Paul D. Rosenblit

CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM--2016 EXECUTIVE SUMMARY.

Abbreviations: A1C = hemoglobin A1C AACE = American Association of Clinical Endocrinologists ACCORD = Action to Control Cardiovascular Risk in Diabetes ACCORD BP = Action to Control Cardiovascular Risk in Diabetes Blood Pressure ACEI = angiotensinconverting enzyme inhibitor AGI = alpha-glucosidase inhibitor apo B = apolipoprotein B ARB = angiotensin II receptor blocker ASCVD = atherosclerotic cardiovascular disease BAS = bile acid sequestrant BMI = body mass index BP = blood pressure CHD = coronary heart disease CKD = chronic kidney disease CVD = cardiovascular disease DKA = diabetic ketoacidosis DPP-4 = dipeptidyl peptidase 4 EPA = eicosapentaenoic acid FDA = Food and Drug Administration GLP-1 = glucagon-like peptide 1 HDL-C = high-density-lipoprotein cholesterol LDL-C = low-densitylipoprotein cholesterol LDL-P = low-density-lipoprotein particle Look AHEAD = Look Action for Health in Diabetes NPH = neutral protamine Hagedorn OSA = obstructive sleep apnea SFU = sulfonylurea SGLT-2 = sodium glucose cotrans...

American Association of Clinical Endocrinologists' Comprehensive Diabetes Management Algorithm 2013 Consensus Statement - Executive Summary

Alan J. Garber, MD, PhD, FACE; Martin J. Abrahamson, MD; Joshua I. Barzilay, MD, FACE; Lawrence Blonde, MD, FACP, FACE; Zachary T. Bloomgarden, MD, MACE; Michael A. Bush, MD; Samuel Dagogo-Jack, MD, FACE; Michael B. Davidson, DO, FACE; Daniel Einhorn, MD, FACP, FACE; W. Timothy Garvey, MD; George Grunberger, MD, FACP, FACE; Yehuda Handelsman, MD, FACP, FACE, FNLA; Irl B. Hirsch, MD; Paul S. Jellinger, MD, MACE; Janet B. McGill, MD, FACE; Jeffrey I. Mechanick, MD, FACE, ECNU, FACN, FACP; Paul D. Rosenblit, MD, PhD, FACE, FNLA; Guillermo E. Umpierrez, MD, FACE; Michael H. Davidson, MD, FACC, FACP, FNLA

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY - CLINICAL PRACTICE GUIDELINES FOR DEVELOPING A DIABETES MELLITUS COMPREHENSIVE CARE PLAN - 2015

The American Association of Clinical Endocrinologists/American College of Endocrinology Medical Guidelines for Clinical Practice are systematically developed statements to assist healthcare professionals in medical decision making for specific clinical conditions. Most of the content herein is based on literature reviews. In areas of uncertainty, professional judgment was applied. These guidelines are a working document that reflects the state of the field at the time of publication. Because rapid changes in this area are expected, periodic revisions are inevitable. We encourage medical professionals to use this information in conjunction with their best clinical judgment. The presented recommendations may not be appropriate in all situations. Any decision by practitioners to apply these guidelines must be made in light of local resources and individual patient circumstances. Abbreviations: A1C = hemoglobin A1c AACE = American Association of Clinical Endocrinologists ACCORD = Action to Control Cardiovascu...

American association of clinical endocrinologists' comprehensive diabetes management algorithm 2013 consensus statement

Alan J. Garber, MD, PhD, FACE; Martin J. Abrahamson, MD; Joshua I. Barzilay, MD, FACE; Lawrence Blonde, MD, FACP, FACE; Zachary T. Bloomgarden, MD, MACE; Michael A. Bush, MD; Samuel Dagogo-Jack, MD, FACE; Michael B. Davidson, DO, FACE; Daniel Einhorn, MD, FACP, FACE; W. Timothy Garvey, MD; George Grunberger, MD, FACP, FACE; Yehuda Handelsman, MD, FACP, FACE, FNLA; Irl B. Hirsch, MD; Paul S. Jellinger, MD, MACE; Janet B. McGill, MD, FACE; Jeffrey I. Mechanick, MD, FACE, ECNU, FACN, FACP; Paul D. Rosenblit, MD, PhD, FACE, FNLA; Guillermo E. Umpierrez, MD, FACE; Michael H. Davidson, MD, FACC, FACP, FNLA

