, Kabour A, Markus T, McKenzie W, Moursi M, Mystkowski P, Ovalle F, Perkins R, Popeil L, Saniuk R, Sierra Y, Alvarado O, Anderson J, Bajaj M, Blank R, Chu A, Levinsky L, Levy P, Osborne J, Pavon H, Sanderlin D, Schaer G, Zarich S, Atassi K, Bayron C, Casagrande M, Das D, Gimness M, Handel F, Kinstrey T, Leu S, Osei K, Nouel JS, Soltani Z, Sussman H, Chiu K, Duda R, Farnsworth K, Lano M, Lee F, Levin P, Pratt S, Richwine R, Ruiz-Rivera L, Turner J, Wood J, Zigrang WD, Baquerizo HR, Colon CB, Demattia J, Desai V, Fitz-Patrick D, Goral S, Odhav A, Prentiss A, Ruff C, Wu W, Wyne K, Abbott LG, Applegate R, Cabral J, Kotha P, Ortega P, and Simmons D

Abstract

BACKGROUND: The cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear. METHODS: We randomly assigned 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years. Physicians were permitted to adjust other medications, including antihyperglycemic agents. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. RESULTS: A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3% and 7.2%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95% confidence interval [CI], 0.89 to 1.12; P=0.99 for superiority; P<0.001 for noninferiority); the results were similar in the "on-treatment" analysis (hazard ratio, 1.03; 95% CI, 0.91 to 1.17). The major secondary end point of a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or heart failure occurred in 1059 patients in the saxagliptin group and in 1034 patients in the placebo group (12.8% and 12.4%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio, 1.02; 95% CI, 0.94 to 1.11; P=0.66). More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure (3.5% vs. 2.8%; hazard ratio, 1.27; 95% CI, 1.07 to 1.51; P=0.007). Rates of adjudicated cases of acute and chronic pancreatitis were similar in the two groups (acute pancreatitis, 0.3% in the saxagliptin group and 0.2% in the placebo group; chronic pancreatitis, <0.1% and 0.1% in the two groups, respectively). CONCLUSIONS: DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events, though the rate of hospitalization for heart failure was

