Data di Pubblicazione:
2021
Abstract:
BACKGROUND Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure or death from cardiovascular causes among patients with stable heart failure. However, the safety and efficacy of SGLT2 inhibitors when initiated soon after an episode of decompensated heart failure are unknown. METHODS We performed a multicenter, double-blind trial in which patients with type 2 diabetes mellitus who were recently hospitalized for worsening heart failure were randomly assigned to receive sotagliflozin or placebo. The primary end point was the total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure (first and subsequent events). The trial ended early because of loss of funding from the sponsor. RESULTS A total of 1222 patients underwent randomization (608 to the sotagliflozin group and 614 to the placebo group) and were followed for a median of 9.0 months; the first dose of sotagliflozin or placebo was administered before discharge in 48.8% and a median of 2 days after discharge in 51.2%. Among these patients, 600 primary end-point events occurred (245 in the sotagliflozin group and 355 in the placebo group). The rate (the number of events per 100 patient-years) of primary end-point events was lower in the sotagliflozin group than in the placebo group (51.0 vs. 76.3; hazard ratio, 0.67; 95% confidence interval [CI], 0.52 to 0.85; P<0.001). The rate of death from cardiovascular causes was 10.6 in the sotagliflozin group and 12.5 in the placebo group (hazard ratio, 0.84; 95% CI, 0.58 to 1.22); the rate of death from any cause was 13.5 in the sotagliflozin group and 16.3 in the placebo group (hazard ratio, 0.82; 95% CI, 0.59 to 1.14). Diarrhea was more common with sotagliflozin than with placebo (6.1% vs. 3.4%), as was severe hypoglycemia (1.5% vs. 0.3%). The percentage of patients with hypotension was similar in the sotagliflozin group and the placebo group (6.0% and 4.6%, respectively), as was the percentage with acute kidney injury (4.1% and 4.4%, respectively). The benefits of sotagliflozin were consistent in the prespecified subgroups of patients stratified according to the timing of the first dose. CONCLUSIONS In patients with diabetes and recent worsening heart failure, sotagliflozin therapy, initiated before or shortly after discharge, resulted in a significantly lower total number of deaths from cardiovascular causes and hospitalizations and urgent visits for heart failure than placebo. (Funded by Sanofi and Lexicon Pharmaceuticals; SOLOIST-WHF ClinicalTrials.gov number, NCT03521934.).
Tipologia CRIS:
1.1 Articolo in rivista
Keywords:
Acute Kidney Injury; Aged; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Double-Blind Method; Female; Glycosides; Heart Failure; Hospitalization; Humans; Hypotension; Male; Middle Aged; Sodium-Glucose Transporter 1; Sodium-Glucose Transporter 2 Inhibitors
Elenco autori:
D. L., Bhatt; M., Szarek; P., Gabriel Steg; C. P., Cannon; L. A., Leiter; D. K., Mcguire; J. B., Lewis; M. C., Riddle; A. A., Voors; M., Metra; L. H., Lund; M., Komajda; J. M., Testani; C. S., Wilcox; P., Ponikowski; R. D., Lopes; S., Verma; P., Lapuerta; SOLOIST-WHF Trial Investigators: Deepak L Bhatt, Pitt B.; P Cannon, Christopher; A Leiter, Lawrence; B Lewis, Julia; K McGuire, Darren; Pitt, Bertram; C Riddle, Matthew; Steg, Gabriel; C Gerstein, Hertzel; S Francis, Gary; E Gerich, John; E Mann, Johannes F; Joe Shih, Weichung; B Young, James; Komajda, Michel; H