Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research

Benchmarking the Cost- Effectiveness of Interventions Delaying Diabetes: A Simulation Study Based on NAVIGATOR Data
Jose Leal, Shelby D Ree, Rishi Patel, Oliver Rivero-Arias, Yanhong Li, Kevin A Schulman, Robert M Califf, Rury R. Holman, Alastair Gray
Diabetes Care 2020;43:2485-2492. Published:Oct-2020. Epub:12-Aug-2020. PMID:32796009. doi:10.2337/dc20-0717

An Outcome Model Approach to Generalizing Randomized Controlled Trial Results to a Target Population
Benjamin A. Goldstein, Matthew Phelan, Neha J. Pagidipati, Rury R. Holman, Michael J. Pencina, Elizabeth A. Stuart
J Am Med Inform Assoc. 2019;5:429–437. Published:May-2019. Epub:14-Mar-2019. PMID:30869798. doi:10.1093/jamia/ocy188

Relationship between Baseline Physical Activity Assessed by Pedometer Count and New-onset Diabetes in the NAVIGATOR Trial
William E. Kraus, Thomas Yates, Jaakko Tuomilehto, Jie-Lena Sun, Laine Thomas, John J.V. McMurray, M. Angelyn Bethel, Steven M. Haffner, Rury R. Holman
BMJ Open Diabetes Research & Care 2018;6:e000523. Published:19-Jul-2018. PMID:30073088. doi:10.1136/bmjdrc-2018-000523

Updated risk factors should be used to predict development of diabetes
Mary Angelyn Bethel, Kristen A. Hyland, Antonio R. Chacra, Prakash Deedwania, Gregory R. Fulcher, Rury R. Holman, Trond Jenssen, Naomi S. Levitt, John J.V. McMurray, Eleni Boutati, Laine Thomas, Jie-Lena Sun, Steven M. Haffner for the NAVIGATOR Study Group
J Diabetes Complications 2017;31:859-863. Published:May-2017. Epub:02-Mar-2017. PMID:28319004. doi:10.1016/j.jdiacomp.2017.02.012

Noncardiovascular deaths are more common than cardiovascular deaths in patients with cardiovascular disease or cardiovascular risk factors and impaired glucose tolerance: Insights from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial
Sharma A, de Souza Brito F2, Sun JL, Thomas L, Haffner S, Holman RR, Lopes RD
Am Heart J. 2017;186:73-82. Published:Apr-2017. Epub:29-Dec-2016. PMID:28454835. doi:10.1016/j.ahj.2016.12.011

International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance
Harumi Higuchi Dos Santos M, Sharma A, Sun JL, Pieper K, McMurray JJ, Holman RR, Lopes RD
J Am Heart Assoc 2017;6:e003892. Published:13-Jan-2017. Epub:13-Jan-2017. PMID:28087508. doi:10.1161/JAHA.116.003892

Effect of valsartan on kidney outcomes in people with impaired glucose tolerance
Currie G, Angelyn Bethel M, Holzhauer B, Haffner SM, Holman RR, McMurray JJ
Diabetes Obes Metab. 2017;19:791-799. Epub:17-Jul-2017. PMID:28093841. doi:10.1111/dom.12877

Prospective relationships between body weight and physical activity: an observational analysis from the NAVIGATOR study
David Preiss, Laine E Thomas, Daniel M Wojdyla, Steven M Haffner, Jason M R Gill, Thomas Yates, Melanie J Davies, Rury R Holman, John J McMurray, Robert M Califf, William E Kraus, on behalf of the NAVIGATOR investigators
BMJ Open 2015;5:e007901. Published:11-Nov-2015. Epub:14-Aug-2015. PMID:26275900. doi:10.1136/bmjopen-2015-007901

