George Bakris - Academia.edu (original) (raw)

Papers by George Bakris

Research paper thumbnail of Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study

American Journal of Hypertension

BACKGROUND Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is docum... more BACKGROUND Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is documented to lower blood pressure in patients with stage 3b/4 chronic kidney disease (CKD) with uncontrolled or resistant hypertension (BLOCK-CKD study). However, the efficacy and safety of Ocedurenone in subgroups such as Hispanic patients or those with stage 4 CKD, diabetes, or very high albuminuria have not been reported. METHODS A total of 162 patients were enrolled in the BLOCK-CKD study. The primary endpoint of these analyses was change in systolic blood pressure (SBP) from baseline to day 84. Prespecified subgroup analysis of SBP focused on demographic (e.g., ethnicity, age) and medical (e.g., CKD stage, diabetes, albuminuria, baseline estimated glomerular filtration rate [eGFR]). The safety analysis focused on changes in serum potassium levels from baseline. RESULTS SBP reductions were consistent across subgroups compared with the overall study cohort. Placebo-adjusted SBP reductions...

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Research paper thumbnail of Resistant hypertension: cardiorenal protection with mineralocorticoid receptor blockade

European Heart Journal

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Research paper thumbnail of Reduction of serum K+ with patiromer for 1 year in patients with diabetic CKD who developed hyperkalemia while on maximal losartan and/or spironolactone

Journal of the American Society of Hypertension, 2015

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Research paper thumbnail of Renal outcomes in hypertensive Black patients at high cardiovascular risk

Kidney International, 2012

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Research paper thumbnail of SGLT2 inhibitors might halt progression of diabetic nephropathy

Nature Reviews Nephrology, 2016

Blood pressure lowering slows the progression of diabetic nephropathy whereas the effects of glyc... more Blood pressure lowering slows the progression of diabetic nephropathy whereas the effects of glycaemic control are smaller and slower. New findings from the EMA-REG OUTCOME investigators indicate that SGLT2 inhibition slows the progression of kidney disease by lowering glucose and blood pressure, thereby lowering the risk of adverse renal outcomes in this patient group.

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Research paper thumbnail of Demographic Analyses of the Effects of Carvedilol vs Metoprolol on Glycemic Control and Insulin Sensitivity in Patients With Type 2 Diabetes and Hypertension in the Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) Study

Journal of the CardioMetabolic Syndrome, 2008

In the Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives (... more In the Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) trial, carvedilol added to angiotensin-converting enzyme inhibitors and angiotensin receptor blockers had neutral or beneficial effects on glycemic measures compared with metoprolol tartrate. For the 1235 diabetic hypertensive GEMINI patients, the authors assessed treatment differences by race (white/black/other), age (continuous variable), and sex on hemoglobin A(1c), insulin resistance (homeostasis model assessment-insulin resistance [HOMA-IR]), and blood pressure. Both treatments significantly reduced blood pressure in all subgroups, but the metabolic effects of carvedilol were more beneficial in subgroups of race and sex. Carvedilol did not affect hemoglobin A(1c) but improved HOMA-IR results in all subgroups, significantly in males and "other…

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Research paper thumbnail of Comparison of the Novel Angiotensin II Receptor Blocker Azilsartan Medoxomil vs Valsartan by Ambulatory Blood Pressure Monitoring

The Journal of Clinical Hypertension, 2011

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Research paper thumbnail of Controlled-Release Carvedilol in the Treatment of Essential Hypertension

