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5. Standardising clinical outcomes measures for adult clinical trials in Fabry disease:A global Delphi consensus

Author

Moreno-Martinez, D., Aguiar, P., Auray-Blais, C., Beck, M., Bichet, D. G., Burlina, A., Cole, D., Elliott, P., Feldt-Rasmussen, U., Feriozzi, S., Fletcher, J., Giugliani, R., Jovanovic, A., Kampmann, C., Langeveld, M., Lidove, O., Linhart, A., Mauer, M., Moon, J. C., Muir, A., Nowak, A., Oliveira, J. P., Ortiz, A., Pintos-Morell, G., Politei, J., Rozenfeld, P., Schiffmann, R., Svarstad, E., Talbot, A. S., Thomas, M., Tøndel, C., Warnock, D., West, M. L., Hughes, D. A., Moreno-Martinez, D., Aguiar, P., Auray-Blais, C., Beck, M., Bichet, D. G., Burlina, A., Cole, D., Elliott, P., Feldt-Rasmussen, U., Feriozzi, S., Fletcher, J., Giugliani, R., Jovanovic, A., Kampmann, C., Langeveld, M., Lidove, O., Linhart, A., Mauer, M., Moon, J. C., Muir, A., Nowak, A., Oliveira, J. P., Ortiz, A., Pintos-Morell, G., Politei, J., Rozenfeld, P., Schiffmann, R., Svarstad, E., Talbot, A. S., Thomas, M., Tøndel, C., Warnock, D., West, M. L., and Hughes, D. A.

Abstract

Background: Recent years have witnessed a considerable increase in clinical trials of new investigational agents for Fabry disease (FD). Several trials investigating different agents are currently in progress; however, lack of standardisation results in challenges to interpretation and comparison. To facilitate the standardisation of investigational programs, we have developed a common framework for future clinical trials in FD. Methods and findings: A broad consensus regarding clinical outcomes and ways to measure them was obtained via the Delphi methodology. 35 FD clinical experts from 4 continents, representing 3389 FD patients, participated in 3 rounds of Delphi procedure. The aim was to reach a consensus regarding clinical trial design, best treatment comparator, clinical outcomes, measurement of those clinical outcomes and inclusion and exclusion criteria. Consensus results of this initiative included: the selection of the adaptative clinical trial as the ideal study design and agalsidase beta as ideal comparator treatment due to its longstanding use in FD. Renal and cardiac outcomes, such as glomerular filtration rate, proteinuria and left ventricular mass index, were prioritised, whereas neurological outcomes including cerebrovascular and white matter lesions were dismissed as a primary or secondary outcome measure. Besides, there was a consensus regarding the importance of patient-related outcomes such as general quality of life, pain, and gastrointestinal symptoms. Also, unity about lysoGb3 and Gb3 tissue deposits as useful surrogate markers of the disease was obtained. The group recognised that cardiac T1 mapping still has potential but requires further development before its widespread introduction in clinical trials. Finally, patients with end-stage renal disease or renal transplant should be excluded unless a particular group for them is created inside the clinical trial. Conclusion: This consensus will help to shape the future of clinical trials in

Published
2021

6. Adiposity and risk of decline in glomerular filtration rate : Meta-analysis of individual participant data in a global consortium

Author

Chang AR, Grams ME, Ballew SH, Bilo H, Correa A, Evans M, Gutierrez OM, Hosseinpanah F, Iseki K, Kenealy T, Klein B, Kronenberg F, Lee BJ, Li Y, Miura K, Navaneethan SD, Roderick PJ, Valdivielso JM, Visseren FLJ, Zhang L, Gansevoort RT, Hallan SI, Levey AS, Matsushita K, Shalev V, Woodward M, Astor B, Appel L, Greene T, Chen T, Chalmers J, Arima H, Perkovic V, Yatsuya H, Tamakoshi K, Hirakawa Y, Coresh J, Sang Y, Polkinghorne K, Chadban S, Atkins R, Levin A, Djurdjev O, Klein R, Lee K, Liu L, Zhao M, Wang F, Wang J, Tang M, Heine G, Emrich I, Zawada A, Bauer L, Nally J, Schold J, Shlipak M, Sarnak M, Katz R, Hiramoto J, Iso H, Yamagishi K, Umesawa M, Muraki I, Fukagawa M, Maruyama S, Hamano T, Hasegawa T, Fujii N, Jafar T, Hatcher J, Poulter N, Chaturvedi N, Wheeler D, Emberson J, Townend J, Landray M, Brenner H, Schöttker B, Saum KU, Rothenbacher D, Fox C, Hwang SJ, Köttgen A, Schneider MP, Eckardt KU, Green J, Kirchner HL, Ito S, Miyazaki M, Nakayama M, Yamada G, Cirillo M, Romundstad S, Øvrehus M, Langlo KA, Irie F, Sairenchi T, Rebholz CM, Young B, Boulware LE, Ishikawa S, Yano Y, Kotani K, Nakamura T, Jee SH, Kimm H, Mok Y, Chodick G, Wetzels JFM, Blankestijn PJ, van Zuilen AD, Bots M, Inker L, Peralta C, Kollerits B, Ritz E, Nitsch D, Fletcher A, Bottinger E, Nadkarni GN, Ellis SB, Nadukuru R, Fernandez E, Betriu A, Bermudez-Lopez M, Stengel B, Metzger M, Flamant M, Houillier P, Haymann JP, Froissart M, Ueshima H, Okayama A, Tanaka S, Okamura T, Elley CR, Collins JF, Drury PL, Ohkubo T, Asayama K, Metoki H, Kikuya M, Iseki C, Nelson RG, Knowler WC, Bakker SJL, Heerspink HJL, Brunskill N, Major R, Shepherd D, Medcalf J, Jassal SK, Bergstrom J, Ix JH, Barrett-Connor E, Kovesdy C, Kalantar-Zadeh K, Sumida K, Muntner P, Warnock D, Judd S, Panwar B, de Zeeuw D, Brenner B, Sedaghat S, Ikram MA, Hoorn EJ, Dehghan A, Wong TY, Sabanayagam C, Cheng CY, Banu R, Segelmark M, Stendahl M, Schön S, Tangri N, Sud M, Naimark D, Wen CP, Tsao CK, Tsai MK, Chen CH, Konta T, Hirayama A, Ichikawa K, Hadaegh F, Mirbolouk M, Azizi F, Solbu MD, Jenssen TG, Eriksen BO, Eggen AE, Lannfelt L, Larsson A, Ärnlöv J, Landman GWD, van Hateren KJJ, Kleefstra N, Chen J, Kwak L, Surapaneni A., Chang, Ar, Grams, Me, Ballew, Sh, Bilo, H, Correa, A, Evans, M, Gutierrez, Om, Hosseinpanah F, Iseki K, Kenealy, T, Klein, B, Kronenberg, F, Lee, Bj, Li, Y, Miura, K, Navaneethan, Sd, Roderick, Pj, Valdivielso, Jm, Visseren, Flj, Zhang, L, Gansevoort, Rt, Hallan, Si, Levey, A, Matsushita, K, Shalev, V, Woodward, M, Astor, B, Appel, L, Greene, T, Chen, T, Chalmers, J, Arima, H, Perkovic, V, Yatsuya, H, Tamakoshi, K, Hirakawa, Y, Coresh, J, Sang, Y, Polkinghorne, K, Chadban, S, Atkins, R, Levin, A, Djurdjev, O, Klein, R, Lee, K, Liu, L, Zhao, M, Wang, F, Wang, J, Tang, M, Heine, G, Emrich, I, Zawada, A, Bauer, L, Nally, J, Schold, J, Shlipak, M, Sarnak, M, Katz, R, Hiramoto, J, Iso, H, Yamagishi, K, Umesawa, M, Muraki, I, Fukagawa, M, Maruyama, S, Hamano, T, Hasegawa, T, Fujii, N, Jafar, T, Hatcher, J, Poulter, N, Chaturvedi, N, Wheeler, D, Emberson, J, Townend, J, Landray, M, Brenner, H, Schöttker, B, Saum, Ku, Rothenbacher, D, Fox, C, Hwang, Sj, Köttgen, A, Schneider, Mp, Eckardt, Ku, Green, J, Kirchner, Hl, Ito, S, Miyazaki, M, Nakayama, M, Yamada, G, Cirillo, M, Romundstad, S, Øvrehus, M, Langlo, Ka, Irie, F, Sairenchi, T, Rebholz, Cm, Young, B, Boulware, Le, Ishikawa, S, Yano, Y, Kotani, K, Nakamura, T, Jee, Sh, Kimm, H, Mok, Y, Chodick, G, Wetzels, Jfm, Blankestijn, Pj, van Zuilen, Ad, Bots, M, Inker, L, Peralta, C, Kollerits, B, Ritz, E, Nitsch, D, Fletcher, A, Bottinger, E, Nadkarni, Gn, Ellis, Sb, Nadukuru, R, Fernandez, E, Betriu, A, Bermudez-Lopez, M, Stengel, B, Metzger, M, Flamant, M, Houillier, P, Haymann, Jp, Froissart, M, Ueshima, H, Okayama, A, Tanaka, S, Okamura, T, Elley, Cr, Collins, Jf, Drury, Pl, Ohkubo, T, Asayama, K, Metoki, H, Kikuya, M, Iseki, C, Nelson, Rg, Knowler, Wc, Bakker, Sjl, Heerspink, Hjl, Brunskill, N, Major, R, Shepherd, D, Medcalf, J, Jassal, Sk, Bergstrom, J, Ix, Jh, Barrett-Connor, E, Kovesdy, C, Kalantar-Zadeh, K, Sumida, K, Muntner, P, Warnock, D, Judd, S, Panwar, B, de Zeeuw, D, Brenner, B, Sedaghat, S, Ikram, Ma, Hoorn, Ej, Dehghan, A, Wong, Ty, Sabanayagam, C, Cheng, Cy, Banu, R, Segelmark, M, Stendahl, M, Schön, S, Tangri, N, Sud, M, Naimark, D, Wen, Cp, Tsao, Ck, Tsai, Mk, Chen, Ch, Konta, T, Hirayama, A, Ichikawa, K, Hadaegh, F, Mirbolouk, M, Azizi, F, Solbu, Md, Jenssen, Tg, Eriksen, Bo, Eggen, Ae, Lannfelt, L, Larsson, A, Ärnlöv, J, Landman, Gwd, van Hateren, Kjj, Kleefstra, N, Chen, J, Kwak, L, Surapaneni, A., Lifestyle Medicine (LM), Cardiovascular Centre (CVC), Groningen Kidney Center (GKC), Groningen Institute for Organ Transplantation (GIOT), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Asayama, Kei, and Sedaghat, SeyyedMah