Published
2013

12. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus

Author

Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I, Desai N, Abrahamsen T, Grossman M, Morin S, Im K, Hoffman E, Gabovitch D, Pricken A, Buskila A, Stahre C, Price D, Billing-Clason S, Sabel K, Monyak J, Sjostrand M, Wei C, Lu J, Miller E, Raichlen J, Fitt S, Iqbal N, Donovan M, Davidson JA, Aguilar-Salinas C, Alvarsson M, Amerena J, Ardissino D, Averkov O, Avogaro A, Barnett A, Bretzel R, Chiang CE, Codoceo V, Corbalan R, Dalby A, Darius H, Deerochanawong C, Dellborg M, Eliaschewitz F, Garcia-Castillo A, Gomis R, Henry P, Hoekstra J, Jermendy G, Kastelein J, Keech A, Kiss R, Krempf M, Laakso M, Leiter L, Leitersdorf E, Lewis B, Litwak L, Lopez-Sendon J, Ma R, McGuire D, Medina F, Moses R, Nicolau JC, Opolski G, Ophuis TO, Paolasso E, Ruda M, Kumar KMP, Shestakova M, Sheu WHH, Smahelova A, Bhupathiraju BSR, Spinar J, Sritata P, Strojeck K, Villena-Chavez JE, Jia WP, Huo Y, Lowe C, Awtry E, Berger C, Desai AS, Gelfand E, Leeman D, Link M, Ruberg F, Vita J, Rost N, Silverman S, Greenberger NJ, Lerch MM, Gersh B, Nesto R, Del Prato S, Tuomilehto J, Kelsey S, Alvarisqueta A, Cuadrado J, Rista L, Hermida S, Baccaro C, Luquez C, Lagrutta M, Maffei L, Bartolacci I, Montana O, Cutuli H, Berli M, Lorenzatti A, Frechtel G, La Greca R, Fretes O, Diaz M, Papini NR, Farias E, Issa C, Elbert A, Lehman R, Arya M, Singh B, Colquhoun D, Jayasinghe R, de Looze F, Blombery P, Ward G, Szto G, Abhayaratna W, Borges J, Russo L, Felicio J, Santos F, Guimaraes F, Castro ML, Rossi P, Armaganijan D, Leaes P, Bandeira F, Franken M, Rassi N, Rea R, Zanella M, Amodeo C, Cesar L, Betti R, Chacra A, Schmid H, Bell A, Syan G, Zadra R, Conter H, Dumas R, Borts D, Dattani I, Poirier P, Cha J, Dzongowski P, Labonte R, St Pierre B, Gaudet D, Kouz S, Lamy A, Tishler S, Chehayeb R, Bedard J, Hramiak I, Teitelbaum I, Fortin C, Woo V, Conway J, Mehta P, Robinson S, Sussex B, Chiasson J, Muirhead N, Bose S, Ouellet A, Yale J, Bhargava R, Lau D, Tobe S, Perron P, Sigalas J, Bilodeau L, Tytus R, Achyuthan G, Pearce M, Steele A, Bailey G, Ma P, St-Maurice F, Rupka D, Houlden R, Bailey A, Rewa G, Sohal P, Ting R, Prieto J, Rodriguez M, Godoy G, Larenas G, Pincetti C, Cobos L, Saavedra V, Varleta P, Lucero F, Kuzmanic O, Acevedo M, Aguirre M, Florenzano F, Ma J, Bao Y, Jiang M, Xu W, Shi Y, Zheng M, Li Y, Dong Y, Zhao W, Sun M, Lei M, Wang J, Pistek Z, Rihacek I, Kucera D, Brada M, Naplava R, Karasova J, Vlasicova H, Skopecek J, Spinarova L, Raclavska L, Sarbochova R, Okenka L, Racicka E, Urbancova K, Oznerova M, Lorenc Z, Wasserburger B, Zahumensky E, Grunfeldova H, Hradec J, Lukac M, Svacina S, Podzimek J, Hemzsky L, Mikulkova I, Pavlickova J, Brychta T, Chochola J, Couffinhal T, Elbaz M, Petit C, Faller B, Marechaud R, Moulin P, Fendri S, Nazeyrollas P, Wendisch U, Busch K, Klausmann G, Duengen H, Appel K, Toursarkissian N, Jung T, Ott P, Schenkenberger I, Kuesters D, Landers B, Nischik R, Fischer H, Tschoepe D, Paschen B, Krause K, Derwahl K, Wenzl-Bauer V, Hamann A, Strotmann H, Milek K, Mueller S, Chu D, Tan K, Kung K, Tsang C, Tomlinson B, Koranyi L, Kerenyi Z, Benczur B, Illyes L, Hidvegi T, Somogyi A, Valco J, Ferenczi S, Rapi J, Voros P, Winkler G, Sydo T, Hetey M, Simon K, Penzes J, Kempler P, Bako B, Lengyel Z, Witmann I, Dudas M, Vandorfi G, Takacs J, Matoltsy A, Ladanyi E, Gyimesi A, Sadikot S, Parikh K, Jain S, Yajnik C, Sosale A, Shamanna P, Srikanta S, Shah S, Srinivas A, Banker D, Shah P, Sharda A, Makkar B, Rais N, Mardikar H, Mishra A, Bhupati S, Menon J, Sathe S, Gupta R, Sharma V, Darawsha M, Herskovits T, Hamoud S, Nikolsky E, Adawi F, Zimlichman R, Tsalihin D, Wainstein J, Klainman E, Mosseri M, Yerushalmi Y, Karnieli E, Knobler H, Benchetrit S, Tsur A, Yagil Y, Atar S, Beberashvili I, Fuchs S, Stern N, Pollak A, Chajek-Shaul T, Rozenman Y, Biton A, Bramucci E, Fiscella A, Grassia V, Piatti P, De Cosmo S, Di Lorenzo L, Merlini P, Mannucci E, Frontoni S, Trevisan R, Zenari L, Lambiase C, Salvioni A, Silvestri O, Ambrosio G, Di Bartolo P, Fattore L, Presbitero P, Calabrese M, Evola R, Gamba MA, Ibarra MOD, Munoz EC, Sanchez DR, Herrera CH, Rios JP, Llamas EB, Esperon GL, Cantu EG, Fragoso JN, Gonzalez JG, Martinez GR, Padilla FP, Mier GM, Marmolejo DH, Ruiz JG, Portilla NC, Rosas EL, Machado GM, Ramos JC, Briones IR, van Hessen MWJ, Strikwerda S, The SHK, Kooy A, Ronner E, Nierop PR, Remmen JJ, Groenemeijer BE, Hamer BJB, Basart DCG, van Lennep HWOR, Nieuwdorp M, van Dijk MPM, Kentgens S, van Kempen WW, Hoogendijk J, Spiering W, Voors-Pette C, Kose V, de Waard DEP, Gonkel F, Kaasjager HAH, Lingan GMR, Agous I, Kruik HJ, Imholz BPM, Pieterse M, Manrique H, Villena J, Leon L, Kundert K, Minchola J, Pinto M, Heredia J, Rodriguez A, Guerreros C, Berrospi P, Zubiate C, Allemant A, Arbanil H, Ponciano W, Calderon J, Lisson R, Segura L, Sidorowicz-Bialynicka A, Sciborski R, Fares I, Mader P, Skierkowska