The American Journal of Cardiology, 2006

Carvedilol is a beta1-, beta2-, and alpha1-adrenergic blocker that is approved for the treatment ... more Carvedilol is a beta1-, beta2-, and alpha1-adrenergic blocker that is approved for the treatment of hypertension. A new once-daily, controlled-release (CR) formulation of carvedilol has been shown to be effective in a double-blind, randomized, multicenter, placebo-controlled, parallel-group study. In this article, we summarize the primary results of, and present additional analyses from, that trial. A total of 338 patients with essential hypertension (sitting diastolic blood pressure [DBP] >/=90 and </=109 mm Hg) were randomized to receive carvedilol CR 20, 40, or 80 mg or placebo for 6 weeks. The primary objective was to compare the effects of the 3 carvedilol CR doses with placebo on 24-hour mean blood pressure using ambulatory blood pressure monitoring (ABPM). Mean DBP and systolic BP (SBP) at the drug trough (20-24 hour) blood levels for carvedilol CR and comparison of DBP and SBP at the drug peak (3-7 hour) blood levels for each dose of carvedilol CR and placebo were investigated. The effects of carvedilol CR on heart rate and pulse pressure were also examined. Once-daily administration of carvedilol CR, alone or in combination with other agents, produced clinically and statistically significant reductions compared with placebo for both DBP and SBP after 6 weeks of treatment for the following parameters: trough blood pressure by office cuff or ABPM measurements, peak blood pressure by ABPM, and 24-hour mean blood pressure by ABPM. Placebo-corrected trough-to-peak ratios for DBP were >0.6 for each carvedilol CR dose. Heart rate and pulse pressure were each significantly reduced compared with placebo for each carvedilol CR dose. We conclude that carvedilol CR is a very effective antihypertensive agent with clear dose-related peak blood pressure reduction and continuous 24-hour control.

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Research paper thumbnail of Relationships Between Systolic Blood Pressure and Cardiovascular Outcomes in Patients with High Risk Hypertension: An Analysis of the Accomplish Trial

Journal of the American College of Cardiology, 2013

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Research paper thumbnail of Diretrizes da hipertensão arterial: ACC/AHA vs. ESC/ESH. Comparação de diretrizes no JACC

Este estudo compara as recomendações das mais recentes diretrizes sobre pressão arterial divulgad... more Este estudo compara as recomendações das mais recentes diretrizes sobre pressão arterial divulgadas pelo American College of Cardiology (ACC)/American Heart Association (AHA) e pela European Society of Cardiology (ESC)/European Society of Hypertension (ESH). As duas diretrizes representam atualizações de publicações anteriores e reforçam conceitos prévios de prevenção da elevação da pressão arterial. Mais especificamente, elas dão ênfase para dieta com baixo teor de sódio, redução do peso corporal, consumo de álcool em nível baixo a moderado e ingestão adequada de potássio. De forma geral, as duas diretrizes concordam quanto ao método adequado de medição da pressão arterial, ao uso de monitorização residencial ou ambulatorial da pressão arterial e ao uso restrito de betabloqueadores como terapia de primeira linha. As principais discordâncias são relacionadas ao nível de pressão arterial que define hipertensão, à flexibilidade na identificação de metas no tratamento da pressão arteri...

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Research paper thumbnail of Paradoxical Cardiorenal Responses Following Acute Vasodilator/Natriuretic Treatment in Presystolic Heart Failure

JACC: Basic to Translational Science, 2019

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Research paper thumbnail of Presence of Diabetes Does Not Mandate Lower Blood Pressure to Reduce Cardiovascular Events

Journal of the American College of Cardiology, 2018

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Research paper thumbnail of ACC/AHA Versus ESC/ESH on Hypertension Guidelines

Journal of the American College of Cardiology, 2019

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Research paper thumbnail of Assessing Wide Pulse Pressure Hypertension

Journal of the American College of Cardiology, 2019

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Research paper thumbnail of Barriers to guideline mandated renin–angiotensin inhibitor use: focus on hyperkalaemia

European Heart Journal Supplements, 2019

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Research paper thumbnail of Initial single-pill combinations for antihypertensive treatment: greater cardiovascular mortality reduction yet still not used

European heart journal, Jan 21, 2018

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Research paper thumbnail of Early and Chronic Dipeptidyl-Peptidase-IV Inhibition and Cardiovascular Events in Patients With Type 2 Diabetes Mellitus After an Acute Coronary Syndrome: A Landmark Analysis of the EXAMINE Trial

Journal of the American Heart Association, Jan 16, 2018

Antihyperglycemic therapies may increase the risk of cardiovascular events including hospitalizat... more Antihyperglycemic therapies may increase the risk of cardiovascular events including hospitalization for heart failure. There is a paucity of data evaluating the cardiovascular safety of antihyperglycemic therapies in the high-risk period following an acute coronary syndrome (ACS). The EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial randomized 5380 patients who were 15 to 90 days post ACS to the dipeptidyl dipeptidase-IV (DPP-IV) inhibitor alogliptin versus placebo; mean follow-up was 18 months. Using a landmark analysis, we assessed the (1) burden of cardiovascular events from randomization to 6 months (early period) and from 6 months to the end of follow-up (late period) and (2) the risk of cardiovascular events associated with early (up to 6 months) and chronic (6 months to end of follow-up) DPP-IV inhibition with alogliptin. Patients with early versus late events had similar baseline demographic profiles. Overall, 42.1% of the compo...