Subjects
CHRONIC KIDNEY-DISEASE, Male, 030232 urology & nephrology, 030204 cardiovascular system & hematology, OBESITY PARADOX, Body Mass Index, BMI, eGFR, CKD-PC, Cohort Studies, 0302 clinical medicine, Risk Factors, Urologi och njurmedicin, Medicine, ALL-CAUSE MORTALITY, Adiposity, 2. Zero hunger, Aged, 80 and over, Medicine(all), education.field_of_study, Hazard ratio, ASSOCIATION, General Medicine, Middle Aged, 3. Good health, Cohort, Female, Waist Circumference, Life Sciences & Biomedicine, WAIST CIRCUMFERENCE, Obesity paradox, Glomerular Filtration Rate, Adult, Waist, Population, Renal function, 03 medical and health sciences, Medicine, General & Internal, General & Internal Medicine, CKD, Urology and Nephrology, Humans, Mortality, education, Aged, Science & Technology, business.industry, Research, medicine.disease, Body Height, BODY-MASS INDEX, Kidney Failure, Chronic, WEIGHT, Renal disorders Radboud Institute for Health Sciences [Radboudumc 11], business, Body mass index, Demography, Kidney disease
Abstract

ObjectiveTo evaluate the associations between adiposity measures (body mass index, waist circumference, and waist-to-height ratio) with decline in glomerular filtration rate (GFR) and with all cause mortality.DesignIndividual participant data meta-analysis.SettingCohorts from 40 countries with data collected between 1970 and 2017.ParticipantsAdults in 39 general population cohorts (n=5 459 014), of which 21 (n=594 496) had data on waist circumference; six cohorts with high cardiovascular risk (n=84 417); and 18 cohorts with chronic kidney disease (n=91 607).Main outcome measuresGFR decline (estimated GFR decline ≥40%, initiation of kidney replacement therapy or estimated GFR 2) and all cause mortality.ResultsOver a mean follow-up of eight years, 246 607 (5.6%) individuals in the general population cohorts had GFR decline (18 118 (0.4%) end stage kidney disease events) and 782 329 (14.7%) died. Adjusting for age, sex, race, and current smoking, the hazard ratios for GFR decline comparing body mass indices 30, 35, and 40 with body mass index 25 were 1.18 (95% confidence interval 1.09 to 1.27), 1.69 (1.51 to 1.89), and 2.02 (1.80 to 2.27), respectively. Results were similar in all subgroups of estimated GFR. Associations weakened after adjustment for additional comorbidities, with respective hazard ratios of 1.03 (0.95 to 1.11), 1.28 (1.14 to 1.44), and 1.46 (1.28 to 1.67). The association between body mass index and death was J shaped, with the lowest risk at body mass index of 25. In the cohorts with high cardiovascular risk and chronic kidney disease (mean follow-up of six and four years, respectively), risk associations between higher body mass index and GFR decline were weaker than in the general population, and the association between body mass index and death was also J shaped, with the lowest risk between body mass index 25 and 30. In all cohort types, associations between higher waist circumference and higher waist-to-height ratio with GFR decline were similar to that of body mass index; however, increased risk of death was not associated with lower waist circumference or waist-to-height ratio, as was seen with body mass index.ConclusionsElevated body mass index, waist circumference, and waist-to-height ratio are independent risk factors for GFR decline and death in individuals who have normal or reduced levels of estimated GFR.

Published
2019

7. Standardising clinical outcomes measures for adult clinical trials in Fabry disease: A global Delphi consensus

Author

Moreno-Martinez, D., primary, Aguiar, P., additional, Auray-Blais, C., additional, Beck, M., additional, Bichet, D.G., additional, Burlina, A., additional, Cole, D., additional, Elliott, P., additional, Feldt-Rasmussen, U., additional, Feriozzi, S., additional, Fletcher, J., additional, Giugliani, R., additional, Jovanovic, A., additional, Kampmann, C., additional, Langeveld, M., additional, Lidove, O., additional, Linhart, A., additional, Mauer, M., additional, Moon, J.C., additional, Muir, A., additional, Nowak, A., additional, Oliveira, J.P., additional, Ortiz, A., additional, Pintos-Morell, G., additional, Politei, J., additional, Rozenfeld, P., additional, Schiffmann, R., additional, Svarstad, E., additional, Talbot, A.S., additional, Thomas, M., additional, Tøndel, C., additional, Warnock, D., additional, West, M.L., additional, and Hughes, D.A., additional

Published
2021
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8. Blood pressure and metabolic effects of acetyl-L-carnitine in type 2 diabetes: DIABASI randomized controlled trial

Author

Parvanova, A, Trillini, M, Podesta, M, Iliev, I, Aparicio, C, Perna, A, Peraro, F, Rubis, N, Gaspari, F, Cannata, A, Ferrari, S, Bossi, A, Trevisan, R, Parameswaran, S, Chavez-Iniguez, J, Masnic, F, Seck, S, Jiamjariyaporn, T, Cortinovis, M, Perico, L, Sharma, K, Remuzzi, G, Ruggenenti, P, Warnock, D, Parvanova A., Trillini M., Podesta M. A., Iliev I. P., Aparicio C., Perna A., Peraro F., Rubis N., Gaspari F., Cannata A., Ferrari S., Bossi A. C., Trevisan R., Parameswaran S., Chavez-Iniguez J. S., Masnic F., Seck S. M., Jiamjariyaporn T., Cortinovis M., Perico L., Sharma K., Remuzzi G., Ruggenenti P., Warnock D. G., Parvanova, A, Trillini, M, Podesta, M, Iliev, I, Aparicio, C, Perna, A, Peraro, F, Rubis, N, Gaspari, F, Cannata, A, Ferrari, S, Bossi, A, Trevisan, R, Parameswaran, S, Chavez-Iniguez, J, Masnic, F, Seck, S, Jiamjariyaporn, T, Cortinovis, M, Perico, L, Sharma, K, Remuzzi, G, Ruggenenti, P, Warnock, D, Parvanova A., Trillini M., Podesta M. A., Iliev I. P., Aparicio C., Perna A., Peraro F., Rubis N., Gaspari F., Cannata A., Ferrari S., Bossi A. C., Trevisan R., Parameswaran S., Chavez-Iniguez J. S., Masnic F., Seck S. M., Jiamjariyaporn T., Cortinovis M., Perico L., Sharma K., Remuzzi G., Ruggenenti P., and Warnock D. G.

Abstract

Context: Acetyl-L-carnitine (ALC), a mitochondrial carrier involved in lipid oxidation and glucose metabolism, decreased systolic blood pressure (SBP), and ameliorated insulin sensitivity in hypertensive nondiabetic subjects at high cardiovascular risk. Objective: To assess the effects of ALC on SBP and glycemic and lipid control in patients with hypertension, type 2 diabetes mellitus (T2D), and dyslipidemia on background statin therapy. Design: After 4-week run-in period and stratification according to previous statin therapy, patients were randomized to 6-month, double-blind treatment with ALC or placebo added-on simvastatin. Setting: Five diabetology units and one clinical research center in Italy. Patients: Two hundred twenty-nine patients with hypertension and dyslipidemic T2D > 40 years with stable background antihypertensive, hypoglycemic, and statin therapy and serum creatinine < 1.5 mg/ dL. Interventions: Oral ALC 1000 mg or placebo twice daily on top of stable simvastatin therapy. Outcome and Measures: Primary outcome was SBP. Secondary outcomes included lipid and glycemic profiles. Total-body glucose disposal rate and glomerular filtration rate were measured in subgroups by hyperinsulinemic-euglycemic clamp and iohexol plasma clearance, respectively. Results: SBP did not significantly change after 6-month treatment with ALC compared with placebo (-2.09mmHg vs-3.57mmHg, P = 0.9539). Serum cholesterol, triglycerides, and lipoprotein(a), as well as blood glucose, glycated hemoglobin, fasting insulin levels, homeostatic model assessment of insulin resistance index, glucose disposal rate, and glomerular filtration rate did not significantly differ between treatments. Adverse events were comparable between groups. Conclusions: Six-month oral ALC supplementation did not affect blood pressure, lipid and glycemic control, insulin sensitivity and kidney function in hypertensive normoalbuminuric and microalbuminuric T2D patients on background statin therapy.

