Author: "Mcguire, P. K." - Searchworks@Jio Institute Digital Library Search Results

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820 results on '"Mcguire, P. K."'

201. Biologics-based regenerative technologies for periodontal soft tissue engineering.

Author: Tavelli, Lorenzo, McGuire, Michael K., Zucchelli, Giovanni, Rasperini, Giulio, Feinberg, Stephen E., Wang, Hom‐Lay, Giannobile, William V., and Wang, Hom-Lay
Abstract: This manuscript provides a state-of-the-art review on the efficacy of biologics in root coverage procedures, including enamel matrix derivative, platelet-derived growth factor, platelet concentrates, and fibroblast-growth factor-2. The mechanism of action and the rationale for using biologics in periodontal plastic surgery, as well as their anticipated benefits when compared with conventional approaches are discussed. Although the clinical significance is still under investigation, preclinical data and histologic evidence demonstrate that biologic-based techniques are able to promote periodontal regeneration coupled with the provision of tooth root coverage. [ABSTRACT FROM AUTHOR]
Published: 2020
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202. Autogenous soft tissue grafting for periodontal and peri-implant plastic surgical reconstruction.

Author: Zucchelli, Giovanni, Tavelli, Lorenzo, McGuire, Michael K., Rasperini, Giulio, Feinberg, Stephen E., Wang, Hom‐Lay, Giannobile, William V., and Wang, Hom-Lay
Abstract: This state-of-the-art review presents the latest evidence and the current status of autogenous soft tissue grafting for soft tissue augmentation and recession coverage at teeth and dental implant sites. The indications and predictability of the free gingival graft and connective tissue graft (CTG) techniques are highlighted, together with their expected clinical and esthetic outcomes. CTGs can be harvested from the maxillary tuberosity or from palate with different approaches that can have an impact on graft quality and patient morbidity. The influence of CTGs on soft tissue thickness and keratinized tissue width are also discussed. [ABSTRACT FROM AUTHOR]
Published: 2020
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203. Extracellular matrix‐based scaffolding technologies for periodontal and peri‐implant soft tissue regeneration.

Author: Tavelli, Lorenzo, McGuire, Michael K., Zucchelli, Giovanni, Rasperini, Giulio, Feinberg, Stephen E., Wang, Hom‐Lay, and Giannobile, William V.
Abstract: The present article focuses on the properties and indications of scaffold‐based extracellular matrix (ECM) technologies as alternatives to autogenous soft tissue grafts for periodontal and peri‐implant plastic surgical reconstruction. The different processing methods for the creation of cell‐free constructs resulting in preservation of the extracellular matrices influence the characteristics and behavior of scaffolding biomaterials. The aim of this review is to discuss the properties, clinical application, and limitations of ECM‐based scaffold technologies in periodontal and peri‐implant soft tissue augmentation when used as alternatives to autogenous soft tissue grafts. [ABSTRACT FROM AUTHOR]
Published: 2020
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204. Association of obesity with cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease: Insights from TECOS.

Author: Pagidipati, Neha J., Zheng, Yinggan, Green, Jennifer B., McGuire, Darren K., Mentz, Robert J., Shah, Svati, Aschner, Pablo, Delibasi, Tuncay, Rodbard, Helena W., Westerhout, Cynthia M., Holman, Rury R., Peterson, Eric D., and TECOS Study Group
Abstract: Background: Obesity is a risk factor for type 2 diabetes (T2D) and cardiovascular disease (CVD). Whether obesity affects outcomes among those with T2D and atherosclerotic CVD (ASCVD) remains uncertain. Our objective was to investigate the relationship between body mass index (BMI) and ASCVD outcomes among TECOS participants with T2D and ASCVD.Methods: BMI categories were defined as underweight/normal weight (BMI <25 kg/m2), overweight (25-29.9 kg/m2), obese class I (30-34.9 kg/m2), obese class II (35-39.9 kg/m2), and obese class III (≥ 40 kg/m2). Asian-specific BMI categories were applied to Asian participants. Kaplan-Meier survival analysis and Cox proportional hazards models were used to examine associations between baseline BMI and a composite CV outcome (CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina).Results: For 14,534 TECOS patients with available BMI, mean age was 65.5 years; 29.3% were female, 32.0% non-White, and 23.1% insulin-treated, with median 3 years' follow-up. At baseline, 11.6% (n = 1686) were underweight/normal weight, 38.1% (n = 5532) overweight, 32.2% (n = 4683) obese class I, 12.4% (n = 1806) obese class II, and 5.7% (n = 827) obese class III. The composite CV outcome occurred in 11.4% (n = 1663) of participants; the outcome risk was lower, compared with under/normal weight, in overweight (HR 0.83, 95% CI 0.71-0.98) and obese class I (HR 0.79, 95% CI 0.67-0.93) individuals. Obesity was not associated with worse glycemic control.Conclusions: The majority of TECOS participants with ASCVD and T2D were overweight or obese, yet overweight or obese class I individuals had lower CV risk than those who were under/normal weight. These results suggest the presence of an obesity paradox, but this paradox may reflect an epidemiological artifact rather than a true negative association between normal weight and clinical outcomes. [ABSTRACT FROM AUTHOR]
Published: 2020
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205. Associations between β-blocker therapy and cardiovascular outcomes in patients with diabetes and established cardiovascular disease.

Author: Shavadia, Jay S., Zheng, Yinggan, Green, Jennifer B., Armstrong, Paul W., Westerhout, Cynthia M., McGuire, Darren K., Cornel, Jan H., Holman, Rury R., and Peterson, Eric D.
Abstract: Background: The effects of β-blocker therapy in patients with type 2 diabetes (T2D) and established atherosclerotic cardiovascular disease (ASCVD) are unclear. We sought to evaluate associations between β-blocker use in T2D with ASCVD and cardiovascular (CV) outcomes.Methods: In patients with T2D and ASCVD enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), an inverse probability of treatment-weighted Cox proportional hazards model was used to examine the association between baseline β-blocker therapy (at randomization) and the primary CV composite (defined as CV death, non-fatal myocardial infarction [MI], non-fatal stroke, or hospitalization for unstable angina), including in subgroups with prior MI and heart failure (HF); other outcomes evaluated included individual components of the primary composite, hospitalization for HF, and severe hypoglycemic events.Results: Of the 14,671 patients randomized, 9322 (64%) were on a β-blocker at baseline; these patients were more likely to have prior MI or HF. Over a median 3.0 (25th, 75th percentile: 2.2, 3.6) years, the risk of the primary CV composite was significantly higher with baseline β-blocker use versus no β-blocker use (4.5 vs. 3.4 events/100-patient years, adjusted hazard ratio [HR] 1.17, 95% confidence interval [CI] 1.05-1.29); no significant interaction was noted for patients with versus without prior MI or HF. Baseline β-blocker use was not associated with risks for severe hypoglycemic events (HR 1.14, 95% CI 0.88-1.48).Conclusions: In this observational analysis of T2D and ASCVD, baseline β-blocker use was not associated with risks for severe hypoglycemia yet also was not associated with CV risk reduction over 3 years of follow-up, supporting a randomized examination of chronic β-blocker therapy in this patient population. (TECOS ClinicalTrials.gov number, NCT00790205). [ABSTRACT FROM AUTHOR]
Published: 2019
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206. International variation in characteristics and clinical outcomes of patients with type 2 diabetes and heart failure: Insights from TECOS.

Author: Bhatt, Ankeet S., Luo, Nancy, Solomon, Nicole, Pagidipati, Neha J., Ambrosio, Giuseppe, Green, Jennifer B., McGuire, Darren K., Standl, Eberhard, Cornel, Jan H., Halvorsen, Sigrun, Lopes, Renato D., White, Harvey D., Holman, Rury R., Peterson, Eric D., Mentz, Robert J., and TECOS Study Group
Abstract: International differences in management/outcomes among patients with type 2 diabetes and heart failure (HF) are not well characterized. We sought to evaluate geographic variation in treatment and outcomes among these patients. METHODS AND RESULTS: Among 14,671 participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), those with HF at baseline and a documented ejection fraction (EF) (N = 1591; 10.8%) were categorized by enrollment region (North America, Latin America, Western Europe, Eastern Europe, and Asia Pacific). Cox models were used to examine the association between geographic region and the primary outcome of all-cause mortality (ACM) or hospitalization for HF (hHF) in addition to ACM alone. Analyses were stratified by those with EF <40% or EF ≥40%. The majority of participants with HF were enrolled in Eastern Europe (53%). Overall, 1,267 (79.6%) had EF ≥40%. β-Blocker (83%) and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (86%) use was high across all regions in patients with EF <40%. During a median follow-up of 2.9 years, Eastern European participants had lower rates of ACM/hHF compared with North Americans (adjusted hazard ratio: 0.45; 95% CI: 0.32-0.64). These differences were seen only in the EF ≥40% subgroup and not the EF <40% subgroup. ACM was similar among Eastern European and North American participants (adjusted hazard ratio: 0.79; 95% CI: 0.44-1.45). CONCLUSIONS: Significant variation exists in the clinical features and outcomes of HF patients across regions in TECOS. Patients from Eastern Europe had lower risk-adjusted ACM/hHF than those in North America, driven by those with EF ≥40%. These data may inform the design of future international trials. [ABSTRACT FROM AUTHOR]
Published: 2019
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207. High Circulating Triglycerides Are Most Commonly a Marker of Ectopic Fat Accumulation: Connecting the Clues to Advance Lifestyle Interventions

Author: Sattar, Naveed, McGuire, Darren K., and Gill, Jason M.R.
Published: 2022
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208. Increased hippocampal engagement during learning as a marker of sensitivity to psychotomimetic effects of δ-9-THC

Author: Bhattacharyya, Sagnik, primary, Sainsbury, Thomas, additional, Allen, Paul, additional, Nosarti, Chiara, additional, Atakan, Zerrin, additional, Giampietro, Vincent, additional, Brammer, Michael, additional, and McGuire, P K, additional
Published: 2018
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209. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial

