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1. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial

Author

Giugliano, Robert P, Pedersen, Terje R, Park, Jeong-Gun, De Ferrari, Gaetano M, Gaciong, Zbigniew A, Ceska, Richard, Toth, Kalman, Gouni-Berthold, Ioanna, Lopez-Miranda, Jose, Schiele, François, Mach, François, Ott, Brian R, Kanevsky, Estella, Pineda, Armando Lira, Somaratne, Ransi, Wasserman, Scott M, Keech, Anthony C, Sever, Peter S, and Sabatine, Marc S

Published
2017
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3. Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk)

Author

Bonaca, Marc P., Nault, Patrice, Giugliano, Robert P., Keech, Anthony C., Pineda, Armando Lira, Kanevsky, Estella, Kuder, Julia, Murphy, Sabina A., Jukema, J. Wouter, Lewis, Basil S., Tokgozoglu, Lale, Somaratne, Ransi, Sever, Peter S., Pedersen, Terje R., and Sabatine, Marc S.

Published
2018
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6. Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk

Author

O'Donoghue, Michelle L., Fazio, Sergio, Giugliano, Robert P., Stroes, Erik S. G., Kanevsky, Estella, Gouni-Berthold, Ioanna, Im, KyungAh, Lira Pineda, Armando, Wasserman, Scott M., Češka, Richard, Ezhov, Marat V., Jukema, J. Wouter, Jensen, Henrik K., Tokgözoğlu, S. Lale, Mach, François, Huber, Kurt, Sever, Peter S., Keech, Anthony C., Pedersen, Terje R., Sabatine, Marc S., Experimental Vascular Medicine, Vascular Medicine, and ACS - Atherosclerosis & ischemic syndromes

Abstract

BACKGROUND: Lipoprotein(a) [Lp(a)] may play a causal role in atherosclerosis. PCSK9 (proprotein convertase subtilisin/kexin 9) inhibitors have been shown to significantly reduce plasma Lp(a) concentration. However, the relationship between Lp(a) levels, PCSK9 inhibition, and cardiovascular risk reduction remains undefined. METHODS: Lp(a) was measured in 25 096 patients in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a randomized trial of evolocumab versus placebo in patients with established atherosclerotic cardiovascular disease (median follow-up, 2.2 years). Cox models were used to assess the independent prognostic value of Lp(a) and the efficacy of evolocumab for coronary risk reduction by baseline Lp(a) concentration. RESULTS: The median (interquartile range) baseline Lp(a) concentration was 37 (13-165) nmol/L. In the placebo arm, patients with baseline Lp(a) in the highest quartile had a higher risk of coronary heart disease death, myocardial infarction, or urgent revascularization (adjusted hazard ratio quartile 4: quartile 1, 1.22; 95% CI, 1.01-1.48) independent of low-density lipoprotein cholesterol. At 48 weeks, evolocumab significantly reduced Lp(a) by a median (interquartile range) of 26.9% (6.2%-46.7%). The percent change in Lp(a) and low-density lipoprotein cholesterol at 48 weeks in patients taking evolocumab was moderately positively correlated ( r=0.37; 95% CI, 0.36-0.39; Pmedian, and by 7% (hazard ratio, 0.93; 95% CI, 0.80-1.08; P interaction=0.07) in those ≤median. Coupled with the higher baseline risk, the absolute risk reductions, and number needed to treat over 3 years were 2.49% and 40 versus 0.95% and 105, respectively. CONCLUSIONS: Higher levels of Lp(a) are associated with an increased risk of cardiovascular events in patients with established cardiovascular disease irrespective of low-density lipoprotein cholesterol. Evolocumab significantly reduced Lp(a) levels, and patients with higher baseline Lp(a) levels experienced greater absolute reductions in Lp(a) and tended to derive greater coronary benefit from PCSK9 inhibition. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01764633.