Published
2018

22. Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis

Author

Chertow GM, Block GA, Correa-Rotter R, Drüeke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Trotman ML, Wheeler DC, Parfrey PS., Evolve Team, Chertow G, Parfrey P, Block G, Drüeke T, Goodman W, Herzog C, London G, Mahaffey K, Moe S, Wheeler D, Hennekens C, Baigent C, Brown W, O'Brien P, Anderson S, Hoel J, Szczech L, Patel U, Wampole J, Pun P, Felker M, Inrig J, Shah S, Hernandez A, Patel C, Brennan M, Albizem M, Capper E, Cauchi L, Cheng S, Dehmel B, Dhami K, Durham C, Francioni M, Gadd S, Goodman B, Guimaraes L, Grey N, Hamlin R, Harris C, Harris E, Heavey S, Heiges T, Heiser D, Jaeger P, James M, James P, Karimi S, Kewalramani R, Kraszewski A, Liang J, Maguire J, McCormick K, McFarlane K, Mix C, Modafferi D, Prathikanti R, Ryan C, Santiago N, Schumacher J, Seder C, Shahinfar S, Soares B, Stolman D, Tisher C, Trotman M, Tseng S, Ulias G, Unger P, Vyshenskaya A, Walsh L, White C, Wilde K, Santos J, Zarazaga C, Marin I, Garrote N, Cusumano A, Penalba N, Del Valle E, Juncos L, Saye J, Lef L, Altobelli V, Petraglia G, Rosa-Diez G, Douthat W, Lobo J, Gallart C, Lafalla A, Diez G, Linares B, Lopez N, Ramirez N, Gonzalez R, Valtuille R, Beresan H, Hermida O, Rudolf G, Marchetta N, Rano M, Ramirez M, Garcia N, Gillies A, Jones B, Pedagogos E, Walker R, Talaulikar G, Bannister K, Suranyi M, Kark A, Roger S, Kerr P, Disney A, Mount P, Fraenkel M, Mathew M, Fassett R, Jose M, Hawley C, Lonergan M, Mackie J, Ferrari P, Menahem S, Sabto J, Hutchison B, Langham R, Pollock C, Holzer H, Oberbauer R, Arias I, Graf H, Mayer G, Lhotta K, Neyer U, Klauser-Braun R, Hoerl W, Horn S, Kovarik J, Kramar R, Eigner M, Dhaene M, Billiouw J, De Meester J, Warling X, Cambier-Dwelschauwers P, Evenepoel P, Daelemans R, Dratwa M, Maes B, Stolear J, Dejagere T, Vanwalleghem J, Bouman K, Jadoul M, Peeters J, Vanholder R, Tielemans C, Donck J, Almeida F, de Oliveira J, Burdmann E, Garcia V, Thome F, Deboni L, Bregman R, Lugon J, Araújo S, Ferreira Filho S, Daher Ede F, Baptista M, Carvalho A, d'Avila D, Moyses Neto M, Yu L, Bastos M, Lacativa P, Jorgetti V, Romão Ede A, da Costa JC, Pecoits Filho R, Gordan P, Salgado N, Araújo M, Coelho S, Oliveira I, Moysés R, Vasconcellos L, Batista P, Gross J, Pedrosa A, Cournoyer S, LeBlanc M, Chow S, Karunakaran S, Wong G, Tobe S, Desmeules S, Zimmerman D, Murphy S, Montambault P, Donnelly S, MacRae J, Culleton B, Soroka S, Rabbat C, Jindal K, Vasilevsky M, Michaud M, Wijeyesinghe E, Zacharias J, Lok C, Muirhead N, Verrelli M, Da Roza G, Sapir D, Olgaard K, Daugaard H, Brandi L, Jensen P, Boulechfar H, Ang K, Simon P, Rieu P, Brunet P, Touchard G, Torres P, Combe C, Durrbach A, Ortiz J, Hannedouche T, Vela C, Lionet A, Ryckelynck P, Zaoui P, Choukroun G, Fessi H, Lang P, Stroumza P, Joly D, Mousson C, Laville M, Dellanna F, Erley C, Braun J, Rambausek M, Riegel W, Klingberg M, Schwertfeger E, Wizemann V, Eckardt K, Reichel H, Passauer J, Hübel E, Frischmuth N, Liebl R, Fiedler R, Schwenger V, Voßkühler A, Kunzendorf U, Renders L, Rattensberger D, Rump L, Ketteler M, Neumayer H, Zantvoort F, Stahl R, Ladanyi E, Braun B, Kulcsar I, Mezei I, Csiky B, Rikker C, Arkossy O, Berta K, Szegedi J, Major L, Ferenczi S, Fekete A, Szabo T, Zakar G, Wagner G, Erdelyine S, Borbas B, Eustace J, Reddan D, Capasso G, Locatelli F, Villa G, Cozzolino M, Brancaccio D, Messa P, Bolasco P, Ricciardi B, Malberti F, Moriero E, Cannella G, Ortalda V, Stefoni S, Frascà G, Cappelli G, Albertazzi A, Zoccali C, Farina M, Elli A, Avella F, Ondei P, Mingardi G, Errico R, Losito A, Di Giulio S, Pertosa G, Schena F, Grandaliano G, Gesualdo L, Auricchio M, Bochicchio-Ricardelli T, Correa-Rotter J, Verástegui F, Peña J, Wong A, Cruz-Valdez J, Zamora M, Solis M, Diaz M, Flores M, Sandoval E, van den Dorpel M, Brink H, Van Kuijk W, Vermeij C, Gregoor P, Hagen E, van der Sande F, Klinger M, Nowicki M, Muszytowski M, Bidas K, Bentkowski W, Wiecek A, Ksiazek A, Marczewski K, Ostrowski M, Switalski M, Sulowicz W, Matuszkiewicz-Rowinska J, Mysliwiec M, Durlik M, Rutkowski B, Macario F, Carvalho B, Frazao J, Machado D, Weigert A, Andrusev A, Khrustalev O, Zemtchenkov A, Gurevich K, Staroselsky K, Khadikova N, Rozhinskaya L, Timokhovskaya G, Strokov A, Balkarova O, Ermolenko V, Kolmakova E, Komandenko M, Timofeev M, Shilo V, Shostka G, Smirnov A, Anashkin V, Volgina G, Domashenko O, Gurevich A, Perlin D, García J, Ribes E, Piera E, Lucas M, Galicia M, Prados M, González M, Romero R, de Francisco ÁM, Montenegro J, Santiago C, García F, de La Ossa J, Arrieta J, Pons J, Martín-Malo A, Amigó J, Cases A, Sterner G, Jensen G, Wikström B, Jacobson S, Lund U, Weiss L, Ståhl A, von Albertini B, Burnier M, Meier P, Martin P, Uehlinger D, Dickenmann M, Yaqoob M, Zehnder D, Kalra P, Padmanabhan N, Roe S, Eadington D, Pritchard N, Hutchison A, Davies S, Wilkie M, Davies M, Pai P, Swift P, Kwan J, Goldsmith D, Tomson C, Stratton J, Dasgupta I, Sarkar S, Moustafa M, Gandhi K, Jamal A, Galindo-Ramos E, Tuazon J, Batlle D, Tucker K, Schiller-Moran B, Assefi A, Martinez C, Samuels L, Goldman J, Cangiano-Rivera J, Darwish R, Lee M, Topf J, Kapatkin K, Baer H, Kopelman R, Acharya M, Tharpe D, Bernardo M, Nader P, Guzman-Rivera J, Pergola P, Sekkarie M, Alas E, Zager P, Liss K, Navarro J, Roppolo M, Denu-Ciocca C, Kshirsagar A, El Khatib M, Kant K, Scott D, Murthyr B, Finkelstein F, Keightley G, McCrary R, Pitone J, Cavalieri T, Tsang A, Pellegrino B, Schmidt R, Ahmad S, Brown C, Friedman E, Mittman N, Fadem S, Shapiro W, Reddy M, Goldberger S, Woredekal Y, Agarwal A, Anger M, Haque M, Chidester P, Kohli R, Rubinstein S, Newman G, Gladish R, Ayodeji O, Soman S, Sprague S, Hunt N, Gehr T, Rizk D, Warnock D, Polack D, Pahl M, Fischer D, Dreyer P, James G, Husserl F, Rogers T, Raff A, Sedor J, Silver M, Smith M, Steinberg S, DelGiorno T, Jones E, Cunha P, Cheng J, Pogue V, Blumenthal S, Brown E, Charytan C, Buerkert J, Cook M, Felsenfeld A, Tareen N, Gupta A, Herman T, Diamond S, Hura C, Laski M, MacLaurin J, Plumb T, Brosnahan G, Kumar J, Henriquez M, Poole C, Osanloo E, Matalon A, Sholer C, Arfeen S, Azer M, Belledonne M, Gross M, Dunnigan E, McConnell K, Becker B, Rigolosi R, Spiegel D, Stegman M, Patak R, Streja D, Ranjit U, Youell T, Wooldridge T, Stafford C, Cottiero R, Weinberg M, Schonefeld M, Shahmir E, Hazzan A, Ashfaq A, Bhandari K, Cleveland W, Culpepper M, Golden J, Lai L, Lien Y, Lorica V, Robertson J, Malireddi K, Morse S, Thakur V, Israelit A, Raguram P, Alfred H, Weise W, Al-Saghir F, El Shahawy M, Rastogi A, Nissenson A, Kopyt N, Lynn R, Lea J, McClellan W, Teredesai P, Ong S, Tolkan S, Sugihara J, Minga T, Mehrotra R, Minasian R, Bhatia D, Specter R, Capelli J, Sidhu P, Dalal S, Dykes P, Khan M, Rahim F, Saklayen M, Thomas A, Michael B, Torres M, Al-Bander H, Murray B, Abukurah A, Gupta B, Nosrati S, Raja R, Zeig S, Braun M, Amatya A, Endsley J, Sharon Z, Dolson G, Dumler F, Ntoso K, Rosansky S, Kumar N, Gura V, Thompson N, Goldfarb D, Halligan R, Middleton J, Widerhorn A, Arbeit L, Arruda J, Crouch T, Friedman L, Khokhar S, Mittleman J, Light P, Taparia B, West C, Cotton J, Dhingra R, Kleinman L, Arif F, Lew S, Nammour T, Sterrett J, Williams M, Ramirez J, Rubin J, McCarthy J, Noble S, Chaffin M, Rekhi A., Chertow, Gm, Block, Ga, Correa-Rotter, R, Drüeke, Tb, Floege, J, Goodman, Wg, Herzog, Ca, Kubo, Y, London, Gm, Mahaffey, Kw, Mix, Tc, Moe, Sm, Trotman, Ml, Wheeler, Dc, Parfrey, Ps., Evolve, Team, Chertow, G, Parfrey, P, Block, G, Drüeke, T, Goodman, W, Herzog, C, London, G, Mahaffey, K, Moe, S, Wheeler, D, Hennekens, C, Baigent, C, Brown, W, O'Brien, P, Anderson, S, Hoel, J, Szczech, L, Patel, U, Wampole, J, Pun, P, Felker, M, Inrig, J, Shah, S, Hernandez, A, Patel, C, Brennan, M, Albizem, M, Capper, E, Cauchi, L, Cheng, S, Dehmel, B, Dhami, K, Durham, C, Francioni, M, Gadd, S, Goodman, B, Guimaraes, L, Grey, N, Hamlin, R, Harris, C, Harris, E, Heavey, S, Heiges, T, Heiser, D, Jaeger, P, James, M, James, P, Karimi, S, Kewalramani, R, Kraszewski, A, Liang, J, Maguire, J, Mccormick, K, Mcfarlane, K, Mix, C, Modafferi, D, Prathikanti, R, Ryan, C, Santiago, N, Schumacher, J, Seder, C, Shahinfar, S, Soares, B, Stolman, D, Tisher, C, Trotman, M, Tseng, S, Ulias, G, Unger, P, Vyshenskaya, A, Walsh, L, White, C, Wilde, K, Santos, J, Zarazaga, C, Marin, I, Garrote, N, Cusumano, A, Penalba, N, Del Valle, E, Juncos, L, Saye, J, Lef, L, Altobelli, V, Petraglia, G, Rosa-Diez, G, Douthat, W, Lobo, J, Gallart, C, Lafalla, A, Diez, G, Linares, B, Lopez, N, Ramirez, N, Gonzalez, R, Valtuille, R, Beresan, H, Hermida, O, Rudolf, G, Marchetta, N, Rano, M, Ramirez, M, Garcia, N, Gillies, A, Jones, B, Pedagogos, E, Walker, R, Talaulikar, G, Bannister, K, Suranyi, M, Kark, A, Roger, S, Kerr, P, Disney, A, Mount, P, Fraenkel, M, Mathew, M, Fassett, R, Jose, M, Hawley, C, Lonergan, M, Mackie, J, Ferrari, P, Menahem, S, Sabto, J, Hutchison, B, Langham, R, Pollock, C, Holzer, H, Oberbauer, R, Arias, I, Graf, H, Mayer, G, Lhotta, K, Neyer, U, Klauser-Braun, R, Hoerl, W, Horn, S, Kovarik, J, Kramar, R, Eigner, M, Dhaene, M, Billiouw, J, De Meester, J, Warling, X, Cambier-Dwelschauwers, P, Evenepoel, P, Daelemans, R, Dratwa, M, Maes, B, Stolear, J, Dejagere, T, Vanwalleghem, J, Bouman, K, Jadoul, M, Peeters, J, Vanholder, R, Tielemans, C, Donck, J, Almeida, F, de Oliveira, J, Burdmann, E, Garcia, V, Thome, F, Deboni, L, Bregman, R, Lugon, J, Araújo, S, Ferreira Filho, S, Daher Ede, F, Baptista, M, Carvalho, A, D'Avila, D, Moyses Neto, M, Yu, L, Bastos, M, Lacativa, P, Jorgetti, V, Romão Ede, A, da Costa, Jc, Pecoits Filho, R, Gordan, P, Salgado, N, Araújo, M, Coelho, S, Oliveira, I, Moysés, R, Vasconcellos, L, Batista, P, Gross, J, Pedrosa, A, Cournoyer, S, Leblanc, M, Chow, S, Karunakaran, S, Wong, G, Tobe, S, Desmeules, S, Zimmerman, D, Murphy, S, Montambault, P, Donnelly, S, Macrae, J, Culleton, B, Soroka, S, Rabbat, C, Jindal, K, Vasilevsky, M, Michaud, M, Wijeyesinghe, E, Zacharias, J, Lok, C, Muirhead, N, Verrelli, M, Da Roza, G, Sapir, D, Olgaard, K, Daugaard, H, Brandi, L, Jensen, P, Boulechfar, H, Ang, K, Simon, P, Rieu, P, Brunet, P, Touchard, G, Torres, P, Combe, C, Durrbach, A, Ortiz, J, Hannedouche, T, Vela, C, Lionet, A, Ryckelynck, P, Zaoui, P, Choukroun, G, Fessi, H, Lang, P, Stroumza, P, Joly, D, Mousson, C, Laville, M, Dellanna, F, Erley, C, Braun, J, Rambausek, M, Riegel, W, Klingberg, M, Schwertfeger, E, Wizemann, V, Eckardt, K, Reichel, H, Passauer, J, Hübel, E, Frischmuth, N, Liebl, R, Fiedler, R, Schwenger, V, Voßkühler, A, Kunzendorf, U, Renders, L, Rattensberger, D, Rump, L, Ketteler, M, Neumayer, H, Zantvoort, F, Stahl, R, Ladanyi, E, Braun, B, Kulcsar, I, Mezei, I, Csiky, B, Rikker, C, Arkossy, O, Berta, K, Szegedi, J, Major, L, Ferenczi, S, Fekete, A, Szabo, T, Zakar, G, Wagner, G, Erdelyine, S, Borbas, B, Eustace, J, Reddan, D, Capasso, G, Locatelli, F, Villa, G, Cozzolino, M, Brancaccio, D, Messa, P, Bolasco, P, Ricciardi, B, Malberti, F, Moriero, E, Cannella, G, Ortalda, V, Stefoni, S, Frascà, G, Cappelli, G, Albertazzi, A, Zoccali, C, Farina, M, Elli, A, Avella, F, Ondei, P, Mingardi, G, Errico, R, Losito, A, Di Giulio, S, Pertosa, G, Schena, F, Grandaliano, G, Gesualdo, L, Auricchio, M, Bochicchio-Ricardelli, T, Correa-Rotter, J, Verástegui, F, Peña, J, Wong, A, Cruz-Valdez, J, Zamora, M, Solis, M, Diaz, M, Flores, M, Sandoval, E, van den Dorpel, M, Brink, H, Van Kuijk, W, Vermeij, C, Gregoor, P, Hagen, E, van der Sande, F, Klinger, M, Nowicki, M, Muszytowski, M, Bidas, K, Bentkowski, W, Wiecek, A, Ksiazek, A, Marczewski, K, Ostrowski, M, Switalski, M, Sulowicz, W, Matuszkiewicz-Rowinska, J, Mysliwiec, M, Durlik, M, Rutkowski, B, Macario, F, Carvalho, B, Frazao, J, Machado, D, Weigert, A, Andrusev, A, Khrustalev, O, Zemtchenkov, A, Gurevich, K, Staroselsky, K, Khadikova, N, Rozhinskaya, L, Timokhovskaya, G, Strokov, A, Balkarova, O, Ermolenko, V, Kolmakova, E, Komandenko, M, Timofeev, M, Shilo, V, Shostka, G, Smirnov, A, Anashkin, V, Volgina, G, Domashenko, O, Gurevich, A, Perlin, D, García, J, Ribes, E, Piera, E, Lucas, M, Galicia, M, Prados, M, González, M, Romero, R, de Francisco, Ám, Montenegro, J, Santiago, C, García, F, de La Ossa, J, Arrieta, J, Pons, J, Martín-Malo, A, Amigó, J, Cases, A, Sterner, G, Jensen, G, Wikström, B, Jacobson, S, Lund, U, Weiss, L, Ståhl, A, von Albertini, B, Burnier, M, Meier, P, Martin, P, Uehlinger, D, Dickenmann, M, Yaqoob, M, Zehnder, D, Kalra, P, Padmanabhan, N, Roe, S, Eadington, D, Pritchard, N, Hutchison, A, Davies, S, Wilkie, M, Davies, M, Pai, P, Swift, P, Kwan, J, Goldsmith, D, Tomson, C, Stratton, J, Dasgupta, I, Sarkar, S, Moustafa, M, Gandhi, K, Jamal, A, Galindo-Ramos, E, Tuazon, J, Batlle, D, Tucker, K, Schiller-Moran, B, Assefi, A, Martinez, C, Samuels, L, Goldman, J, Cangiano-Rivera, J, Darwish, R, Lee, M, Topf, J, Kapatkin, K, Baer, H, Kopelman, R, Acharya, M, Tharpe, D, Bernardo, M, Nader, P, Guzman-Rivera, J, Pergola, P, Sekkarie, M, Alas, E, Zager, P, Liss, K, Navarro, J, Roppolo, M, Denu-Ciocca, C, Kshirsagar, A, El Khatib, M, Kant, K, Scott, D, Murthyr, B, Finkelstein, F, Keightley, G, Mccrary, R, Pitone, J, Cavalieri, T, Tsang, A, Pellegrino, B, Schmidt, R, Ahmad, S, Brown, C, Friedman, E, Mittman, N, Fadem, S, Shapiro, W, Reddy, M, Goldberger, S, Woredekal, Y, Agarwal, A, Anger, M, Haque, M, Chidester, P, Kohli, R, Rubinstein, S, Newman, G, Gladish, R, Ayodeji, O, Soman, S, Sprague, S, Hunt, N, Gehr, T, Rizk, D, Warnock, D, Polack, D, Pahl, M, Fischer, D, Dreyer, P, James, G, Husserl, F, Rogers, T, Raff, A, Sedor, J, Silver, M, Smith, M, Steinberg, S, Delgiorno, T, Jones, E, Cunha, P, Cheng, J, Pogue, V, Blumenthal, S, Brown, E, Charytan, C, Buerkert, J, Cook, M, Felsenfeld, A, Tareen, N, Gupta, A, Herman, T, Diamond, S, Hura, C, Laski, M, Maclaurin, J, Plumb, T, Brosnahan, G, Kumar, J, Henriquez, M, Poole, C, Osanloo, E, Matalon, A, Sholer, C, Arfeen, S, Azer, M, Belledonne, M, Gross, M, Dunnigan, E, Mcconnell, K, Becker, B, Rigolosi, R, Spiegel, D, Stegman, M, Patak, R, Streja, D, Ranjit, U, Youell, T, Wooldridge, T, Stafford, C, Cottiero, R, Weinberg, M, Schonefeld, M, Shahmir, E, Hazzan, A, Ashfaq, A, Bhandari, K, Cleveland, W, Culpepper, M, Golden, J, Lai, L, Lien, Y, Lorica, V, Robertson, J, Malireddi, K, Morse, S, Thakur, V, Israelit, A, Raguram, P, Alfred, H, Weise, W, Al-Saghir, F, El Shahawy, M, Rastogi, A, Nissenson, A, Kopyt, N, Lynn, R, Lea, J, Mcclellan, W, Teredesai, P, Ong, S, Tolkan, S, Sugihara, J, Minga, T, Mehrotra, R, Minasian, R, Bhatia, D, Specter, R, Capelli, J, Sidhu, P, Dalal, S, Dykes, P, Khan, M, Rahim, F, Saklayen, M, Thomas, A, Michael, B, Torres, M, Al-Bander, H, Murray, B, Abukurah, A, Gupta, B, Nosrati, S, Raja, R, Zeig, S, Braun, M, Amatya, A, Endsley, J, Sharon, Z, Dolson, G, Dumler, F, Ntoso, K, Rosansky, S, Kumar, N, Gura, V, Thompson, N, Goldfarb, D, Halligan, R, Middleton, J, Widerhorn, A, Arbeit, L, Arruda, J, Crouch, T, Friedman, L, Khokhar, S, Mittleman, J, Light, P, Taparia, B, West, C, Cotton, J, Dhingra, R, Kleinman, L, Arif, F, Lew, S, Nammour, T, Sterrett, J, Williams, M, Ramirez, J, Rubin, J, Mccarthy, J, Noble, S, Chaffin, M, and Rekhi, A.