Author: Bhatt, Deepak L, Steg, Philippe Gabriel, Mehta, Shamir R, Leiter, Lawrence A, Simon, Tabassome, Fox, Kim, Held, Claes, Andersson, Marielle, Himmelmann, Anders, Ridderstråle, Wilhelm, Chen, Jersey, Song, Yang, Diaz, Rafael, Goto, Shinya, James, Stefan K, Ray, Kausik K, Parkhomenko, Alexander N, Kosiborod, Mikhail N, McGuire, Darren K, Harrington, Robert A, Santos, Vladimir, Jain, Ashit, Lendel, Irina, Russo, Michael, Haught, W H, Bouza, Manuel, Gogia, Harinder, Banerjee, Supratim, Kichura, George, Kantaros, Louis, Padron, Francisco, Passi, Rakesh, Stone, Jay, Pursley, Michael, D'Urso, Michael, Gardner, Timothy, Bennett, James, Nour, Khaled, Saini, Satinder, Zhang, Wenwu, Kumbhani, Dharam, Thomas, Dustin, Angiolillo, Dominick, Bertolet, Barry, Roman-Miranda, Amaury, Black, Robert, Manshadi, Ramin, Vaca, Carlos, Blanco, Antonio, Napoli, Mark, Brabham, David, Akyea-Djamson, Ayim, Desai, Pratik, Prasada, Sudhir, Khaira, Ajit, Forgosh, Leslie, Lieber, Ira, Umpierrez, Guillermo, Singal, Dinesh, Londono, Juan, Fraser, Neil, Ruiz, Jose, Vega, Damaris, Rodriguez, Lilia, Brown, Christopher, Syed, Faizullah, Aggarwala, Guarav, Eaves, William, Foster, Michael, Gupta, Dinesh, Avino, David, Asfour, Wail, Tonnessen, Glen, Zhao, Xue-Qiao, Singh, Narendra, Brockmyre, Andrew, Lepor, Norman, Shammas, Nicolas, Blick, David, Hearne, Steven, Prodafikas, John, Carell, Edgar, Izzo, Mark, Karim, Amin, Zakhary, Bosh, Atieh, Mahmoud, Leichter, Steven, Meadows, Charles, Hotchkiss, David, Abu-Fadel, Mazen, Wiseman, Alan, Bander, Jeffrey, Shah, Mahesh, Banerjee, Subhash, Ganim, Ricky, Sopko, Karen, Khan, Misal, Lloret, Ramon, Weirick, Troy, Mehta, Rajendra, Thadani, Udho, Bhargava, Anuj, Kosiborod, Mikhail, Moya, Jaynier, Staniloae, Cezar, Guerra, Yamirka D, Chhabra, Anil, Kosmicki, Douglas, Shaheen, Wassim, Mohammed, Akber, Bitters, J'Cinda, Pattanayak, Jan, Javier, Julian, Srivastava, Sunny, Phillips, Roland, Al-Amin, Jessie, Lillestol, Michael, Simpson, Patrick, Hazan, Lydie, Amin, Amit, Shah, Gopi, Korpas, Denes, Platt, Bruce, Dickert, Jim, Puente, Orlando, Hiotis, Louis, Doyle, Timothy, Rajan, Raj, Meholick, Alan, Gring, Christian, Hage-Korban, Elie, Feldman, Robert, Colfer, Harry, Butman, Samuel, Foster, Malcolm, Hart, Terence, Huling, Randall, Eshaghian, Shervin, Quintana, Ofsman, Cheung, Deanna, Handel, Franklin, Rodriguez, Mara, Suh, David, Gordon, Paul, Pressman, Gregg, Bauer, Michael, French, William, Barettella, Mark, Chatrathi, Sridhar, Suresh, Damodhar, Goldberg, Ronald, Huth, Mark, Younis, Liwa, Rahman, Aref, Mascolo, Richard, Welch, Michelle, Suneja, Randeep, Smith, Stephen, Shurmur, Scott, Agaiby, John, Jingo, Ahmad, Johnston, Janice, Beth, Mary, Vlastaris, Anthony, Kemp, Susan, Taheri, Hamid, Pereira, Edward, Deyoung, Michael, Hawa, Zafir, Smith, Ray, Galski, Thomas, Garas, Samer, Reddy, M, Sharma, Susheel, Hargrove, Joeseph, Treasure, Charles, Emerson, Ronald, Haddad, Tariq, Rohr, Kathryn, Levinson, Larry, Gaona, Raul, Uretsky, Barry, Maheshwari, Hiralal, Lee, Denny, Kinnaman, Stephanie, Singal, Robert, Geohas, Jeffrey, Gigliotti, Osvaldo, Raisinghani, Ajit, Khurana, Charanjit, Hella, Brent, Kelberman, Michael, Voyce, Steven, Singh, Sanjay, Lo, Eric, Singh, Pradeep, Goodfellow, Ross, Fischer, Stuart, Lorraine, Richard, Turner, Traci, Shanes, Jeffrey, Busch, Robert, Broker, Robert, Zaniewski, Michelle, Pounds, Kevin, Debs-Perez, Giselle, Ong, Stephen, Frandsen, Brad, Fullington, Douglas, Jaffrani, Naseem, Khan, Ahtaram, Lee, Marcus, Pouzar, Joe, Revtyak, George, Gonzalez, Julian, Nakhle, Samer, Murillo, Abel, Young, Douglas, Makam, Sashi, Syed, Mushtaq, Woolf, Kevin, Grena, Paul, Alfata, Sarab, Mahal, Sharan, Hoffman, David, Kizhakekuttu, Tinoy, Deering, Joseph, Bhavsar, Janak, Mikesell, Scott, Wilson, William, Wilson, Vance, El, Salah, Spinale, Francis, Kannarkat, Vinod, Rao, Sunder, Hanson, Lenita, Bertsch, John, Gonzalez-Ortiz, Elena, Severino, Norma, Willis, John, Schock, Joel, Bakhtari, Ladan, Gazmuri, Raul, Ansari, Saadat, Hall, Jason, Mehta, Arvind, Shealy, Neal, Zarich, Stuart, Singh, Deovrat, Vora, Kishor, Andrawis, Nabil, Molter, Darron, Maron, David, Cardona, Jose, D'Agostino, Ronald, Arshad, Tamjeed, Samaan, Rodney, Jones, David, Presser, Dale, Heath, John, Green, Sandy, Bittar, George, Henry, Sheldon, Korn, David, Schmedtje, John, Nadar, Venkatesh, Graham, Bruce, Labroo, Ajay, Clavijo, Leonardo, Roseman, Hal, Ledesma, Gilbert, Rosen, Robert, Dor, Isaac, Kirby, William, Sutton, Jennefer, Eder, Frank, Iteld, Bruce, Gomez-Cortes, Jose, Buchbinder, Maurice, Kasper, Joseph, Terrelonge, Antonio, Torres, Gustavo, Jagielo, Ted, Alvarez, Jose, Handelsman, Yehuda, Guillen, Mario, Richwine, Randall, Lewy-Alterbaum, Lorena, Corder, Clinton, Arvind, Moogali, Bolshoun, David, Mikhail, Magdy, Minton, Stephen, Alvarado, Odilon, Abbott, J, Cauthen, Brett, Welter, Ryan, Mintz, Randy, Cox, John, Quick, Annette, Weiss, Melvin, Dy, Johnny, Zebrack, James, Gandelman, Glenn, Hegde, Vinayak, Silver, Marc, DeGregorio, Michele, Lawson, William, Paa, Christopher, Bortnick, Anna, Krolick, Merrill, Sotolongo, Rodolfo, Cheirif, Jorge, Kumar, Priya, Nadar, Venkatesh, Jetty, Preetham, Patel, Ambar, Kruk, Mariusz, Kobielusz-Gembala, Iwona, Rewerska, Barbara, Madrzejewski, Adam, Milewski, Krzysztof, Cygler, Jerzy, Petryka-Mazurkiewicz, Joanna, Jastrzebski, Waldemar, Korecki, Janusz, Fil, Wojciech, Prokopczuk, Janusz, Bochenek, Anna, Wujkowski, Marek, Witek, Robert, Konczakowski, Piotr, Miekus, Pawel, Szczasny, Marcin, Musial, Wlodzimierz, Cymerman, Krzysztof, Lampart, Jacek, Mikosinski, Jacek, Szynal, Slawomir, Fares, Issa, Opolski, Grzegorz, Mazur, Stanislaw, Wozakowska-Kaplon, Beata, Bijata-Bronisz, Renata, Wierucki, Lukasz, Losa, Beata, Drelich, Grzegorz, Konieczny, Marek, Starczewski, Pawel, Pawlowicz, Lidia, Jesionowski, Pawel, Jurowiecki, Jaroslaw, Gniot, Jacek, Czyzycki, Mariusz, Stania, Karol, Kucharczyk-Bauman, Izabela, Busz-Papiez, Benita, Karczmarczyk, Agnieszka, Sudnik, Wanda, Koszek, Alina, Kolodziej, Piotr, Skwarna, Bartosz, Jaramillo, Nicolás, Jankowski, Maciej, Czochra, Wojciech, Kinasz, Leszek, Miklaszewicz, Beata, Stasinska, Teresa, Pluta, Wladyslaw, Basiak, Marcin, Rusicka, Teresa, Niedbal-Yahfouf, Izabela, Popenda, Grazyna, Korzeniak, Romuald, Mirek, Agnieszka, Mariankowski, Rafal, Wojnowski, Lukasz, Korol, Marek, Baszak, Jacek, Podolec, Piotr, Piesiewicz, Wojciech, Zurakowski, Aleksander, Luengas, Carlos, Skura, Marek, Pilecki, Piotr, Majchrzak, Piotr, Krzyzagórska, Ewa, Drozd, Marcin, Kaczmarek, Barbara, Sliwinska, Teresa, Zelazowska, Katarzyna, Sztembis, Rafal, Landa, Katarzyna, Matyszczak-Toniak, Lidia, Strojek, Krzysztof, Piepiorka, Marek, Malinowski, Robert, Górska, Maria, Stolarczyk-Sowa, Edyta, Romanowski, Leszek, Zinka, Elzbieta, Reszka, Zygfryd, Skierkowska, Joanna, Uzunow, Anna, Laskowska-Derlaga, Ewa, Puntus, Ekaterina, Kosmacheva, Elena D, Koziolova, Natalia, Pavlov, Prokhor, Supryadkina, Tatiana, Didenko, Yury, Kopylov, Philipp, Kazakov, Andrei, Aksentiev, Sergei, Vishneva, Elena, Repin, Alexey, Smolenskaya, Olga, Mantserova, Olga, Khrustalev, Oleg, Privalova, Elena, Konstantinov, Vladimir, Boldueva, Svetlana, Ezhov, Andrey, Chernyavsky, Alexander, Kamalov, Gadel, Galyavich, Albert, Zubeeva, Galina, Nechaeva, Galina, Shustov, Sergey, Dzhaiani, Nino, Treshkur, Tatiana, Osokina, Nataliya, Panov, Alexey, Shutemova, Elena, Makukhin, Valeriy, Kropotina, Tatiana, Tsyba, Larisa, Karpov, Yuri, Sizova, J M, Ballyuzek, Marina, Tarasov, Nikolay, Demchenko, Elena, Barbarash, Olga, Moiseev, Valentin, Markov, Valentin, Kuznetsov, Vadim, Viktorova, Inna, Sergienko, Igor, Ermoshkina, Lyudmila, Khasanov, Niyaz, Khlevchuk, Tatiana, Baglikov, Andrey, Shalaev, Sergey, Zonova, Elena, Reznik, Elena, Haisheva, Larisa, Morugova, Tatyana, Lomakin, Nikita, Vishnevsky, Alexander, Shvarts, Yuri, Magnitskaya, Olga, Mikhailusova, Marina, Pavlysh, Elena, Libov, Igor, Zateyschikova, Anna, Kostenko, Victor, Edin, Anton, Khovaeva, Yaroslava, Zakharov, Konstantin, Stryuk, Raisa, Khirmanov, Vladimir, Kanorskiy, Sergey, Yakushin, Sergey, Barabashkina, Anna, Li, Hongwei, Zhao, Qiang, Zhang, Jian, Ma, Jianhua, He, Yong, Luo, Ming, Zhang, Aidong, Zhang, Ningru, Chai, Yingru, Ma, Genshan, Wang, Hao, Liu, Zhigang, He, Lanjie, Song, Zhifang, Dong, Xiaolin, Tao, Liang, Li, Zhanquan, Su, Xi, Kong, Xiangqing, Niu, Heping, Ge, Junbo, Luo, Zhurong, Huang, Wenjun, Peng, Daoquan, Yuan, Zuyi, Milanova, Maria, Tenev, Doncho, Gogov, Antoni, Karageorgiev, Dimitar, Kolchev, Todor, Rusev, Nikolay, Georgieva, Nikolina, Kondov, Rumen, Rusinov, Veselin, Petrov, Ivo, Stanchev, Georgi, Konteva, Mariana, Dincheva, Adriana, Yaneva, Zdravka, Vatova, Ralitsa, Ilieva, Katya, Runev, Nikolai, Kolomanov, Borislav, Petrov, Ivan, Iliev, Nikolay, Tisheva, Snezhanka, Chompalova, Boryana, Tokmakova, Maria, Raev, Dimitar, Byanov, Kolyo, Markov, Dimitar, Mihov, Lenko, Mihov, Atanas, Milcheva, Nora, Minchev, Milen, Mollov, Mihail, Borisov, Borislav, Tihchev, Tihomir, Karakolev, Venelin, Dimov, Bojidar, Georgiev, Svetoslav, Smilov, Lachezar, Koo, Bon K, Ahn, Taehoon, Hong, Soon J, Yoon, Junghan, Oh, Seok K, Jeong, Myung H, Kim, Doo-Il, Chang, Kiyuk, Kim, Weon, Hahn, Joo-Yong, Cha, Kwang S, Lee, Jung-Hee, Choi, Si-Wan, Nam, Chang-Wook, Chae, In-Ho, Park, Yong H, Tahk, Seung-Jea, Shin, Won-Yong, Chae, Jei-Keon, Kim, Byung J, Bae, Jang-Whan, Park, Woo J, Rha, Seung W, Choi, Young J, Hwang, Jin-Yong, Park, Hun S, Baracioli, Luciano, Guimaraes, Fabio, Vasconcellos, Eduardo, Saraiva, José, Pereira, Adamastor, Santos, Queulla, Rossi, Paulo, Maia, Lilia, Madeira, Miguel, Pereira, Marcio, Botelho, Roberto, Reis, Gilmar, Eliaschewitz, Freddy, Borges, Joao, Nascimento, Carlos, Fortes, Jose A, de Souza, Weimar, Pimentel, Pedro, Hissa, Miguel, Franchetti, Marcos, Precoma, Dalton, Ortiz, Costantino, Hernandes, Mauro, Saporito, Wladmir, dos Santos, Fabio R, Kormann, Adrian, Neuenschwander, Fernando, Dutra, Oscar, Rassi, Nelson, Tanajura, Luiz, Souza, Juliana, Junior, Delcio S, Leaes, Paulo, Forte, Adriana, Bonansea, Teresa C, Marin, Jose, Machado, Bruno, Cerqueira, Maria J, Silva, Frederico, Michalaros, Yorghos, Manenti, Euler, Cercato, Cintia, Figueiredo, Estevao, Liu, Ming-En, Wang, Yi-Chih, Lee, Tsung-Ming, Fang, Chih, Wu, Yen-Wen, Ueng, Kwo-Chang, Sheu, Huey-Herng, Lai, Wen T, Hsieh, I-Chang, Chen, Zhih-Cherng, Lee, Mu-Jang, Chiang, Chern, Shyu, Kou-Gi, Hsia, Chien-Hsun, Mar, Guang-Yuan, Chan, Shih-Hung, Wu, Chih-Cheng, Tseng, Wei-Kung, Chang, Kuan-Cheng, Yeh, Hung-I, Wang, Ji-Hung, Hou, Charles, Sorokina, Inna, Dolzhenko, Maryna, Horoshko, Olha, Karpenko, Oleksandr, Rudenko, Leonid, Vakaliuk, Igor, Kulyk, Anna, Levchenko, Olena, Prokhorov, Oleksandr, Reshotko, Dmytro, Sorokivskyy, Mykhaylo, Velichko, Nataliia, Maslovskyi, Valentyn, Teliatnikova, Zinaida, Dotsenko, Sergiy, Krakhmalova, Olena, Kraiz, Igor, Zharinova, Viktoria, Bula, Larysa, Kaydashev, Igor, Molodtsov, Valeriy, Rasputina, Lesya, Pidlisna, Viktoriya, Lysunets, Olena, Kravchenko, Anatoliy, Glushko, Liubomyr, Khomazyuk, Tetyana, Svyshchenko, Yevgeniya, Parkhomenko, Oleksandr, Mankovsky, Boris, Abrahamovych, Orest, Yagensky, Andriy, Stanislavchuk, Mykola, Vasilyeva, Larisa, Sokolova, Liubov, Sychov, Oleg, Tseluyko, Vira, Kyrychenko, Igor, Rishko, Mykola, Furkalo, Sergiy, Gallo, Richard, Bertrand, Olivier, Mehta, Shamir, Constance, Christian, Sussex, Bruce, Zadra, Remo, Kouz, Simon, Chehayeb, Raja, Pandey, Amritanshu, Dion, Danielle, Bailey, Gordon, Hill, Laurie, Ramanathan, Krishnan, Dorsch, Micha, Nanji, Alykhan, Babapulle, Mohan, Montigny, Martine, Gosselin, Gilbert, Dehghani, Payam, Rupka, Dennis, Le