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.

Abstract:

:Patients with impaired glucose tolerance (IGT) have increased risk for developing type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). Lifestyle modification and medication can prevent or delay progression to diabetes (PD), but whether such interventions also reduce the risk of CVD has not been rigorously tested. The Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial is a multinational, randomized, double-blind, 2 x 2 factorial trial in subjects with IGT (on a screening oral glucose tolerance test [OGTT]) aged > or = 50 years with known CVD or aged > or = 55 years with > or = 1 CVD risk factor. Enrollment began in January 2002 and was completed January 2004, with 9,518 patients randomized to receive 1 of 4 possible treatment combinations as follows: nateglinide with valsartan, nateglinide with valsartan-placebo, nateglinide-placebo with valsartan, or nateglinide-placebo with valsartan-placebo. All subjects are participating in a clinic-based and telephone-based lifestyle intervention aimed at reducing weight and dietary fat and increasing physical activity. The 3 coprimary end points are new onset of T2DM, a "core" composite of major cardiovascular events (death, myocardial infarction, stroke, or hospitalization for heart failure), and an "extended" composite including the components of the core composite plus coronary revascularization and hospitalization for unstable angina. The study was designed to evaluate whether reducing postprandial hyperglycemia, blockade of the renin-angiotensin-aldosterone system, or both interventions reduce the risk of T2DM or cardiovascular events in patients with IGT.

journal_name

Am Heart J

journal_title

American heart journal

authors

Califf RM,Boolell M,Haffner SM,Bethel M,McMurray J,Duggal A,Holman RR,NAVIGATOR Study Group.

doi

10.1016/j.ahj.2008.05.017

subject

Has Abstract

pub_date

2008-10-01 00:00:00

pages

623-32

issue

4

eissn

0002-8703

issn

1097-6744

pii

S0002-8703(08)00389-X

journal_volume

156

pub_type

杂志文章,多中心研究,随机对照试验
  • Angiotensin II receptor antagonists: a new approach to blockade of the renin-angiotensin system.

    abstract::A-II exerts its activity on various target tissues by binding to its receptors. The discovery of local RASs and A-II receptors within various tissues has generated interest in the clinical usefulness of RAS inhibition by directly blocking the action of A-II at the receptor level. Different A-II receptor subtypes have ...

    journal_title:American heart journal

    pub_type: 杂志文章,评审

    doi:10.1016/0002-8703(94)90061-2

    authors: Kang PM,Landau AJ,Eberhardt RT,Frishman WH

    更新日期:1994-05-01 00:00:00

  • Optimal features of a new beta-blocker.

    abstract::Therapeutics involves the careful balance between treatment disadvantages and advantages--the so-called risk-benefit ratio. Even after 20 years beta-blockers must be selected carefully to suit the patient's needs. This review examines several problems associated with beta-blockade. Generally, beta1-cardioselectivity i...

    journal_title:American heart journal

    pub_type: 杂志文章,评审

    doi:10.1016/0002-8703(88)90130-5

    authors: Reid JL

    更新日期:1988-11-01 00:00:00

  • Intrinsic heart rate in children and young adults: an index of sinus node function isolated from autonomic control.

    abstract::Standard evaluation of children with sinus node (SN) dysfunction cannot distinguish abnormal autonomic tone from intrinsic SN disease. This distinction has potentially important therapeutic and prognostic implications. Intrinsic heart rate (IHR)--the peak heart rate (HR) measured during pharmacologic combined autonomi...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/s0002-8703(05)80331-x

    authors: Marcus B,Gillette PC,Garson A Jr

    更新日期:1990-04-01 00:00:00

  • Operative and long-term survival of elderly is significantly improved by mitral valve repair.

    abstract:BACKGROUND:We review our 10-year experience of mitral valve (MV) repair in comparison with MV replacement in the elderly for floppy mitral valves/mitral valve prolapse (FMV/MVP). The use of MV repair for this entity has not been fully utilized by surgeons. METHODS:Two hundred ninety-two consecutive patients aged > or ...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/j.ahj.2005.07.003

    authors: Gogbashian A,Sepic J,Soltesz EG,Nascimben L,Cohn LH

    更新日期:2006-06-01 00:00:00

  • The assessment of contractile reserve after thrombolytic therapy for acute myocardial infarction.