AACE/ACE COMPREHENSIVE DIABETES MANAGEMENT ALGORITHM 2015

George Grunberger, MD, FACP, FACE Yehuda Handelsman, MD, FACP, FNLA, FACE Irl B. Hirsch, MD Paul S. Jellinger, MD, MACE Janet B. McGill, MD, FACE Je rey I. Mechanick, MD, FACP, FACE, FACN, ECNU Paul D. Rosenblit, MD, PhD, FNLA, FACE Guillermo Umpierrez, MD, FACP, FACE Michael H. Davidson, MD, Advisor Martin J. Abrahamson, MD Joshua I. Barzilay, MD, FACE Lawrence Blonde, MD, FACP, FACE Zachary T. Bloomgarden, MD, MACE Michael A. Bush, MD Samuel Dagogo-Jack, MD, DM, FRCP, FACE Michael B. Davidson, DO, FACE Daniel Einhorn, MD, FACP, FACE Je rey R. Garber, MD, FACP, FACE W. Timothy Garvey, MD, FACE TASK FORCE Alan J. Garber, MD, PhD, FACE, Chair AACE/ACE COMPREHENSIVE DIABETES MANAGEMENT ALGORITHM 2015

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF DYSLIPIDEMIA AND PREVENTION OF CARDIOVASCULAR DISEASE - EXECUTIVE SUMMARYComplete Appendix to Guidelines available at http://journals.aace.com.

OBJECTIVE The development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs). METHODS Each Recommendation is based on a diligent review of the clinical evidence with transparent incorporation of subjective factors. RESULTS The Executive Summary of this document contains 87 Recommendations of which 45 are Grade A (51.7%), 18 are Grade B (20.7%), 15 are Grade C (17.2%), and 9 (10.3%) are Grade D. These detailed, evidence-based recommendations allow for nuance-based clinical decision making that addresses multiple aspects of real-world medical care. The evidence base presented in the subsequent Appendix provides relevant supporting information for Executive Summary Recommendations. This update contains 695 citations of which 202 (29.1 %) are evidence level (EL) 1 (strong), 137 (19.7%) are EL 2 (intermediate), 119 (17.1%) are EL 3 (weak), and 237 (34.1%) are EL 4 (no clinical evidence). CONCLUSION This CPG is a practical tool that endocrinologists, other healthcare professionals, regulatory bodies and health-related organizations can use to reduce the risks and consequences of dyslipidemia. It provides guidance on screening, risk assessment, and treatment recommendations for a range of patients with various lipid disorders. These recommendations emphasize the importance of treating low-density lipoprotein cholesterol (LDL-C) in some individuals to lower goals than previously recommended and support the measurement of coronary artery calcium scores and inflammatory markers to help stratify risk. Special consideration is given to patients with diabetes, familial hypercholesterolemia, women, and pediatric patients with dyslipidemia. Both clinical and cost-effectiveness data are provided to support treatment decisions. ABBREVIATIONS A1C = hemoglobin A1C ACE = American College of Endocrinology ACS = acute coronary syndrome AHA = American Heart Association ASCVD = atherosclerotic cardiovascular disease ATP = Adult Treatment Panel apo = apolipoprotein BEL = best evidence level CKD = chronic kidney disease CPG = clinical practice guidelines CVA = cerebrovascular accident EL = evidence level FH = familial hypercholesterolemia HDL-C = high-density lipoprotein cholesterol HeFH = heterozygous familial hypercholesterolemia HIV = human immunodeficiency virus HoFH = homozygous familial hypercholesterolemia hsCRP = high-sensitivity C-reactive protein LDL-C = low-density lipoprotein cholesterol Lp-PLA2 = lipoprotein-associated phospholipase A2 MESA = Multi-Ethnic Study of Atherosclerosis MetS = metabolic syndrome MI = myocardial infarction NCEP = National Cholesterol Education Program PCOS = polycystic ovary syndrome PCSK9 = proprotein convertase subtilisin/kexin type 9 T1DM = type 1 diabetes mellitus T2DM = type 2 diabetes mellitus TG = triglycerides VLDL-C = very low-density lipoprotein cholesterol.