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Research paper thumbnail of Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes

Journal of the American College of Cardiology, Feb 28, 2018

Despite multiple examples of glucose-lowering therapies affecting heart failure (HF) risk, ascert... more Despite multiple examples of glucose-lowering therapies affecting heart failure (HF) risk, ascertainment of HF data in cardiovascular outcome trials of these medications has not been systematically characterized. In this review, large (n >1,000) published phase III and IV cardiovascular outcome trials evaluating glucose-lowering therapies through June 2017 were identified. Data were abstracted from publications, U.S. Food and Drug Administration advisory committee records, and U.S. Food and Drug Administration labeling documents. Overall, 21 trials including 152,737 patients were evaluated. Rates and definitions of baseline HF and incident HF were inconsistently provided. Baseline ejection fraction data were provided in 3 studies but not specific to patients with HF. No trial reported functional class, ejection fraction, or HF therapy at the time of incident HF diagnosis. HF hospitalization data were available in 15 trials, but only 2 included HF-related events within the primary...

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Research paper thumbnail of A randomized titrate-to-target study comparing fixed-dose combinations of azilsartan medoxomil and chlorthalidone with olmesartan and hydrochlorothiazide in stage-2 systolic hypertension

Journal of hypertension, 2018

Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker, has been developed in fixed-dos... more Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker, has been developed in fixed-dose combinations (FDCs) with chlorthalidone (CTD). We compared FDCs of AZL-M/CTD 20/12.5 mg once daily titrated to 40/25 mg if needed or AZL-M/CTD 40/12.5 mg once daily titrated to 80/25 mg if needed with an olmesartan medoxomil (OLM)-hydrochlorothiazide (HCTZ) 20/12.5 mg FDC once daily titrated to 40/25 mg if needed in a randomized, double-blind, 8-week study of 1085 participants with clinic SBP 160-190 mmHg and DBP 119 mmHg or less. Titration to higher doses occurred at week 4 if BP was at least 140/90 mmHg (≥130/80 mmHg if diabetes or chronic kidney disease). The primary endpoint was change from baseline in clinic SBP; 24-h ambulatory BP monitoring was also measured. Greater reductions in clinic SBP from a baseline of 165 mmHg were observed (P < 0.001) in both AZL-M/CTD arms (-37.6 and -38.2 mmHg) versus OLM/HCTZ (-31.5 mmHg), despite greater dose titration in the OLM/HCTZ group. At ...

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Research paper thumbnail of Kidney Biomarkers and Decline in eGFR in Patients with Type 2 Diabetes

Clinical journal of the American Society of Nephrology : CJASN, Jan 16, 2018

Biomarkers may improve identification of individuals at risk of eGFR decline who may benefit from... more Biomarkers may improve identification of individuals at risk of eGFR decline who may benefit from intervention or dialysis planning. However, available biomarkers remain incompletely validated for risk stratification and prediction modeling. We examined serum cystatin C, urinary kidney injury molecule-1 (uKIM-1), and urinary neutrophil gelatinase-associated lipocalin (UNGAL) in 5367 individuals with type 2 diabetes mellitus and recent acute coronary syndromes enrolled in the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) trial. Baseline concentrations and 6-month changes in biomarkers were also evaluated. Cox proportional regression was used to assess associations with a 50% decrease in eGFR, stage 5 CKD (eGFR<15 ml/min per 1.73 m), or dialysis. eGFR decline occurred in 98 patients (1.8%) over a median of 1.5 years. All biomarkers individually were associated with higher risk of eGFR decline (<0.001). However, when adjusting for baseli...