    abstract::"Stunned" myocardium prevents the assessment of myocardial salvage after streptokinase. In order to unmask "stunning," we sought to evaluate left ventricular inotropic contractile reserve of patients after streptokinase. Radionuclide ventriculograms were obtained in 75 consecutive patients 2 weeks after myocardial inf...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(86)90628-9

    authors: Satler LF,Kent KM,Fox LM,Goldstein HA,Green CE,Rogers WJ,Pallas RS,Del Negro AA,Pearle DL,Rackley CE

    更新日期:1986-05-01 00:00:00

  • Atrial fibrillation: A major risk factor for cognitive decline.

    abstract::Atrial fibrillation is a common disease of the elderly, conferring considerable morbidity and mortality related to cardiovascular effects and thromboembolic risks. Anticoagulation, antiarrhythmic medications, and rate control are the cornerstone of contemporary management, whereas ablation and evolving surgical techni...

    journal_title:American heart journal

    pub_type: 杂志文章,评审

    doi:10.1016/j.ahj.2014.12.015

    authors: Hui DS,Morley JE,Mikolajczak PC,Lee R

    更新日期:2015-04-01 00:00:00

  • Effect of discontinuance of type A behavioral counseling on type A behavior and cardiac recurrence rate of post myocardial infarction patients.

    abstract::Three hundred post infarction participants who had received type A behavioral counseling in the Recurrent Coronary Prevention Project, (RCPP) agreed to be followed for 1 additional year after stopping 4.5 years of continuous type A behavioral counseling. One hundred fourteen participants who had served for 4.5 years a...

    journal_title:American heart journal

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/0002-8703(87)90742-3

    authors: Friedman M,Powell LH,Thoresen CE,Ulmer D,Price V,Gill JJ,Thompson L,Rabin DD,Brown B,Breall WS

    更新日期:1987-09-01 00:00:00

  • Ventricular septal defect: selection of patients and timing for surgery.

    abstract::Eighty-seven patients with isolated ventricular septal defect (VSD) operated on in the first 5 years of life, that had a mean interval of 10 months between diagnostic catheterization and surgery, were studied retrospectively. The size of the VSD was correlated with diagnostic catheterization data and comparative analy...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/s0002-8703(77)80170-1

    authors: Yasui H,Yoshitoshi M,Miyamoto AT,Kato H,Takeda Y

    更新日期:1977-01-01 00:00:00

  • Effects of ryanodine on cat papillary muscle and isolated rat heart.

    abstract::The neutral alkaloid, ryanodine, has several actions on cardiac muscle. To delineate better its mode of action, we studied ryanodine's effect upon contracting cat papillary muscles under changing loading conditions and stimulation frequencies. We also studied ryanodine's physiologic and metabolic effects upon isolated...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(85)90161-9

    authors: Blumlein SL,Sievers R,Wikman-Coffelt J,Parmley WW,Rouleau JL

    更新日期:1985-08-01 00:00:00

  • Sustained-release local hirulog therapy decreases early thrombosis but not neointimal thickening after arterial stenting.

    abstract::Adventitial heparin delivery has been shown to inhibit thrombosis and neointimal thickening in a rat carotid injury model. To determine whether sustained, local delivery of hirulog, a potent antithrombin agent, inhibits thrombus formation and neointimal thickening after arterial stenting, silicone polymers containing ...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/s0002-8703(96)90343-9

    authors: Muller DW,Gordon D,Topol EJ,Levy RJ,Golomb G

    更新日期:1996-02-01 00:00:00

  • Cost effectiveness of a gene expression score and myocardial perfusion imaging for diagnosis of coronary artery disease.

    abstract:BACKGROUND:Over 3 million patients annually present with symptoms suggestive of obstructive coronary artery disease (oCAD) in the United States (US), but a cardiac etiology is found in as few as 10% of cases. Usual care may include advanced cardiac testing with myocardial perfusion imaging (MPI), with attendant radiati...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/j.ahj.2014.02.005

    authors: Phelps CE,O'Sullivan AK,Ladapo JA,Weinstein MC,Leahy K,Douglas PS

    更新日期:2014-05-01 00:00:00

  • Hemodynamic, renal, and neurohumoral effects of a selective oral DA1 receptor agonist (fenoldopam) in patients with congestive heart failure.