May, Michel, Pichette, Francis, St-Maurice, Francois, Teefy, Patrick, Mansour, Samer, Kassam, Saleem, Cheung, Stephen, Siega, Anthony D, O'Keefe, Dennis, Sabbah, Eric, Bell, Alan, Chouinard, Guy, Wong, Brian, Miller, Mark, Gaudet, Daniel, Lachance, Pierre, Bata, Iqbal, Petrella, Robert, Gossard, Denis, Dumas, Richard, Ing, Douglas, Boyrazian, Hagop, Bessoudo, Ricardo, Huynh, Thao T, Hart, Randy, Belle-Isle, Jasmin, Shukla, Dinkar, Kelly, Allan, Mazza, Giuseppe, Cha, James, Henein, Sam, Frechette, Andre, Vizel, Saul, Liutkus, Joanne F, O'Mahony, Michael, Halperin, Frank, Kooy, Jacobus, Graham, John, Bailey, Allan, Wojcik, Ronald, Wilderman, Igor, Turi, Tibor, Motyovszki, Ákos, Merkely, Béla, Király, Csaba, Andrássy, Péter, Sárszegi, Zsolt, Fülöp, Tibor, Zilahi, Zsolt, Édes, István, Papp, Andras, Müller, Gábor, Czigány, Anna, Zólyomi, Szilárd, Korányi, László, Takács, János, Juhász, Ferenc, Benczur, Bela, Kancz, Sándor, Földi, András, Nagy, András C, Bakai, Judit, Greschik, István, Püski, László, Nagy, László, Kirschner, Róbert, Kuchar, Roman, Hajek, Petr, Busak, Ladislav, Michalik, Daniel, Matyasek, Ivo, Marusincova, Ivana, Kucera, Dusan, Jerabek, Ondrej, Honkova, Michaela, Dedek, Vratislav, Rihacek, Ivan, Kos, Pavel, Slaby, Josef, Machkova, Martina, Zidkova, Eva, Elbl, Lubomir, Grunfeldova, Hana, Carda, Jiri, Mrozek, Vladimir, Maly, Jiri, Milkovic, Richard, Malecha, Jan, Skalicka, Hana, Oral, Ivo, Krcova, Eva, Lisa, Libor, Belohlavek, Jan, Miklik, Roman, Cermak, Ondrej, Bednarova, Jana, Peroutka, Zdenek, Spinar, Jindrich, Wilke, Andreas, Appel, Karl-Friedrich, Taggeselle, Jens, Förster, Andreas, Toursarkissian, Nicole, Schmidt, Ekkehard, Bott, Jochen, Al-Zoebi, Ayham, Hennig, Dirk, Fischer, Sabine, Schön, Norbert, Sauter, Joachim, Simonis, Gregor, Nischik, Ruth, Rieker, Werner, Schenkenberger, Isabelle, Behnke, Thomas, Klausmann, Gerhard, Jeserich, Michael, Trenk, Dietmar, Weigmann, Ingo, Reuter, Hannes, Rummel, Reinhard, von Münchhausen, Candy, von Engelhardt, Charlotte, Horibe, Eishun, Shibasaki, Taro, Sato, Tomohiko, Kakuta, Tsunekazu, Michishita, Ichiro, Tan, Michinao, Ishiki, Ryoji, Aoyama, Takahiko, Higashiue, Shinichi, Niijima, Yawara, Idogaki, Akira, Hasegawa, Toru, Kiyosue, Arihiro, Tomobuchi, Yoshiaki, Kawamitsu, Katsunori, Kawasaki, Satsuki, Hata, Yoshiki, Fukui, Kazuki, Seki, Kozaburo, Takenaka, Takashi, Abe, Mitsuru, Utsu, Noriaki, Oono, Atsuyuki, Mitsuo, Kazuhisa, Sueyoshi, Atsushi, Hirohata, Atsushi, Tsujimoto, Mitsuru, Ueda, Osamu, Takase, Shinichi, Suzuki, Masahiro, Sakuragi, Satoru, Yamamoto, Fumi, Fujimoto, Noritaka, Kakinoki, Shigeo, Sugiura, Tatsushi, Sugino, Hiroshi, Nakamura, Toshihiro, Goto, Shinya, Kadokami, Toshiaki, Uehara, Hiroki, Ono, Masahiro, Yokoya, Koichi, Koike, Akihiro, Komatsu, Sei, Sonoda, Masahiro, Ueno, Hideki, Doi, Tomofumi, Takagi, Yuichiro, Fujimoto, Kazuteru, Eki, Yutaka, Okubo, Munenori, Sasaki, Kenichiro, van Eck, Martijn, Ronner, Eelko, The, Salem, van de Wal, Ruud, Nierop, Pieter, de Nooijer, Cornelis, The, Salem, The, Salem, Werner, Henri, Westendorp, Iris, van der Zwaan, Coen, Crijns, Hendrikus, Cornel, Jan H, Strikwerda, Sipke, Bos, Robert, de Melker, Edwin, Kuijper, Adrianus, Louwerenburg, Hans, Plomp, Jacobus, Dantzig, Jan-Melle, Prins, Francisco, van Kesteren, Henricus, Willems, Frank, Amoroso, Giovanni, Carnero, Gabriela, Duronto, Ernesto, Besada, Diego, Chacon, Carolina, Zangroniz, Pedro, Solis, Silvana, Liberman, Alberto, Sernia, Virginia, Alvarisqueta, Andres, Maffei, Laura, Vilamajo, Oscar G, García, Celso, Sicer, Maximiliano, Muntaner, Juan, Bordonava, Anselmo, Albisu, Juan, Zanini, Alejandra, Rista, Lucas, Hominal, Miguel, Estrada, José N, Prado, Aldo, Gosparini, Diego M, Schiavi, Beatriz, Castillo, Armando G, Ruíz, José G, Martinez, Guillermo R, López, Víctor G, Rosas, Enrique L, Lopez, Gabriel R, Cantu, Elias G, de los Ríos Ibarra, Manuel, Padilla, Francisco P, Carrasco, Jose P, Carrillo, Luis V, García, Joel D, Askar, Alfredo N, Salinas, Carlos A, Gamba, Marco A, Sanchez, Carlos G, Cantú, Arnulfo G, Sánchez, Raul V, Madrigal, Jaime C, Urbano, Rafael H, Romo, Andrés Í, González Juanatey, José R, Racugno, Paolo, Fillat, Angel C, de la Torre Hernández, José M, Peláez, Juan A, Cortada, Jorge B, Pavia, Pablo G, Navarro, Manuel J, Asenjo, Roberto M, Díaz, Francisco F, Peligero, Eduard B, Manterola, Fernando A, Ortiz, Antonio F, Mediavilla García, Juan D, Ortuño, Francisco M, Vera, Tomás R, González, Alfonso S, Viñas, Jaime A, Fernández Portales, Francisco J, Mayordomo, Petra S, Ojeda, Francisco B, Domínguez, Antonio R, González, Rosa S, Guerrero, Diego B, Ruiz Nodar, Juan M, Marimon, Xavier G, Margáez, José G, Aguilera, Roberto M, Díaz Fernández, José F, Zamorano Gómez, José L, González, Vicente B, del Blanco, Bruno G, Pérez, Ignacio P, Moreno, Mercé R, Ereño, Ainhoa R, García Lledó, José A, Prieto, Juan, Villablanca, Alex, Raffo, Carlos, Pincetti, Christian, Conejeros, Carlos, Roman, Oscar, Rodriguez, Manuel, Varleta, Paola, Goldberg, Cindy, Sandoval, Jorge, Arriagada, German, Leon, Lucio, Potthoff, Sergio, Cobos, Jorge, Figueroa, Christian, Makotoko, Ellen, Fourie, Nyda, Burgess, Lesley, Nortje, Hendrik, Theron, Rust, Pillai, Perumal, Ranjith, Naresh, Trokis, Julien, Pillay, Soobramoney, Reddy, Jeevren, Nunkoo, Theema, Kapp, Cornelia, Urbach, Dorothea, Distiller, Lawrence, Horak, Adrian, van Zyl, Louis, Coetzee, Kathleen, Punt, Zelda, Bayat, Junaid, Dawood, Saleem, Mitha, Ismail, Padayachee, Trevenesan, Hoosen, Farzana, Dalby, Anthony, Prabhavathi, Gowdaiah, Prakash, Mehta, Vimal, Chag, Milan, Gadkari, Milind, Ramamurthee, Kannaiyan, Das, Asit, Sawhney, Jitendra S, Banerjee, Suvro, Sathe, Prachee, Adhyapak, Srilakshmi, Nguyen, Tuan, Pham, Vinh, Do, Huan, Nguyen, Anh, Nguyen, Hien, Truong, Binh, Jamil-Copley, Shahnaz, Lang, Chim, Pell, Alastair, Zaman, Azfar, Storey, Robert, Swanson, Neil, Smith, Simon, Sharman, David, Braganza, Denise, Hammond, Peter, Moriarty, Andrew, Bain, Stephen, Pye, Maurice, Sharp, Andrew, Blagden, Mark, Randeva, Harpal, Myhill, Timothy, Viswanathan, Girish, Keeling, Philip, Clifford, Piers, Saxena, Manish, Lyons, Kristopher, McMurray, John, Jaafar, Feeroz, Murphy, Clare, Cartwright, Simon, Abouglila, Kamal, Antalik, Lubomir, Krajci, Peter, Urban, Miroslav, Fazekas, Frantisek, Pella, Daniel, Koleny, Daniel, Vykoukalova, Tatiana, Macek, Vladimir, Vinanska, Daniela, Jamriskova, Livia, Such, Slavomir, Fulop, Peter, Farsky, Stefan, Bugan, Viliam, Strbova, Jaroslava, Micko, Karol, Palka Jr, Juraj, Sivak, Vladimir, Kristensen, Dalby, Refsgaard, Jens, Holmvang, Lene, Dixen, Ulrik, Nielsen, Henrik, Egstrup, Kenneth, Jensen, Lisette O, Sykulski, Roman, Rasmussen, Ole, Andries, Alin, Luckow, Anders, Nielsen, Gitte, Sørensen, Torben, Wongvipaporn, Chaiyasith, Chamnarnphol, Noppadol, Srimahachota, Suphot, Sansanayudh, Nakarin, Kuanprasert, Srun, Tresukosol, Damras, Sookananchai, Bancha, Kanadasi, Mehmet, Ozcan, Turkay, Kucuk, Murathan, Ongen, Zeki, Okuyan, Ertugrul, Arat, Alev, Acikel, Sadik, Yalcin, Ahmet, Guray, Umit, Ceyhan, Ceyhun, Ozer, Necla, Arslan, Sakir, Angerås, Oskar, Johnston, Nina, Weiderman, Ann-Charlotte, Bandh, Stellan, Hansen, Ole, Larnefeldt, Hans, Kusiak, Dawid, Lindholm, Carl-Johan, Hedman, Anders, Erlinge, David, Curiac, Dan, Lundman, Pia, Zucconi-Mazzini, Roberto, Aladellie, Layth, Jensen, Jens, Verwerft, Jan, Vrolix, Mathias, Faes, Dirk, Striekwold, Harry, Sinnaeve, Peter, Timmermans, Patrick, Guedes, Antoine, Delforge, Marc, Nimmegeers, Jan, Stammen, Francis, Buysschaert, Ian, Hoffer, Etienne, Hollanders, Geert, Vervoort, Geert, Coussement, Patrick, de Maeseneire, Stefan, Janssens, Luc, Gravdal, Stein A, Risberg, Knut, Gullestad, Lars, Hofseth, Ola D, Nilsen, Dennis, Lappegård, Knut T, van den Heuvel, Christian, Gibbs, Charlotte, Khusrawi, Alamdar, Arora, Satish, Tomala, Tadeusz, Kjærnli, Thorbjørn, Berg-Johansen, Jan, Hagemeier, Robert, Skjelvan, Gunnar, Colquhoun, David, Amerena, John, Morbey, Claire, Hammett, Christopher, Dart, Anthony, Lehman, Ronald, Hamilton, Andrew, Worthley, Matthew, Purnell, Peter, Whelan, Alan, MacIsaac, Richard, Arya, Ktut, Linjawi, Sultan, Proietto, Joseph, Prasad, Lakshman, Rodriguez, Aldo, Godoy, Armando, Rodriguez, Victor, Berrospi, Percy, Chavez, Carlos, Negron, Sandra, Heredia, Javier, Medina, Felix, Manrique, Helard, Cabrera, Walter, Cordova, Fernando, Quinteros, Trinidad, Haro, Jaime M, Regalado, Susana, Guitton, Javier, Arbanil, Hugo, Pansieri, Michel, Decoulx, Eric, Goube, Pascal, de Labriolle, Axel, Labeque, Jean N, Range, Gregoire, Cottin, Yves, Montalescot, Gilles, Cayla, Guillaume, Danchin, Nicolas, Angoulvant, Denis, Ferrario, Emile, Elbaz, Meyer, Dubreuil, Olivier, Steg, Philippe G, Fontaine, Caroline, Sorbets, Emmanuel, Omer, Hafiz, Al-Saif, Shukri, Al-Faleh, Hussam, Al-Shehri, Abdullah, Alshehri, Halia, Bazari, Rasha, Hei, Pak, Ying, Man, Chan, Michael, Wong, Michelle, Ma, Ronald, Siu, Shing C, Tsang, Chiu C, Ferrario, Maurizio, Assanelli, Emilio, Senni, Michele, Piatti, Piermarco, Calabrò, Paolo, Urbinati, Stefano, Michisanti, Massimo, Varbella, Ferdinando, de Cosmo, Salvatore, Trevisan, Roberto, Bellotti, Sandro, Di Pasquale, Giuseppe, Bongo, Angelo S, Uguccioni, Massimo, Mannucci, Edoardo, Mauro, Ciro, Ragonese, Mauro, Fresco, Claudio, Turturo, Maurizio, Marcucci, Rossella, Lievano Triana, Manuel J, Arana, Camilo, Accini, Jose, Botero, Rodrigo, Muzyk-Osikowicz, Marlena, Dada, Fredy T, Vallejo, Gregorio S, Manzur, Fernando, Isaza, Daniel, Molina, Dora, Mesa, Juan G, Quintero, Alvaro, Nyman, Kai, Mäkelä, Jyrki, Strand, Jorma, Nieminen, Sakari, Taurio, Jyrki, Kuusela, Matti, Valle, Timo, Pietilä, Mikko, Kekki, Sakari, Strandberg, Timo, Klutstein, Marc, Greenberg, Gabriel, Rozenman, Yoseph, Chorin, Ehud, Roguin, Ariel, Lewis, Basil, Bashkin, Amir, Tan, Edgar, Prado, Jose P, Ferrolino, Arthur, Babilonia, Noe, Barbas, Benny, Matiga, Generoso, Coching, Raul M, Drexel, Heinz, Brath, Helmut, Schnack, Christoph, Hanusch, Ursula, Fließer-Görzer, Evelyn, Paulweber, Bernhard, Ebenbichler, Christoph, Prager, Rudolf, Huber, Kurt, Wolzt, Michael, Auer, Johann, Berger, Rudolf, Schernthaner, Gerit-Holger, Stanciulescu, Gabriela, Creteanu, Mihai, Spiridon, Marilena, Dobreanu, Viorica, Vinereanu, Dragos, Iosipescu, Laura C, Istratoaie, Octavian, Coman, Ioan, Militaru, Constantin, Cinteza, Mircea, Bhatt, Deepak L, Fox, Kim, Harrington, Robert A, Leiter, Lawrence A, Mehta, Shamir R, Simon, Tabassome, Andersson, Marielle, Himmelmann, Anders, Steg, Philippe G, Diaz, Rafael, Amerena, John, Huber, Kurt, Sinnaeve, Peter R, Nicolau, José C, Kerr Saraiva, José F, Petrov, Ivo, Leiter, Lawrence A, Mehta, Shamir R, Corbalán, Ramón, Ge, Junbo, Zhao, Qiang, Botero, Rodrigo, Widimský, Petr, Kristensen, Steen D, Hartikainen, Juha, Danchin, Nicolas, Darius, Harald, Tse, Hung F, Kiss, Robert G, Pais, Prem, Lev, Eli, de Luca, Leonardo, Goto, Shinya, Ramos López, Gabriel A, Cornel, Jan H, Kontny, Frederic, Medina, Felix, Babilonia, Noe A, Opolski, Grzegorz, Vinereanu, Dragos, Zateyshchikov, Dmitry A, Ruda, Mikhail, Elamin, Omer, Kovář, František, Dalby, Anthony J, Jeong, Myung H, Bueno, Héctor, James, Stefan K, Chiang, Chern-En, Tresukosol, Damras, Ongen, Zeki, Ray, Kausik K, Parkhomenko, Alexander, McGuire, Darren K, Kosiborod, Mikhail N, Nguyen, Tuan Q, Andersson, Marielle, Chen, Jersey, Himmelmann, Anders, Leonsson-Zachrisson, Maria, and Ridderstråle, Wilhelm
Abstract: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor.
Published: 2019
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210. Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial

Author: Bohula, Erin A, Scirica, Benjamin M, Inzucchi, Silvio E, McGuire, Darren K, Keech, Anthony C, Smith, Steven R, Kanevsky, Estella, Murphy, Sabina A, Leiter, Lawrence A, Dwyer, Jamie P, Corbalan, Ramon, Hamm, Christian, Kaplan, Lee, Nicolau, Jose Carlos, Ophuis, Ton Oude, Ray, Kausik K, Ruda, Mikhail, Spinar, Jindrich, Patel, Tushar, Miao, Wenfeng, Perdomo, Carlos, Francis, Bruce, Dhadda, Shobha, Bonaca, Marc P, Ruff, Christian T, Sabatine, Marc S, Wiviott, Stephen D, Sabatine, Marc S, Wiviott, Stephen D, Scirica, Benjamin M, Inzucchi, Silvio, Keech, Anthony, McGuire, Darren K, Smith, Steven R, Satlin, Andrew, Brown, Conville, Budaj, Andrzej, Corbalan, Ramon, Dwyer, Jamie, Garcia-Castillo, Armando, Gupta, Milan, Hamm, Christian, Kaplan, Lee, Keech, Anthony, Leiter, Lawrence A, Nicolau, Jose Carlos, Oude Ophuis, Ton, Ray, Kauski, Ruda, Mikhail, Scirica, Benjamin M, Spinar, Jindrich, Weissman, Neil, White, Harvey D, Wiviott, Stephen D, Amerena, J, Arstall, M, Colquhoun, D, Jayasinghe, R, Lee, A, Lehman, R, Moses, R, Proietto, J, Purnell, P, Waites, J, Blombery, P, Cross, D, Worthley, M, d'Emden, M, Selvanayagam, J, Oqueli, RE, Whelan, A, Garrahy, P, de Looze, F, Ninio, D, Horowitz, J, William, M, Suranyi, M, Wittert, G, Le May, M, Pandey, AS, Vizel, S, Labonte, R, Beaudry, Y, Fortin, C, Bell, A, Kouz, S, St-Amour, É, Bata, I, St Maurice, F, Chehayeb, R, Constance, C, Wong, G, Hess, A, Liutkus, J, Poirier, P, Teitelbaum, I, Berlingieri, J, Cha, J, Hartleib, M, Heffernan, M, Twum-Barima, D, Pandith, V, Aronson, R, Goldenberg, R, Ajala, B, Jain, A, Ross, S, Bajaj, H, Khandwala, H, Yared, Z, Gupta, N, Bédard, J, Wharton, S, Blouin, F, Savard, D, Shukla, D, Cobos, J, Godoy, G, Perez, L, Pincetti, C, Saavedra Guajardo, V, Varleta, P, Conejeros, C, Lanas, F, Bayram Llamas, E, Cardona Muñoz, E, Garcia, R, Garza Ruiz, J, Llamas Esperon, G, Lopez Rosas, E, Melendez Mier, G, Ramos, G, Hart, H, Scott, D, Ternouth, I, Benatar, J, Elliott, J, Cutfield, R, Manning, P, Williams, M, Ferrier, K, Scott, R, Wilson, S, Leikis, R, Nirmalaraj, BK, Krzyżagórska, E, Miękus, P, Bronisz, M, Mirek-Bryniarska, E, Łanda, K, Stasiewski, A, Żechowicz, T, Zytkiewicz-Jaruga, D, Korecki, J, Ogórek, M, Pawłowicz, L, Piepiorka, M, Skierkowska, J, Stankiewicz, A, Szyprowska, E, Witek, R, Bochenek, A, Kończakowski, P, Wojnowski, Ł, Wujkowski, M, Cymerman, K, Korzeniak, R, Mąder, P, Mikłaszewicz, B, Stachlewski, P, Goch, A, Pomiećko, W, Skórski, M, Romanowski, L, Jusiak, K, Laskowska-Derlaga, E, Bijata-Bronisz, R, Kaźmierczak, J, Goldberg, R, Henderson, D, Korban, E, Rohr, K, Claxton, E, Weiss, R, Angiolillo, D, Boccalandro, F, Chu, K, Thorn, E, Randhawa, P, Singh, N, Bittar, G, Guarnieri, T, Saeed, S, Sharma, S, Shepard, M, French, W, Desai, P, Bernstein, R, Rogers, W, Singal, R, Schneider, R, Shanes, J, Ong, S, Condit, J, Donahoe, S, Brill, D, Einhorn, D, Ebrahimi, R, Labroo, A, Graf, R, Scott, J, Hoekstra, J, Jetty, P, Luckasen, G, O'Donnell, P, Gonte, W, Pomposini, D, Quadrel, M, Koren, M, Schlager, D, Schramm, E, Singal, D, Lupovitch, S, Soni, A, Seigel, P, Roberts, J, Soufer, J, Reza, S, Quinlan, E, Moretto, T, First, B, Khan, M, Chilka, S, Colfer, H, Teklinski, A, Wallace-Wilding, K, Ellison, H, Muse, D, Aronoff, S, Higgins, A, Patel, S, Elinoff, V, Karim, A, Awasty, V, Chuang, R, Roseman, H, Dugano-Daphnis, P, Albert, M, Sheikh, K, Bays, H, Kaster, S, Goldstein, M, Rubino, D, Calatayud, G, Snyder, H, Williams, T, Hershon, K, Hagan, M, Isserman, S, Kahn, B, Anderson, J, Gimness, MP, Raisinghani, A, Christina, M, Raikhel, M, Gillespie, E, Portnay, E, Heiman, M, Qureshi, M, Lee, J, Blonder, R, Cucher, F, Miller, G, Kotlaba, D, Cornett, G, Beavins, J, Augenbraun, C, Reinhardt, S, Bartkowiak, A, Salacata, A, Blevins, T, Benjamin, S, Diener, J, George, W, Barker, B, Richwine, R, Baldari, D, Alfieri, A, Barreto, A, Zhang, L, Shah, R, Hendrix, E, Subramaniyam, V, Hurley, S, Lillestol, M, O'Donoghue, M, Shayani, S, Ryan, E, Call, R, Zemel, L, Chang, A, Kivitz, A, Freyne, B, Bland, V, Shore, K, Mostel, E, Uzoaga, E, Andrawis, N, Gabra, N, Ghitis, A, Sabatino, K, Browder, D, Varma, S, Smith, S, Fink, R, Aycock, GR, Doty, WD, Alfonso, T, Eshaghian, S, Karlsberg, R, Zarich, S, Landau, C, McKenzie, M, Krause, R, Davis, W, Haddad, T, Voyce, S, Alford, C, LeDoux, J, O'Dea, D, McKenzie, M, Park, J, Aroda, V, Getaneh, A, Graham, B, Bhagwat, R, Korn, D, Ruoff, G, Wiseman, A, Lieber, I, Fialkow, J, Gonzalez-Campoy, JM, Bayron, C, Bertolet, B, Lash, J, Gerrish, C, Robertson, D, Rosenfeld, J, Seidner, M, Agaiby, J, Silverfield, J, Sugimoto, D, Lubin, B, Alhaddad, M, Lui, H, Lakin, G, Chokshi, S, Donovan, D, Felten, W, Minton, S, Kimmelstiel, C, Kuvin, J, Still, C, Byars, W, Talano, J, Desai, V, Bradley, AJ, Baker, S, Chane, M, Mercado, A, Baron, S, Harris, B, Mayer, N, Concha, M, Carr, K, Chaykin, L, Willis, J, Clay, A, Fenstad, E, Furda, J, Peterson, P, Chang, M, Aronne, L, Jones, D, Prashad, R, Benson, M, Stegemoller, R, Longshaw, K, Saleh, J, Jennings, W, Detweiler, R, Viswanath, D, Patel, R, Miller, G, Lederman, S, Weinstein, D, Korabathina, R, Singh, V, Rosen, J, Estevez, R, Levin, P, McNeill, R, Kalen, V, Reed, J, Ashley, R, Herman, L, Tsai, Y, Kayne, D, White, A, Hussain, I, Tami, L, Cohen, K, Robinson, J, Sharma, S, Fuchs-Ertman, D, Platt, G, Belardo, L, Reddy, R, Rosendorff, C, Saba, F, Powell, S, Anderson, K, Abidi, M, Rezkalla, S, Paraschos, A, Wilson, J, Moursi, M, Shah, A, Patel, R, Nadar, V, Stonesifer, L, Bialow, M, Cannon, K, Ellison, W, Stedman, M, Brown, J, Harper, W, Lucas, KJ, DiGiovanna, M, Rodbard, H, Biscoveanu, M, Davis, C, Hall, J, Littlefield, R, Gorman, T, Kereiakes, D, Chang, FM, Tatu, H, Cheung, D, Kaine, J, Knutson, T, Logemann, T, Pueblitz, G, Bianco, J, Henson, B, Neustel, M, Gelernt, M, Nelson, W, Moriarty, K, Lefebvre, G, Maw, K, Rink, L, Behn, P, Studdard, H, Argoud, G, O'Connor, T, Krichmar, P, Raad, G, Pereles-Ortiz, J, Sorli, C, Cohen, A, Pettis, K, Cavanaugh, B, Phillips, C, Wahlen, J, Radin, D, Rider, J, Kosinski, E, Leimbach, W, Odhav, A, Hakas, J, Tan, A, Howell, M, Wombolt, D, Fishman, N, Shah, P, Wylie, P, Arauz-Pacheco, C, Cavale, A, George, A, Kroll, R, Krantzler, J, Tahirkheli, N, Jabro, M, Newell, M, Mullen, P, Gencheff, N, Meli, J, Vora, K, Kotek, L, Pyzdrowski, K, Paez, H, Moran, J, Tannenbaum, A, Deck, K, Busch, R, Levinson, L, Azizad, M, Whitaker, J, Fox, B, Huffman, C, Ashraf, M, Diogo, J, Kushner, R, Tallet, J, Channamsetty, V, Suh, D, Atieh, M, Navas, J, Young, V, Shaw, S, Dor, I, Duffy, B, Rubin, P, Lewis, D, Kaye, W, Benton, R, Burbano, J, Hotchkiss, D, Magno, A, Alberton, A, Collins, J, Alvarado, O, Stich, M, Mahal, S, Liu, J, Hong, M, Dy, J, Block, B, Lamantia, J, Pritchard, J, Davis, M, Srivastava, S, Bilazarian, S, Rosario, R, McCartney, M, Blumberg, V, Rajan, R, Martin, E, Wright, S, White, A, Levinson, L, Brinson, C, Johnston, J, Wilson, S, Graves, M, Dominguez, M, McKenzie, W, Abadier, R, Tran, C, Castello, R, Morawski, E, White, J, Morris, F, Perez, A, Trueba, P, Sanchez, M, Andersen, J, Kastelic, R, Khan, J, Rodriguez, H, Izquierdo, W, Matias, A, Essandoh, L, and Ince, C
Abstract: There is a direct relationship between bodyweight and risk of diabetes. Lorcaserin, a selective serotonin 2C receptor agonist that suppresses appetite, has been shown to facilitate sustained weight loss in obese or overweight patients. We aimed to evaluate the long-term effects of lorcaserin on diabetes prevention and remission.
Published: 2018
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211. Patients with diabetes mellitus and atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants: meta-analysis of eight outcomes in 58 634 patients across four randomized controlled trials