J, Stasinska T, Pomiecko W, Skorski M, Krzyzagorska E, Polaszewska-Muszynska M, Sowinski D, Strojek K, Rosinska-Migda J, Romanczuk P, Golebiowski G, Kubica J, Mazurek T, Wojnowski L, Pasternak D, Stachlewski P, Trzepla E, Bogdanowicz G, Uzunow A, Potakowska I, Miszczyszyn Z, Waszyrowski T, Smolenskaya O, Lukyanov Y, Vorokhobina N, Khalimov Y, Orlikova O, Rebrov A, Kukharchuk V, Boldueva S, Arkhipov M, Zhelninova T, Pavlysh E, Antsiferov M, Panov A, Pavlova M, Shustov S, Demchenko E, Galyavich A, Malakhina E, Semenova O, Kobalava Z, Kotova S, Gavrisheva I, Oschepkova E, Karpov Y, Sidorenko B, Kislyak O, Ametov A, Dreval A, Grineva E, Mkrtumyan A, Tyurina T, Sazonova O, Bonnici F, Ranjith N, Burgess L, Nortje H, Distiller L, Mitha I, Moore R, Conradie M, Horak A, Pillay S, Wellmann H, Berg E, Pillai P, Padayachee T, Corbett C, Makan H, Wing J, Vawda Z, Ebrahim I, Mitha E, Bhorat A, Fernandez JC, Munoz C, Cortada JB, Conde AC, Calvo C, Extremera BG, Delgado E, Masmiquel L, Puig JG, Parreno LD, Mauricio D, Redon J, Brito M, Lopez C, de la Morera JS, Linderfalk C, Larnefeldt H, Olsson A, Lonneborg L, Ekelund M, Samad B, Borgencrantz B, Nilsson J, Berglund O, Svensson M, Mooe T, Curiac D, Albin J, Angesjo E, Lannemyr O, Chiang C, Sheu W, Chen J, Tien K, Ueng K, Lai W, Yin W, Hung Y, Shyu K, Hou J, Lam H, Laothavorn P, Kuanprasert S, Khovidhunkit W, Benjasuratwong Y, Chotinaiwattarakul C, Mamanasiri S, Suraamornkul S, Pratipanawatr T, Nitiyanant W, Heller S, Ray K, Pieters R, Strang C, Bodalia B, Middleton A, Hall T, Chapman G, Calvert J, Reed R, Tam D, Butcher G, Jones N, Takhar A, Turner W, McNally D, Corey O, Chapman J, Mohr S, Edwards S, Bhatt D, Ocampo A, Kandath D, Aude Y, Ervin W, Savin V, Anderson R, Littlefield R, Oberoi M, Platt GE, Yazdani S, Mangoo-Karim R, Walder J, Gogia H, Chandrashekhar Y, Boccalandro F, Rogers W, Bilazarian S, Zieve F, Siage Y, O'Connor T, Mudaliar S, Nikas A, Giusti R, Glover R, Chilka S, French W, Roth E, Singh N, Christofferson R, Stich M, Dagogo-Jack S, Allison J, Zengotita GA, Ison R, Iteld B, Sulistio M, Gonzalez E, Gorman T, Hage-Korban E, Reddy R, Byars W, Antonishen M, Benjamin S, First B, Rosado J, Bruschetta H, Poling T, Rosendorff C, Kerstein HJ, Saba F, Willis J, Adams K, Vazquez EC, Ellison H, Kahn B, Kereiakes D, Powell S, Raskin P, Smith K, Varma S, Whittier F, Casanova R, Isserman S, Kaye W, McGuinn W, Bartkowiak A, Dworkin L, Labrador CA, Podlecki D, Popovtzer M, Aronoff S, Ballantyne C, Ortiz EG, Mora A, Pitts T, Reinhardt S, Soucie G, Wainwright W, Henson B, Sklaver N, Arakaki R, Brown J, Chalavarya G, Chochinov R, Dixon T, Kutner M, Perlman R, Raisinghani A, Salacata A, Awasty V, Elinoff V, George W, LaRochelle-Gryseels A, Mercado A, Miller G, Qureshi M, Steljes A, Wefald F, Wilson J, Chinn J, Chuang RB, Comulada-Rivera A, Hartman I, Narayan P, Pacheco T, Weiss R, Beavins J, Creevy J, Hamroff G, Hodson R, Kosinski E, Krichmar P, Patel R, Schneider R, Shapiro J, Sharp D, Speer J, Stegemoller R, Waxman F, Chang FY, Braun E, Eder F, Minor S, Albert M, Carr KW, Diaczok B, Gastman I, Gupta V, Longshaw K, Gonzalez-Campoy JM, Raikhel M, Thomas J, Wood K, Diab I, Furda J, Gelernt M, Halter M, House B, Kaster S, Raad G, Stamatin R, Barker B, Blonder R, Bloomberg RJ, Calderon RB, Carrol A, Comerota A, Feinglos M, Henderson D, Kastelic R, Stonesifer LD, Talano J, Lee PV, Brosseau J, Clark W, Cohen E, Fialkow J, Horton K, Kozman H, McGill J, Mihills C, Poonawala R, Shore K, Tejada L, Torres R, Wright W, Calatayud G, Chandna H, Drozdiak R, Fink R, Gill R, Glandt M, Gottlieb DW, Hack T, Kay J, Mansouri V, McKnight T, Mostel E, Schmidt L, Seide H, Sonel E, Taylor R, Velasquez M, Bretton E, Feldman R, Hartman A, Hershon K, Leach CR, Martin E, Mohiuddin F, Naygandhi Y, Riske T, Schima S, Uzoaga ER, Ward H, Weinstock R, Williams T, Altschuller A, Aoki T, Blumenthal S, Cash A, Eisner G, Gutmann J, Hagan M, Kabour A, Markus T, McKenzie W, Moursi M, Mystkowski P, Ovalle F, Perkins R, Popeil L, Saniuk R, Sierra Y, Alvarado O, Anderson J, Bajaj M, Blank R, Chu A, Levinsky L, Levy P, Osborne J, Pavon H, Sanderlin D, Schaer G, Zarich S, Atassi K, Bayron C, Casagrande M, Das D, Gimness M, Handel F, Kinstrey T, Leu S, Osei K, Nouel JS, Soltani Z, Sussman H, Chiu K, Duda R, Farnsworth K, Lano M, Lee F, Levin P, Pratt S, Richwine R, Ruiz-Rivera L, Turner J, Wood J, Zigrang WD, Baquerizo HR, Colon CB, Demattia J, Desai V, Fitz-Patrick D, Goral S, Odhav A, Prentiss A, Ruff C, Wu W, Wyne K, Abbott LG, Applegate R, Cabral J, Kotha P, Ortega P, Simmons D, General Internal Medicine, Vascular Medicine, Other