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This work was supported by the Boehringer Ingelheim and Eli Lilly and Co Diabetes Alliance. Boehringer Ingelheim was involved in the design and conduct of the study; collection, analysis, and interpretation of data; and preparation of this manuscript. Dr Marx received grant support from the German Research Foundation: SFB TRR 219 (projects M-03 and M-05).
Linagliptin Effects on Heart Failure and Related Outcomes in Individuals With Type 2 Diabetes Mellitus at High Cardiovascular and Renal Risk in CARMELINA
Publicated to:Circulation. 139 (3): 351-361 - 2019-01-15 139(3), DOI: 10.1161/CIRCULATIONAHA.118.038352
Authors: McGuire, Darren K; Alexander, John H; Johansen, Odd Erik; Perkovic, Vlado; Rosenstock, Julio; Cooper, Mark E; Wanner, Christoph; Kahn, Steven E; Toto, Robert D; Zinman, Bernard; Baanstra, David; Pfarr, Egon; Schnaidt, Sven; Meinicke, Thomas; George, Jyothis T; von Eynatten, Maximilian; Marx, Nikolaus; Aizenberg, D; Fiorella, A; Edgardo, N; Belen, C Ianina; Alonso, P; Walter, M; Maia, K; Guillermo, S; Leandro, B; Constanza, R M; Alejandra, N M; Melina, C; Ariel, I L; Martin, S; Rodrigo, C; Alvarez, C; Jorge, M Z; Gabriel, C; German, S; Bartolacci, I; Bolobanich, G A; Tale, T; Meritano, M; Echeverria, M G; Gerrini, S P; Alvarez, M R y; Torrijos, N; Berli, M; Coggiola, J; Castaneda, G; Rode, R; Milessi, R; Roude, A; Bono, J; Caresani, J; Arias, V; Westberg, J C; Allende, G; Liberman, A; Bordonava, A; Almagro, S M; Gerbaudo, C; Schiavi, L B; Budassi, N; Cecilia, M; Buncuga, M; Carlos, S; Osvaldo, T; Mercedes, S; Agustina, V M M; Aljandro, M; Alberto, D; Fiorella, M; Cantero, M; Cariganano, M S; Anadon, P; Cartasegna, L; Gabriela, M; Fernanda, A M; Alberto, Re Matias; Chacon, C; Jazmin, F M M; Colombo, H; Coni, E; Mattausch, S E; Thomsenhall, K; della Torre, M; Morandini, M; Zanini, A; Berra, F Colombo; Margarita, H; Commendatore, V; Tedesco, J; Bolzan, P G; Cuneo, C; Narcisa, G; Caputi, V Fernandez; Pablo, S; Sandra, G; Pacora, F Ferre; Tinari, M B; Jure, H O; Parody, M L; Toranzo, A; Frechtel, G; Yohena, S; Lovecchio, S; Muller, C; Olivera, C; Breyaui, M Dib; Bianchi, G; Garcia, C; Luciana, V; Florencia, F M; Ruben, G D; Gelersztein, E; Rey, G R; Sanchez, C; Fornasari, L; Di Pierro, L; Giacomi, G; Miguel, S; Laura, T; Gonzalo, C; Ramon, C; Glenny, J; Koretzky, M; Porto, A; Tiberio, O; Ellenberg, A; Saurral, R; Igarzabal, C; Vilamajo, O Gomez; Matkovich, J; de Lapertosa, S Gorban; Villagra, Mirtha; Cuzziol, G; de la Cruz, M; Pinchetti, R; Mierez, M; Lopez, C; Gorosito, V; Gabito, A; Kleiban, A; Grosembacher, L; Adrian, P; Paula, R M; Javier, G; Kraft, F; Andres, F; Krynski, F; Nicolas, P R; Marcelo, F; Alfredo, F A; de la Fuente, R Leon; Natalia, C; Luquez, H; Recuero, Yanina; Becchetti, N S; Ruiz, M; Costantino, M; Vazquez, G; Guzman, C; Pelatia, P; Maffei, L; Sassone, S; Yantorno, M; Prado, G; Khron, B; Maldonado, N; Gustavo, L; Veronica, V P; Marino, J; Viviana, C; Elizabeth, A; Alejandra, C; Oscar, R; Azize, G Moises; Gallardo, Mariela Yanez; Escudero, M L; Vargas, E; Ramos, H; Lucero, C; Najenson, M; Crocci, I T; Chiesa, A; Nardone, L; Dominguez, S; Manghi, F Perez; Grossman, M; Giudice, G L; Romeo, A; Piskorz, D; Miguel, C; Susana, D; Noeli, U; Rosa, S; Martin, V Quevedo; Soledad, A