Author: Plitt, Anna, Zelniker, Thomas A, Park, Jeong-Gun, McGuire, Darren K, Ruff, Christian T, Antman, Elliott M, Braunwald, Eugene, and Giugliano, Robert P
Published: 2021
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212. Trends in Hospitalizations for Heart Failure and Ischemic Heart Disease Among US Adults With Diabetes

Author: Honigberg, Michael C., Patel, Ravi B., Pandey, Ambarish, Fonarow, Gregg C., Butler, Javed, McGuire, Darren K., and Vaduganathan, Muthiah
Published: 2021
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213. Biomarker-Based Risk Prediction of Incident Heart Failure in Pre-Diabetes and Diabetes

Author: Pandey, Ambarish, Vaduganathan, Muthiah, Patel, Kershaw V., Ayers, Colby, Ballantyne, Christie M., Kosiborod, Mikhail N., Carnethon, Mercedes, DeFilippi, Christopher, McGuire, Darren K., Khan, Sadiya S., Caughey, Melissa C., de Lemos, James A., and Everett, Brendan M.
Abstract: This study evaluated the application of a biomarker-based risk score to identify individuals with dysglycemia who are at high risk for incident heart failure (HF) and to inform allocation of effective preventive interventions.
Published: 2021
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214. Association of SGLT2 Inhibitors With Cardiovascular and Kidney Outcomes in Patients With Type 2 Diabetes: A Meta-analysis

Author: McGuire, Darren K., Shih, Weichung J., Cosentino, Francesco, Charbonnel, Bernard, Cherney, David Z. I., Dagogo-Jack, Samuel, Pratley, Richard, Greenberg, Michelle, Wang, Shuai, Huyck, Susan, Gantz, Ira, Terra, Steven G., Masiukiewicz, Urszula, and Cannon, Christopher P.
Abstract: IMPORTANCE: Sodium-glucose cotransporter 2 (SGLT2) inhibitors favorably affect cardiovascular (CV) and kidney outcomes; however, the consistency of outcomes across the class remains uncertain. OBJECTIVE: To perform meta-analyses that assess the CV and kidney outcomes of all 4 available SGLT2 inhibitors in patients with type 2 diabetes. DATA SOURCES: A systematic literature search was conducted in PubMed from January 1, 2015, to January 31, 2020. STUDY SELECTION: One hundred forty-five records were initially identified; 137 were excluded because of study design or topic of interest. As a result, a total of 6 randomized, placebo-controlled CV and kidney outcomes trials of SGLT2 inhibitors in patients with type 2 diabetes were identified, with contributory data from 9 publications. All analyses were conducted on the total patient population of these trials. DATA EXTRACTION AND SYNTHESIS: Standardized data search and abstraction were performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Statement. Data were analyzed using a fixed-effect model. MAIN OUTCOMES AND MEASURES: Outcomes included time to the first event of (1) the composite of major adverse CV events of myocardial infarction, stroke, or CV death, and each component, (2) the composite of hospitalization for heart failure (HHF) or CV death (HHF/CV death) and each component, and (3) kidney composite outcomes. For outcomes in the overall trial populations and in selected subgroups, hazard ratios (HRs) and 95% CIs were pooled and meta-analyzed across trials. RESULTS: Data from 6 trials comprised 46 969 unique patients with type 2 diabetes, including 31 116 (66.2%) with atherosclerotic CV disease. The mean (SD) age of all trial participants was 63.7 (7.9) years; 30 939 (65.9%) were men, and 36 849 (78.5%) were White. The median number of participants per trial was 8246 (range, 4401-17 160). Overall, SGLT2 inhibitors were associated with a reduced risk of major adverse CV events (HR, 0.90; 95% CI, 0.85-0.95; Q statistic, P = .27), HHF/CV death (HR, 0.78; 95% CI, 0.73-0.84; Q statistic, P = .09), and kidney outcomes (HR, 0.62; 95% CI, 0.56-0.70; Q statistic, P = .09), with no significant heterogeneity of associations with outcome. Associated risk reduction for HHF was consistent across the trials (HR, 0.68; 95% CI, 0.61-0.76; I2 = 0.0%), whereas significant heterogeneity of associations with outcome was observed for CV death (HR, 0.85; 95% CI, 0.78-0.93; Q statistic, P = .02; I2 = 64.3%). The presence or absence of atherosclerotic CV disease did not modify the association with outcomes for major adverse CV events (HR, 0.89; 95% CI, 0.84-0.95 and HR, 0.94; 95% CI, 0.83-1.07, respectively; P = .63 for interaction), with similar absence of associations with outcome modification by prevalent atherosclerotic CV disease for HHF/CV death (P = .62 for interaction), HHF (P = .26 for interaction), or kidney outcomes (P = .73 for interaction). CONCLUSIONS AND RELEVANCE: In this meta-analysis, SGLT2 inhibitors were associated with a reduced risk of major adverse CV events; in addition, results suggest significant heterogeneity in associations with CV death. The largest benefit across the class was for an associated reduction in risk for HHF and kidney outcomes, with benefits for HHF risk being the most consistent observation across the trials.
Published: 2021
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215. SGLT2 Inhibition for CKD and Cardiovascular Disease in Type 2 Diabetes: Report of a Scientific Workshop Sponsored by the National Kidney Foundation

Author: Tuttle, Katherine R., Brosius, Frank C., Cavender, Matthew A., Fioretto, Paola, Fowler, Kevin J., Heerspink, Hiddo J.L., Manley, Tom, McGuire, Darren K., Molitch, Mark E., Mottl, Amy K., Perreault, Leigh, Rosas, Sylvia E., Rossing, Peter, Sola, Laura, Vallon, Volker, Wanner, Christoph, and Perkovic, Vlado
Abstract: Diabetes is the most frequent cause of chronic kidney disease (CKD), leading to nearly half of all cases of kidney failure requiring replacement therapy. The principal cause of death among patients with diabetes and CKD is cardiovascular disease (CVD). Sodium/glucose cotransporter 2 (SGLT2) inhibitors were developed to lower blood glucose levels by inhibiting glucose reabsorption in the proximal tubule. In clinical trials designed to demonstrate the CVD safety of SGLT2 inhibitors in type 2 diabetes mellitus (T2DM), consistent reductions in risks for secondary kidney disease end points (albuminuria and a composite of serum creatinine doubling or 40% estimated glomerular filtration rate decline, kidney failure, or death), along with reductions in CVD events, were observed. In patients with CKD, the kidney and CVD benefits of canagliflozin were established by the CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation) trial in patients with T2DM, urinary albumin-creatinine ratio>300mg/g, and estimated glomerular filtration rate of 30 to<90mL/min/1.73m2. To clarify and support the role of SGLT2 inhibitors for treatment of T2DM and CKD, the National Kidney Foundation convened a scientific workshop with an international panel of more than 80 experts. They discussed the current state of knowledge and unanswered questions to propose therapeutic approaches and delineate future research. SGLT2 inhibitors improve glomerular hemodynamic function and are thought to ameliorate other local and systemic mechanisms involved in the pathogenesis of CKD and CVD. SGLT2 inhibitors should be used when possible by people with T2DM to reduce risks for CKD and CVD in alignment with the clinical trial entry criteria. Important risks of SGLT2 inhibitors include euglycemic ketoacidosis, genital mycotic infections, and volume depletion. Careful consideration should be given to the balance of benefits and harms of SGLT2 inhibitors and risk mitigation strategies. Effective implementation strategies are needed to achieve widespread use of these life-saving medications.
Published: 2021
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216. Best Practices for Human Milk Collection for COVID-19 Research

Author: McGuire, Michelle K., Seppo, Antti, Goga, Ameena, Buonsenso, Danilo, Collado, María Carmen, Donovan, Sharon M., Müller, Janis A., Ofman, Gaston, Monroy-Valle, Michele, O'Connor, Deborah L., Pace, Ryan M., and Van de Perre, Philippe
Abstract: In addition to providing life-giving nutrients and other substances to the breastfed infant, human milk can also represent a vehicle of pathogen transfer. As such, when an infectious disease outbreak, epidemic, or pandemic occurs—particularly when it is associated with a novel pathogen—the question will naturally arise as to whether the pathogen can be transmitted through breastfeeding. Until high-quality data are generated to answer this question, abandonment of breastfeeding due to uncertainty can result. The COVID-19 pandemic, which was in full swing at the time this document was written, is an excellent example of this scenario. During these times of uncertainty, it is critical for investigators conducting research to assess the possible transmission of pathogens through milk, whether by transfer through the mammary gland or contamination from respiratory droplets, skin, breast pumps, and milk containers, and/or close contact between mother and infant. To promote the most rigorous science, it is critical to outline optimal methods for milk collection, handling, storage, and analysis in these situations, and investigators should openly share their methods in published materials. Otherwise, the risks of inconsistent test results from preanalytical and analytical variation, false positives, and false negatives are unacceptably high and the ability to provide public health guidance poor. In this study, we provide “best practices” for collecting human milk samples for COVID-19 research with the intention that this will also be a useful guide for future pandemics.
Published: 2021
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217. Two Tales: One Story

Author: Verma, Subodh, McGuire, Darren K., and Kosiborod, Mikhail N.
Published: 2020
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218. Efficacy of Ertugliflozin on Heart Failure–Related Events in Patients With Type 2 Diabetes Mellitus and Established Atherosclerotic Cardiovascular Disease

Author: Cosentino, Francesco, Cannon, Christopher P., Cherney, David Z.I., Masiukiewicz, Urszula, Pratley, Richard, Dagogo-Jack, Sam, Frederich, Robert, Charbonnel, Bernard, Mancuso, James, Shih, Weichung J., Terra, Steven G., Cater, Nilo B., Gantz, Ira, and McGuire, Darren K.
Abstract: Supplemental Digital Content is available in the text.
Published: 2020
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219. Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial

Author: McGuire, Darren K, Zinman, Bernard, Inzucchi, Silvio E, Wanner, Christoph, Fitchett, David, Anker, Stefan D, Pocock, Stuart, Kaspers, Stefan, George, Jyothis T, von Eynatten, Maximilian, Johansen, Odd Erik, Jamal, Waheed, Mattheus, Michaela, Elsasser, Ulrich, Hantel, Stefan, and Lund, Søren S
Abstract: Patients with type 2 diabetes and atherosclerotic cardiovascular disease are at high clinical risk. We assessed the effect of the sodium-glucose co-transporter-2 inhibitor, empagliflozin, on total cardiovascular events and admissions to hospital in the EMPA-REG OUTCOME trial.
Published: 2020
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220. Celebrating The Next Generation of Cardiovascular Investigators

Author: de Lemos, James A., McGuire, Darren K., and Hill, Joseph A.
Published: 2022
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221. Use of Glucagon-Like Peptide-1 Receptor Agonists in Patients With Type 2 Diabetes and Cardiovascular Disease: A Review

Author: Honigberg, Michael C., Chang, Lee-Shing, McGuire, Darren K., Plutzky, Jorge, Aroda, Vanita R., and Vaduganathan, Muthiah
Abstract: IMPORTANCE: Recent randomized clinical trials have demonstrated that glucagon-like peptide-1 receptor agonists (GLP-1RAs) reduce cardiovascular events in at-risk individuals with type 2 diabetes. Despite these findings, GLP-1RAs are underused in eligible patients, particularly by cardiologists. OBSERVATIONS: To date, randomized clinical trials of albiglutide, dulaglutide, liraglutide, and injectable semaglutide have reported favorable cardiovascular outcomes. Most recently approved for clinical use, oral semaglutide has a favorable safety profile and is currently undergoing regulatory evaluation and further study for cardiovascular outcomes. Professional society guidelines now recommend GLP-1RA therapy for cardiovascular risk mitigation in patients with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors, independent of glucose control or background antihyperglycemic therapy (other diabetes medications being used). Additional conditions suitable for GLP-1RA therapy include obesity and advanced chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1.73 m2), for which cardiovascular risk-reducing options are limited. Out-of-pocket costs and secondary advantages (eg, weight loss) may inform shared decision-making discussions regarding potential therapies. GLP-1RA therapy has a favorable safety profile. Its most common adverse effect is gastrointestinal upset, which typically wanes during the early weeks of therapy and may be mitigated by starting at the lowest dose and escalating as tolerated. Depending on baseline glycemic control, sulfonylureas and insulin may need to be decreased before GLP-1RA initiation; without concurrent use of insulin or sulfonylureas, GLP-1RAs are not associated with hypoglycemia. Multidisciplinary follow-up and collaborative care with primary care physicians and/or endocrinologists are important. CONCLUSIONS AND RELEVANCE: Findings from this review suggest that GLP-1RAs are safe, are well tolerated, and improve cardiovascular outcomes, largely independent of their antihyperglycemic properties, but they remain underused by cardiologists. This review provides a practical resource for cardiologists for initiating GLP-1RAs and managing the therapy in patients with type 2 diabetes and established ASCVD or high risk for ASCVD.
Published: 2020
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222. Glucagon-Like Peptide 1 Receptor Agonists and Heart Failure