    abstract::Fenoldopam mesylate (SK&F 82526-J) is a novel benzazepine derivative. It has selective agonist activity at post-junctional (DA1) vascular dopaminergic receptors, which normally subserve renal artery vasodilation. Previous studies in normal subjects and in patients with hypertension indicate that fenoldopam increases r...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(88)90620-5

    authors: Francis GS,Wilson BC,Rector TS

    更新日期:1988-08-01 00:00:00

  • Effect of concealed anterograde impulse penetration on retrograde atrioventricular nodal conduction in man.

    abstract::The manner in which concealed anterograde impulse penetration may affect retrograde atrioventricular nodal conduction was studied systematically in 12 patients with intact ventriculoatrial (VA) conduction. After the last beat of a basic atrial drive (A1), an extrastimulus (A2) was introduced 20 msec inside the effecti...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(87)90539-4

    authors: Lehmann MH,Mahmud R,Denker ST,Tchou PJ,Dongas J,Akhtar M

    更新日期:1987-12-01 00:00:00

  • Effects of hyperoxia on myocardial injury following cardioversion-A randomized clinical trial.

    abstract::Oxygen has long been assumed beneficial for all ill and injured patients. However, hyperoxia may be harmful and aggravate myocardial injury such as that caused by myocardial infarction. We aimed to investigate if hyperoxia increases myocardial injury following direct current cardioversion compared with room air. METH...

    journal_title:American heart journal

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.ahj.2017.10.006

    authors: Lauridsen KG,Schmidt AS,Adelborg K,Bach L,Hornung N,Jepsen SM,Deakin CD,Rickers H,Løfgren B

    更新日期:2018-02-01 00:00:00

  • Transcatheter closure of patent ductus arteriosus with the use of Rashkind occluders and/or Gianturco coils: long-term follow-up in 123 patients and special reference to comparison, residual shunts, complications, and technique.

    abstract:BACKGROUND:This report describes the long-term follow-up of transcatheter closure of patent ductus arteriosus (PDA) with 2 different modalities in 123 patients of diverse ages. METHODS AND RESULTS:Between October 1990 and August 1997, 123 patients underwent transcatheter PDA (1.9 to 7.5 mm) closure at a mean age of 6....

    journal_title:American heart journal

    pub_type: 临床试验,杂志文章

    doi:10.1016/s0002-8703(99)70085-2

    authors: Janorkar S,Goh T,Wilkinson J

    更新日期:1999-12-01 00:00:00

  • Pharmacology of eprosartan, an angiotensin II receptor antagonist: exploring hypotheses from clinical data.

    abstract::Selective blockade of the angiotensin II AT1 receptor represents a novel mechanism for interrupting the renin-angiotensin system without altering the potential benefits of AT2 receptor stimulation. This selective inhibition produces none of the disadvantages associated with reduced bradykinin metabolism and angiotensi...

    journal_title:American heart journal

    pub_type: 杂志文章,评审

    doi:10.1016/s0002-8703(99)70317-0

    authors: Brooks DP,Ohlstein EH,Ruffolo RR Jr

    更新日期:1999-09-01 00:00:00

  • Impact of beta-blockade on complex cognitive functioning.

    abstract::Fifty adult men with mild to moderate hypertension were recruited to participate in a double-blind crossover study. Each subject received 14 days of drug treatment and 14 days of placebo treatment (random order). Half the subjects were assigned to a metoprolol (150 mg/day) vs placebo treatment regimen and half to an a...

    journal_title:American heart journal

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/0002-8703(88)90106-8

    authors: Streufert S,DePadova A,McGlynn T,Pogash R,Piasecki M

    更新日期:1988-07-01 00:00:00

  • Electrocardiographic presentation of blacks with first myocardial infarction does not explain race differences in thrombolysis administration.