M; Virginia, M M; Lorena, G M; Prado, A; Veronica, L; Eduardo, H; Adolfo, P G; Florencia, W; Rista, L; Scolari, C; Rojas, N; Bertolio, V; Zarandon, R Saa; Jair, S; Orlando, C; Sanabria, H; Ignacio, De U; Marina, R C; Sarjanovich, R; Scaro, G; Huerta, C M; Schiavi, L; Mana, M; Gutierrez, M; Dain, A; Gavicola, R; Sessa, H; Sacripanti, J; Felman, R; Vilarino, P; Sicer, M; Lagrutta, M; Sala, J; Casabella, T Smith; Cecilia, H M; Carlos, B; Vines, G; Javier, R; Vico, M; Lanchiotti, P; Martella, C; Torres, L; Villarino, A; Molina, M P de Valle; Martinez, J M; Farias, C; Bertola, S; Rojas, M; Guzman, P N; Nisi, J S; Martinez, D F; Barrionuevo, M; Vita, N; Lopez, A; Vottero, E; Giuliano, M E; Paron, L; Vogel, D; Mele, P; Imposti, H; Dominguez, A; Zaidman, C; Fernando, G; Beck, M de Oliveira; Beltrame, P A; Chemello, D; Junior, R Magalhaes Montenegro; Abreu, A P; Fernandes, V; Saboia, J; Rodrigues, L; Carvalho, M; Gurgel, M H; Gadelha, D; Ramos, C Slompo; Borba, V Z C; Golbert, M Moyses; Pitthan, M; Golbert, L; Valentini, R; Gross, J L; Canani, L H; Valenti, A M; Sartori, C C; Dutra, O Pereira; Azevedo, E; Azevedo, A; Vaz, R; Vaz, H; da Costa, Fe Alves; da Costa, L M Alves; Panarotto, D; Lain, F V; Camazzola, F E; Dellomea, B S; Rech, R; Pizzato, P E; Nunes, C E; Jaeger, C; Silveira, D; Wagner, L; Machado, L F G; Rea, R Roginski; de Bem, A Boeving; Alves, J M; Jonasson, T H; Malucelli, F J; Betti, R Barcellos; Lerario, A C; Lisboa, H Kurtz; Batista, J; Bem, J; Tres, G; Tavares, C B; Nardi, A; Pozzatto, M; Backes, L; Reolao, J B C; Scariot, E; Ziguer, E; Baldissera, D M B; Griz, L Maciel; Antunes, D; Victor, F; Freire, K; Barros, A; Costi, B; Sa, M; Carneiro, A; Felicio, J Soares; Felicio, K; Penha, P; Ferreira, J; Melo, F; Alves, A; Souza, A C; Costa, L; Pinheiro, D; Andreotti Turatti, L; Augusto, G A; Leanca, C C; Santomauro Junior, A C; Costa e Forti, A; Sena, R; Marinho, A E; Facanha, C; Barroso de Souza, K; Barroso de Souza, A S; Barroso de Queiroz, W C; de Oliveira Leite, S; do Carmo Vieira, S; Ramos Gubert, L F; Olsen, A C; Piazzetta, G; Fuck, A R; Ferreira, M A; Ribas Fortes, J; Drulla Brandao, T J; Padilha, M; Alves, F; Radice, E; dos Santos, J A; Simoes de Almeida, R; Franco, D M; Saporito, W F; Goldberg Eliaschewitz, F; Reis Franco, D; Nunes de Siqueira, K; de Carvalho Camara Bona, R; Rizzo Genestreti, P R; Costa de Castro, D L; de Lima Visconti, G; 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Affiliations
Abstract
Background: Individuals with type 2 diabetes mellitus are at increased risk for heart failure (HF), particularly those with coexisting atherosclerotic cardiovascular disease and/or kidney disease. Some but not all dipeptidyl peptidase-4 inhibitors have been associated with increased HF risk. We performed secondary analyses of HF and related outcomes with the dipeptidyl peptidase-4 inhibitor linagliptin versus placebo in CARMELINA (The Cardiovascular and Renal Microvascular Outcome Study With Linagliptin), a cardiovascular outcomes trial that enrolled participants with type 2 diabetes mellitus and atherosclerotic cardiovascular disease and/or kidney disease. Methods: Participants in 27 countries with type 2 diabetes mellitus and concomitant atherosclerotic cardiovascular disease and/or kidney disease were randomized 1:1 to receive once