Author: Khan, Muhammad Shahzeb, Fonarow, Gregg C., McGuire, Darren K., Hernandez, Adrian F., Vaduganathan, Muthiah, Rosenstock, Julio, Handelsman, Yehuda, Verma, Subodh, Anker, Stefan D., McMurray, John J.V., Kosiborod, Mikhail N., and Butler, Javed
Abstract: Supplemental Digital Content is available in the text.With worsening epidemiological trends for both the incidence and prevalence of type 2 diabetes mellitus (T2DM) and heart failure (HF) worldwide, it is critical to implement optimal prevention and treatment strategies for patients with these comorbidities, either alone or concomitantly. Several guidelines and consensus statements have recommended glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter type 2 inhibitors as add-ons to lifestyle interventions with or without metformin in those at high atherosclerotic cardiovascular disease risk. However, these recommendations are either silent about HF or fail to differentiate between the prevention of HF in those at risk versus the treatment of individuals with manifest HF. Furthermore, these documents do not differentiate among those with different HF phenotypes. This distinction, even though important, may not be critical for sodium-glucose cotransporter type 2 inhibitors in view of the consistent data for benefit for both atherosclerotic cardiovascular disease– and HF-related outcomes that have emerged from the regulatory-mandated cardiovascular outcome trials for all sodium-glucose cotransporter type 2 inhibitors and the recent DAPA-HF trial (Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction)demonstrating the benefit of dapagliflozin on HF-related outcomes in patients with HF with reduced ejection fraction with or without T2DM. However, the distinction may be crucial for glucagon-like peptide-1 receptor agonists and other antihyperglycemic agents. Indeed, in several of the new statements, glucagon-like peptide-1 receptor agonists are suggested treatment not only for patients with T2DM and atherosclerotic cardiovascular disease, but also in those with manifest HF, despite a lack of evidence for the latter recommendation. Although glucagon-like peptide-1 receptor agonists may be appropriate to use in patients at risk for HF, mechanistic insights and observations from randomized trials suggest no clear benefit on HF-related outcomes and even uncertainty regarding the safety in those with HF with reduced ejection fraction. Conversely, theoretical rationales suggest that these agents may benefit patients with HF with preserved ejection fraction. Considering that millions of patients with T2DM have HF, these concerns have public health implications that necessitate the thoughtful use of these therapies. Achieving this aim will require dedicated trials with these drugs in both patients who have HF with reduced ejection fraction and HF with preserved ejection fraction with T2DM to assess their efficacy, safety, and risk-benefit profile.
Published: 2020
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223. Characteristics and Outcomes of Children With Coronavirus Disease 2019 (COVID-19) Infection Admitted to US and Canadian Pediatric Intensive Care Units

Author: Shekerdemian, Lara S., Mahmood, Nabihah R., Wolfe, Katie K., Riggs, Becky J., Ross, Catherine E., McKiernan, Christine A., Heidemann, Sabrina M., Kleinman, Lawrence C., Sen, Anita I., Hall, Mark W., Priestley, Margaret A., McGuire, John K., Boukas, Konstantinos, Sharron, Matthew P., and Burns, Jeffrey P.
Abstract: IMPORTANCE: The recent and ongoing coronavirus disease 2019 (COVID-19) pandemic has taken an unprecedented toll on adults critically ill with COVID-19 infection. While there is evidence that the burden of COVID-19 infection in hospitalized children is lesser than in their adult counterparts, to date, there are only limited reports describing COVID-19 in pediatric intensive care units (PICUs). OBJECTIVE: To provide an early description and characterization of COVID-19 infection in North American PICUs, focusing on mode of presentation, presence of comorbidities, severity of disease, therapeutic interventions, clinical trajectory, and early outcomes. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included children positive for COVID-19 admitted to 46 North American PICUs between March 14 and April 3, 2020. with follow-up to April 10, 2020. MAIN OUTCOMES AND MEASURES: Prehospital characteristics, clinical trajectory, and hospital outcomes of children admitted to PICUs with confirmed COVID-19 infection. RESULTS: Of the 48 children with COVID-19 admitted to participating PICUs, 25 (52%) were male, and the median (range) age was 13 (4.2-16.6) years. Forty patients (83%) had significant preexisting comorbidities; 35 (73%) presented with respiratory symptoms and 18 (38%) required invasive ventilation. Eleven patients (23%) had failure of 2 or more organ systems. Extracorporeal membrane oxygenation was required for 1 patient (2%). Targeted therapies were used in 28 patients (61%), with hydroxychloroquine being the most commonly used agent either alone (11 patients) or in combination (10 patients). At the completion of the follow-up period, 2 patients (4%) had died and 15 (31%) were still hospitalized, with 3 still requiring ventilatory support and 1 receiving extracorporeal membrane oxygenation. The median (range) PICU and hospital lengths of stay for those who had been discharged were 5 (3-9) days and 7 (4-13) days, respectively. CONCLUSIONS AND RELEVANCE: This early report describes the burden of COVID-19 infection in North American PICUs and confirms that severe illness in children is significant but far less frequent than in adults. Prehospital comorbidities appear to be an important factor in children. These preliminary observations provide an important platform for larger and more extensive studies of children with COVID-19 infection.
Published: 2020
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224. Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58

Author: Bonaca, Marc P., Wiviott, Stephen D., Zelniker, Thomas A., Mosenzon, Ofri, Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Goodrich, Erica L., De Mendonca Furtado, Remo Holanda, Wilding, John P.H., Cahn, Avivit, Gause-Nilsson, Ingrid A.M., Johanson, Per, Fredriksson, Martin, Johansson, Peter A., Langkilde, Anna Maria, Raz, Itamar, and Sabatine, Marc S.
Abstract: Supplemental Digital Content is available in the text.
Published: 2020
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225. Association of Intensive Lifestyle Intervention, Fitness, and Body Mass Index With Risk of Heart Failure in Overweight or Obese Adults With Type 2 Diabetes Mellitus

Author: Pandey, Ambarish, Patel, Kershaw V., Bahnson, Judy L., Gaussoin, Sarah A., Martin, Corby K., Balasubramanyam, Ashok, Johnson, Karen C., McGuire, Darren K., Bertoni, Alain G., Kitzman, Dalane, and Berry, Jarett D.
Abstract: Supplemental Digital Content is available in the text.
Published: 2020
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226. Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus

Author: Zelniker, Thomas A., Bonaca, Marc P., Furtado, Remo H.M., Mosenzon, Ofri, Kuder, Julia F., Murphy, Sabina A., Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., Budaj, Andrzej, Kiss, Robert G., Padilla, Francisco, Gause-Nilsson, Ingrid, Langkilde, Anna Maria, Raz, Itamar, Sabatine, Marc S., and Wiviott, Stephen D.
Abstract: Supplemental Digital Content is available in the text.
Published: 2020
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227. Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus

Author: Sharma, Abhinav, Pagidipati, Neha J., Califf, Robert M., McGuire, Darren K., Green, Jennifer B., Demets, Dave, George, Jyothis Thomas, Gerstein, Hertzel C., Hobbs, Todd, Holman, Rury R., Lawson, Francesca C., Leiter, Lawrence A., Pfeffer, Marc A., Reusch, Jane, Riesmeyer, Jeffrey S., Roe, Matthew T., Rosenberg, Yves, Temple, Robert, Wiviott, Stephen, McMurray, John, and Granger, Christopher
Abstract: Responding to concerns about the potential for increased risk of adverse cardiovascular outcomes, specifically myocardial infarction, associated with certain glucose-lowering therapies, the US Food and Drug Administration and the Committee for Medicinal Products for Human Use of the European Medicines Agency issued guidance to the pharmaceutical industry in 2008. Glucose-lowering therapies were granted regulatory approval primarily from smaller studies that have demonstrated reductions in glycated hemoglobin concentration. Such studies were overall underpowered and of insufficient duration to show any effect on cardiovascular outcomes. The 2008 guidance aimed to ensure the cardiovascular safety of new glucose-lowering therapies to treat patients with type 2 diabetes mellitus. This resulted in a plethora of new cardiovascular outcome trials, most designed primarily as placebo-controlled noninferiority trials, but with many also powered for superiority. Several of these outcome trials demonstrated cardiovascular benefits of the newer agents, resulting in the first-ever cardiovascular protection indications for glucose-lowering therapies. Determining whether the guidance continues to have value in its current form is critically important as we move forward after the first decade of implementation. In February 2018, a think tank comprising representatives from academia, industry, and regulatory agencies convened to consider the guidance in light of the findings of the completed cardiovascular outcome trials. The group made several recommendations for future regulatory guidance and for cardiovascular outcome trials of glucose-lowering therapies. These recommendations include requiring only the 1.3 noninferiority margin for regulatory approval, conducting trials for longer durations, considering studying glucose-lowering therapies as first-line management of type 2 diabetes mellitus, considering heart failure or kidney outcomes within the primary outcome, considering head-to-head active comparator trials, increasing the diversity of patients enrolled, evaluating strategies to streamline registries and the study of unselected populations, and identifying ways to improve translation of trial results to general practice.
Published: 2020
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228. Trends in Aggregate Use and Associated Expenditures of Antihyperglycemic Therapies Among US Medicare Beneficiaries Between 2012 and 2017

Author: Sumarsono, Andrew, Everett, Brendan M., McGuire, Darren K., Fonarow, Gregg C., Butler, Javed, Pandey, Ambarish, and Vaduganathan, Muthiah
Published: 2020
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229. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Author: Berg, David D., Wiviott, Stephen D., Scirica, Benjamin M., Gurmu, Yared, Mosenzon, Ofri, Murphy, Sabina A., Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., Johanson, Per, Johansson, Peter A., Langkilde, Anna Maria, Raz, Itamar, Braunwald, Eugene, and Sabatine, Marc S.
Abstract: Supplemental Digital Content is available in the text.
Published: 2019
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230. "I Couldn't See a Downside": Decision-Making About Gender-Affirming Hormone Therapy.

Author: Daley, Thomas, Grossoehme, Daniel, McGuire, Jenifer K., Corathers, Sarah, Conard, Lee Ann, and Lipstein, Ellen A.
Abstract: The aim of the article was to understand adolescents' and parents' decision-making process related to gender-affirming hormone therapy (GAHT). We conducted qualitative semistructured interviews with transgender adolescents who began testosterone for GAHT in the prior year and the parents of such adolescents. Questions focused on decision-making roles, steps in the decision process, and factors considered in the decision. Participants used pie charts to describe the division of responsibility for the decision. All interviews were coded by at least two members of the research team with disagreements resolved through discussion. Thematic analysis was used to analyze the data. Seventeen adolescents and 13 parents were interviewed (12 dyads). The process of deciding about GAHT involves a series of small conversations, typically with the adolescent advocating to start treatment and the parent feeling hesitant. In most cases, after seeking information from the Internet, healthcare providers and personal contacts move toward acceptance and agree to start treatment. Although adolescents have some short-term concerns, such as about needles, parents' concerns relate more to long-term risks. Ultimately, for both parents and adolescents, the benefits of treatment outweigh any concerns, and they are in agreement about the goals of personal confidence, comfort in one's body and happiness. To the extent that the decision about GAHT is a medical decision, the decision process is similar to others. However, decisions about GAHT are much more about gender identity than medical risks, suggesting that interventions based in a medical framework may not aid in supporting decision-making. [ABSTRACT FROM AUTHOR]
Published: 2019
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231. Heart Failure Epidemiology in Patients With Diabetes Mellitus Without Coronary Heart Disease.

Author: Khan, Hassan, Anker, Stefan D., Januzzi, James L., McGuire, Darren K., Sattar, Naveed, Woerle, Hans Juergen, Butler, Javed, and Januzzi, James L Jr
Abstract: Background: Epidemiology of patients with comorbid heart failure (HF) and diabetes mellitus (DM) without coronary heart disease (CHD) is not well described.Methods and Results: We assessed HF incidence and outcomes in 2896 participants of the Health ABC Study (age 74.0 ± 3.0 years, 48.4% men, 41.1% black, 34.6% with DM) in relation to prio DM and CHD status. During a median follow-up of 11.4 years, 484 participants (16.7%) developed incident HF; 214 (44.2%) had DM of whom 71 (33.1%) had no prio CHD. Incident HF rate was 2.5% per 100 person-years in those with and 1.5% in those without DM (hazard ratio [HR] 1.66, 95% CI 1.39-1.99). In those with DM, incident HF rate was 4.6% in those with and 1.3% in those without CHD (HR 3.75, 95% CI 2.81-4.99). During a median follow-up of 2.1 years after HF onset, 329 (68.0%) of the participants died. Amongst those with DM, annual mortality was 22.6% in those with versus 25.9% without CHD (HR 0.86, 95% CI 0.61-1.22). All-cause hospitalizations after incident HF in DM patients were 55.0 per 100 person-years in those with and 33.3 in those without CHD (rate ratio [RR] 1.64, 95% CI 1.24-2.16); HF hospitalizations were 42.7 and 30.7 per 100-person years (RR 1.39, 95% CI 1.03-1.86) in those with and without CHD. Reduced ejection fraction was seen in 49.6% of HF patients with DM and CHD and in 34.7% of those without CHD (P = .08); mortality but not hospitalization risk tended to be lower in those with reduced compared with preserved ejection fraction regardless of CHD status.Conclusions: A sizeable proportion of HF in patients with DM develops in the absence of prior CHD; these patients are at risk for mortality similar to those with CHD. These data underscore the importance of modulating risk beyond atherosclerosis in patients with comorbid HF and DM. [ABSTRACT FROM AUTHOR]
Published: 2019
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232. Design and baseline characteristics of the eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial (VERTIS-CV).