    abstract:BACKGROUND:Previous studies have suggested that thrombolysis is used less often in blacks than in whites. However, whether the greater prevalence of contraindications or less specific electrocardiographic manifestations of myocardial infarction (MI) account for this difference is unclear. METHODS AND RESULTS:We studie...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1067/mhj.2000.107173

    authors: Manhapra A,Khaja F,Syed M,Rybicki BA,Wulbrecht N,Alam M,Sabbah H,Goldstein S,Borzak S

    更新日期:2000-08-01 00:00:00

  • Rationale and design of a multicenter randomized trial to compare the graft patency between no-touch vein harvesting technique and conventional approach in coronary artery bypass graft surgery.

    abstract:BACKGROUND:Vein graft failure is a crucial challenge in coronary artery bypass graft (CABG) surgery. Previous studies have suggested a patency benefit of the No-Touch vein harvesting technique, but only with small sample sizes. MATERIALS AND METHODS:This study is a prospective, multicenter randomized clinical trial wi...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/j.ahj.2018.11.011

    authors: Wang X,Tian M,Zheng Z,Gao H,Wang Y,Wang L,Hu S

    更新日期:2019-04-01 00:00:00

  • The impact of the AMPD1 gene polymorphism on exercise capacity, other prognostic parameters, and survival in patients with stable congestive heart failure: a study in 686 consecutive patients.

    abstract:BACKGROUND:Previous studies have demonstrated that the adenosine monophosphate deaminase 1 (AMPD1) C34T polymorphism may be associated with survival in cardiac populations with a protective effect of the T allele. However, these studies included limited number of patients with few cardiovascular events. METHODS:We pro...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/j.ahj.2006.04.003

    authors: de Groote P,Lamblin N,Helbecque N,Mouquet F,Hermant X,Amouyel P,Dallongeville J,Bauters C

    更新日期:2006-10-01 00:00:00

  • Prognostic implications of complicated ventricular arrhythmias early after hospital discharge in acute myocardial infarction: a serial ambulatory electrocardiography study.

    abstract::To assess the prevalence and prognostic implications of complicated ventricular ectopic depolarizations (VEDs) after hospital discharge in patients with acute myocardial infarction (AMI), we obtained serial 24-hour Holter recordings in 85 patients during the first 6 weeks after AMI. Recordings were obtained during two...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(84)90745-2

    authors: Olson HG,Lyons KP,Troop P,Butman SM,Piters KM

    更新日期:1984-11-01 00:00:00

  • Quantification of amounts of coronary arterial narrowing in patients with types II and IV hyperlipoproteinemia and in those with known normal lipoprotein patterns.

    abstract::The amount of cross-sectional area narrowing by atherosclerotic plaques in each 5 mm long sement of the left main, left anterior descending, left circumflex, and right coronary arteries was analyzed at necropsy in 15 patients with type II hyperlipoproteinemia (HLP), in 13 with type IV HLP, and in 10 with known normal ...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(81)90383-5

    authors: Cabin HS,Roberts WC

    更新日期:1981-01-01 00:00:00

  • The Coronary Artery Revascularisation in Diabetes (CARDia) trial: background, aims, and design.

    abstract:BACKGROUND:Patients with diabetes have an increased incidence and severity of ischemic heart disease, which leads to an increased requirement for coronary revascularization. Comparative information regarding mode of revascularization--coronary artery bypass graft surgery surgery (CABG) or percutaneous coronary interven...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/j.ahj.2004.07.001

    authors: Kapur A,Malik IS,Bagger JP,Anderson JR,Kooner JS,Thomas M,Punjabi P,Mayet J,Millane T,Goedicke J,Jamrozik K,de Belder MA,Hall RJ,Beatt KJ

    更新日期:2005-01-01 00:00:00

  • The influence of exercise training on the ventilatory threshold of patients with coronary heart disease.

    abstract::Out of 156 patients with stable coronary heart disease randomized to either an exercise intervention group or a control group, 41 had complete gas analysis data. Continuous gas exchange data, including the ventilatory threshold, and selected heart rates were determined initially and at 1 year. The mean attendance for ...

