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Bays H.E.,Louisville Metabolic and Atherosclerosis Research Center Inc.
Journal of Clinical Lipidology | Year: 2016

Having knowledge of worldwide areas of harmonization and consensus regarding lipid guidelines and recommendations may provide clinicians a more global perspective on lipid management. This review examines 8 international scientific/medical organizations that have issued lipid guidelines, recommendations, and position papers: the National Lipid Association (2014), National Institute for Health and Care Excellence (2014), International Atherosclerosis Society (2013), American College of Cardiology/American Heart Association (2013), Canadian Cardiovascular Society (2013), Japan Atherosclerosis Society (2012), European Society of Cardiology/European Atherosclerosis Society (2012), and Adult Treatment Panel III (2001/2004). Part 1 of this perspective focused on sentinel components of these lipid guidelines and recommendations as applied to the role of atherogenic lipoprotein cholesterol levels, primary lipid target of therapy, other primary and secondary lipid treatment targets, and assessment of atherosclerotic cardiovascular disease (ASCVD) risk. This part 2 examines goals of lipid-altering therapy. While lipid guidelines and recommendations may differ regarding ASCVD risk assessment and lipid treatment goals, lipid guidelines and recommendations generally agree on the need to reduce atherogenic lipoprotein cholesterol levels, with statins being the first-line treatment of choice. © 2016 National Lipid Association. Source


Zhu D.,Shanghai Ruijin Hospital | Bays H.,Louisville Metabolic and Atherosclerosis Research Center Inc. | Gao P.,Shanghai Ruijin Hospital | Mattheus M.,Boehringer Ingelheim | And 2 more authors.
Integrated Blood Pressure Control | Year: 2013

Background: The purpose of this work was to describe the efficacy and safety of a telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) single-pill combination therapy in patients with moderate-severe hypertension (mean seated trough cuff systolic blood pressure [BP] ≥ 160 mmHg and diastolic BP ≥ 100 mmHg) in specific patient subpopulations. Methods: This was a planned analysis of a double-blind, multicenter, parallel-group trial that demonstrated the superiority of a single-pill combination of T80/H25 versus T80 monotherapy in terms of systolic BP change from baseline to week 7. Subpopulations included older (aged ≥ 65 years) versus younger, gender, race, hypertension severity, and prior antihypertensive therapy. Endpoints were change from baseline in mean seated trough cuff systolic and diastolic BP, proportion of patients achieving their BP goal (systolic/diastolic BP < 140/90 mmHg), and proportion of patients attaining systolic BP reductions of > 30 mmHg and > 40 mmHg. Results: Across all subgroups, the T80/H25 single-pill combination provided consistently greater systolic and diastolic BP reductions than T80 and more patients had systolic BP reductions of > 30 mmHg. In the T80 and T80/H25 groups, BP control was achieved in 34.1% and 48.8% of men, 35.5% and 62.7% of women, 34.5% and 56.6% of Asians, 22.6% and 38.6% of blacks, 36.7% and 57.8% of whites, 36.9% and 57.5% of patients < 65 years, 29.3% and 49.3% ≥65 years, 44.2% and 66.2% of those with grade 2 hypertension, 20.4% and 39.4% of those with grade 3 hypertension, 38.9% and 53.2% of previously untreated patients, 38.1% and 62.5% of patients previously treated with one antihypertensive, and 29.7% and 48.9% of patients previously treated with two or more antihypertensive agents respectively. Treatment was generally well tolerated across the patient subgroups. Conclusion: The T80/H25 single-pill combination provides consistent BP reductions and higher goal attainment rates versus T80 across a range of hypertensive patient subgroups, which are likely to have a positive impact on patients' cardiovascular risk. © 2013 Zhu et al, publisher and licensee Dove Medical Press Ltd. Source


Bays H.E.,Louisville Metabolic and Atherosclerosis Research Center Inc.
Journal of Clinical Lipidology | Year: 2016

Having knowledge of worldwide lipid guidelines and recommendations may provide clinicians a more global perspective on lipid management. This perspective reviews 8 international scientific and/or medical organizations' lipid guidelines, recommendations, and position papers: the National Lipid Association (2014), National Institute for Health and Care Excellence (2014), International Atherosclerosis Society (2013), American College of Cardiology/American Heart Association (2013), Canadian Cardiovascular Society (2013), Japan Atherosclerosis Society (2012), European Society of Cardiology/European Atherosclerosis Society (2012), and Adult Treatment Panel III (2001/2004). Part 1 of this perspective focuses on sentinel components of these lipid guidelines and recommendations as applied to the role of atherogenic lipoprotein cholesterol levels, primary lipid target of therapy, other primary and secondary lipid treatment targets, and assessment of atherosclerotic cardiovascular disease (ASCVD) risk. Part 2 examines goals of lipid-altering therapy to reduce ASCVD events. Both parts 1 and 2 include the author's perspective on sentinel topics. In general, some guidelines and recommendations differ with regard to ASCVD risk assessment and lipid treatment goals. However, lipid guidelines and recommendations have significant concordance regarding the need to reduce atherogenic lipoprotein cholesterol levels, and are in general agreement on the primary lipid treatment targets. Finally, a substantial degree of agreement exists among guidelines and recommendations in their emphasis on the need for aggressive treatment of hypercholesterolemia, for which the predominance of ASCVD outcomes studies suggests statins as the first-line treatment of choice. © 2016 National Lipid Association. Source