Published
2019

7. Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk

Author

O’Donoghue, Michelle L., primary, Fazio, Sergio, additional, Giugliano, Robert P., additional, Stroes, Erik S.G., additional, Kanevsky, Estella, additional, Gouni-Berthold, Ioanna, additional, Im, KyungAh, additional, Lira Pineda, Armando, additional, Wasserman, Scott M., additional, Češka, Richard, additional, Ezhov, Marat V., additional, Jukema, J. Wouter, additional, Jensen, Henrik K., additional, Tokgözoğlu, S. Lale, additional, Mach, François, additional, Huber, Kurt, additional, Sever, Peter S., additional, Keech, Anthony C., additional, Pedersen, Terje R., additional, and Sabatine, Marc S., additional

Published
2019
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8. 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, primary, Scirica, Benjamin M, additional, Inzucchi, Silvio E, additional, McGuire, Darren K, additional, Keech, Anthony C, additional, Smith, Steven R, additional, Kanevsky, Estella, additional, Murphy, Sabina A, additional, Leiter, Lawrence A, additional, Dwyer, Jamie P, additional, Corbalan, Ramon, additional, Hamm, Christian, additional, Kaplan, Lee, additional, Nicolau, Jose Carlos, additional, Ophuis, Ton Oude, additional, Ray, Kausik K, additional, Ruda, Mikhail, additional, Spinar, Jindrich, additional, Patel, Tushar, additional, Miao, Wenfeng, additional, Perdomo, Carlos, additional, Francis, Bruce, additional, Dhadda, Shobha, additional, Bonaca, Marc P, additional, Ruff, Christian T, additional, Sabatine, Marc S, additional, Wiviott, Stephen D, additional, Inzucchi, Silvio, additional, Keech, Anthony, additional, Satlin, Andrew, additional, Brown, Conville, additional, Budaj, Andrzej, additional, Dwyer, Jamie, additional, Garcia-Castillo, Armando, additional, Gupta, Milan, additional, Oude Ophuis, Ton, additional, Ray, Kauski, additional, Weissman, Neil, additional, White, Harvey D, additional, Amerena, J, additional, Arstall, M, additional, Colquhoun, D, additional, Jayasinghe, R, additional, Lee, A, additional, Lehman, R, additional, Moses, R, additional, Proietto, J, additional, Purnell, P, additional, Waites, J, additional, Blombery, P, additional, Cross, D, additional, Worthley, M, additional, d'Emden, M, additional, Selvanayagam, J, additional, Oqueli, RE, additional, Whelan, A, additional, Garrahy, P, additional, de Looze, F, additional, Ninio, D, additional, Horowitz, J, additional, William, M, additional, Suranyi, M, additional, Wittert, G, additional, Le May, M, additional, Pandey, AS, additional, Vizel, S, additional, Labonte, R, additional, Beaudry, Y, additional, Fortin, C, additional, Bell, A, additional, Kouz, S, additional, St-Amour, É, additional, Bata, I, additional, St Maurice, F, additional, Chehayeb, R, additional, Constance, C, additional, Wong, G, additional, Hess, A, additional, Liutkus, J, additional, Poirier, P, additional, Teitelbaum, I, additional, Berlingieri, J, additional, Cha, J, additional, Hartleib, M, additional, Heffernan, M, additional, Twum-Barima, D, additional, Pandith, V, additional, Aronson, R, additional, Goldenberg, R, additional, Ajala, B, additional, Jain, A, additional, Ross, S, additional, Bajaj, H, additional, Khandwala, H, additional, Yared, Z, additional, Gupta, N, additional, Bédard, J, additional, Wharton, S, additional, Blouin, F, additional, Savard, D, additional, Shukla, D, additional, Cobos, J, additional, Godoy, G, additional, Perez, L, additional, Pincetti, C, additional, Saavedra