Subjects
Adult, Male, Dialysis, Cinacalcet, Cardiovascular Disease, medicine.medical_specialty, Calcimimetic, medicine.medical_treatment, Naphthalenes, Coronary artery disease, Renal Dialysis, Internal medicine, Odds Ratio, medicine, Humans, Intensive care medicine, Aged, Etelcalcetide, Hyperparathyroidism, Hypocalcemia, business.industry, General Medicine, Middle Aged, medicine.disease, Intention to Treat Analysis, Cardiovascular Diseases, Parathyroid Hormone, Cinacalcet Hydrochloride, Kidney Failure, Chronic, Female, Hyperparathyroidism, Secondary, Secondary hyperparathyroidism, business, medicine.drug
Abstract

Disorders of mineral metabolism, including secondary hyperparathyroidism, are thought to contribute to extraskeletal (including vascular) calcification among patients with chronic kidney disease. It has been hypothesized that treatment with the calcimimetic agent cinacalcet might reduce the risk of death or nonfatal cardiovascular events in such patients.In this clinical trial, we randomly assigned 3883 patients with moderate-to-severe secondary hyperparathyroidism (median level of intact parathyroid hormone, 693 pg per milliliter [10th to 90th percentile, 363 to 1694]) who were undergoing hemodialysis to receive either cinacalcet or placebo. All patients were eligible to receive conventional therapy, including phosphate binders, vitamin D sterols, or both. The patients were followed for up to 64 months. The primary composite end point was the time until death, myocardial infarction, hospitalization for unstable angina, heart failure, or a peripheral vascular event. The primary analysis was performed on the basis of the intention-to-treat principle.The median duration of study-drug exposure was 21.2 months in the cinacalcet group, versus 17.5 months in the placebo group. The primary composite end point was reached in 938 of 1948 patients (48.2%) in the cinacalcet group and 952 of 1935 patients (49.2%) in the placebo group (relative hazard in the cinacalcet group vs. the placebo group, 0.93; 95% confidence interval, 0.85 to 1.02; P=0.11). Hypocalcemia and gastrointestinal adverse events were significantly more frequent in patients receiving cinacalcet.In an unadjusted intention-to-treat analysis, cinacalcet did not significantly reduce the risk of death or major cardiovascular events in patients with moderate-to-severe secondary hyperparathyroidism who were undergoing dialysis. (Funded by Amgen; EVOLVE ClinicalTrials.gov number, NCT00345839.).