Physical activity as a determinant of fasting and 2-h post-challenge glucose: a prospective cohort analysis of the NAVIGATOR trial
T. Yates, M. J. Davies, S. M. Haffner, P. J. Schulte, L. Thomas, K. M. Huffman, C. W. Bales, D. Preiss, R. M. Califf, R. R. Holman, J. J. V. McMurray, M. A. Bethel, J. Tuomilehto and W. E. Kraus
Diab Med. 2015;32:1090-1096. Published:Aug-2015. Epub:12-Apr-2015. PMID:25818859. doi:10.1111/dme.12762

Chronic Obstructive Pulmonary Disease and Cardiovascular Risk: Insights from the NAVIGATOR Trial
Pedro G.M. de Barros e Silva, Robert M. Califf, Jie-Lena Sun, John J.V. McMurray, Rury R. Holman, Steven Haffner, Laine Thomas, Renato D. Lopes
International Joural of Cardiology 2014;176:1126-1128. Published:25-Mar-2015. Epub:12-Aug-2014. PMID:25220176. doi:10.1016/j.ijcard.2014.07.297

Change in levels of physical activity after diagnosis of type 2 diabetes: an observational analysis from the NAVIGATOR study
D. Preiss, S. M. Haffner, L. E.Thomas, J.-L. Sun, N. Sattar, T. Yates, M. J Davies, J. J. McMurray, R. R. Holman, R. M. Califf & W. E. Kraus
Diabetes Obesity and Metabolism 2014;16:1265-1268. Published:Dec-2014. Epub:19-Jun-2014. PMID:24861892. doi:10.1111/dom.12320

Impact of baseline physical activity and diet behavior on metabolic syndrome in a pharmaceutical trial: Results from NAVIGATOR
Huffman KM, Sun JL, Thomas L, Bales CW, Califf RM, Yates T, Davies MJ, Holman RR, McMurray JJ, Bethel MA, Tuomilehto J, Haffner SM, Kraus WE.
Metabolism 2014;63:554-561. Published:Apr-2014. Epub:15-Jan-2014. PMID:24559843. doi:10.1016/j.metabol.2014.01.002

Association between change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance (NAVIGATOR trial): a cohort analysis
Thomas Yates, Steven M Haffner, Phillip J Schulte, Laine Thomas, Kim M Huff man, Connie W Bales, Robert M Califf , Rury R Holman, John J V McMurray, M Angelyn Bethel, Jaakko Tuomilehto, Melanie J Davies, William E Kraus
Lancet 2014;383:1059-66. Published:22-Mar-2014. Epub:20-Dec-2013. PMID:24361242. doi:10.1016/S0140-6736(13)62061-9

Role of diuretics, beta blockers, and statins in increasing the risk of diabetes in patients with impaired glucose tolerance: reanalysis of data from the NAVIGATOR study
Lan Shen, Bimal R Shah, Eric M Reyes, Laine Thomas, Daniel Wojdyla, Peter Diem, Lawrence A Leiter, Bernard Charbonnel, Viacheslav Mareev, Edward S Horton, Steven M Haffner, Vladimir Soska, Rury Holman, M Angelyn Bethel, Frank Schaper, Jie-Lena Sun, John JV McMurray, Robert M Califf, Henry Krum
British Medical Journal 2013;347:f6745. Published:09-Dec-2013. PMID:24322398. doi:10.1136/bmj.f6745

Incidence of atrial fibrillation in a population with impaired glucose tolerance: The contribution of glucose metabolism and other risk factors. A post hoc analysis of the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research trial
Latini R, Staszewsky L, Sun JL, Bethel MA, Disertori M, Haffner SM, Holman RR, Chang F, Giles TD, Maggioni AP, Rutten GE, Standl E, Thomas L, Tognoni G, Califf RM, McMurray JJ
American Heart Journal 2013;166:935-940.e1. Published:Nov-2013. Epub:07-Oct-2013. PMID:24176451. doi:10.1016/j.ahj.2013.08.012