Author: Cannon, Christopher P., McGuire, Darren K., Pratley, Richard, Dagogo-Jack, Sam, Mancuso, James, Huyck, Susan, Charbonnel, Bernard, Shih, Weichung J., Gallo, Silvina, Masiukiewicz, Urszula, Golm, Gregory, Cosentino, Francesco, Lauring, Brett, Terra, Steven G., and VERTIS-CV Investigators
Abstract: Background: Ertugliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), approved in the United States and European Union to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). The VERTIS cardiovascular (CV) outcomes trial (NCT01986881) has a primary objective to demonstrate non-inferiority of ertugliflozin versus placebo on major adverse CV events: time to the first event of CV death, nonfatal myocardial infarction, or nonfatal stroke. Secondary objectives are to demonstrate superiority of ertugliflozin versus placebo on time to: 1) the composite outcome of CV death or hospitalization for heart failure (HF); 2) CV death; and 3) the composite outcome of renal death, dialysis/transplant, or doubling of serum creatinine from baseline.Methods: Patients ≥40 years old with T2DM (HbA1c 7.0-10.5%) and established atherosclerotic cardiovascular disease (ASCVD) of the coronary, cerebral, and/or peripheral arterial systems, were randomized 1:1:1 to once daily double-blind placebo, ertugliflozin 5 mg or 15 mg added to existing therapy.Results: 8246 patients were randomized and 8238 received at least 1 dose of investigational product. Mean age was 64.4 years, 11.0% were ≥75 years old, and mean diabetes duration was 12.9 years with screening HbA1c of 8.3%. At entry, coronary artery disease, cerebrovascular disease, and peripheral arterial disease were present in 76.3%, 23.1%, and 18.8% of patients, respectively. HF was present in 23.1%, and Stage 3 kidney disease in 21.6% of patients.Conclusion: The results from the VERTIS-CV trial will define the CV and renal safety and efficacy of ertugliflozin in patients with T2DM and ASCVD. [ABSTRACT FROM AUTHOR]
Published: 2018
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233. Associations between SARS-CoV-2 Infection or COVID-19 Vaccination and Human Milk Composition: A Multi-Omics Approach

Author: Couvillion, Sneha P., Nakayasu, Ernesto S., Webb-Robertson, Bobbie-Jo M., Yang, Isabella H., Eder, Josie G., Nicora, Carrie D., Bramer, Lisa M., Gao, Yuqian, Fox, Alisa, DeCarlo, Claire, Yang, Xiaoqi, Zhou, Mowei, Pace, Ryan M., Williams, Janet E., McGuire, Mark A., McGuire, Michelle K., Metz, Thomas O., and Powell, Rebecca L.R.
Abstract: The risk of contracting SARS-CoV-2 via human milk-feeding is virtually non-existent. Adverse effects of COVID-19 vaccination for lactating individuals are not different from the general population, and no evidence has been found that their infants exhibit adverse effects. Yet, there remains substantial hesitation among this population globally regarding the safety of these vaccines.
Published: 2024
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234. Reinvisioning Coparent Curriculum: Meeting the Needs of a Changing Population

Author: McCann, Ellie, Powell, Sharon, Becher, Emily H., and McGuire, Jenifer K.
Abstract: The goal of this article is to provide a framework for practitioners to update their curriculum using an in-depth case study of the Parents Forever program. As new research and best practices change, curriculum authors and program administrators should consider revising both the content and method of delivery of their courses. However, little literature exists to document the pragmatics of this process, particularly when operating within the context of a legislative mandate. The case study of the Parents Forever program curriculum update is grounded in a program life cycle model. Using this model, in-depth descriptions are provided, from beginning observations of current classes to final stages of the evaluation. This included piloting, formative evaluation, implementation, and summative evaluation, including results of a year of teaching the new curriculum, which are described along with next steps.
Published: 2024
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235. Maternal Cannabis Use during Lactation and Potential Effects on Human Milk Composition and Production: A Narrative Review

Author: Castro-Navarro, Irma, McGuire, Mark A, Williams, Janet E, Holdsworth, Elizabeth A, Meehan, Courtney L, and McGuire, Michelle K
Abstract: Cannabis use has increased sharply in the last 20 y among adults, including reproductive-aged women. Its recent widespread legalization is associated with a decrease in risk perception of cannabis use during breastfeeding. However, the effect of cannabis use (if any) on milk production and milk composition is not known. This narrative review summarizes current knowledge related to maternal cannabis use during breastfeeding and provides an overview of possible pathways whereby cannabis might affect milk composition and production. Several studies have demonstrated that cannabinoids and their metabolites are detectable in human milk produced by mothers who use cannabis. Due to their physicochemical properties, cannabinoids are stored in adipose tissue, can easily reach the mammary gland, and can be secreted in milk. Moreover, cannabinoid receptors are present in adipocytes and mammary epithelial cells. The activation of these receptors directly modulates fatty acid metabolism, potentially causing changes in milk fatty acid profiles. Additionally, the endocannabinoid system is intimately connected to the endocrine system. As such, it is probable that interactions of exogenous cannabinoids with the endocannabinoid system might modify release of critical hormones (e.g., prolactin and dopamine) that regulate milk production and secretion. Nonetheless, few studies have investigated effects of cannabis use (including on milk production and composition) in lactating women. Additional research utilizing robust methodologies are needed to elucidate whether and how cannabis use affects human milk production and composition.
Published: 2024
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236. Heterogeneity of psychosis risk within individuals at clinical high risk: A meta-analytical stratification

Author: Fusar-Poli, P, Cappucciati, M, Borgwardt, S, Woods, S W, Addington, J, Nelson, B, Nieman, D H, Stahl, D R, Rutigliano, G, Riecher-Rössler, A, Simon, A E, Mizuno, M, Lee, T Y, Kwon, J S, Lam, M M L, Perez, J, Keri, S, Amminger, P, Metzler, S, Kawohl, W, Rössler, W, Lee, J, Labad, J, Ziermans, T, An, S K, Liu, C C, Woodberry, K A, Braham, A, Corcoran, C, McGorry, P, Yung, Alison, McGuire, P K, Fusar-Poli, P, Cappucciati, M, Borgwardt, S, Woods, S W, Addington, J, Nelson, B, Nieman, D H, Stahl, D R, Rutigliano, G, Riecher-Rössler, A, Simon, A E, Mizuno, M, Lee, T Y, Kwon, J S, Lam, M M L, Perez, J, Keri, S, Amminger, P, Metzler, S, Kawohl, W, Rössler, W, Lee, J, Labad, J, Ziermans, T, An, S K, Liu, C C, Woodberry, K A, Braham, A, Corcoran, C, McGorry, P, Yung, Alison, and McGuire, P K
Published: 2016

237. Common and Distinct Neural Substrates for Pragmatic, Semantic, and Syntactic Processing of Spoken Sentences: An fMRI Study

Author: Kuperberg, G. R., McGuire, P. K., Bullmore, E. T., Brammer, M. J., Rabe-Hesketh, S., Wright, I. C., Lythgoe, D. J., Williams, S. C. R., and David, A. S.
Subjects: Brain -- Localization of functions, Neurolinguistics -- Research, Human information processing -- Research, Meaning (Psychology) -- Research, Neurology -- Research, Health, Psychology and mental health, Research
Abstract: Abstract * Extracting meaning from speech requires the use of pragmatic, semantic, and syntactic information. A central question is: Does the processing of these different types of linguistic information have [...]
Published: 2000

238. Finerenone and Cardiorenal Outcomes by History of Cardiovascular Disease in Patients with Type 2 Diabetes: Fidelity Analyses.

Author: Filippatos, Gerasimos, Anker, Stefan D., Pitt, Bertram, Rossing, Peter, Ruilope, Luis M., McGuire, Darren K., Jankowska, Ewa A., Michos, Erin D., Butler, Javed, Farjat, Alfredo E., Kolkhof, Peter, Scalise, Andrea, Joseph, Amer, Viaud, Marco A.L., Bakris, George L., and Agarwal, Rajiv
Abstract: Patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are at risk of cardiovascular complications. FIDELITY (prespecified pooled analysis of FIDELIO-DKD [NCT02540993] and FIGARO-DKD [NCT02545049]) evaluated finerenone (a selective, nonsteroidal mineralocorticoid receptor antagonist) in patients with CKD and T2D. Cardiovascular and kidney outcomes were compared in primary and secondary prevention populations. Patients with T2D, and either urine albumin-to-creatinine ratio (UACR [mg/g])≥30–<300 and estimated glomerular filtration rate (eGFR [mL/min/1.73m2])≥25–≤90, or UACR≥300–≤5,000 and eGFR≥25, treated with optimized renin–angiotensin system blockade, were randomized to finerenone or placebo. Cardiovascular outcomes (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or heart failure hospitalization) and kidney outcomes (kidney failure, sustained eGFR decrease≥57% or kidney death) were categorized by prior atherosclerotic cardiovascular disease (CVD). Investigator-reported adverse events (AEs) were assessed. 5,935/13,026 of eligible patients had a history of CVD. Finerenone lowered the risk of the cardiovascular outcome vs placebo (HR=0.86; 95%CI=0.78-0.95; 3.0-year median follow-up), with no treatment modification by CVD history (HR=0.83 [95%CI=0.74-0.94] in patients with CVD; HR=0.91 [95%CI=0.78-1.06] in patients without CVD; Pinteraction=0.375). The effect of finerenone on the kidney outcome (HR=0.77; 95%CI=0.67-0.88) was not modified by CVD (HR=0.71 [95%CI=0.57-0.88] and HR=0.81 [95%CI=0.68-0.97] in patients with and without CVD history, respectively; Pinteraction=0.325). AEs did not differ between CVD subgroups, with a low incidence of hyperkalemia-related treatment discontinuation that was more frequent in the finerenone group but similar between CVD subgroups. Finerenone reduced the risk of cardiovascular and kidney outcomes in patients with CKD and T2D vs placebo, irrespective of CVD history. [ABSTRACT FROM AUTHOR]
Published: 2022
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239. The effect of sodium nitroprusside on psychotic symptoms and spatial working memory in patients with schizophrenia: a randomized, double-blind, placebo-controlled trial

Author: Stone, J. M., primary, Morrison, P. D., additional, Koychev, I., additional, Gao, F., additional, Reilly, T. J., additional, Kolanko, M., additional, Mohammadinasab, A., additional, Kapur, S., additional, and McGuire, P. K., additional
Published: 2016
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240. Autoantibodies to central nervous system neuronal surface antigens: psychiatric symptoms and psychopharmacological implications

Author: Pollak, T. A., primary, Beck, K., additional, Irani, S. R., additional, Howes, O. D., additional, David, A. S., additional, and McGuire, P. K., additional
Published: 2015
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241. Cell-cell interactions in the rheumatoid joint

Author: McGuire, Mary K. B., Meats, Judith E., and Russell, R. G. G.
Published: 1980
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242. Properties of rheumatoid and normal synovial tissue in vitro and cells derived from them: Production of prostaglandins and collagenase in response to factors derived from cultured blood mononuclear cells and from synovium

Author: McGuire, M. K. B., Meats, J. E., Ebsworth, N. M., Harvey, L., Murphy, G., Russell, R. G. G., and Reynolds, J. J.
Published: 1982
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243. Enhanced production of prostaglandins and plasminogen activator during activation of human articular chondrocytes by products of mononuclear cells

Author: Meats, J. E., McGuire, M. K. B., Ebsworth, N. M., Englis, D. J., and Russell, R. G. G.
Published: 1984
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244. Patterns of glucose-lowering medication use in patients with type 2 diabetes and heart failure. Insights from the Diabetes Collaborative Registry (DCR).