Lund, Lars; Metra, Marco; Ponikowski, Piotr; M Testani, Jeffrey; Voors, Adriaan; Wilcox, Christopher; D Lopes, Renato; B Green, Jennifer; P Alexander, Karen; C Batch, Bryan; Schuyler Jones, W; Dedrick Jordan, J; J Kolls, Bradley; F Kong, David; C Lakey, Wanda; H Lee, Richard; Mathews, Robin; W McGarrah, Robert; H Mehta, Rajendra; Melloni, Chiara; P Middleton, John; J Povsic, Thomas; H Pun, Patrick; J Scialla, Julia; Shah, Shreyansh; A Sposato, Luciano; J Weber, Thomas; Norris, Casey; Marcus, Jill; Hayden, Nikieia; Stournaras, Dimitrios; Sophie Wang, Z; Brown, Linley; Larrey, Dominique; Lewis, James; Beckman, Joshua; Bonaca, Marc; Leeper, Nicholas; Banks, Phillip; Tesfaye, Eshetu; Kassler-Taub, Kenneth; Warner, Chris; O'Neill, Mark; Molinari Covance, Rosemary; Mentz, Robert; Peacock, Frank; Greenberg, Barry; States, United; Verma, Subodh; Ezekowitz, Justin; Janssens, Stefan; Schaap, Jeroen; Lawrence Clark, Andrew; Schou, Morten; Harjola, Veli-Pekka; Erglis, Andrejs; Celutkiene, Jelena; Spinar, Jindrich; Murin, Jan; Peter Merkely, Béla; Maria Nessler, Jadwiga; Dungen, Hans-Dirk; Huber, Kurt; Eugen Muller, Christian; Lamblin, Nicolas; Agostoni, Piergiuseppe; Frigerio, Maria; Parissis, John; Andrei Dan, Gheorghe; Generosa Crespo-Leiro, Maria; Ben-Gal, Tuvia; Fonseca, Cândida; Birhan Yilmaz, Mehmet; Barbarash, Olga; Carlos Nicolau, José; Roque Perna, Eduardo; Luis Corbalan Herreros, Ramon; Ryu, Kyu-Hyung; D White, Harvey; Tsao, Lana; Pendril Lewis, Neil; Foucauld, Jean; El Shahawy, Mahfouz; J French, William; Schmalfuss, Carsten; Zhang, Lily; M Graham, Bruce; J Koren, Michael; Landau, Charles; Martin Ennis, Bruce; J Fulmer, James; Meymandi, Sheba; Gus Sokos, George; Sharma, Saurabh; John Heilman 3rd, K; Gelzer Bell, Ramona; Sayer, Gabriel; Rosenberg, Michael; Jay Budoff, Matthew; Hotchkiss, David; Rosendorff, Clive; Williams, Robert; Lupovitch, Steven; Deedwania, Prakash; Stoller, Douglas; Banerjee, Supratim; Tita, Cristina; Sokolowicz, John; Uretsky, Barry; Aboeata, Ahmed; S White, Matthew; Ramanathan, Kodangudi; J Vittorio, Timothy; L Guichard, Jason; Gupta, Ashish; A Boddicker, Kimberly; Mcginty, John; Diez, Mirta; Elizabeth Arias, Viviana; Nancy Mana, Melina; Marcos Schmidberg, Jorge; Alejandro Garrido, Marcelo; Daniel Caime, Guillermo; Alfonso León de la Fuente, Ricardo; Rubén Hershson, Alejandro; Garcia Brasca, Daniela; Beatriz Schiavi, Lilia; Nani, Sebastián; Oscar Zapata, Gerardo; Marcela Del Valle Almagro, Sandra; Angel Hominal, Miguel; Alberto Berli, Mario; Alberto Poy, Carlos; Daniel Prado, Aldo; Andres Ahuad Guerrero, Rodolfo; Andrés Duarte, Raúl; Alfredo Fernández, Alberto; Maria Huerta, Clara; Armando Luquez, Hugo; Adolfo Mercau, Guillermo; Cecilia Beltrano, María; Luz Lobo Marquez, Lilia; Tereschenko, Sergey; Karpov, Yuri; Gordeev, Ivan; Lebedeva, Anastasiya; Alexandrovna Berns, Svetlana; Boldueva, Svetlana; Vishnevsky, Alexander; Ruda, Mikhail; Pevzner, Dmitry; Goloshchekin, Boris; Sitnikova, Maria; Khaisheva, Larisa; Ryabov, Vyacheslav; Kruberg, Lilly; Zykov, Mikhail; Baranov, Evgeny; Kobalava, Zhanna; Isaeva, Elena; Pavlikova, Elena; Eryshev, Sergey; Shutemova, Elena; Reyes Domínguez, Antonio; Garcia Del Rio, Enrique; López Suárez, Alejandro; Manuel García Pinilla, José; Garcia Quintana, Antonio; A Pascual Figal, Domingo; Bover Freire, Ramón; Francisco Gomez Cerezo, Jorge; Almenar, Luis; Pérez Silvestre, J
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