Published
2012

25. Aggregatibacter, Capnocytophaga, Eikenella, Kingella, Pasteurella, and other fastidious or rarely encountered Gram-negative rods

Author

Jorgensen, J H, Pfaller, M A, Carroll, K C, Funke, G, Landry, M L, Richter, S S, Warnock, D W, Jorgensen, J H ( J H ), Pfaller, M A ( M A ), Carroll, K C ( K C ), Funke, G ( G ), Landry, M L ( M L ), Richter, S S ( S S ), Warnock, D W ( D W ), Zbinden, R, Jorgensen, J H, Pfaller, M A, Carroll, K C, Funke, G, Landry, M L, Richter, S S, Warnock, D W, Jorgensen, J H ( J H ), Pfaller, M A ( M A ), Carroll, K C ( K C ), Funke, G ( G ), Landry, M L ( M L ), Richter, S S ( S S ), Warnock, D W ( D W ), and Zbinden, R

Published
2015

26. Estimated glomerular filtration rate and albuminuria for prediction of cardiovascular outcomes: a collaborative meta-analysis of individual participant data

Author

Matsushita, K, Coresh, J, Sang, Y, Chalmers, J, Fox, C, Guallar, E, Jafar, T, Jassal, Sk, Landman, Gw, Muntner, P, Roderick, P, Sairenchi, T, Schöttker, B, Shankar, A, Shlipak, M, Tonelli, M, Townend, J, van Zuilen, A, Yamagishi, K, Yamashita, K, Gansevoort, R, Sarnak, M, Warnock, Dg, Woodward, M, Ärnlöv J, CKD Prognosis Consortium, Macmahon, S, Arima, H, Yatsuya, H, Toyoshima, H, Tamakoshi, K, Atkins, Rc, Polkinghorne, Kr, Chadban, S, Klein, R, Klein, Be, Lee, Ke, Sacks, Fm, Curhan, Gc, Sarnak, Mj, Katz, R, Iso, H, Kitamura, A, Imano, H, Jafar, Th, Islam, M, Hatcher, J, Poulter, N, Chaturvedi, N, Wheeler, Dc, Emberson, J, Townend, Jn, Landray, Mj, Brenner, H, Rothenbacher, D, Müller, H, Fox, Cs, Hwang, Sj, Meigs, Jb, Upadhyay, A, Perkins, R, Chang, Ar, Cirillo, Massimo, Hallan, S, Aasarød, K, Øien, Cm, Romundstad, S, Ryu, S, Chang, Y, Cho, J, Shin, H, Chodick, G, Shalev, V, Ash, N, Shainberg, B, Wetzels, Jf, Blankestijn, Pj, Van, Zuilen, Levey, As, Inker, La, Menon, V, Peralta, C, Nitsch, D, Fletcher, A, Bulpitt, C, Elley, Cr, Kenealy, T, Moyes, Sa, Collins, Jf, Drury, P, Ohkubo, T, Metoki, H, Nakayama, M, Kikuya, M, Imai, Y, Gansevoort, Rt, Bakker, Sj, Hillege, Hl, Heerspink, Hj, Bergstrom, J, Jh, Ix, Barrett Connor, E, Judd, S, Mcclellan, W, Jee, Sh, Kimm, H, Mok, Y, Tangri, N, Sud, M, Naimark, D, Wen, Cp, Wen, Sf, Tsao, Ck, Tsai, Mk, Ärnlöv, J, Lannfelt, L, Larsson, A, Bilo, Hj, Kleefstra, N, Groenier, Kh, Joosten, H, Drion, I, Jong, De, Iseki, K, Stengel, B, Warnock, D, Ballew, Sh, Woodward, M., Matsushita, K, Coresh, J, Sang, Y, Chalmers, J, Fox, C, Guallar, E, Jafar, T, Jassal, Sk, Landman, Gw, Muntner, P, Roderick, P, Sairenchi, T, Schöttker, B, Shankar, A, Shlipak, M, Tonelli, M, Townend, J, van Zuilen, A, Yamagishi, K, Yamashita, K, Gansevoort, R, Sarnak, M, Warnock, Dg, Woodward, M, Ärnlöv, J, CKD Prognosis, Consortium, Macmahon, S, Arima, H, Yatsuya, H, Toyoshima, H, Tamakoshi, K, Atkins, Rc, Polkinghorne, Kr, Chadban, S, Klein, R, Klein, Be, Lee, Ke, Sacks, Fm, Curhan, Gc, Sarnak, Mj, Katz, R, Iso, H, Kitamura, A, Imano, H, Jafar, Th, Islam, M, Hatcher, J, Poulter, N, Chaturvedi, N, Wheeler, Dc, Emberson, J, Townend, Jn, Landray, Mj, Brenner, H, Rothenbacher, D, Müller, H, Hwang, Sj, Meigs, Jb, Upadhyay, A, Perkins, R, Chang, Ar, Cirillo, Massimo, Hallan, S, Aasarød, K, Øien, Cm, Romundstad, S, Ryu, S, Chang, Y, Cho, J, Shin, H, Chodick, G, Shalev, V, Ash, N, Shainberg, B, Wetzels, Jf, Blankestijn, Pj, Van, Zuilen, Ad, Levey, A, Inker, La, Menon, V, Peralta, C, Nitsch, D, Fletcher, A, Bulpitt, C, Elley, Cr, Kenealy, T, Moyes, Sa, Collins, Jf, Drury, P, Ohkubo, T, Metoki, H, Nakayama, M, Kikuya, M, Imai, Y, Gansevoort, Rt, Bakker, Sj, Hillege, Hl, Heerspink, Hj, Bergstrom, J, Ix, Jh, Barrett Connor, E, Judd, S, Mcclellan, W, Jee, Sh, Kimm, H, Mok, Y, Tangri, N, Sud, M, Naimark, D, Wen, Cp, Wen, Sf, Tsao, Ck, Tsai, Mk, Lannfelt, L, Larsson, A, Bilo, Hj, Kleefstra, N, Groenier, Kh, Joosten, H, Drion, I, De, Jong, Pe, Iseki, K, Stengel, B, Warnock, D, Ballew, Sh, Woodward, M., Cardiovascular Centre (CVC), and Groningen Kidney Center (GKC)

Subjects
CHRONIC KIDNEY-DISEASE, Male, Endocrinology, Diabetes and Metabolism, Coronary Disease, 030204 cardiovascular system & hematology, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, cardiovascular disease, Risk Factors, eGFR, EQUATION, ARTERY-DISEASE, EPIDEMIOLOGY, 030212 general & internal medicine, RISK, education.field_of_study, CYSTATIN C, biology, ASSOCIATION, Middle Aged, 3. Good health, Stroke, 1101 Medical Biochemistry and Metabolomics, Cardiovascular Diseases, Creatinine, eGFR, albuminuria, cardiovascular disease, HEART, Female, medicine.symptom, Life Sciences & Biomedicine, Glomerular Filtration Rate, Adult, medicine.medical_specialty, Population, Renal function, 1117 Public Health and Health Services, Endocrinology & Metabolism, 03 medical and health sciences, Diabetes mellitus, Internal medicine, CKD, Internal Medicine, medicine, Albuminuria, Humans, education, CKD Prognosis Consortium, Heart Failure, Science & Technology, business.industry, MORTALITY, 1103 Clinical Sciences, medicine.disease, chemistry, Cystatin C, Heart failure, biology.protein, Renal disorders Radboud Institute for Health Sciences [Radboudumc 11], business, Follow-Up Studies, Kidney disease
Abstract

Item does not contain fulltext BACKGROUND: The usefulness of estimated glomerular filtration rate (eGFR) and albuminuria for prediction of cardiovascular outcomes is controversial. We aimed to assess the addition of creatinine-based eGFR and albuminuria to traditional risk factors for prediction of cardiovascular risk with a meta-analytic approach. METHODS: We meta-analysed individual-level data for 637 315 individuals without a history of cardiovascular disease from 24 cohorts (median follow-up 4.2-19.0 years) included in the Chronic Kidney Disease Prognosis Consortium. We assessed C statistic difference and reclassification improvement for cardiovascular mortality and fatal and non-fatal cases of coronary heart disease, stroke, and heart failure in a 5 year timeframe, contrasting prediction models for traditional risk factors with and without creatinine-based eGFR, albuminuria (either albumin-to-creatinine ratio [ACR] or semi-quantitative dipstick proteinuria), or both. FINDINGS: The addition of eGFR and ACR significantly improved the discrimination of cardiovascular outcomes beyond traditional risk factors in general populations, but the improvement was greater with ACR than with eGFR, and more evident for cardiovascular mortality (C statistic difference 0.0139 [95% CI 0.0105-0.0174] for ACR and 0.0065 [0.0042-0.0088] for eGFR) and heart failure (0.0196 [0.0108-0.0284] and 0.0109 [0.0059-0.0159]) than for coronary disease (0.0048 [0.0029-0.0067] and 0.0036 [0.0019-0.0054]) and stroke (0.0105 [0.0058-0.0151] and 0.0036 [0.0004-0.0069]). Dipstick proteinuria showed smaller improvement than ACR. The discrimination improvement with eGFR or ACR was especially evident in individuals with diabetes or hypertension, but remained significant with ACR for cardiovascular mortality and heart failure in those without either of these disorders. In individuals with chronic kidney disease, the combination of eGFR and ACR for risk discrimination outperformed most single traditional predictors; the C statistic for cardiovascular mortality fell by 0.0227 (0.0158-0.0296) after omission of eGFR and ACR compared with less than 0.007 for any single modifiable traditional predictor. INTERPRETATION: Creatinine-based eGFR and albuminuria should be taken into account for cardiovascular prediction, especially when these measures are already assessed for clinical purpose or if cardiovascular mortality and heart failure are outcomes of interest. ACR could have particularly broad implications for cardiovascular prediction. In populations with chronic kidney disease, the simultaneous assessment of eGFR and ACR could facilitate improved classification of cardiovascular risk, supporting current guidelines for chronic kidney disease. Our results lend some support to also incorporating eGFR and ACR into assessments of cardiovascular risk in the general population. FUNDING: US National Kidney Foundation, National Institute of Diabetes and Digestive and Kidney Diseases.

Published
2015

27. Cinacalcet, fibroblast growth factor-23, and cardiovascular disease in hemodialysis: The evaluation of cinacalcet HCl therapy to lower cardiovascular events (EVOLVE) trial