departments, Scirica, B, Bhatt, D, Braunwald, E, Steg, P, Davidson, J, Hirshberg, B, Ohman, P, Frederich, R, Wiviott, S, Hoffman, E, Cavender, M, Udell, J, Desai, N, Mosenzon, O, Mcguire, D, Ray, K, Leiter, L, Raz, I, Abrahamsen, T, Grossman, M, Morin, S, Im, K, Gabovitch, D, Pricken, A, Buskila, A, Stahre, C, Price, D, Billing-Clason, S, Sabel, K, Monyak, J, Sjostrand, M, Wei, C, Lu, J, Miller, E, Raichlen, J, Fitt, S, Iqbal, N, Donovan, M, Aguilar-Salinas, C, Alvarsson, M, Amerena, J, Ardissino, D, Averkov, O, Avogaro, A, Barnett, A, Bretzel, R, Chiang, C, Codoceo, V, Corbalan, R, Dalby, A, Darius, H, Deerochanawong, C, Dellborg, M, Eliaschewitz, F, Garcia-Castillo, A, Gomis, R, Henry, P, Hoekstra, J, Jermendy, G, Kastelein, J, Keech, A, Kiss, R, Krempf, M, Laakso, M, Leitersdorf, E, Lewis, B, Litwak, L, Lopez-Sendon, J, Ma, R, Medina, F, Moses, R, Nicolau, J, Opolski, G, Ophuis, T, Paolasso, E, Ruda, M, Kumar, K, Shestakova, M, Sheu, W, Smahelova, A, Bhupathiraju, B, Spinar, J, Sritata, P, Strojeck, K, Villena-Chavez, J, Jia, W, Huo, Y, Lowe, C, Awtry, E, Berger, C, Desai, A, Gelfand, E, Leeman, D, Link, M, Ruberg, F, Vita, J, Rost, N, Silverman, S, Greenberger, N, Lerch, M, Gersh, B, Nesto, R, Del Prato, S, Tuomilehto, J, Kelsey, S, Alvarisqueta, A, Cuadrado, J, Rista, L, Hermida, S, Baccaro, C, Luquez, C, Lagrutta, M, Maffei, L, Bartolacci, I, Montana, O, Cutuli, H, Berli, M, Lorenzatti, A, Frechtel, G, La Greca, R, Fretes, O, Diaz, M, Papini, N, Farias, E, Issa, C, Elbert, A, Lehman, R, Arya, M, Singh, B, Colquhoun, D, Jayasinghe, R, de Looze, F, Blombery, P, Ward, G, Szto, G, Abhayaratna, W, Borges, J, Russo, L, Felicio, J, Santos, F, Guimaraes, F, Castro, M, Rossi, P, Armaganijan, D, Leaes, P, Bandeira, F, Franken, M, Rassi, N, Rea, R, Zanella, M, Amodeo, C, Cesar, L, Betti, R, Chacra, A, Schmid, H, Bell, A, Syan, G, Zadra, R, Conter, H, Dumas, R, Borts, D, Dattani, I, Poirier, P, Cha, J, Dzongowski, P, Labonte, R, St Pierre, B, Gaudet, D, Kouz, S, Lamy, A, Tishler, S, Chehayeb, R, Bedard, J, Hramiak, I, Teitelbaum, I, Fortin, C, Woo, V, Conway, J, Mehta, P, Robinson, S, Sussex, B, Chiasson, J, Muirhead, N, Bose, S, Ouellet, A, Yale, J, Bhargava, R, Lau, D, Tobe, S, Perron, P, Sigalas, J, Bilodeau, L, Tytus, R, Achyuthan, G, Pearce, M, Steele, A, Bailey, G, Ma, P, St-Maurice, F, Rupka, D, Houlden, R, Bailey, A, Rewa, G, Sohal, P, Ting, R, Prieto, J, Rodriguez, M, Godoy, G, Larenas, G, Pincetti, C, Cobos, L, Saavedra, V, Varleta, P, Lucero, F, Kuzmanic, O, Acevedo, M, Aguirre, M, Florenzano, F, Ma, J, Bao, Y, Jiang, M, Xu, W, Shi, Y, Zheng, M, Li, Y, Dong, Y, Zhao, W, Sun, M, Lei, M, Wang, J, Pistek, Z, Rihacek, I, Kucera, D, Brada, M, Naplava, R, Karasova, J, Vlasicova, H, Skopecek, J, Spinarova, L, Raclavska, L, Sarbochova, R, Okenka, L, Racicka, E, Urbancova, K, Oznerova, M, Lorenc, Z, Wasserburger, B, Zahumensky, E, Grunfeldova, H, Hradec, J, Lukac, M, Svacina, S, Podzimek, J, Hemzsky, L, Mikulkova, I, Pavlickova, J, Brychta, T, Chochola, J, Couffinhal, T, Elbaz, M, Petit, C, Faller, B, Marechaud, R, Moulin, P, Fendri, S, Nazeyrollas, P, Wendisch, U, Busch, K, Klausmann, G, Duengen, H, Appel, K, Toursarkissian, N, Jung, T, Ott, P, Schenkenberger, I, Kuesters, D, Landers, B, Nischik, R, Fischer, H, Tschoepe, D, Paschen, B, Krause, K, Derwahl, K, Wenzl-Bauer, V, Hamann, A, Strotmann, H, Milek, K, Mueller, S, Chu, D, Tan, K, Kung, K, Tsang, C, Tomlinson, B, Koranyi, L, Kerenyi, Z, Benczur, B, Illyes, L, Hidvegi, T, Somogyi, A, Valco, J, Ferenczi, S, Rapi, J, Voros, P, Winkler, G, Sydo, T, Hetey, M, Simon, K, Penzes, J, Kempler, P, Bako, B, Lengyel, Z, Witmann, I, Dudas, M, Vandorfi, G, Takacs, J, Matoltsy, A, Ladanyi, E, Gyimesi, A, Sadikot, S, Parikh, K, Jain, S, Yajnik, C, Sosale, A, Shamanna, P, Srikanta, S, Shah, S, Srinivas, A, Banker, D, Shah, P, Sharda, A, Makkar, B, Rais, N, Mardikar, H, Mishra, A, Bhupati, S, Menon, J, Sathe, S, Gupta, R, Sharma, V, Darawsha, M, Herskovits, T, Hamoud, S, Nikolsky, E, Adawi, F, Zimlichman, R, Tsalihin, D, Wainstein, J, Klainman, E, Mosseri, M, Yerushalmi, Y, Karnieli, E, Knobler, H, Benchetrit, S, Tsur, A, Yagil, Y, Atar, S, Beberashvili, I, Fuchs, S, Stern, N, Pollak, A, Chajek-Shaul, T, Rozenman, Y, Biton, A, Bramucci, E, Fiscella, A, Grassia, V, Piatti, P, De Cosmo, S, Di Lorenzo, L, Merlini, P, Mannucci, E, Frontoni, S, Trevisan, R, Zenari, L, Lambiase, C, Salvioni, A, Silvestri, O, Ambrosio, G, Di Bartolo, P, Fattore, L, Presbitero, P, Calabrese, M, Evola, R, Gamba, M, Ibarra, M, Munoz, E, Sanchez, D, Herrera, C, Rios, J, Llamas, E, Esperon, G, Cantu, E, Fragoso, J, Gonzalez, J, Martinez, G, Padilla, F, Mier, G, Marmolejo, D, Ruiz, J, Portilla, N, Rosas, E, Machado, G, Ramos, J, Briones, I, van Hessen, M, Strikwerda, S, The, S, Kooy, A, Ronner, E, Nierop, P, Remmen, J, Groenemeijer, B, Hamer, B, Basart, D, van Lennep, H, Nieuwdorp, M, van Dijk, M, Kentgens, S, van Kempen, W, Hoogendijk, J, Spiering, W, Voors-Pette, C, Kose, V, de