Guajardo, V, additional, Varleta, P, additional, Conejeros, C, additional, Lanas, F, additional, Bayram Llamas, E, additional, Cardona Muñoz, E, additional, Garcia, R, additional, Garza Ruiz, J, additional, Llamas Esperon, G, additional, Lopez Rosas, E, additional, Melendez Mier, G, additional, Ramos, G, additional, Hart, H, additional, Scott, D, additional, Ternouth, I, additional, Benatar, J, additional, Elliott, J, additional, Cutfield, R, additional, Manning, P, additional, Williams, M, additional, Ferrier, K, additional, Scott, R, additional, Wilson, S, additional, Leikis, R, additional, Nirmalaraj, BK, additional, Krzyżagórska, E, additional, Miękus, P, additional, Bronisz, M, additional, Mirek-Bryniarska, E, additional, Łanda, K, additional, Stasiewski, A, additional, Żechowicz, T, additional, Zytkiewicz-Jaruga, D, additional, Korecki, J, additional, Ogórek, M, additional, Pawłowicz, L, additional, Piepiorka, M, additional, Skierkowska, J, additional, Stankiewicz, A, additional, Szyprowska, E, additional, Witek, R, additional, Bochenek, A, additional, Kończakowski, P, additional, Wojnowski, Ł, additional, Wujkowski, M, additional, Cymerman, K, additional, Korzeniak, R, additional, Mąder, P, additional, Mikłaszewicz, B, additional, Stachlewski, P, additional, Goch, A, additional, Pomiećko, W, additional, Skórski, M, additional, Romanowski, L, additional, Jusiak, K, additional, Laskowska-Derlaga, E, additional, Bijata-Bronisz, R, additional, Kaźmierczak, J, additional, Goldberg, R, additional, Henderson, D, additional, Korban, E, additional, Rohr, K, additional, Claxton, E, additional, Weiss, R, additional, Angiolillo, D, additional, Boccalandro, F, additional, Chu, K, additional, Thorn, E, additional, Randhawa, P, additional, Singh, N, additional, Bittar, G, additional, Guarnieri, T, additional, Saeed, S, additional, Sharma, S, additional, Shepard, M, additional, French, W, additional, Desai, P, additional, Bernstein, R, additional, Rogers, W, additional, Singal, R, additional, Schneider, R, additional, Shanes, J, additional, Ong, S, additional, Condit, J, additional, Donahoe, S, additional, Brill, D, additional, Einhorn, D, additional, Ebrahimi, R, additional, Labroo, A, additional, Graf, R, additional, Scott, J, additional, Hoekstra, J, additional, Jetty, P, additional, Luckasen, G, additional, O'Donnell, P, additional, Gonte, W, additional, Pomposini, D, additional, Quadrel, M, additional, Koren, M, additional, Schlager, D, additional, Schramm, E, additional, Singal, D, additional, Lupovitch, S, additional, Soni, A, additional, Seigel, P, additional, Roberts, J, additional, Soufer, J, additional, Reza, S, additional, Quinlan, E, additional, Moretto, T, additional, First, B, additional, Khan, M, additional, Chilka, S, additional, Colfer, H, additional, Teklinski, A, additional, Wallace-Wilding, K, additional, Ellison, H, additional, Muse, D, additional, Aronoff, S, additional, Higgins, A, additional, Patel, S, additional, Elinoff, V, additional, Karim, A, additional, Awasty, V, additional, Chuang, R, additional, Roseman, H, additional, Dugano-Daphnis, P, additional, Albert, M, additional, Sheikh, K, additional, Bays, H, additional, Kaster, S, additional, Goldstein, M, additional, Rubino, D, additional, Calatayud, G, additional, Snyder, H, additional, Williams, T, additional, Hershon, K, additional, Hagan, M, additional, Isserman, S, additional, Kahn, B, additional, Anderson, J, additional, Gimness, MP, additional, Raisinghani, A, additional, Christina, M, additional, Raikhel, M, additional, Gillespie, E, additional, Portnay, E, additional, Heiman, M, additional, Qureshi, M, additional, Lee, J, additional, Blonder, R, additional, Cucher, F, additional, Miller, G, additional, Kotlaba, D, additional, Cornett, G, additional, Beavins, J, additional, Augenbraun, C, additional, Reinhardt, S, additional, Bartkowiak, A, additional, Salacata, A, additional, Blevins, T, additional, Benjamin, S, additional, Diener, J, additional, George, W, additional, Barker, B, additional, Richwine, R, additional, Baldari, D, additional, Alfieri, A, additional, Barreto, A, additional, Zhang, L, additional, Shah, R, additional, Hendrix, E, additional, Subramaniyam, V, additional, Hurley, S, additional, Lillestol, M, additional, O'Donoghue, M, additional, Shayani, S, additional, Ryan, E, additional, Call, R, additional, Zemel, L, additional, Chang, A, additional, Kivitz, A, additional, Freyne, B, additional, Bland, V, additional, Shore, K, additional, Mostel, E, additional, Uzoaga, E, additional, Andrawis, N, additional, Gabra, N, additional, Ghitis, A, additional, Sabatino, K, additional, Browder, D, additional, Varma, S, additional, Smith, S, additional, Fink, R, additional, Aycock, GR, additional, Doty, WD, additional, Alfonso, T, additional, Eshaghian, S, additional, Karlsberg, R, additional, Zarich, S, additional, Landau, C, additional, McKenzie, M, additional, Krause, R, additional, Davis, W, additional, Haddad, T, additional, Voyce, S, additional, Alford, C, additional, LeDoux, J, additional, O'Dea, D, additional, Park, J, additional, Aroda, V, additional, Getaneh, A, additional, Graham, B, additional, Bhagwat, R, additional, Korn, D, additional, Ruoff, G, additional, Wiseman, A, additional, Lieber, I, additional, Fialkow, J, additional, Gonzalez-Campoy, JM, additional, Bayron, C, additional, Bertolet, B, additional, Lash, J, additional, Gerrish, C, additional, Robertson, D, additional, Rosenfeld, J, additional, Seidner, M, additional, Agaiby, J, additional, Silverfield, J, additional, Sugimoto, D, additional, Lubin, B, additional, Alhaddad, M, additional, Lui, H, additional, Lakin, G, additional, Chokshi, S, additional, Donovan, D, additional, Felten, W, additional, Minton, S, additional, Kimmelstiel, C, additional, Kuvin, J, additional, Still, C, additional, Byars, W, additional, Talano, J, additional, Desai, V, additional, Bradley, AJ, additional, Baker, S, additional, Chane, M, additional, Mercado, A, additional, Baron, S, additional, Harris, B, additional, Mayer, N, additional, Concha, M, additional, Carr, K, additional, Chaykin, L, additional, Willis, J, additional, Clay, A, additional, Fenstad, E, additional, Furda, J, additional, Peterson, P, additional, Chang, M, additional, Aronne, L, additional, Jones, D, additional, Prashad, R, additional, Benson, M, additional, Stegemoller, R, additional, Longshaw, K, additional, Saleh, J, additional, Jennings, W, additional, Detweiler, R, additional, Viswanath, D, additional, Patel, R, additional, Lederman, S, additional, Weinstein, D, additional, Korabathina, R, additional, Singh, V, additional, Rosen, J, additional, Estevez, R, additional, Levin, P, additional, McNeill, R, additional, Kalen, V, additional, Reed, J, additional, Ashley, R, additional, Herman, L, additional, Tsai, Y, additional, Kayne, D, additional, White, A, additional, Hussain, I, additional, Tami, L, additional, Cohen, K, additional, Robinson, J, additional, Fuchs-Ertman, D, additional, Platt, G, additional, Belardo, L, additional, Reddy, R, additional, Rosendorff, C, additional, Saba, F, additional, Powell, S, additional, Anderson, K, additional, Abidi, M, additional, Rezkalla, S, additional, Paraschos, A, additional, Wilson, J, additional, Moursi, M, additional, Shah, A, additional, Nadar, V, additional, Stonesifer, L, additional, Bialow, M, additional, Cannon, K, additional, Ellison, W, additional, Stedman, M, additional, Brown, J, additional, Harper, W, additional, Lucas, KJ, additional, DiGiovanna, M, additional, Rodbard, H, additional, Biscoveanu, M, additional, Davis, C, additional, Hall, J, additional, Littlefield, R, additional, Gorman, T, additional, Kereiakes, D, additional, Chang, FM, additional, Tatu, H, additional, Cheung, D, additional, Kaine, J, additional, Knutson, T, additional, Logemann, T, additional, Pueblitz, G, additional, Bianco, J, additional, Henson, B, additional, Neustel, M, additional, Gelernt, M, additional, Nelson, W, additional, Moriarty, K, additional, Lefebvre, G, additional, Maw, K, additional, Rink, L, additional, Behn, P, additional, Studdard, H, additional, Argoud, G, additional, O'Connor, T, additional, Krichmar, P, additional, Raad, G, additional, Pereles-Ortiz, J, additional, Sorli, C, additional, Cohen, A, additional, Pettis, K, additional, Cavanaugh, B, additional, Phillips, C, additional, Wahlen, J, additional, Radin, D, additional, Rider, J, additional, Kosinski, E, additional, Leimbach, W, additional, Odhav, A, additional, Hakas, J, additional, Tan, A, additional, Howell, M, additional, Wombolt, D, additional, Fishman, N, additional, Shah, P, additional, Wylie, P, additional, Arauz-Pacheco, C, additional, Cavale, A, additional, George, A, additional, Kroll, R, additional, Krantzler, J, additional, Tahirkheli, N, additional, Jabro, M, additional, Newell, M, additional, Mullen, P, additional, Gencheff, N, additional, Meli, J, additional, Vora, K, additional, Kotek, L, additional, Pyzdrowski, K, additional, Paez, H, additional, Moran, J, additional, Tannenbaum, A, additional, Deck, K, additional, Busch, R, additional, Levinson, L, additional, Azizad, M, additional, Whitaker, J, additional, Fox, B, additional, Huffman, C, additional, Ashraf, M, additional, Diogo, J, additional, Kushner, R, additional, Tallet, J, additional, Channamsetty, V, additional, Suh, D, additional, Atieh, M, additional, Navas, J, additional, Young, V, additional, Shaw, S, additional, Dor, I, additional, Duffy, B, additional, Rubin, P, additional, Lewis, D, additional, Kaye, W, additional, Benton, R, additional, Burbano, J, additional, Hotchkiss, D, additional, Magno, A, additional, Alberton, A, additional, Collins, J, additional, Alvarado, O, additional, Stich, M, additional, Mahal, S, additional, Liu, J, additional, Hong, M, additional, Dy, J, additional, Block, B, additional, Lamantia, J, additional, Pritchard, J, additional, Davis, M, additional, Srivastava, S, additional, Bilazarian, S, additional, Rosario, R, additional, McCartney, M, additional, Blumberg, V, additional, Rajan, R, additional, Martin, E, additional, Wright, S, additional, Brinson, C, additional, Johnston, J, additional, Graves, M, additional, Dominguez, M, additional, McKenzie, W, additional, Abadier, R, additional, Tran, C, additional, Castello, R, additional, Morawski, E, additional, White, J, additional, Morris, F, additional, Perez, A, additional, Trueba, P, additional, Sanchez, M, additional, Andersen, J, additional, Kastelic, R, additional, Khan, J, additional, Rodriguez, H, additional, Izquierdo, W, additional, Matias, A, additional, Essandoh, L, additional, and Ince, C, additional