Predictors of stroke in patients with impaired glucose tolerance: results from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research trial
David Preiss, Thomas D. Giles, Laine E. Thomas, Jie-Lena Sun, Steven M. Haffner, Rury R. Holman, Eberhard Standl, Theodore Mazzone, Guy E. Rutten, Gianni Tognoni, Fu-Tien Chiang, John J.V. McMurray, Robert M. Califf
Stroke 2013;44:2590-2593. Published:Sep-2013. Epub:30-Jul-2013. PMID:23899915. doi:10.1161/STROKEAHA.113.001177

A Novel Risk Classification Paradigm for Patients With Impaired Glucose Tolerance and High Cardiovascular Risk
Bethel MA, Chacra AR, Deedwania P, Fulcher GR, Holman RR, Jenssen T, Kahn SE, Levitt NS, McMurray JJ, Califf RM, Raptis SA, Thomas L, Sun JL, Haffner SM
Am J Cardiol 2013;112:231-237. Published:15-Jul-2013. Epub:19-Apr-2013. PMID:23608615. doi:10.1016/j.amjcard.2013.03.019

Predictors of cardiovascular events in a contemporary population with impaired glucose tolerance: an observational analysis of the Nateglinide and Valsartan in impaired glucose tolerance outcomes research (NAVIGATOR) trial
David Preiss, Laine E Thomas, Jie-Lena Sun, Steven M Haffner, Rury R Holman, Eberhard Standl, Lawrence A Leiter, Theodore Mazzone, Guy E Rutten, Gianni Tognoni, Felipe A Martinez, Fu-Tien Chiang, Robert M Califf, John J McMurray
BMJ Open 2012;2:e001925. Published:30-Nov-2012. Epub:30-Nov-2012. PMID:23204139. doi:10.1136/bmjopen-2012-001925

Prediabetes and the risk of diabetes – Authors' reply
John JV McMurray, Steven M Haffner, Robert M Califf, Rury R Holman
The Lancet 2012;380:1225-1226. Published:06-Oct-2012. PMID:23040850. doi:10.1016/S0140-6736(12)61706-1

Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers for Hypertension on Clinical End Points: A Cohort Study
John J.V. McMurray, Robert M. Califf, Angelyn M. Bethel, Steven M. Haffner, Rury R. Holman
The Journal of Clinical Hypertension 2012;14:731. Published:Oct-2012. Epub:26-Jul-2012. PMID:23031154. doi:10.1111/j.1751-7176.2012.00687.x

Baseline Characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial Population: Comparison with Other Diabetes Prevention Trials
Henry Krum, John J.V. McMurray, Edward Horton, Teresa Gerlock, Bjoern Holzhauer, Lineke Zuurman, Steven M. Haffner, M. Angelyn Bethel, Rury R. Holman, Robert M. Califf
Cardiovascular Therapeutics 2010;28(2):124-132. Published:29-Apr-2010. PMID:20184589. doi:10.1111/j.1755-5922.2010.00146.x

Effect of Nateglinide on the Incidence of Diabetes and Cardiovascular Events
NAVIGATOR Study Group; Holman, R.R., Haffner, S.M., McMurray, J.J., Bethel, M.A., Holzhauer, B., Hua, T.A., Belenkov, Y., Boolell, M., Buse, J.B., Buckley, B.M., Chacra, A.R., Chiang, F.-T., Charbonnel, B., Chow, C.-C., Davies, M.J., Deedwania, P., Diem, P., Einhorn, D., Fonseca, V., Fulcher, G.R., Gaciong, Z., Gaztambide, S., Giles, T., Horton, E., Ilkova, H., Jenssen, T., Kahn, S.E., Krum, H., Laakso, M., Leiter, L.A., Levitt, N.S., Mareev, V., Martinez, F., Masson, C., Mazzone, T., Meaney, E., Nesto, R., Pan, C., Prager, R., Raptis, S.A., Rutten, G.E.H.M., Sandstroem, H., Schaper, F., Scheen, A., Schmitz, O., Sinay, I., Soska, V., Stender, S., Tamás, G., Tognoni, G., Tuomilehto, J., Villamil, A.S., Vozar, J., Califf, R.M.
N Engl J Med 2010;362:1463-76. Published:22-Apr-2010. Epub:14-Mar-2010. PMID:20228402. doi:10.1056/NEJMoa1001122
[Presentation] [Slides]