Waard, D, Gonkel, F, Kaasjager, H, Lingan, G, Agous, I, Kruik, H, Imholz, B, Pieterse, M, Manrique, H, Villena, J, Leon, L, Kundert, K, Minchola, J, Pinto, M, Heredia, J, Rodriguez, A, Guerreros, C, Berrospi, P, Zubiate, C, Allemant, A, Arbanil, H, Ponciano, W, Calderon, J, Lisson, R, Segura, L, Sidorowicz-Bialynicka, A, Sciborski, R, Fares, I, Mader, P, Skierkowska, J, Stasinska, T, Pomiecko, W, Skorski, M, Krzyzagorska, E, Polaszewska-Muszynska, M, Sowinski, D, Strojek, K, Rosinska-Migda, J, Romanczuk, P, Golebiowski, G, Kubica, J, Mazurek, T, Wojnowski, L, Pasternak, D, Stachlewski, P, Trzepla, E, Bogdanowicz, G, Uzunow, A, Potakowska, I, Miszczyszyn, Z, Waszyrowski, T, Smolenskaya, O, Lukyanov, Y, Vorokhobina, N, Khalimov, Y, Orlikova, O, Rebrov, A, Kukharchuk, V, Boldueva, S, Arkhipov, M, Zhelninova, T, Pavlysh, E, Antsiferov, M, Panov, A, Pavlova, M, Shustov, S, Demchenko, E, Galyavich, A, Malakhina, E, Semenova, O, Kobalava, Z, Kotova, S, Gavrisheva, I, Oschepkova, E, Karpov, Y, Sidorenko, B, Kislyak, O, Ametov, A, Dreval, A, Grineva, E, Mkrtumyan, A, Tyurina, T, Sazonova, O, Bonnici, F, Ranjith, N, Burgess, L, Nortje, H, Distiller, L, Mitha, I, Moore, R, Conradie, M, Horak, A, Pillay, S, Wellmann, H, Berg, E, Pillai, P, Padayachee, T, Corbett, C, Makan, H, Wing, J, Vawda, Z, Ebrahim, I, Mitha, E, Bhorat, A, Fernandez, J, Munoz, C, Cortada, J, Conde, A, Calvo, C, Extremera, B, Delgado, E, Masmiquel, L, Puig, J, Parreno, L, Mauricio, D, Redon, J, Brito, M, Lopez, C, de la Morera, J, Linderfalk, C, Larnefeldt, H, Olsson, A, Lonneborg, L, Ekelund, M, Samad, B, Borgencrantz, B, Nilsson, J, Berglund, O, Svensson, M, Mooe, T, Curiac, D, Albin, J, Angesjo, E, Lannemyr, O, Chen, J, Tien, K, Ueng, K, Lai, W, Yin, W, Hung, Y, Shyu, K, Hou, J, Lam, H, Laothavorn, P, Kuanprasert, S, Khovidhunkit, W, Benjasuratwong, Y, Chotinaiwattarakul, C, Mamanasiri, S, Suraamornkul, S, Pratipanawatr, T, Nitiyanant, W, Heller, S, Pieters, R, Strang, C, Bodalia, B, Middleton, A, Hall, T, Chapman, G, Calvert, J, Reed, R, Tam, D, Butcher, G, Jones, N, Takhar, A, Turner, W, Mcnally, D, Corey, O, Chapman, J, Mohr, S, Edwards, S, Ocampo, A, Kandath, D, Aude, Y, Ervin, W, Savin, V, Anderson, R, Littlefield, R, Oberoi, M, Platt, G, Yazdani, S, Mangoo-Karim, R, Walder, J, Gogia, H, Chandrashekhar, Y, Boccalandro, F, Rogers, W, Bilazarian, S, Zieve, F, Siage, Y, O'Connor, T, Mudaliar, S, Nikas, A, Giusti, R, Glover, R, Chilka, S, French, W, Roth, E, Singh, N, Christofferson, R, Stich, M, Dagogo-Jack, S, Allison, J, Zengotita, G, Ison, R, Iteld, B, Sulistio, M, Gonzalez, E, Gorman, T, Hage-Korban, E, Reddy, R, Byars, W, Antonishen, M, Benjamin, S, First, B, Rosado, J, Bruschetta, H, Poling, T, Rosendorff, C, Kerstein, H, Saba, F, Willis, J, Adams, K, Vazquez, E, Ellison, H, Kahn, B, Kereiakes, D, Powell, S, Raskin, P, Smith, K, Varma, S, Whittier, F, Casanova, R, Isserman, S, Kaye, W, Mcguinn, W, Bartkowiak, A, Dworkin, L, Labrador, C, Podlecki, D, Popovtzer, M, Aronoff, S, Ballantyne, C, Ortiz, E, Mora, A, Pitts, T, Reinhardt, S, Soucie, G, Wainwright, W, Henson, B, Sklaver, N, Arakaki, R, Brown, J, Chalavarya, G, Chochinov, R, Dixon, T, Kutner, M, Perlman, R, Raisinghani, A, Salacata, A, Awasty, V, Elinoff, V, George, W, LaRochelle-Gryseels, A, Mercado, A, Miller, G, Qureshi, M, Steljes, A, Wefald, F, Wilson, J, Chinn, J, Chuang, R, Comulada-Rivera, A, Hartman, I, Narayan, P, Pacheco, T, Weiss, R, Beavins, J, Creevy, J, Hamroff, G, Hodson, R, Kosinski, E, Krichmar, P, Patel, R, Schneider, R, Shapiro, J, Sharp, D, Speer, J, Stegemoller, R, Waxman, F, Chang, F, Braun, E, Eder, F, Minor, S, Albert, M, Carr, K, Diaczok, B, Gastman, I, Gupta, V, Longshaw, K, Gonzalez-Campoy, J, Raikhel, M, Thomas, J, Wood, K, Diab, I, Furda, J, Gelernt, M, Halter, M, House, B, Kaster, S, Raad, G, Stamatin, R, Barker, B, Blonder, R, Bloomberg, R, Calderon, R, Carrol, A, Comerota, A, Feinglos, M, Henderson, D, Kastelic, R, Stonesifer, L, Talano, J, Lee, P, Brosseau, J, Clark, W, Cohen, E, Fialkow, J, Horton, K, Kozman, H, Mcgill, J, Mihills, C, Poonawala, R, Shore, K, Tejada, L, Torres, R, Wright, W, Calatayud, G, Chandna, H, Drozdiak, R, Fink, R, Gill, R, Glandt, M, Gottlieb, D, Hack, T, Kay, J, Mansouri, V, Mcknight, T, Mostel, E, Schmidt, L, Seide, H, Sonel, E, Taylor, R, Velasquez, M, Bretton, E, Feldman, R, Hartman, A, Hershon, K, Leach, C, Martin, E, Mohiuddin, F, Naygandhi, Y, Riske, T, Schima, S, Uzoaga, E, Ward, H, Weinstock, R, Williams, T, Altschuller, A, Aoki, T, Blumenthal, S, Cash, A, Eisner, G, Gutmann, J, Hagan, M, Kabour, A, Markus, T, Mckenzie, W, Moursi, M, Mystkowski, P, Ovalle, F, Perkins, R, Popeil, L, Saniuk, R, Sierra, Y, Alvarado, O, Anderson, J, Bajaj, M, Blank, R, Chu, A, Levinsky, L, Levy, P, Osborne, J, Pavon, H, Sanderlin, D, Schaer, G, Zarich, S, Atassi, K, Bayron, C, Casagrande, M, Das, D, Gimness, M, Handel, F, Kinstrey, T, Leu, S, Osei, K, Nouel, J, Soltani, Z, Sussman, H, Chiu, K, Duda, R, Farnsworth, K, Lano, M, Lee, F, Levin, P, Pratt, S, Richwine, R, Ruiz-Rivera, L, Turner, J, Wood, J, Zigrang, W, Baquerizo, H, Colon, C, Demattia, J, Desai, V, Fitz-Patrick, D, Goral, S, Odhav, A, Prentiss, A, Ruff, C, Wu, W, Wyne, K, Abbott, L, Applegate, R, Cabral, J, Kotha, P, Ortega, P, and Simmons, D

Subjects
Male, Adamantane, Dipeptidyl peptidase-4 inhibitor, Type 2 diabetes, Kaplan-Meier Estimate, Saxagliptin, chemistry.chemical_compound, 80 and over, glucose, saxagliptin, Aged, 80 and over, Medicine (all), Hazard ratio, 11 Medical And Health Sciences, General Medicine, Dipeptides, Middle Aged, Hospitalization, Cardiovascular Diseases, Female, Aged, Diabetes Mellitus, Type 2, Dipeptidyl-Peptidase IV Inhibitors, Double-Blind Method, Heart Failure, Humans, Hypoglycemia, Hypoglycemic Agents, Pancreatitis, Alogliptin, Type 2, medicine.drug, insulin, medicine.medical_specialty, General & Internal Medicine, Internal medicine, Diabetes mellitus, medicine, Empagliflozin, Diabetes Mellitus, Intensive care medicine, glycosylated hemoglobin, business.industry, Semaglutide, SAVOR-TIMI 53 Steering Committee and Investigators, medicine.disease, chemistry, placebo, business
Abstract

BACKGROUND: The cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear. METHODS: We randomly assigned 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years. Physicians were permitted to adjust other medications, including antihyperglycemic agents. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke. RESULTS: A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3% and 7.2%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95% confidence interval [CI], 0.89 to 1.12; P=0.99 for superiority; P