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Research paper thumbnail of Efficacy and Safety of Ocedurenone: Subgroup Analysis of the BLOCK-CKD Study

American Journal of Hypertension

BACKGROUND Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is docum... more BACKGROUND Ocedurenone (KBP-5074), a nonsteroidal mineralocorticoid receptor antagonist, is documented to lower blood pressure in patients with stage 3b/4 chronic kidney disease (CKD) with uncontrolled or resistant hypertension (BLOCK-CKD study). However, the efficacy and safety of Ocedurenone in subgroups such as Hispanic patients or those with stage 4 CKD, diabetes, or very high albuminuria have not been reported. METHODS A total of 162 patients were enrolled in the BLOCK-CKD study. The primary endpoint of these analyses was change in systolic blood pressure (SBP) from baseline to day 84. Prespecified subgroup analysis of SBP focused on demographic (e.g., ethnicity, age) and medical (e.g., CKD stage, diabetes, albuminuria, baseline estimated glomerular filtration rate [eGFR]). The safety analysis focused on changes in serum potassium levels from baseline. RESULTS SBP reductions were consistent across subgroups compared with the overall study cohort. Placebo-adjusted SBP reductions...

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Research paper thumbnail of Resistant hypertension: cardiorenal protection with mineralocorticoid receptor blockade

European Heart Journal

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Research paper thumbnail of Reduction of serum K+ with patiromer for 1 year in patients with diabetic CKD who developed hyperkalemia while on maximal losartan and/or spironolactone

Journal of the American Society of Hypertension, 2015

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Research paper thumbnail of Renal outcomes in hypertensive Black patients at high cardiovascular risk

Kidney International, 2012

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Research paper thumbnail of SGLT2 inhibitors might halt progression of diabetic nephropathy

Nature Reviews Nephrology, 2016

Blood pressure lowering slows the progression of diabetic nephropathy whereas the effects of glyc... more Blood pressure lowering slows the progression of diabetic nephropathy whereas the effects of glycaemic control are smaller and slower. New findings from the EMA-REG OUTCOME investigators indicate that SGLT2 inhibition slows the progression of kidney disease by lowering glucose and blood pressure, thereby lowering the risk of adverse renal outcomes in this patient group.

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Research paper thumbnail of Demographic Analyses of the Effects of Carvedilol vs Metoprolol on Glycemic Control and Insulin Sensitivity in Patients With Type 2 Diabetes and Hypertension in the Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) Study

Journal of the CardioMetabolic Syndrome, 2008

In the Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives (... more In the Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) trial, carvedilol added to angiotensin-converting enzyme inhibitors and angiotensin receptor blockers had neutral or beneficial effects on glycemic measures compared with metoprolol tartrate. For the 1235 diabetic hypertensive GEMINI patients, the authors assessed treatment differences by race (white/black/other), age (continuous variable), and sex on hemoglobin A(1c), insulin resistance (homeostasis model assessment-insulin resistance [HOMA-IR]), and blood pressure. Both treatments significantly reduced blood pressure in all subgroups, but the metabolic effects of carvedilol were more beneficial in subgroups of race and sex. Carvedilol did not affect hemoglobin A(1c) but improved HOMA-IR results in all subgroups, significantly in males and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;other…

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Research paper thumbnail of Comparison of the Novel Angiotensin II Receptor Blocker Azilsartan Medoxomil vs Valsartan by Ambulatory Blood Pressure Monitoring

The Journal of Clinical Hypertension, 2011

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Research paper thumbnail of Controlled-Release Carvedilol in the Treatment of Essential Hypertension

The American Journal of Cardiology, 2006

Carvedilol is a beta1-, beta2-, and alpha1-adrenergic blocker that is approved for the treatment ... more Carvedilol is a beta1-, beta2-, and alpha1-adrenergic blocker that is approved for the treatment of hypertension. A new once-daily, controlled-release (CR) formulation of carvedilol has been shown to be effective in a double-blind, randomized, multicenter, placebo-controlled, parallel-group study. In this article, we summarize the primary results of, and present additional analyses from, that trial. A total of 338 patients with essential hypertension (sitting diastolic blood pressure [DBP] &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;/=90 and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;/=109 mm Hg) were randomized to receive carvedilol CR 20, 40, or 80 mg or placebo for 6 weeks. The primary objective was to compare the effects of the 3 carvedilol CR doses with placebo on 24-hour mean blood pressure using ambulatory blood pressure monitoring (ABPM). Mean DBP and systolic BP (SBP) at the drug trough (20-24 hour) blood levels for carvedilol CR and comparison of DBP and SBP at the drug peak (3-7 hour) blood levels for each dose of carvedilol CR and placebo were investigated. The effects of carvedilol CR on heart rate and pulse pressure were also examined. Once-daily administration of carvedilol CR, alone or in combination with other agents, produced clinically and statistically significant reductions compared with placebo for both DBP and SBP after 6 weeks of treatment for the following parameters: trough blood pressure by office cuff or ABPM measurements, peak blood pressure by ABPM, and 24-hour mean blood pressure by ABPM. Placebo-corrected trough-to-peak ratios for DBP were &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;0.6 for each carvedilol CR dose. Heart rate and pulse pressure were each significantly reduced compared with placebo for each carvedilol CR dose. We conclude that carvedilol CR is a very effective antihypertensive agent with clear dose-related peak blood pressure reduction and continuous 24-hour control.

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Research paper thumbnail of Relationships Between Systolic Blood Pressure and Cardiovascular Outcomes in Patients with High Risk Hypertension: An Analysis of the Accomplish Trial

Journal of the American College of Cardiology, 2013

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Research paper thumbnail of Diretrizes da hipertensão arterial: ACC/AHA vs. ESC/ESH. Comparação de diretrizes no JACC

Este estudo compara as recomendações das mais recentes diretrizes sobre pressão arterial divulgad... more Este estudo compara as recomendações das mais recentes diretrizes sobre pressão arterial divulgadas pelo American College of Cardiology (ACC)/American Heart Association (AHA) e pela European Society of Cardiology (ESC)/European Society of Hypertension (ESH). As duas diretrizes representam atualizações de publicações anteriores e reforçam conceitos prévios de prevenção da elevação da pressão arterial. Mais especificamente, elas dão ênfase para dieta com baixo teor de sódio, redução do peso corporal, consumo de álcool em nível baixo a moderado e ingestão adequada de potássio. De forma geral, as duas diretrizes concordam quanto ao método adequado de medição da pressão arterial, ao uso de monitorização residencial ou ambulatorial da pressão arterial e ao uso restrito de betabloqueadores como terapia de primeira linha. As principais discordâncias são relacionadas ao nível de pressão arterial que define hipertensão, à flexibilidade na identificação de metas no tratamento da pressão arteri...

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Research paper thumbnail of Paradoxical Cardiorenal Responses Following Acute Vasodilator/Natriuretic Treatment in Presystolic Heart Failure

JACC: Basic to Translational Science, 2019

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Research paper thumbnail of Presence of Diabetes Does Not Mandate Lower Blood Pressure to Reduce Cardiovascular Events

Journal of the American College of Cardiology, 2018

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Research paper thumbnail of ACC/AHA Versus ESC/ESH on Hypertension Guidelines

Journal of the American College of Cardiology, 2019

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Research paper thumbnail of Assessing Wide Pulse Pressure Hypertension

Journal of the American College of Cardiology, 2019

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Research paper thumbnail of Barriers to guideline mandated renin–angiotensin inhibitor use: focus on hyperkalaemia

European Heart Journal Supplements, 2019

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Research paper thumbnail of Initial single-pill combinations for antihypertensive treatment: greater cardiovascular mortality reduction yet still not used

European heart journal, Jan 21, 2018

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Research paper thumbnail of Early and Chronic Dipeptidyl-Peptidase-IV Inhibition and Cardiovascular Events in Patients With Type 2 Diabetes Mellitus After an Acute Coronary Syndrome: A Landmark Analysis of the EXAMINE Trial

Journal of the American Heart Association, Jan 16, 2018

Antihyperglycemic therapies may increase the risk of cardiovascular events including hospitalizat... more Antihyperglycemic therapies may increase the risk of cardiovascular events including hospitalization for heart failure. There is a paucity of data evaluating the cardiovascular safety of antihyperglycemic therapies in the high-risk period following an acute coronary syndrome (ACS). The EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial randomized 5380 patients who were 15 to 90 days post ACS to the dipeptidyl dipeptidase-IV (DPP-IV) inhibitor alogliptin versus placebo; mean follow-up was 18 months. Using a landmark analysis, we assessed the (1) burden of cardiovascular events from randomization to 6 months (early period) and from 6 months to the end of follow-up (late period) and (2) the risk of cardiovascular events associated with early (up to 6 months) and chronic (6 months to end of follow-up) DPP-IV inhibition with alogliptin. Patients with early versus late events had similar baseline demographic profiles. Overall, 42.1% of the compo...