Author: Arnold, Suzanne V., Echouffo-Tcheugui, Justin B., Lam, Carolyn SP, Inzucchi, Silvio E, Tang, Fengming, McGuire, Darren K, Goyal, Abhinav, Maddox, Thomas M, Sperling, Laurence S, Fonarow, Gregg C, Masoudi, Frederick A, Kosiborod, Mikhail, and Lam, Carolyn S P
Abstract: Background: Optimal glucose-lowering strategies in patients with both heart failure (HF) and type 2 diabetes mellitus (T2D) are not well defined, particularly as novel medication classes emerge.We sought to evaluate current patterns of glucose-lowering medication use in adults with T2D with and without HF.Methods: The DCR is a US-based outpatient registry of adults with diabetes; currently includes 3074 providers in 203 practices. We used hierarchical, modified Poisson regression models to examine the relationship between concomitant HF with use of each glucose-lowering medication class, adjusting for other factors that could impact selection of one medication class over another: age, chronic kidney disease (CKD), coronary artery disease (CAD), number of glucose-lowering medications, and insurance.Results: Among 456,106 adults with T2D, 125,161 (27%) had a diagnosis of HF (30% HFrEF, 15%HFmrEF, 55% HFpEF). Patients with T2D and HF were more likely to be older and male, and to have CAD, atrial fibrillation, and CKD. In the multivariable models, HF was associated with a greater use of insulin (RR 1.39, 95% CI 1.36-1.42) and lower use of thiazolidinediones (RR 0.79, 95% CI 0.74-0.83), SGLT2 inhibitors (RR 0.83, 95% CI 0.79-0.89), and metformin (RR 0.84, 95% CI 0.82-0.86). Among the subgroup of patients with HF, thiazolidinediones, GLP-1 receptor agonists, and SGLT2 inhibitors were used even less often in patients with lower ejection fraction, indicating that both the diagnosis of clinical HF and ejection fraction may influence the choice of glucose-lowering medications.Conclusion: In a large US-based outpatient registry, we found that a quarter of adults with T2D had a diagnosis of HF, which was predominantly HFpEF. Although certain T2D medication use in patients with HF appeared consistent with evidence (less use of thiazolidinediones), others appeared contrary to evidence (less use of metformin and SGLT2 inhibitors). [ABSTRACT FROM AUTHOR]
Published: 2018
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245. Design and rationale for the Cardiovascular and Metabolic Effects of Lorcaserin in Overweight and Obese Patients-Thrombolysis in Myocardial Infarction 61 (CAMELLIA-TIMI 61) trial.

Author: Bohula, Erin A., Scirica, Benjamin M., Fanola, Christina, Inzucchi, Silvio E., Keech, Anthony, McGuire, Darren K., Smith, Steven R., Abrahamsen, Tim, Francis, Bruce H., Miao, Wenfeng, Perdomo, Carlos A., Satlin, Andrew, Wiviott, Stephen D., and Sabatine, Marc S.
Abstract: Objectives: Lorcaserin, a selective serotonin 2C receptor agonist, is an effective pharmacologic weight-loss therapy that improves several cardiovascular risk factors. The long-term clinical cardiovascular and metabolic safety and efficacy in patients with elevated cardiovascular risk are unknown.Research Design and Methods: CAMELLIA-TIMI 61 (NCT02019264) is a randomized, double-blind, placebo-controlled, multinational clinical trial designed to evaluate the safety and efficacy of lorcaserin with regard to major adverse cardiovascular events and progression to diabetes in overweight or obese patients at high cardiovascular risk. Overweight or obese patients either with established cardiovascular disease or with diabetes and at least 1 other cardiovascular risk factor were randomized in a 1:1 ratio to lorcaserin 10 mg twice daily or matching placebo. The primary safety objective is to assess for noninferiority of lorcaserin for the composite end point of cardiovascular death, myocardial infarction, or stroke (major adverse cardiovascular event [MACE]) (with noninferiority defined as the upper bound of a 1-sided 97.5% CI excluding a hazard ratio of 1.4) compared with placebo assessed at an interim analysis with 460 adjudicated events. The efficacy objectives, assessed at study completion, will evaluate the superiority of lorcaserin for the primary composite end point of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, heart failure, or any coronary revascularization (MACE+) and the key secondary end point of conversion to diabetes. Recruitment began in January 2014 and was completed in November 2015 resulting in a total population of 12,000 patients. The trial is planned to continue until at least 1,401 adjudicated MACE+ events are accrued and the median treatment duration exceeds 2.5 years.Conclusion: CAMELLIA-TIMI 61 is investigating the safety and efficacy of lorcaserin for MACEs and conversion to diabetes in overweight or obese patients with established cardiovascular disease or multiple cardiovascular risk factors. [ABSTRACT FROM AUTHOR]
Published: 2018
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246. Periodontal manifestations of systemic diseases and developmental and acquired conditions: Consensus report of workgroup 3 of the 2017 World Workshop on the Classification of Periodontal and Peri‐Implant Diseases and Conditions.

Author: Jepsen, Søren, Caton, Jack G., Albandar, Jasim M., Bissada, Nabil F., Bouchard, Philippe, Cortellini, Pierpaolo, Demirel, Korkud, Sanctis, Massimo, Ercoli, Carlo, Fan, Jingyuan, Geurs, Nicolaas C., Hughes, Francis J., Jin, Lijian, Kantarci, Alpdogan, Lalla, Evanthia, Madianos, Phoebus N., Matthews, Debora, McGuire, Michael K., Mills, Michael P., and Preshaw, Philip M.
Abstract: Background: A variety of systemic diseases and conditions can affect the course of periodontitis or have a negative impact on the periodontal attachment apparatus. Gingival recessions are highly prevalent and often associated with hypersensitivity, the development of caries and non‐carious cervical lesions on the exposed root surface and impaired esthetics. Occlusal forces can result in injury of teeth and periodontal attachment apparatus. Several developmental or acquired conditions associated with teeth or prostheses may predispose to diseases of the periodontium. The aim of this working group was to review and update the 1999 classification with regard to these diseases and conditions, and to develop case definitions and diagnostic considerations. Methods: Discussions were informed by four reviews on 1) periodontal manifestions of systemic diseases and conditions; 2) mucogingival conditions around natural teeth; 3) traumatic occlusal forces and occlusal trauma; and 4) dental prostheses and tooth related factors. This consensus report is based on the results of these reviews and on expert opinion of the participants. Results: Key findings included the following: 1) there are mainly rare systemic conditions (such as Papillon‐Lefevre Syndrome, leucocyte adhesion deficiency, and others) with a major effect on the course of periodontitis and more common conditions (such as diabetes mellitus) with variable effects, as well as conditions affecting the periodontal apparatus independently of dental plaque biofilm‐induced inflammation (such as neoplastic diseases); 2) diabetes‐associated periodontitis should not be regarded as a distinct diagnosis, but diabetes should be recognized as an important modifying factor and included in a clinical diagnosis of periodontitis as a descriptor; 3) likewise, tobacco smoking – now considered a dependence to nicotine and a chronic relapsing medical disorder with major adverse effects on the periodontal supporting tissues – is an important modifier to be included in a clinical diagnosis of periodontitis as a descriptor; 4) the importance of the gingival phenotype, encompassing gingival thickness and width in the context of mucogingival conditions, is recognized and a novel classification for gingival recessions is introduced; 5) there is no evidence that traumatic occlusal forces lead to periodontal attachment loss, non‐carious cervical lesions, or gingival recessions; 6) traumatic occlusal forces lead to adaptive mobility in teeth with normal support, whereas they lead to progressive mobility in teeth with reduced support, usually requiring splinting; 7) the term biologic width is replaced by supracrestal tissue attachment consisting of junctional epithelium and supracrestal connective tissue; 8) infringement of restorative margins within the supracrestal connective tissue attachment is associated with inflammation and/or loss of periodontal supporting tissue. However, it is not evident whether the negative effects on the periodontium are caused by dental plaque biofilm, trauma, toxicity of dental materials or a combination of these factors; 9) tooth anatomical factors are related to dental plaque biofilm‐induced gingival inflammation and loss of periodontal supporting tissues. Conclusion: An updated classification of the periodontal manifestations and conditions affecting the course of periodontitis and the periodontal attachment apparatus, as well as of developmental and acquired conditions, is introduced. Case definitions and diagnostic considerations are also presented. [ABSTRACT FROM AUTHOR]
Published: 2018
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247. The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Trial.

Author: Wiviott, Stephen D., Raz, Itamar, Bonaca, Marc P, Mosenzon, Ofri, Kato, Eri T, Cahn, Avivit, Silverman, Michael G, Bansilal, Sameer, Bhatt, Deepak L, Leiter, Lawrence A., McGuire, Darren K., Wilding, John PH, Gause-Nilsson, Ingrid AM, Langkilde, Anna Maria, Johansson, Peter A., and Sabatine, Marc S.
Abstract: Background: Dapagliflozin is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor that reduces blood glucose in patients with type 2 diabetes mellitus (T2DM) by promoting glycosuria via inhibiting urinary glucose reabsorption. In addition to improving blood glucose control, treatment with dapagliflozin results in glucose-induced osmotic diuresis, weight loss, and blood pressure lowering. Previous trials of SGLT-2 inhibitors showed reductions in cardiovascular (CV) events, including CV death and hospitalization for heart failure, and ischemic events in patients with atherosclerotic cardiovascular disease (ASCVD).Research Design and Methods: DECLARE-TIMI 58 (NCT01730534) is a phase 3b randomized, double-blind, placebo-controlled trial designed to evaluate the CV safety and efficacy of dapagliflozin that has completed randomization of 17,160 patients with T2DM and a history of either established ASCVD (n=6,971) or multiple risk factors for ASCVD (n=10,189). Patients were randomized in a 1:1 fashion to dapagliflozin 10 mg or matching placebo. The primary safety outcome is the time to the first event of the composite of CV death, myocardial infarction, or ischemic stroke (major adverse cardiovascular events; MACEs). The co-primary efficacy outcomes are the composite of CV death, myocardial infarction, or ischemic stroke and the composite of CV death or hospitalization for heart failure. This event-driven trial will continue until at least 1,390 subjects have a MACE outcome, thereby providing >99% power to test for the primary outcome of safety of dapagliflozin measured by rejecting the hypothesis that the upper bound of the CI >1.3 for the primary outcome of MACE, as well as 85% power to detect a 15% relative risk reduction in MACE and an estimated 87% power to detect a 20% reduction in the composite of CV death or hospitalization for heart failure at a 1-sided α level of .0231.Conclusion: The DECLARE-TIMI 58 trial is testing the hypotheses that dapagliflozin is safe (does not increase) and may reduce the occurrence of major CV events. DECLARE-TIMI 58 is the largest study to address this question with an SGLT-2 inhibitor in patients with T2DM and with established CV disease and without CV disease but with multiple risk factors. [ABSTRACT FROM AUTHOR]
Published: 2018
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248. Hypertension Control in Adults With Diabetes Mellitus and Recurrent Cardiovascular Events: Global Results From the Trial Evaluating Cardiovascular Outcomes With Sitagliptin.

Author: Navar, Ann Marie, Gallup, Dianne S., Lokhnygina, Yuliya, Green, Jennifer B., McGuire, Darren K., Armstrong, Paul W., Buse, John B., Engel, Samuel S., Lachin, John M., Standl, Eberhard, Van de Werf, Frans, Holman, Rury R., Peterson, Eric D., and TECOS Study Group
Abstract: Systolic blood pressure (SBP) treatment targets for adults with diabetes mellitus remain unclear. SBP levels among 12 275 adults with diabetes mellitus, prior cardiovascular disease, and treated hypertension were evaluated in the TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) randomized trial of sitagliptin versus placebo. The association between baseline SBP and recurrent cardiovascular disease was evaluated using multivariable Cox proportional hazards modeling with restricted cubic splines, adjusting for clinical characteristics. Kaplan-Meier curves by baseline SBP were created to assess time to cardiovascular disease and 2 potential hypotension-related adverse events: worsening kidney function and fractures. The association between time-updated SBP and outcomes was examined using multivariable Cox proportional hazards models. Overall, 42.2% of adults with diabetes mellitus, cardiovascular disease, and hypertension had an SBP ≥140 mm Hg. The association between SBP and cardiovascular disease risk was U shaped, with a nadir ≈130 mm Hg. When the analysis was restricted to those with baseline SBP of 110 to 150 mm Hg, the adjusted association between SBP and cardiovascular disease risk was flat (hazard ratio per 10-mm Hg increase, 0.96; 95% confidence interval, 0.91-1.02). There was no association between SBP and risk of fracture. Above 150 mm Hg, higher SBP was associated with increasing risk of worsening kidney function (hazard ratio per 10-mm Hg increase, 1.10; 95% confidence interval, 1.02-1.18). Many patients with diabetes mellitus have uncontrolled hypertension. The U-shaped association between SBP and cardiovascular disease events was largely driven by those with very high or low SBP, with no difference in cardiovascular disease risk between 110 and 150 mm Hg. Lower SBP was not associated with higher risks of fractures or worsening kidney function. [ABSTRACT FROM AUTHOR]
Published: 2017
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249. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction

Author: Bergmark, Brian A., Bhatt, Deepak L., McGuire, Darren K., Cahn, Avivit, Mosenzon, Ofri, Steg, Ph. Gabriel, Im, KyungAh, Kanevsky, Estella, Gurmu, Yared, Raz, Itamar, Braunwald, Eugene, and Scirica, Benjamin M.
Abstract: Supplemental Digital Content is available in the text.
Published: 2019
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250. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE–TIMI 58 randomised trial

Author: Mosenzon, Ofri, Wiviott, Stephen D, Cahn, Avivit, Rozenberg, Aliza, Yanuv, Ilan, Goodrich, Erica L, Murphy, Sabina A, Heerspink, Hiddo J L, Zelniker, Thomas A, Dwyer, Jamie P, Bhatt, Deepak L, Leiter, Lawrence A, McGuire, Darren K, Wilding, John P H, Kato, Eri T, Gause-Nilsson, Ingrid A M, Fredriksson, Martin, Johansson, Peter A, Langkilde, Anna Maria, Sabatine, Marc S, and Raz, Itamar
Abstract: Sodium-glucose co-transporter-2 (SGLT2) inhibitors have shown beneficial effects on renal outcomes mainly in patients with established atherosclerotic cardiovascular disease. Here we report analyses of renal outcomes with the SGLT2 inhibitor dapagliflozin in the DECLARE–TIMI 58 cardiovascular outcomes trial, which included patients with type 2 diabetes both with and without established atherosclerotic cardiovascular disease and mostly with preserved renal function.
Published: 2019
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