Published
2013

18. Cardiac Surgery Increases Serum Concentrations of Adipocyte Fatty Acid-Binding Protein and Its mRNA Expression in Circulating Monocytes but Not in Adipose Tissue

Author

KOTULAK, T., primary, DRAPALOVA, J., additional, LIPS, M., additional, LACINOVA, Z., additional, KRAMAR, P., additional, RIHA, H., additional, NETUKA, I., additional, MALY, J., additional, BLAHA, J., additional, LINDNER, J., additional, SVACINA, S., additional, MRAZ, M., additional, and HALUZIK, M., additional

Published
2014
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30. Metabolic Surgery for the Treatment of Type 2 Diabetes in Patients with BMI <35 kg/m2: An Integrative Review of Early Studies.

Author

Fried, M., Ribaric, G., Buchwald, J. N., Svacina, S., Dolezalova, K., and Scopinaro, N.

Subjects
DIABETES, BARIATRIC surgery, TYPE 2 diabetes, GASTRIC bypass, LAPAROSCOPIC surgery, GASTRIC banding, GASTRECTOMY
Abstract

Type 2 diabetes mellitus (T2DM) resolution in morbidly obese patients following metabolic surgery suggests the efficacy of T2DM surgery in non-morbidly obese patients (body mass index [BMI] <35 kg/m2). This literature review examined research articles in English over the last 30 years (1979–2009) that addressed surgical resolution of T2DM in patients with a mean BMI <35. Weighted and simple means (95% CI) were calculated to analyze study outcomes. Sixteen studies met inclusion criteria; 343 patients underwent one of eight procedures with 6–216 months follow-up. Patients lost a clinically meaningful, not excessive, amount of weight (from BMI 29.4 to 24.2; −5.1), moving from the overweight into the normal weight category. There were 85.3% patients who were off T2DM medications with fasting plasma glucose approaching normal (105.2 mg/dL, −93.3), and normal glycated hemoglobin, 6% (−2.7). In subgroup comparison, BMI reduction and T2DM resolution were greatest following malabsorptive/restrictive procedures, and in the preoperatively mildly obese (30.0–35.0) vs overweight (25.0–25.9) BMI ranges. Complications were few with low operative mortality (0.29%). Novel and/or known mechanisms of T2DM resolution may be engaged by surgery at a BMI threshold ≤30. The majority of low-BMI patients experienced resolution of laboratory and clinical manifestations of T2DM without inappropriate weight loss. [ABSTRACT FROM AUTHOR]

Published
2010
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32. Serum Adipocyte Fatty Acid Binding Protein Levels in Patients with Type 2 Diabetes Mellitus and Obesity: the Influence of Fenofibrate Treatment.