Author

Moe S. M., Chertow G. M., Parfrey P. S., Kubo Y., Block G. A., Correa-Rotter R., Drueke T. B., Herzog C. A., London G. M., Mahaffey K. W., Wheeler D. C., Stolina M., Dehmel B., Goodman W. G., Floege J., Santos J., Najun Zarazaga C., Marin I., Garrote N., Cusumano A., Penalba N., Del Valle E., Juncos L., Martinez Saye J., Lef L., Altobelli V., Petraglia G., Rosa Diez G., Douthat W., Lobo J., Gallart C., Lafalla A., Diez G., Linares B., Lopez N., Ramirez N., Gonzalez R., Valtuille R., Beresan H., Hermida O., Rudolf G., Marchetta N., Rano M., Ramirez M., Garcia N., Gillies A., Jones B., Pedagogos E., Walker R., Talaulikar G., Bannister K., Suranyi M., Kark A., Roger S., Kerr P., Disney A., Mount P., Fraenkel M., Mathew M., Fassett R., Jose M., Hawley C., Lonergan M., Mackie J., Ferrari P., Menahem S., Sabto J., Hutchison B., Langham R., Pollock C., Holzer H., Oberbauer R., Arias I., Graf H., Mayer G., Lhotta K., Neyer U., Klauser R., Hoerl W., Horn S., Kovarik J., Kramar R., Eigner M., Dhaene M., Billiouw J., De Meester J., Warling X., Cambier-Dwelschauwers P., Evenepoel P., Daelemans R., Dratwa M., Maes B., Stolear J., Dejagere T., Vanwalleghem J., Bouman K., Jadoul M., Peeters J., Vanholder R., Tielemans C., Donck J., Almeida F., Picollo De Oliveira J., Burdmann E., Garcia V., Saldanha Thome F., Deboni L., Bregman R., Lugon J., Araujo S., Ferreira Filho S., De Francesco Daher E., Sperto Baptista M., Carvalho A., D'Avila D., Moyses Neto M., Yu L., Bastos M., Sampaio Lacativa P., Jorgetti V., De Almeida Romao E., Cardeal Da Costa J., Pecoits Filho R., Gordan P., Salgado N., Teixeira Araujo M., Neiva Coelho S., Oliveira I., Moyses R., Vasconcellos L., Batista P., Luiz Gross J., Pedrosa A., Cournoyer S., LeBlanc M., Chow S., Karunakaran S., Wong G., Tobe S., Desmeules S., Zimmerman D., Murphy S., Montambault P., Donnelly S., MacRae J., Culleton B., Soroka S., Rabbat C., Jindal K., Vasilevsky M., Michaud M., Wijeyesinghe E., Zacharias J., Lok C., Muirhead N., Verrelli M., Da Roza G., Sapir D., Olgaard K., Daugaard H., Brandi L., Jensen P., Boulechfar H., Ang K., Simon P., Rieu P., Brunet P., Touchard G., Urena Torres P., Combe C., Durrbach A., Ortiz J., Hannedouche T., Vela C., Lionet A., Ryckelynck P., Zaoui P., Choukroun G., Fessi H., Lang P., Stroumza P., Joly D., Mousson C., Laville M., Dellanna F., Erley C., Braun J., Rambausek M., Riegel W., Klingberg M., Schwertfeger E., Wizemann V., Eckardt K., Reichel H., Passauer J., Hubel E., Frischmuth N., Liebl R., Fiedler R., Schwenger V., Vosskuhler A., Kunzendorf U., Renders L., Rattensberger D., Rump L., Ketteler M., Neumayer H., Zantvoort F., Stahl R., Ladanyi E., Kulcsar I., Mezei I., Csiky B., Rikker C., Arkossy O., Berta K., Szegedi J., Major L., Ferenczi S., Fekete A., Szabo T., Zakar G., Wagner G., Kazup Erdelyine S., Borbas B., Eustace J., Reddan D., Capasso G., Locatelli F., Villa G., Cozzolino M., Brancaccio D., Messa P., Bolasco P., Ricciardi B., Malberti F., Moriero E., Cannella G., Ortalda V., Stefoni S., Frasca G., Cappelli G., Albertazzi A., Zoccali C., Farina M., Elli A., Avella F., Ondei P., Mingardi G., Errico R., Losito A., Di Giulio S., Pertosa G., Schena F., Grandaliano G., Gesualdo L., Auricchio M., Bochicchio-Ricardelli T., Aranda Verastegui F., Pena J., Chew Wong A., Cruz-Valdez J., Torres Zamora M., Solis M., Sebastian Diaz M., Vital Flores M., Alvarez Sandoval E., Van Den Dorpel M., Brink H., Van Kuijk W., Vermeij C., Smak Gregoor P., Hagen E., Van Der Sande F., Klinger M., Nowicki M., Muszytowski M., Bidas K., Bentkowski W., Wiecek A., Ksiazek A., Marczewski K., Ostrowski M., Switalski M., Sulowicz W., Matuszkiewicz-Rowinska J., Mysliwiec M., Durlik M., Rutkowski B., Macario F., Carvalho B., Frazao J., Machado D., Weigert A., Andrusev A., Khrustalev O., Zemtchenkov A., Gurevich K., Staroselsky K., Khadikova N., Rozhinskaya L., Timokhovskaya G., Strokov A., Balkarova O., Ermolenko V., Kolmakova E., Komandenko M., Timofeev M., Shilo V., Shostka G., Smirnov A., Anashkin V., Volgina G., Domashenko O., Gurevich A., Perlin D., Martinez Garcia J., Andres Ribes E., Coll Piera E., Fernandez Lucas M., Galicia M., Prados M., Gonzalez M., Romero R., Martin de Francisco A., Montenegro J., Santiago C., Garcia F., Alcazar De La Ossa J., Arrieta J., Pons J., Martin-Malo A., Soler Amigo J., Cases A., Sterner G., Jensen G., Wikstrom B., Jacobson S., Lund U., Weiss L., Stahl A., Von Albertini B., Burnier M., Meier P., Martin P., Uehlinger D., Dickenmann M., Yaqoob M., Zehnder D., Kalra P., Padmanabhan N., Roe S., Eadington D., Pritchard N., Hutchison A., Davies S., Wilkie M., Davies M., Pai P., Swift P., Kwan J., Goldsmith D., Tomson C., Stratton J., Dasgupta I., Sarkar S., Moustafa M., Gandhi K., Jamal A., Galindo-Ramos E., Tuazon J., Batlle D., Tucker K., Schiller-Moran B., Assefi A., Martinez C., Samuels L., Goldman J., Cangiano-Rivera J., Darwish R., Lee M., Topf J., Kapatkin K., Baer H., Kopelman R., Acharya M., Tharpe D., Bernardo M., Nader P., Guzman-Rivera J., Pergola P., Sekkarie M., Alas E., Zager P., Liss K., Navarro J., Roppolo M., Denu-Ciocca C., Kshirsagar A., El Khatib M., Kant K., Scott D., Murthyr B., Finkelstein F., Keightley G., McCrary R., Pitone J., Cavalieri T., Tsang A., Pellegrino B., Schmidt R., Ahmad S., Brown C., Friedman E., Mittman N., Fadem S., Shapiro W., Reddy M., Goldberger S., Woredekal Y., Agarwal A., Anger M., Haque M., Chidester P., Kohli R., Rubinstein S., Newman G., Gladish R., Ayodeji O., Soman S., Sprague S., Hunt N., Gehr T., Rizk D., Warnock D., Polack D., Pahl M., Fischer D., Dreyer P., James G., Husserl F., Rogers T., Raff A., Sedor J., Silver M., Smith M., Steinberg S., DelGiorno T., Jones E., Cunha P. D., Cheng J., Pogue V., Blumenthal S., Brown E., Charytan C., Buerkert J., Cook M., Felsenfeld A., Tareen N., Gupta A., Herman T., Diamond S., Hura C., Laski M., MacLaurin J., Plumb T., Brosnahan G., Kumar J., Henriquez M., Poole C., Osanloo E., Matalon A., Sholer C., Arfeen S., Azer M., Belledonne M., Gross M., Dunnigan E., McConnell K., Becker B., Skinner F., Rigolosi R., Spiegel D., Stegman M., Patak R., Streja D., Ranjit U., Youell T., Wooldridge T., Stafford C., Cottiero R., Weinberg M., Schonefeld M., Shahmir E., Hazzan A., Ashfaq A., Bhandari K., Cleveland W., Culpepper M., Golden J., Lai L., Lien Y., Lorica V., Robertson J., Malireddi K., Morse S., Thakur V., Israelit A., Raguram P., Alfred H., Weise W., Al-Saghir F., El Shahawy M., Rastogi A., Nissenson A., Kopyt N., Lynn R., Lea J., McClellan W., Teredesai P., Ong S., Tolkan S., Sugihara J., Minga T., Mehrotra R., Minasian R., Bhatia D., Specter R., Capelli J., Sidhu P., Dalal S., Dykes P., Khan M., Rahim F., Saklayen M., Thomas A., Michael B., Torres M., Al-Bander H., Murray B., Abukurah A., Gupta B., Nosrati S., Raja R., Zeig S., Braun M., Amatya A., Endsley J., Sharon Z., Dolson G., Dumler F., Ntoso K., Rosansky S., Kumar N., Gura V., Thompson N., Goldfarb D., Halligan R., Middleton J., Widerhorn A., Arbeit L., Arruda J., Crouch T., Friedman L., Khokhar S., Mittleman J., Light P., Taparia B., West C., Cotton J., Dhingra R., Kleinman L., Arif F., Lew S., Nammour T., Sterrett J., Williams M., Ramirez J., Rubin J., McCarthy J., Noble S., Chaffin M., Rekhi A., Moe, S. M., Chertow, G. M., Parfrey, P. S., Kubo, Y., Block, G. A., Correa-Rotter, R., Drueke, T. B., Herzog, C. A., London, G. M., Mahaffey, K. W., Wheeler, D. C., Stolina, M., Dehmel, B., Goodman, W. G., Floege, J., Santos, J., Najun Zarazaga, C., Marin, I., Garrote, N., Cusumano, A., Penalba, N., Del Valle, E., Juncos, L., Martinez Saye, J., Lef, L., Altobelli, V., Petraglia, G., Rosa Diez, G., Douthat, W., Lobo, J., Gallart, C., Lafalla, A., Diez, G., Linares, B., Lopez, N., Ramirez, N., Gonzalez, R., Valtuille, R., Beresan, H., Hermida, O., Rudolf, G., Marchetta, N., Rano, M., Ramirez, M., Garcia, N., Gillies, A., Jones, B., Pedagogos, E., Walker, R., Talaulikar, G., Bannister, K., Suranyi, M., Kark, A., Roger, S., Kerr, P., Disney, A., Mount, P., Fraenkel, M., Mathew, M., Fassett, R., Jose, M., Hawley, C., Lonergan, M., Mackie, J., Ferrari, P., Menahem, S., Sabto, J., Hutchison, B., Langham, R., Pollock, C., Holzer, H., Oberbauer, R., Arias, I., Graf, H., Mayer, G., Lhotta, K., Neyer, U., Klauser, R., Hoerl, W., Horn, S., Kovarik, J., Kramar, R., Eigner, M., Dhaene, M., Billiouw, J., De Meester, J., Warling, X., Cambier-Dwelschauwers, P., Evenepoel, P., Daelemans, R., Dratwa, M., Maes, B., Stolear, J., Dejagere, T., Vanwalleghem, J., Bouman, K., Jadoul, M., Peeters, J., Vanholder, R., Tielemans, C., Donck, J., Almeida, F., Picollo De Oliveira, J., Burdmann, E., Garcia, V., Saldanha Thome, F., Deboni, L., Bregman, R., Lugon, J., Araujo, S., Ferreira Filho, S., De Francesco Daher, E., Sperto Baptista, M., Carvalho, A., D'Avila, D., Moyses Neto, M., Yu, L., Bastos, M., Sampaio Lacativa, P., Jorgetti, V., De Almeida Romao, E., Cardeal Da Costa, J., Pecoits Filho, R., Gordan, P., Salgado, N., Teixeira Araujo, M., Neiva Coelho, S., Oliveira, I., Moyses, R., Vasconcellos, L., Batista, P., Luiz Gross, J., Pedrosa, A., Cournoyer, S., Leblanc, M., Chow, S., Karunakaran, S., Wong, G., Tobe, S., Desmeules, S., Zimmerman, D., Murphy, S., Montambault, P., Donnelly, S., Macrae, J., Culleton, B., Soroka, S., Rabbat, C., Jindal, K., Vasilevsky, M., Michaud, M., Wijeyesinghe, E., Zacharias, J., Lok, C., Muirhead, N., Verrelli, M., Da Roza, G., Sapir, D., Olgaard, K., Daugaard, H., Brandi, L., Jensen, P., Boulechfar, H., Ang, K., Simon, P., Rieu, P., Brunet, P., Touchard, G., Urena Torres, P., Combe, C., Durrbach, A., Ortiz, J., Hannedouche, T., Vela, C., Lionet, A., Ryckelynck, P., Zaoui, P., Choukroun, G., Fessi, H., Lang, P., Stroumza, P., Joly, D., Mousson, C., Laville, M., Dellanna, F., Erley, C., Braun, J., Rambausek, M., Riegel, W., Klingberg, M., Schwertfeger, E., Wizemann, V., Eckardt, K., Reichel, H., Passauer, J., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., Kulcsar, I., Mezei, I., Csiky, B., Rikker, C., Arkossy, O., Berta, K., Szegedi, J., Major, L., Ferenczi, S., Fekete, A., Szabo, T., Zakar, G., Wagner, G., Kazup Erdelyine, S., Borbas, B., Eustace, J., Reddan, D., Capasso, G., Locatelli, F., Villa, G., Cozzolino, M., Brancaccio, D., Messa, P., Bolasco, P., Ricciardi, B., Malberti, F., Moriero, E., Cannella, G., Ortalda, V., Stefoni, S., Frasca, G., Cappelli, G., Albertazzi, A., Zoccali, C., Farina, M., Elli, A., Avella, F., Ondei, P., Mingardi, G., Errico, R., Losito, A., Di Giulio, S., Pertosa, G., Schena, F., Grandaliano, G., Gesualdo, L., Auricchio, M., Bochicchio-Ricardelli, T., Aranda Verastegui, F., Pena, J., Chew Wong, A., Cruz-Valdez, J., Torres Zamora, M., Solis, M., Sebastian Diaz, M., Vital Flores, M., Alvarez Sandoval, E., Van Den Dorpel, M., Brink, H., Van Kuijk, W., Vermeij, C., Smak Gregoor, P., Hagen, E., Van Der Sande, F., Klinger, M., Nowicki, M., Muszytowski, M., Bidas, K., Bentkowski, W., Wiecek, A., Ksiazek, A., Marczewski, K., Ostrowski, M., Switalski, M., Sulowicz, W., Matuszkiewicz-Rowinska, J., Mysliwiec, M., Durlik, M., Rutkowski, B., Macario, F., Carvalho, B., Frazao, J., Machado, D., Weigert, A., Andrusev, A., Khrustalev, O., Zemtchenkov, A., Gurevich, K., Staroselsky, K., Khadikova, N., Rozhinskaya, L., Timokhovskaya, G., Strokov, A., Balkarova, O., Ermolenko, V., Kolmakova, E., Komandenko, M., Timofeev, M., Shilo, V., Shostka, G., Smirnov, A., Anashkin, V., Volgina, G., Domashenko, O., Gurevich, A., Perlin, D., Martinez Garcia, J., Andres Ribes, E., Coll Piera, E., Fernandez Lucas, M., Galicia, M., Prados, M., Gonzalez, M., Romero, R., Martin de Francisco, A., Montenegro, J., Santiago, C., Garcia, F., Alcazar De La Ossa, J., Arrieta, J., Pons, J., Martin-Malo, A., Soler Amigo, J., Cases, A., Sterner, G., Jensen, G., Wikstrom, B., Jacobson, S., Lund, U., Weiss, L., Stahl, A., Von Albertini, B., Burnier, M., Meier, P., Martin, P., Uehlinger, D., Dickenmann, M., Yaqoob, M., Zehnder, D., Kalra, P., Padmanabhan, N., Roe, S., Eadington, D., Pritchard, N., Hutchison, A., Davies, S., Wilkie, M., Davies, M., Pai, P., Swift, P., Kwan, J., Goldsmith, D., Tomson, C., Stratton, J., Dasgupta, I., Sarkar, S., Moustafa, M., Gandhi, K., Jamal, A., Galindo-Ramos, E., Tuazon, J., Batlle, D., Tucker, K., Schiller-Moran, B., Assefi, A., Martinez, C., Samuels, L., Goldman, J., Cangiano-Rivera, J., Darwish, R., Lee, M., Topf, J., Kapatkin, K., Baer, H., Kopelman, R., Acharya, M., Tharpe, D., Bernardo, M., Nader, P., Guzman-Rivera, J., Pergola, P., Sekkarie, M., Alas, E., Zager, P., Liss, K., Navarro, J., Roppolo, M., Denu-Ciocca, C., Kshirsagar, A., El Khatib, M., Kant, K., Scott, D., Murthyr, B., Finkelstein, F., Keightley, G., Mccrary, R., Pitone, J., Cavalieri, T., Tsang, A., Pellegrino, B., Schmidt, R., Ahmad, S., Brown, C., Friedman, E., Mittman, N., Fadem, S., Shapiro, W., Reddy, M., Goldberger, S., Woredekal, Y., Agarwal, A., Anger, M., Haque, M., Chidester, P., Kohli, R., Rubinstein, S., Newman, G., Gladish, R., Ayodeji, O., Soman, S., Sprague, S., Hunt, N., Gehr, T., Rizk, D., Warnock, D., Polack, D., Pahl, M., Fischer, D., Dreyer, P., James, G., Husserl, F., Rogers, T., Raff, A., Sedor, J., Silver, M., Smith, M., Steinberg, S., Delgiorno, T., Jones, E., Cunha, P. D., Cheng, J., Pogue, V., Blumenthal, S., Brown, E., Charytan, C., Buerkert, J., Cook, M., Felsenfeld, A., Tareen, N., Gupta, A., Herman, T., Diamond, S., Hura, C., Laski, M., Maclaurin, J., Plumb, T., Brosnahan, G., Kumar, J., Henriquez, M., Poole, C., Osanloo, E., Matalon, A., Sholer, C., Arfeen, S., Azer, M., Belledonne, M., Gross, M., Dunnigan, E., Mcconnell, K., Becker, B., Skinner, F., Rigolosi, R., Spiegel, D., Stegman, M., Patak, R., Streja, D., Ranjit, U., Youell, T., Wooldridge, T., Stafford, C., Cottiero, R., Weinberg, M., Schonefeld, M., Shahmir, E., Hazzan, A., Ashfaq, A., Bhandari, K., Cleveland, W., Culpepper, M., Golden, J., Lai, L., Lien, Y., Lorica, V., Robertson, J., Malireddi, K., Morse, S., Thakur, V., Israelit, A., Raguram, P., Alfred, H., Weise, W., Al-Saghir, F., El Shahawy, M., Rastogi, A., Nissenson, A., Kopyt, N., Lynn, R., Lea, J., Mcclellan, W., Teredesai, P., Ong, S., Tolkan, S., Sugihara, J., Minga, T., Mehrotra, R., Minasian, R., Bhatia, D., Specter, R., Capelli, J., Sidhu, P., Dalal, S., Dykes, P., Khan, M., Rahim, F., Saklayen, M., Thomas, A., Michael, B., Torres, M., Al-Bander, H., Murray, B., Abukurah, A., Gupta, B., Nosrati, S., Raja, R., Zeig, S., Braun, M., Amatya, A., Endsley, J., Sharon, Z., Dolson, G., Dumler, F., Ntoso, K., Rosansky, S., Kumar, N., Gura, V., Thompson, N., Goldfarb, D., Halligan, R., Middleton, J., Widerhorn, A., Arbeit, L., Arruda, J., Crouch, T., Friedman, L., Khokhar, S., Mittleman, J., Light, P., Taparia, B., West, C., Cotton, J., Dhingra, R., Kleinman, L., Arif, F., Lew, S., Nammour, T., Sterrett, J., Williams, M., Ramirez, J., Rubin, J., Mccarthy, J., Noble, S., Chaffin, M., Rekhi, A., and Clinical sciences

