Nateglinide Data In people with IGT in addition to CV disease or risk factors, nateglinide in addition to lifestyle modification Valsartan Data In people with IGT in addition to CV disease or risk factors, valsartan in addition to lifestyle modification

Nateglinide Data In people with IGT in addition to CV disease or risk factors, nateglinide in addition to lifestyle modification Valsartan Data In people with IGT in addition to CV disease or risk factors, valsartan in addition to lifestyle modification www.phwiki.com

Nateglinide Data In people with IGT in addition to CV disease or risk factors, nateglinide in addition to lifestyle modification Valsartan Data In people with IGT in addition to CV disease or risk factors, valsartan in addition to lifestyle modification

Chavez, Dianna, Office Manager has reference to this Academic Journal, PHwiki organized this Journal Nateglinide in addition to Valsartan in Impaired Glucose Tolerance Outcomes Research Rury R. Holman, MB, ChB, FRCP Professor of Diabetic Medicine Director, Diabetes Trials Unit, Ox as long as d Robert M. Califf, MD, MACC Vice Chancellor as long as Clinical Research Donald F. Fortin Professor of Cardiology, Duke University Director, Duke Translational Medicine Institute For the NAVIGATOR Study Group NAVIGATOR Trial Organization Sponsored by Novartis Pharmaceuticals Executive Committee Trial Oversight Publications Steering Committee 43 Members Data Monitoring Committee Trial Operations Novartis Research Sites 806 centers in 40 countries Endpoint Committees Primary Objective To evaluate whether valsartan or nateglinide, in addition to lifestyle modification, can reduce the risk of diabetes in addition to cardiovascular events in persons with impaired glucose tolerance (IGT) in addition to either cardiovascular disease or risk factors as long as cardiovascular disease

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NAVIGATOR 2 × 2 Factorial Design All subjects participated in a lifestyle modification program Nateglinide 60 mg three times a day be as long as e meals Valsartan 160 mg once a day Nateglinide Comparison Valsartan Comparison North America 2146 Asia-Pacific 692 Africa 153 Central & South America 1406 Europe 4909 NAVIGATOR Global Enrollment 9306 patients 806 centers 40 countries Major Inclusion Criteria IGT plus FPG 95 mg/dL (5.3 mmol/L) in addition to either CVD in addition to age 50 yr or 1 risk factor as long as CVD in addition to age 55 yr Impaired glucose tolerance according to ADA definition: Nathan DM et al, Diabetes Care, 2007 Coprimary Endpoints Incidence of diabetes FPG 126 mg/dL (7.0 mmol/L) in addition to /or 2 hr PG 200 mg/dL (11.1 mmol/L), confirmed on OGTT within 12 weeks Extended cardiovascular outcome CV death, nonfatal MI, nonfatal stroke, hospitalization as long as heart failure, arterial revascularization, or unstable angina Core cardiovascular outcome CV death, nonfatal MI, nonfatal stroke, or hospitalization as long as heart failure

Nateglinide Data Saloranta C et al. Diabetes Care 2002;25:2141-2146 NAVIGATOR Pilot Study Postpr in addition to ial glucose lowering with nateglinide in IGT Baseline Patient Characteristics Holman RR et al, N Engl J Med, 2010

Holman RR et al, N Engl J Med, 2010 Baseline Patient Characteristics (continued) Holman RR et al, N Engl J Med, 2010 Adherence to Protocol Taking study drug at 5 years Nateglinide 70% Placebo 71% 13% withdrew consent or lost to follow-up, mostly during extension of trial Vital status available as long as 96% of the possible follow-up time Median follow-up 6.5 years as long as vital status 5.0 years as long as incident diabetes Concomitant Medications Holman RR et al, N Engl J Med, 2010