Effect of Valsartan on the Incidence of Diabetes and Cardiovascular Events
NAVIGATOR Study Group; John J McMurray, Rury R Holman, Steven M Haffner, M Angelyn Bethel, Björn Holzhauer, Tsushung A Hua, Yuri Belenkov, Mitradev Boolell, John B Buse, Brendan M Buckley, Antonio R Chacra, Fu-Tien Chiang, Bernard Charbonnel, Chun-Chung Chow, Melanie J Davies, Prakash Deedwania, Peter Diem, Daniel Einhorn, Vivian Fonseca, Gregory R Fulcher, Zbigniew Gaciong, Sonia Gaztambide, Thomas Giles, Edward Horton, Hasan Ilkova, Trond Jenssen, Steven E Kahn, Henry Krum, Markku Laakso, Lawrence A Leiter, Naomi S Levitt, Viacheslav Mareev, Felipe Martinez, Chantal Masson, Theodore Mazzone, Eduardo Meaney, Richard Nesto, Changyu Pan, Rudolf Prager, Sotirios A Raptis, Guy E H M Rutten, Herbert Sandstroem, Frank Schaper, Andre Scheen, Ole Schmitz, Isaac Sinay, Vladimir Soska, Steen Stender, Gyula Tamás, Gianni Tognoni, Jaako Tuomilehto, Alberto S Villamil, Juraj Vozár, Robert M Califf.
N Engl J Med 2010;362:1477-90. Published:22-Apr-2010. Epub:14-Mar-2010. PMID:20228403. doi:10.1056/NEJMoa1001121
[Presentation] [Slides]
Erratum in :
N Engl J Med 2010;362:1748, Print:06-May-2010

Metabolic syndrome and alanine aminotransferase: a global perspective from the NAVIGATOR screening population
M. A. Bethel, P. Deedwania, N. S. Levitt, O. Schmitz, A. Huntsman-Labed, R. M. Califf, S. M. Haffner and P. Diem for the NAVIGATOR Study Groupp
Diab Med. 2009;26:1204-1211. Published:Dec-2009. Epub:30-Sep-2009. PMID:20002471. doi:10.1111/j.1464-5491.2009.02864.x
[Abstract]

Prevention of diabetes and cardiovascular disease in patients with impaired glucose tolerance: Rationale and design of the Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) Trial
Robert M. Califf, Mitradev Boolell, Steven M. Haffner, M. Angelyn Bethel, John McMurray, Anil Duggal, Rury R. Holman, for the NAVIGATOR Study Group
Am Heart J 2008;156:623-32. Published:Oct-2008. Epub:09-Sep-2008. PMID:18946890. doi:10.1016/j.ahj.2008.05.017

Determining the most appropriate components for a composite clinical trial outcome
M. Bethel, R. Holman, S. Haffner, R. Califf, A. Huntsman-Labed, T. Hua, J. McMurray
Am Heart J 2008;156:633-40. Published:Oct-2008. Epub:31-Jul-2008. PMID:18926145. doi:10.1016/j.ahj.2008.05.018

Role of Lifestyle and Oral Anti Diabetic Agents to Prevent Type 2 Diabetes Mellitus and Cardiovascular Disease
M.Angelyn Bethel, Robert M. Califf
American Journal of Cardiology 2007;99:726-731. Published:01-Mar-2007. Epub:10-Jan-2007. PMID:17317381. doi:10.1016/j.amjcard.2006.09.122