Subjects
Adult, Male, Fibroblast growth factor 23, medicine.medical_specialty, Cinacalcet, Calcimimetic, medicine.medical_treatment, Naphthalenes, Hyperthyroidism, Gastroenterology, ventricular remodeling, Renal Dialysis, Cinacalcet Hydrochloride, Physiology (medical), Internal medicine, medicine, Humans, renal insufficiency, chronic, Aged, Etelcalcetide, calcium, business.industry, Research Support, Non-U.S. Gov't, death, sudden, cardiac, Middle Aged, arrhythmias, cardiac, Cardiovascular Diseases, Female, Fibroblast Growth Factors, Cardiology and Cardiovascular Medicine, medicine.disease, Fibroblast Growth Factor-23, Endocrinology, Randomized Controlled Trial, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug, Kidney disease
Abstract

Background— Patients with kidney disease have disordered bone and mineral metabolism, including elevated serum concentrations of fibroblast growth factor-23 (FGF23). These elevated concentrations are associated with cardiovascular and all-cause mortality. The objective was to determine the effects of the calcimimetic cinacalcet (versus placebo) on reducing serum FGF23 and whether changes in FGF23 are associated with death and cardiovascular events. Methods and Results— This was a secondary analysis of a randomized clinical trial comparing cinacalcet to placebo in addition to conventional therapy (phosphate binders/vitamin D) in patients receiving hemodialysis with secondary hyperparathyroidism (intact parathyroid hormone ≥300 pg/mL). The primary study end point was time to death or a first nonfatal cardiovascular event (myocardial infarction, hospitalization for angina, heart failure, or a peripheral vascular event). This analysis included 2985 patients (77% of randomized) with serum samples at baseline and 2602 patients (67%) with samples at both baseline and week 20. The results demonstrated that a significantly larger proportion of patients randomized to cinacalcet had ≥30% (68% versus 28%) reductions in FGF23. Among patients randomized to cinacalcet, a ≥30% reduction in FGF23 between baseline and week 20 was associated with a nominally significant reduction in the primary composite end point (relative hazard, 0.82; 95% confidence interval, 0.69–0.98), cardiovascular mortality (relative hazard, 0.66; 95% confidence interval, 0.50–0.87), sudden cardiac death (relative hazard, 0.57; 95% confidence interval, 0.37–0.86), and heart failure (relative hazard, 0.69; 95% confidence interval, 0.48–0.99). Conclusions— Treatment with cinacalcet significantly lowers serum FGF23. Treatment-induced reductions in serum FGF23 are associated with lower rates of cardiovascular death and major cardiovascular events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00345839.

Published
2015

30. Sulfenic Acid Modification of ET- B Receptor is Responsible for the Benefit of a Nonsteroidal MR Antagonist in Renal Ischemia

Author

Barrera-Chimal , J., Prince , S., Fadel , F., El Moghrabi , S., Warnock , D. G., Kolkhof , P., Jaisser , Frederic, HAL-UPMC, Gestionnaire, Centre de Recherche des Cordeliers (CRC), Université Pierre et Marie Curie - Paris 6 (UPMC)-École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Alabama at Birmingham [ Birmingham] (UAB), Bayer HealthCare AG, Research Center, Université Pierre et Marie Curie - Paris 6 (UPMC)-École Pratique des Hautes Études (EPHE), Centre de Recherche des Cordeliers ( CRC ), Université Paris Diderot - Paris 7 ( UPD7 ) -École pratique des hautes études ( EPHE ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Université Paris Descartes - Paris 5 ( UPD5 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), and The University of Alabama at Birmingham [ Birmingham] ( UAB )

Subjects
aldosterone, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, nitric oxide, [ SDV.MHEP ] Life Sciences [q-bio]/Human health and pathology, urologic and male genital diseases, acute renal failure, ischemia-reperfusion, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; AKI is associated with high mortality rates and the development of CKD. Ischemia/reperfusion (IR) is an important cause of AKI. Unfortunately, there is no available pharmacologic approach to prevent or limit renal IR injury in common clinical practice. Renal IR is characterized by diminished nitric oxide bioavailability and reduced renal blood flow; however, the mechanisms leading to these alterations are poorly understood. In a rat model of renal IR, we investigated whether the administration of the novel nonsteroidal mineralocorticoid receptor (MR) antagonist BR-4628 can prevent or treat the renal dysfunction and tubular injury induced by IR. Renal injury induced by ischemia was associated with increased oxidant damage, which led to a cysteine sulfenic acid modification in endothelin B receptor and consequently decreased endothelial nitric oxide synthase activation. These modifications were efficiently prevented by nonsteroidal MR antagonism. Furthermore, we demonstrated that the protective effect of BR-4628 against IR was lost when a selective endothelin B receptor antagonist was coadministered. These data describe a new mechanism for reduced endothelial nitric oxide synthase activation during renal IR that can be blocked by MR antagonism with BR-4628.