Concomitant Medications (continued) Holman RR et al, N Engl J Med, 2010 For those with diabetes: 33.3% nateglinide, 37.7% placebo Holman RR et al, N Engl J Med, 2010 Nateglinide Decreased FPG; Increased 2 Hr PG Holman RR et al, N Engl J Med, 2010 Weight in addition to Waist Circumference Increase with Nateglinide

Holman RR et al, N Engl J Med, 2010 Incidence of Diabetes Placebo 1580 events (33.9%) Nateglinide 1674 events (36.0%) Not significant after adjustment as long as multiple testing Extended in addition to Core CV Outcomes Holman RR et al, N Engl J Med, 2010 Placebo 707 events (15.2%) Nateglinide 658 events (14.2%) Placebo 387 events (8.3%) Nateglinide 365 events (7.9%) Adverse Events: Hypoglycemia Holman RR et al, N Engl J Med, 2010 Includes MedDRA preferred terms: hypoglycemia in addition to hypoglycemic seizure Adverse events otherwise did not differ between treatment groups

Holman RR et al, N Engl J Med, 2010 Nateglinide Conclusions In people with IGT in addition to CV disease or risk factors, nateglinide in addition to lifestyle modification Did not reduce the incidence of diabetes (median follow-up 5 yrs) Did not reduce the co-primary CV outcomes Valsartan Data Baseline Patient Characteristics McMurray JJ et al, N Engl J Med, 2010

Baseline Patient Characteristics (continued) McMurray JJ et al, N Engl J Med, 2010 Adherence to Protocol Taking study drug at 5 years Valsartan 67% Placebo 66% 13% withdrew consent or lost to follow-up, mostly during extension of trial Vital status available as long as 96% of the possible follow-up time Median follow-up 6.5 years as long as vital status 5.0 years as long as incident diabetes Concomitant Medications McMurray JJ et al, N Engl J Med, 2010

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Concomitant Medications (continued) McMurray JJ et al, N Engl J Med, 2010 For those with diabetes: 33.4% valsartan, 37.2% placebo McMurray JJ et al, N Engl J Med, 2010 Valsartan Significantly Reduced Mean Sitting BP McMurray JJ et al, N Engl J Med, 2010 Valsartan Reduced Fasting in addition to 2 Hr Glucose

McMurray JJ et al, N Engl J Med, 2010 Incidence of Diabetes Placebo 1722 events (36.8%) Valsartan 1532 events (33.1%) McMurray JJ et al, N Engl J Med, 2010 Extended in addition to Core CV Outcomes Placebo 693 events (14.8%) Valsartan 672 events (14.5%) Placebo 377 events (8.1%) Valsartan 375 events (8.1%) McMurray JJ et al, N Engl J Med, 2010 Exploratory Outcomes: CV & Total Mortality Placebo 327 events (7.0%) Valsartan 295 events (6.4%) Placebo 116 events (2.5%) Valsartan 128 events (2.8%)

McMurray JJ et al, N Engl J Med, 2010 Adverse Events of Interest MedDRA preferred terms include: hypotension, dizziness (including dizziness exertional, dizziness postural), syncope, presyncope in addition to shock (not otherwise specified) McMurray JJ et al, N Engl J Med, 2010 Valsartan Conclusions In people with IGT in addition to CV disease or risk factors, valsartan in addition to lifestyle modification 14% relative (3.8% absolute) reduction in incident diabetes (median follow-up 5 yrs) Did not reduce the co-primary CV outcomes Thoughts After NAVIGATOR We are in the midst of a global epidemic of obesity, diabetes, in addition to associated cardiovascular disease. Many people with impaired glucose tolerance will develop diabetes in a short period of time, even with st in addition to ard medical care. Lifestyle intervention remains the cornerstone of diabetes prevention in addition to therapy as long as impaired glucose tolerance. We must continue to seek better pharmacological treatments while emphasizing the critical importance of exercise in addition to weight control to prevent diabetes in addition to its morbid in addition to mortal consequences. The effects of medications must be measured in proper clinical trials to underst in addition to their impact.

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