Published
2018
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9. Long-term safety and efficacy of breast biopsy markers in clinical practice.

Author

Smith, Sharon, Taylor, Clayton R., Kanevsky, Estella, Povoski, Stephen P., and Hawley, Jeffrey R.

Subjects
BREAST biopsy, DRUG efficacy, BIOMARKERS, MEDICAL personnel, MEDICATION safety, MEDICAL records
Abstract

Objective: Percutaneous breast and axillary core biopsy followed by marker placement are integral parts of a breast imager's practice benefiting both patients and clinicians. Marker placement is the standard to facilitate future care. The purpose of this study is to characterize the safety and performance of MammoMARK, CorMARK, and HydroMARK biopsy markers by evaluating device-related adverse events, device deficiencies, and long-term safety. Methods: A retrospective review of three radiology practices identified patients who underwent image-guided breast or axillary biopsies followed by marker placement between 1 January 2012 and 1 January 2017. Medical records were reviewed with adverse events related to marker placement and use recorded. Results: 768 markers were placed with three (0.4%) events recorded. Two device deficiencies and one non-serious adverse event occurred in three patients. Device deficiency events involved user errors deploying the markers, one to inability to locate the marker on post-biopsy imaging, and the second to misplacement relative to biopsy target. One non-serious adverse event involved inability to locate/retain the marker in a surgically resected specimen. No serious adverse events were reported. Conclusion: Placement of breast biopsy markers is safe with minimal associated risks. Issues related to device malfunction, durability, reliability, safety, or performance were not reported. [ABSTRACT FROM AUTHOR]

Published
2021
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10. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk

Author

Scirica, Benjamin M., primary, Mosenzon, Ofri, additional, Bhatt, Deepak L., additional, Udell, Jacob, A., additional, Steg, Ph Gabriel, additional, McGuire, Darren K., additional, Im, KyungAh, additional, Kanevsky, Estella, additional, Stahre, Christina, additional, Sjöstrand, Mikaela, additional, Raz, Itamar, additional, and Braunwald, Eugene, additional

Published
2018
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11. Cognitive Function in a Randomized Trial of Evolocumab

Author

Giugliano, Robert P., primary, Mach, François, additional, Zavitz, Kenton, additional, Kurtz, Christopher, additional, Im, Kyungah, additional, Kanevsky, Estella, additional, Schneider, Jingjing, additional, Wang, Huei, additional, Keech, Anthony, additional, Pedersen, Terje R., additional, Sabatine, Marc S., additional, Sever, Peter S., additional, Robinson, Jennifer G., additional, Honarpour, Narimon, additional, Wasserman, Scott M., additional, and Ott, Brian R., additional

Published
2017
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13. Predisposing Factors for Any and Major Hypoglycemia With Saxagliptin Versus Placebo and Overall: Analysis From the SAVOR-TIMI 53 Trial

Author

Cahn, Avivit, primary, Raz, Itamar, additional, Mosenzon, Ofri, additional, Leibowitz, Gil, additional, Yanuv, Ilan, additional, Rozenberg, Aliza, additional, Iqbal, Nayyar, additional, Hirshberg, Boaz, additional, Sjostrand, Mikaela, additional, Stahre, Christina, additional, Im, KyungAh, additional, Kanevsky, Estella, additional, Scirica, Benjamin M., additional, Bhatt, Deepak L., additional, and Braunwald, Eugene, additional

Published
2016
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14. CLINICAL FACTORS ASSOCIATED WITH SUDDEN CARDIAC DEATH IN TYPE 2 DIABETES: INSIGHTS FROM THE SAVOR-TIMI 53 TRIAL

Author

Cavallari, Ilaria, primary, Patel, Ravi, additional, Bhatt, Deepak, additional, Steg, Philippe, additional, Leiter, Lawrence, additional, McGuire, Darren, additional, Mosenzon, Ofri, additional, Kanevsky, Estella, additional, Im, Kyungah, additional, Raz, Itamar, additional, Braunwald, Eugene, additional, and Scirica, Benjamin, additional

Published
2016
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15. 746

Author

Wong, Jackson, primary, Kanevsky, Estella, additional, Agus, Michael, additional, Graham, Dionne, additional, Bartlett, Joshua, additional, and Melendez, Elliot, additional