Published
2016

31. Comparison of Nonculture Blood-Based Tests for Diagnosing Invasive Aspergillosis in an Animal Model

Author

White, P. Lewis, Wiederhold, Nathan P., Loeffler, Juergen, Najvar, Laura K., Melchers, Willem, Herrera, Monica, Bretagne, Stephane, Wickes, Brian, Kirkpatrick, William R., Barnes, Rosemary Ann, Donnelly, J. Peter, Patterson, Thomas F., and Warnock, D. W.

Subjects
Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Time Factors, beta-Glucans, Guinea Pigs, 030106 microbiology, Mycology, Aspergillosis, Polymerase Chain Reaction, Sensitivity and Specificity, Mannans, 03 medical and health sciences, Galactomannan, chemistry.chemical_compound, Blood serum, In vivo, Internal medicine, Animals, Medicine, ddc:610, Stage (cooking), Whole blood, Invasive Pulmonary Aspergillosis, Women's cancers Radboud Institute for Molecular Life Sciences [Radboudumc 17], Diagnostic Tests, Routine, business.industry, Area under the curve, Galactose, medicine.disease, Clinical trial, Disease Models, Animal, Blood, Molecular Diagnostic Techniques, chemistry, Immunology, Proteoglycans, business, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5]
Abstract

The European Aspergillus PCR Initiative (EAPCRI) has provided recommendations for the PCR testing of whole blood (WB) and serum/plasma. It is important to test these recommended protocols on nonsimulated “ in vivo ” specimens before full clinical evaluation. The testing of an animal model of invasive aspergillosis (IA) overcomes the low incidence of disease and provides experimental design and control that is not possible in the clinical setting. Inadequate performance of the recommended protocols at this stage would require reassessment of methods before clinical trials are performed and utility assessed. The manuscript describes the performance of EAPCRI protocols in an animal model of invasive aspergillosis. Blood samples taken from a guinea pig model of IA were used for WB and serum PCR. Galactomannan and β- d -glucan detection were evaluated, with particular focus on the timing of positivity and on the interpretation of combination testing. The overall sensitivities for WB PCR, serum PCR, galactomannan, and β- d -glucan were 73%, 65%, 68%, and 46%, respectively. The corresponding specificities were 92%, 79%, 80%, and 100%, respectively. PCR provided the earliest indicator of IA, and increasing galactomannan and β- d -glucan values were indicators of disease progression. The combination of WB PCR with galactomannan and β- d -glucan proved optimal (area under the curve [AUC], 0.95), and IA was confidently diagnosed or excluded. The EAPRCI-recommended PCR protocols provide performance comparable to commercial antigen tests, and clinical trials are warranted. By combining multiple tests, IA can be excluded or confirmed, highlighting the need for a combined diagnostic strategy. However, this approach must be balanced against the practicality and cost of using multiple tests.

Published
2016

33. Actinobacillus, Capnocytophaga, Eikenella, Kingella, Pasteurella, and other fastidious or rarely encountered gram-negative rods

Author

Versalovic, J, Carroll, K C, Jorgensen, J H, Funke, G, Landry, M L, Warnock, D W, Versalovic, J ( J ), Carroll, K C ( K C ), Jorgensen, J H ( J H ), Funke, G ( G ), Landry, M L ( M L ), Warnock, D W ( D W ), Zbinden, R, von Graevenitz, A, Versalovic, J, Carroll, K C, Jorgensen, J H, Funke, G, Landry, M L, Warnock, D W, Versalovic, J ( J ), Carroll, K C ( K C ), Jorgensen, J H ( J H ), Funke, G ( G ), Landry, M L ( M L ), Warnock, D W ( D W ), Zbinden, R, and von Graevenitz, A

Published
2011

34. Total ankle replacement. Early experiences with STAR prosthesis

Author

Murnaghan, J. M., Warnock, D. S., and Henderson, S. A.

Subjects
Adult, Male, Treatment Outcome, Humans, Female, Prostheses and Implants, Arthroplasty, Replacement, Middle Aged, Prosthesis Design, Ankle Joint, Research Article, Aged
Abstract

Early designs of Total Ankle Replacement (TAR) had a high failure rate. More recent experience with the 3-piece, meniscal bearing, total ankle replacement has been more promising. We report a review of the early results of our first 22 prostheses in 20 patients undergoing Scandinavian Total Ankle Replacement (STAR) in Northern Ireland. There was a mean follow-up time of 26 months. Seventeen patients are pain-free at the ankle joint during normal daily activities. Two of the early cases have required revision surgery due to technical errors. Other complications have included malleolar fractures, poor wound healing and postoperative stiffness. These early results show high levels of patient satisfaction, and we are encouraged to continue with total ankle arthroplasty. There is a steep initial learning curve and use of TAR should be restricted to foot and ankle surgeons. Images Fig 1 Figs 2a and b Figs 2 c and d

Published
2005

35. Annual review of cultural resource investigations by the Savannah River Archaeological Research Program: Fiscal year 1991

Author

Brooks, Mark J., primary, Brooks, Richard D., additional, Sassaman, Kenneth E., additional, Crass, David C., additional, Stephenson, D. Keith, additional, Green, William, additional, Rinehart, Charles J., additional, Lewis, George S., additional, Fuglseth, Ty, additional, Krawczynski, Keith, additional, and Warnock, D. Mark, additional

Published
1991
Full Text
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36. Candida dubliniensis fungemia: the first four cases in North America

Author

Brandt, M. E., Harrison, L. H., Pass, M., Sofair, A. N., Huie, S., Li, R. K., Morrison, C. J., Warnock, D. W., and Hajjeh, R. A.

Subjects
Research Article
Abstract

We report the first four North American cases of Candida dubliniensis fungemia, including the first isolation of this organism from the bloodstream of an HIV-infected person. All isolates were susceptible in vitro to commonly used antifungal drugs. This report demonstrates that C. dubliniensis can cause bloodstream infection; however, the incidence of disease is not known.

Published
2000

37. Women’s Long-Term Reactions to Whole-Body Scanning: A Mixed Methods Approach

Author

Grogan, S, Gill, S, Brownbridge, K, Warnock, D, Armitage, CJ, Grogan, S, Gill, S, Brownbridge, K, Warnock, D, and Armitage, CJ

Abstract

This study investigated long-term impacts of whole-body scanning. A total of 91 women completed a retrospective online questionnaire. Quantitative data revealed that 31 (34%) reported greater body dissatisfaction since the scan, and only 6 (7%) reported increased satisfaction. Positive change in satisfaction was predicted by current body satisfaction but not by body mass index (BMI) at time of scanning or by age. BMI did not predict satisfaction with the scanner process or likelihood of being rescanned, though a longer gap between scanning and questionnaire completion predicted satisfaction with the process. Inductive thematic analysis of responses to an open-ended question suggested that although women were comfortable being scanned and wanted to see an accurate and objective view of their size and shape, they also felt threatened and vulnerable when seeing their bodies on the printed output. It is concluded that whole-body scanning should be used with caution, particularly with women with existing body concerns.

Published
2015

38. Microsporidia

Author

Jorgensen, James H, Pfaller, Michael A, Carroll, Karen C, Funke, Guido, Landry, Marie Louise, Richter, Sandra S, Warnock, David W, Jorgensen, J H ( James H ), Pfaller, M A ( Michael A ), Carroll, K C ( Karen C ), Funke, G ( Guido ), Landry, M L ( Marie Louise ), Richter, S S ( Sandra S ), Warnock, D W ( David W ), Weber, Rainer, Deplazes, Peter, Mathis, Alexander, Jorgensen, James H, Pfaller, Michael A, Carroll, Karen C, Funke, Guido, Landry, Marie Louise, Richter, Sandra S, Warnock, David W, Jorgensen, J H ( James H ), Pfaller, M A ( Michael A ), Carroll, K C ( Karen C ), Funke, G ( Guido ), Landry, M L ( Marie Louise ), Richter, S S ( Sandra S ), Warnock, D W ( David W ), Weber, Rainer, Deplazes, Peter, and Mathis, Alexander

Published
2015

48. Clinical, Morphological, and Molecular Characterization of Penicillium canis sp nov., Isolated from a Dog with Osteomyelitis

Author

Warnock, D. W., Virginia-Maryland Regional College of Veterinary Medicine. Department of Small Animal Clinical Sciences, Langlois, Daniel K., Sutton, Deanna A., Swenson, Cheryl L., Bailey, Chris J., Wiederhold, Nathan P., Nelson, Nathan C., Thompson, Elizabeth H., Wickes, Brian L., French, Stephanie, Fu, Jianmin, Vilar-Saavedra, Paulo, Peterson, Stephen W., Warnock, D. W., Virginia-Maryland Regional College of Veterinary Medicine. Department of Small Animal Clinical Sciences, Langlois, Daniel K., Sutton, Deanna A., Swenson, Cheryl L., Bailey, Chris J., Wiederhold, Nathan P., Nelson, Nathan C., Thompson, Elizabeth H., Wickes, Brian L., French, Stephanie, Fu, Jianmin, Vilar-Saavedra, Paulo, and Peterson, Stephen W.

Abstract

Infections caused by Penicillium species are rare in dogs, and the prognosis in these cases is poor. An unknown species of Penicillium was isolated from a bone lesion in a young dog with osteomyelitis of the right ilium. Extensive diagnostic evaluation did not reveal evidence of dissemination. Resolution of lameness and clinical stability of disease were achieved with intravenous phospholipid- complexed amphotericin B initially, followed by long-term combination therapy with terbinafine and ketoconazole. A detailed morphological and molecular characterization of the mold was undertaken. Sequence analysis of the internal transcribed spacer revealed the isolate to be closely related to Penicillium menonorum and Penicillium pimiteouiense. Additional sequence analysis of beta-tubulin, calmodulin, minichromosome maintenance factor, DNA-dependent RNA polymerase, and pre-rRNA processing protein revealed the isolate to be a novel species; the name Penicillium canis sp. nov. is proposed. Morphologically, smooth, ovoid conidia, a greenish gray colony color, slow growth on all media, and a failure to form ascomata distinguish this species from closely related Penicillium species.

Published
2014

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