Author

HALUZÍK, M. M., ANDERLOVÁ, K., DOLEZALOVÁ, R., ADAMÍKOVÁ, A., HALUZÍKOVÁ, D., HOUSOVÁ, J., SVACINA, S., and HALUZÍK, M.

Subjects
SERUM, BLOOD plasma, FAT cells, FATTY acids, CARRIER proteins, DIABETES, OBESITY
Abstract

Recent studies have demonstrated that adipocyte fatty acid binding proteins (FABP) may play a role in the etiopathogenesis of insulin resistance. The aim of our study was to assess serum FABP levels in obese patients with type 2 diabetes mellitus (T2DM) before and after 3 months of treatment with PPAR-α agonist fenofibrate (F) and to explore the relationship of FABP to biochemical parameters and measures of insulin sensitivity assessed by hyperinsulinemic-isoglycemic clamp. We measured biochemical parameters by standard laboratory methods, insulin sensitivity by hyperinsulinemic-isoglycemic clamp and serum concentrations of FABP by commercial ELISA kit in 11 obese females with T2DM before and after three months of treatment with PPAR-α agonist fenofibrate and in 10 lean healthy control women (C). Serum FABP levels were 2.5-fold higher in T2DM group relative to C and were not affected by fenofibrate treatment (C: 20.6±2.1 μg/l, T2DM before F: 55.6±5.7 μg/l, T2DM after F: 54.2±5.4 μg/l, p<0.0001 for C vs. T2DM before F). Hyperinsulinemia during the clamp significantly suppressed FABP levels in both C and T2DM group. FABP levels positively correlated with BMI, triglyceride levels, blood glucose, glycated hemoglobin, atherogenic index and insulin levels. An inverse relationship was found between FABP and HDL levels, metabolic clearance rate of glucose, M/I and MCRglc/I sensitivity indexes. We conclude that FABP levels are closely related to BMI, parameters of insulin sensitivity, HDL levels and measures of diabetes compensation. This combination makes FABP a valuable marker of metabolic disturbances in patients with type 2 diabetes mellitus. [ABSTRACT FROM AUTHOR]

Published
2009
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33. Multicentric, randomized, controlled trial to evaluate blood glucose control by the model predictive control algorithm versus routine glucose management protocols in intensive care unit patients.

Author

Plank J, Blaha J, Cordingley J, Wilinska ME, Chassin LJ, Morgan C, Squire S, Haluzik M, Kremen J, Svacina S, Toller W, Plasnik A, Ellmerer M, Hovorka R, Pieber TR, Plank, Johannes, Blaha, Jan, Cordingley, Jeremy, Wilinska, Malgorzata E, and Chassin, Ludovic J

Abstract

Objective: To evaluate a fully automated algorithm for the establishment of tight glycemic control in critically ill patients and to compare the results with different routine glucose management protocols of three intensive care units (ICUs) across Europe (Graz, Prague, and London).Research Design and Methods: Sixty patients undergoing cardiac surgery (age 67 +/- 9 years, BMI 27.7 +/- 4.9 kg/m2, 17 women) with postsurgery blood glucose levels >120 mg/dl (6.7 mmol/l) were investigated in three different ICUs (20 per center). Patients were randomized to either blood glucose management (target range 80-110 mg/dl [4.4-6.1 mmol/l]) by the fully automated model predictive control (MPC) algorithm (n = 30, 10 per center) or implemented routine glucose management protocols (n = 30, 10 per center). In all patients, arterial glucose was measured hourly to describe the glucose profile until the end of the ICU stay but for a maximum period of 48 h.Results: Compared with routine protocols, MPC treatment resulted in a significantly higher percentage of time within the target glycemic range (% median [min-max]: 52 [17-92] vs. 19 [0-71]) over 0-24 h (P < 0.01). Improved glycemic control with MPC treatment was confirmed in patients remaining in the ICU for 48 h (0-24 h: 50 [17-71] vs. 21 [4-67], P < 0.05, and 24-48 h: 65 [38-96] vs. 25 [8-79], P < 0.05, for MPC [n = 16] vs. routine protocol [n = 13], respectively). Two hypoglycemic events (<54 mg/dl [3.0 mmol/l]) were observed with routine protocol treatment. No hypoglycemic event occurred with MPC.Conclusions: The data suggest that the MPC algorithm is safe and effective in controlling glycemia in critically ill postsurgery patients. [ABSTRACT FROM AUTHOR]

Published
2006
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35. Dexfenfluramine in psychotic patients.

Author

Svacina S, Sonka J, and Marek J

Abstract

Dexfenfluramine (DF) is contraindicated in severe psychiatric disorders and in depression. We used DF in 3 patients with chronic psychosis and severe overeating without changes in psychiatric pharmacotherapy. Two patients had paranoid schizophrenic psychosis with hallucinations, one patient mixed psychosis, beginning with lactation psychosis, and several attacks of hallucinations and depression later. Overeating was removed in all 3 patients without any negative effect on the psychotic state. All patients were able to maintain their body weight. Two patients with poorly controlled diabetes improved markedly their metabolic status. Doses up to 75 mg per day of DF were necessary during binge eating episodes in one patient. We conclude that DF can be used with care under close psychiatric supervision in psychotic patients with severe overeating. [ABSTRACT FROM AUTHOR]

Published
1998
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