Published
2014
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16. Regional Implementation of a Pediatric Cardiology Chest Pain Guideline Using SCAMPs Methodology

Author

Angoff, Gerald H., primary, Kane, David A., additional, Giddins, Niels, additional, Paris, Yvonne M., additional, Moran, Adrian M., additional, Tantengco, Victoria, additional, Rotondo, Kathleen M., additional, Arnold, Lucy, additional, Toro-Salazar, Olga H., additional, Gauthier, Naomi S., additional, Kanevsky, Estella, additional, Renaud, Ashley, additional, Geggel, Robert L., additional, Brown, David W., additional, and Fulton, David R., additional

Published
2013
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17. Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk.

Author

O'Donoghue ML, Fazio S, Giugliano RP, Stroes ESG, Kanevsky E, Gouni-Berthold I, Im K, Lira Pineda A, Wasserman SM, Češka R, Ezhov MV, Jukema JW, Jensen HK, Tokgözoğlu SL, Mach F, Huber K, Sever PS, Keech AC, Pedersen TR, and Sabatine MS

Subjects
Adult, Aged, Aged, 80 and over, Atherosclerosis pathology, Cholesterol, LDL blood, Double-Blind Method, Female, Humans, Male, Middle Aged, Placebo Effect, Proportional Hazards Models, Proprotein Convertase 9 metabolism, Risk Factors, Treatment Outcome, Antibodies, Monoclonal, Humanized therapeutic use, Anticholesteremic Agents therapeutic use, Atherosclerosis drug therapy, Lipoprotein(a) blood, Proprotein Convertase 9 immunology
Abstract

Background: Lipoprotein(a) [Lp(a)] may play a causal role in atherosclerosis. PCSK9 (proprotein convertase subtilisin/kexin 9) inhibitors have been shown to significantly reduce plasma Lp(a) concentration. However, the relationship between Lp(a) levels, PCSK9 inhibition, and cardiovascular risk reduction remains undefined., Methods: Lp(a) was measured in 25 096 patients in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a randomized trial of evolocumab versus placebo in patients with established atherosclerotic cardiovascular disease (median follow-up, 2.2 years). Cox models were used to assess the independent prognostic value of Lp(a) and the efficacy of evolocumab for coronary risk reduction by baseline Lp(a) concentration., Results: The median (interquartile range) baseline Lp(a) concentration was 37 (13-165) nmol/L. In the placebo arm, patients with baseline Lp(a) in the highest quartile had a higher risk of coronary heart disease death, myocardial infarction, or urgent revascularization (adjusted hazard ratio quartile 4: quartile 1, 1.22; 95% CI, 1.01-1.48) independent of low-density lipoprotein cholesterol. At 48 weeks, evolocumab significantly reduced Lp(a) by a median (interquartile range) of 26.9% (6.2%-46.7%). The percent change in Lp(a) and low-density lipoprotein cholesterol at 48 weeks in patients taking evolocumab was moderately positively correlated ( r=0.37; 95% CI, 0.36-0.39; P<0.001). Evolocumab reduced the risk of coronary heart disease death, myocardial infarction, or urgent revascularization by 23% (hazard ratio, 0.77; 95% CI, 0.67-0.88) in patients with a baseline Lp(a) >median, and by 7% (hazard ratio, 0.93; 95% CI, 0.80-1.08; P interaction=0.07) in those ≤median. Coupled with the higher baseline risk, the absolute risk reductions, and number needed to treat over 3 years were 2.49% and 40 versus 0.95% and 105, respectively., Conclusions: Higher levels of Lp(a) are associated with an increased risk of cardiovascular events in patients with established cardiovascular disease irrespective of low-density lipoprotein cholesterol. Evolocumab significantly reduced Lp(a) levels, and patients with higher baseline Lp(a) levels experienced greater absolute reductions in Lp(a) and tended to derive greater coronary benefit from PCSK9 inhibition., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01764633.

Published
2019
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