Bays H.,Louisville Metabolic and Atherosclerosis Research Center Inc.
Endocrine Practice | Year: 2011

Objective: To evaluate the glucose- and lipid-altering efficacy of colesevelam hydrochloride (HCl) when added to background metformin therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM). Methods: This post hoc analysis included patients with T2DM from 3 randomized, double-blind, placebo-controlled pivotal studies who received metformin as part of their background antidiabetes therapy. In the pivotal studies, patients with T2DM were randomly assigned to receive colesevelam HCl (3.75 g/d) or placebo added to existing metformin (26 weeks), sulfonylurea (26 weeks), or insulin (16 weeks) monotherapy or combination therapy, wherein the combination therapies may have included metformin.Results: In this pooled analysis of 696 patients with T2DM who were receiving metformin monotherapy or metformin combined with other antidiabetes therapies, 355 were randomly assigned to receive colesevelam HCl and 341 to receive placebo. In comparison with placebo, colesevelam HCl significantly reduced hemoglobin A 1c(A1C) and fasting plasma glucose (mean treatment difference: -0.50% and -15.7 mg/dL, respectively; P<.001 for both), as well as significantly reduced levels of low-density lipoprotein cholesterol (LDL-C; mean treatment difference: -16.5%), total cholesterol (TC; -5.8%), non-high-density lipoprotein cholesterol (non-HDL-C; -8.2%), and apolipoprotein (apo) B (-7.6%) (P<.0001 for all). Median triglyceride levels were increased with colesevelam HCl (median treatment difference: +12.8%; P<.0001). In comparison with placebo, colesevelam HCl significantly increased apo A-I (mean treatment difference: +3.3%; P<.0001), whereas the mean increase in HDL-C with colesevelam HCl was not significant. Colesevelam HCl therapy was generally well tolerated. Conclusion: When added to metformin-including therapy, colesevelam HCl significantly reduced A1C and fasting glucose, as well as levels of LDL-C, TC, non-HDL-C, and apo B in patients with inadequately controlled T2DM. © 2011 AACE. Source


Hollander P.,Baylor Medical Center | Gupta A.K.,Louisiana State University | Gupta A.K.,Our Lady of the Lake Physician Group | Plodkowski R.,Scripps Research Institute | And 5 more authors.
Diabetes Care | Year: 2013

Objective-To assess the efficacy and safety of 32 mg naltrexone sustained-release (SR)/360 mg bupropion SR (NB) in overweight/obese individuals with type 2 diabetes with or without background oral antidiabetes drugs. Research design and methods-This was a 56-week, double-blind, placebocontrolled study in which 505 patients received standardized lifestyle intervention and were randomized 2:1 to NB or placebo. Coprimary end points were percent weight change and achievement of ≥5% weight loss. Secondary end points included achievement of HbA1c <7% (53 mmol/mol), achievement of weight loss ≥10%, and change in HbA1c, waist circumference, fasting blood glucose, and lipids. Results-In the modified intent-to-treat population (54% female, 80% Caucasian, and mean age 54 years, weight 106 kg, BMI 37 kg/m 2, and HbA1c 8.0% [64 mmol/mol]), NB resulted in significantly greater weight reduction (-5.0 vs. -1.8%; P < 0.001) and proportion of patients achieving ≥5% weight loss (44.5 vs. 18.9%, P < 0.001) compared with placebo. NB also resulted in significantly greater HbA 1c reduction (-0.6 vs. -0.1% [6.6 vs. 1.1 mmol/mol]; P < 0.001), percent of patients achieving HbA1c, 7% (53 mmol/mol) (44.1 vs. 26.3%; P < 0.001), and improvement in triglycerides and HDL cholesterol compared with placebo. NB was associated with higher incidence of nausea (42.3 vs. 7.1%), constipation (17.7 vs. 7.1%), and vomiting (18.3 vs. 3.6%). No difference was observed between groups in the incidence of depression, suicidal ideation, or hypoglycemia. Conclusions-NB therapy in overweight/obese patients with type 2 diabetes induced weight loss, which was associated with improvements in glycemic control and select cardiovascular risk factors and was generally well toleratedwith a safety profile similar to that in patientswithout diabetes. © 2013 by the American Diabetes Association. Source

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