    journal_title:American heart journal

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/0002-8703(85)90548-4

    authors: Sullivan M,Ahnve S,Froelicher VF,Meyers J

    更新日期:1985-03-01 00:00:00

  • Predictors of prognosis in severe chronic heart failure.

    abstract::A total of 127 patients with chronic heart failure referred to our exercise laboratory were studied retrospectively to identify parameters predictive of prognosis. Patients were followed for a mean of 14.6 months. The group as a whole had severe ventricular dysfunction with a median ejection fraction of 17% and a medi...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(92)90656-g

    authors: Parameshwar J,Keegan J,Sparrow J,Sutton GC,Poole-Wilson PA

    更新日期:1992-02-01 00:00:00

  • Optimized duration of clopidogrel therapy following treatment with the Endeavor zotarolimus-eluting stent in real-world clinical practice (OPTIMIZE) trial: rationale and design of a large-scale, randomized, multicenter study.

    abstract:BACKGROUND:Current recommendations for antithrombotic therapy after drug-eluting stent (DES) implantation include prolonged dual antiplatelet therapy (DAPT) with aspirin and clopidogrel ≥12 months. However, the impact of such a regimen for all patients receiving any DES system remains unclear based on scientific eviden...

    journal_title:American heart journal

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1016/j.ahj.2012.09.009

    authors: Feres F,Costa RA,Bhatt DL,Leon MB,Botelho RV,King SB 3rd,de Paula JE,Mangione JA,Salvadori D Jr,Gusmão MO,Castello H Jr,Nicolela E Jr,Perin MA,Devito FS,Marin-Neto JA,Abizaid A

    更新日期:2012-12-01 00:00:00

  • Atrial automatic ectopic tachycardia due to an atrial tumor.

    abstract::A dilated cardiomyopathy picture has been produced by rapid atrial and ventricular rates sustained for a long period of time in some patients. The ventricular tachycardias have in some instances been associated with ventricular tumors as the cause of the tachycardia. Once the tumor is removed, the tachycardia stops an...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/0002-8703(88)90811-3

    authors: Ross BA,Crawford FA Jr,Whitman V,Gillette PC

    更新日期:1988-03-01 00:00:00

  • Factors for modifying the termination of resuscitation rule in out-of-hospital cardiac arrest.

    abstract:BACKGROUND:False positive rate (FPR) of the current basic life support (BLS) termination of resuscitation (TOR) rule in out-of-hospital cardiac arrest (OHCA) patients (not witnessed; no return of spontaneous circulation prior to transport; and no shocks were delivered) has been ethically challenging. We validated the c...

    journal_title:American heart journal

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.ahj.2019.04.003

    authors: Yoon JC,Kim YJ,Ahn S,Jin YH,Lee SW,Song KJ,Shin SD,Hwang SO,Kim WY,Korean Cardiac Arrest Research Consortium KoCARC.

    更新日期:2019-07-01 00:00:00

  • Effects of physiologic load of pregnancy on left ventricular contractility and remodeling.

    abstract::Left ventricular (LV) adaptation to the hemodynamic load of pregnancy has been studied with load-sensitive ejection-phase indexes, but the results of these studies are conflicting. The aim of this study was to examine the effects of the hemodynamic load of pregnancy on the contractile state of the left ventricle by us...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/s0002-8703(97)70247-3

    authors: Geva T,Mauer MB,Striker L,Kirshon B,Pivarnik JM

    更新日期:1997-01-01 00:00:00

  • Pathophysiologic mechanisms underlying dobutamine- and exercise-induced wall motion abnormalities.

    abstract:BACKGROUND:Dobutamine and exercise echocardiography are accepted as tests of comparable efficacy for the diagnosis of coronary artery disease. Although dobutamine has been classified as "exercise simulating," the mechanisms of ischemia with dobutamine and exercise have not been well studied. This study sought to compar...

    journal_title:American heart journal

    pub_type: 杂志文章

    doi:10.1016/s0002-8703(98)70183-8

    authors: Mairesse GH,Vanoverschelde JL,Robert A,Climov D,Detry JM,Marwick TH

    更新日期:1998-07-01 00:00:00