daily oral linagliptin 5 mg or placebo, on top of standard of care. All hospitalization for HF (hHF), cardiovascular outcomes, and deaths were prospectively captured and centrally adjudicated. In prespecified and post hoc analyses of HF and related events, Cox proportional hazards models adjusting for region and baseline history of HF were used. Recurrent hHF events were analyzed using a negative binomial model. In a subset of participants with left ventricular ejection fraction captured within the year before randomization, HF-related outcomes were assessed in subgroups stratified by left ventricular ejection fraction > or 50%. Results: CARMELINA enrolled 6979 participants (mean age, 65.9 years; estimated glomerular filtration rate, mL/min per 1.73m(2); hemoglobin A1c, 8.0%; 62.9% men; diabetes mellitus duration, 14.8 years), including 1873 (26.8%) with a history of HF at baseline. Median follow-up was 2.2 years. Linagliptin versus placebo did not affect the incidence of hHF (209/3494 [6.0%] versus 226/3485 [6.5%], respectively; hazard ratio [HR], 0.90; 95% CI, 0.74-1.08), the composite of cardiovascular death/hHF (HR, 0.94; 95% CI, 0.82-1.08), or risk for recurrent hHF events (326 versus 359 events, respectively; rate ratio, 0.94; 95% CI, 0.75-1.20). There was no heterogeneity of linagliptin effects on hHF by history of HF at baseline, baseline estimated glomerular filtration rate or urine albumin-creatinine ratio, or prerandomization left ventricular ejection fraction. Conclusions: In a large, international cardiovascular outcome trial in participants with type 2 diabetes mellitus and concomitant atherosclerotic cardiovascular disease and/or kidney disease, linagliptin did not affect the risk of hHF or other selected HF-related outcomes, including among participants with and without a history of HF, across the spectrum of kidney disease, and independent of previous left ventricular ejection fraction. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01897532.
Keywords
Quality index
Bibliometric impact. Analysis of the contribution and dissemination channel
The work has been published in the journal Circulation due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2019, it was in position 1/65, thus managing to position itself as a Q1 (Primer Cuartil), in the category Peripheral Vascular Disease. Notably, the journal is positioned above the 90th percentile.
From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 7.15. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 14, 2024)
This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:
- Field Citation Ratio (FCR) from Dimensions: 24 (source consulted: Dimensions Jul 2025)
Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-07-15, the following number of citations:
- WoS: 167
Impact and social visibility
Leadership analysis of institutional authors
This work has been carried out with international collaboration, specifically with researchers from: Argentina; Armenia; Australia; Brazil; Bulgaria; Canada; Chile; China; Colombia; Croatia; Czech Republic; Denmark; Finland; Germany; Hungary; Israel; Japan; Malaysia; Mexico; Netherlands; Norway; Oman; Poland; Portugal; Republic of Korea; Russia; South African Republic; Switzerland; Taiwan; Ukraine; United Kingdom; United States of America; Venezuela.