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Research paper thumbnail of Prevalent and Incident Heart Failure in Cardiovascular Outcome Trials of Patients With Type 2 Diabetes

Journal of the American College of Cardiology, Feb 28, 2018

Despite multiple examples of glucose-lowering therapies affecting heart failure (HF) risk, ascert... more Despite multiple examples of glucose-lowering therapies affecting heart failure (HF) risk, ascertainment of HF data in cardiovascular outcome trials of these medications has not been systematically characterized. In this review, large (n >1,000) published phase III and IV cardiovascular outcome trials evaluating glucose-lowering therapies through June 2017 were identified. Data were abstracted from publications, U.S. Food and Drug Administration advisory committee records, and U.S. Food and Drug Administration labeling documents. Overall, 21 trials including 152,737 patients were evaluated. Rates and definitions of baseline HF and incident HF were inconsistently provided. Baseline ejection fraction data were provided in 3 studies but not specific to patients with HF. No trial reported functional class, ejection fraction, or HF therapy at the time of incident HF diagnosis. HF hospitalization data were available in 15 trials, but only 2 included HF-related events within the primary...

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Research paper thumbnail of A randomized titrate-to-target study comparing fixed-dose combinations of azilsartan medoxomil and chlorthalidone with olmesartan and hydrochlorothiazide in stage-2 systolic hypertension

Journal of hypertension, 2018

Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker, has been developed in fixed-dos... more Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker, has been developed in fixed-dose combinations (FDCs) with chlorthalidone (CTD). We compared FDCs of AZL-M/CTD 20/12.5 mg once daily titrated to 40/25 mg if needed or AZL-M/CTD 40/12.5 mg once daily titrated to 80/25 mg if needed with an olmesartan medoxomil (OLM)-hydrochlorothiazide (HCTZ) 20/12.5 mg FDC once daily titrated to 40/25 mg if needed in a randomized, double-blind, 8-week study of 1085 participants with clinic SBP 160-190 mmHg and DBP 119 mmHg or less. Titration to higher doses occurred at week 4 if BP was at least 140/90 mmHg (≥130/80 mmHg if diabetes or chronic kidney disease). The primary endpoint was change from baseline in clinic SBP; 24-h ambulatory BP monitoring was also measured. Greater reductions in clinic SBP from a baseline of 165 mmHg were observed (P < 0.001) in both AZL-M/CTD arms (-37.6 and -38.2 mmHg) versus OLM/HCTZ (-31.5 mmHg), despite greater dose titration in the OLM/HCTZ group. At ...

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Research paper thumbnail of Kidney Biomarkers and Decline in eGFR in Patients with Type 2 Diabetes

Clinical journal of the American Society of Nephrology : CJASN, Jan 16, 2018

Biomarkers may improve identification of individuals at risk of eGFR decline who may benefit from... more Biomarkers may improve identification of individuals at risk of eGFR decline who may benefit from intervention or dialysis planning. However, available biomarkers remain incompletely validated for risk stratification and prediction modeling. We examined serum cystatin C, urinary kidney injury molecule-1 (uKIM-1), and urinary neutrophil gelatinase-associated lipocalin (UNGAL) in 5367 individuals with type 2 diabetes mellitus and recent acute coronary syndromes enrolled in the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) trial. Baseline concentrations and 6-month changes in biomarkers were also evaluated. Cox proportional regression was used to assess associations with a 50% decrease in eGFR, stage 5 CKD (eGFR<15 ml/min per 1.73 m), or dialysis. eGFR decline occurred in 98 patients (1.8%) over a median of 1.5 years. All biomarkers individually were associated with higher risk of eGFR decline (<0.001). However, when adjusting for baseli...

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