Residual dyslipidemia according to low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B among statin-treated US adults: National Health and Nutrition Examination Survey 2009-2010.

BACKGROUND Despite being on treatment, many persons with dyslipidemia still have suboptimal lipid levels and still experience cardiovascular disease (CVD) events. OBJECTIVE We examined the extent of residual dyslipidemia in terms of low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein B (apoB), in the US population, despite treatment with statin therapy. METHODS We evaluated the attainment of LDL-C, non-HDL-C, and apoB targets in statin-treated subjects in the National Health and Nutrition Examination Survey 2009-2010. We report on percentage of individuals who attained goal and the mean distance from goal. LDL-C goals were set at <70 mg/dL for those with coronary heart disease, <100 mg/dL for those with other CVDs, diabetes, chronic kidney disease or >20% 10-year CVD risk, <130 mg/dL for those with 10% to 20% 10-year CVD risk or 2+ risk factors, and <160 mg/dL in those with <10% 10-year CVD risk or no more than 1 risk factor. Goals for non-HDL-C were 30 mg/dL higher than corresponding LDL-C goals, and goals of apoB were set to correspond with the same percentile of each LDL-C goal. RESULTS Of the 5995 US adults aged ≥ 18 years surveyed, 463 (7.7%) were identified as being on a statin-based therapy. Overall, 64% of statin users were at goal for LDL-C, 63% were at goal for non-HDL-C, but only 52% were at goal for apoB. Of those who did not reach goal, 41%, 29%, and 39% were 30% or more from goal for LDL-C, non-HDL-C, and apoB, respectively. Non-Hispanic blacks and those with CVD or diabetes had the highest proportions that were not at goal for LDL-C, non-HDL-C, and apoB. Among those at goal for non-HDL-C, 50% of those with CHD and 33% of other high risk adults were not at ApoB goals. CONCLUSIONS Despite statin treatment, many persons continue to have residual dyslipidemia with LDL-C, non-HDL-C, and/or apoB levels not being at recommended levels.

Common medications used by patients with type 2 diabetes mellitus: what are their effects on the lipid profile?

Dyslipidemia is the most fundamental risk factor for atherosclerotic cardiovascular disease (ASCVD). In clinical practice, many commonly prescribed medications can alter the patient’s lipid profile and, potentially, the risk for ASCVD—either favorably or unfavorably. The dyslipidemia observed in type 2 diabetes mellitus (T2DM) can be characterized as both ominous and cryptic, in terms of unrecognized, disproportionately elevated atherogenic cholesterol particle concentrations, in spite of deceptively and relatively lower levels of low-density lipoprotein cholesterol (LDL-C). Several factors, most notably insulin resistance, associated with the unfavorable discordance of elevated triglyceride (TG) levels and low levels of high-density lipoprotein cholesterol (HDL-C), have been shown to correlate with an increased risk/number of ASCVD events in patients with T2DM. This review focuses on known changes in the routine lipid profile (LDL-C, TGs, and HDL-C) observed with commonly prescribed medications for patients with T2DM, including antihyperglycemic agents, antihypertensive agents, weight loss medications, antibiotics, analgesics, oral contraceptives, and hormone replacement therapies. Given that the risk of ASCVD is already elevated for patients with T2DM, the use of polypharmacy may warrant close observation of overall alterations through ongoing lipid-panel monitoring. Ultimately, the goal is to reduce levels of atherogenic cholesterol particles and thus the patient’s absolute risk.

A Comprehensive Evaluation of the Performance of the Test Strip Technology for OneTouch Verio Glucose Meter Systems

BACKGROUND OneTouch® Verio™ test strips (LifeScan Inc., Milpitas, CA) are designed to minimize error when used in blood glucose monitoring systems. These strips have a specialized architecture and incorporate a sophisticated waveform and proprietary algorithm. MATERIALS AND METHODS Performance of OneTouch Verio test strips was assessed in the laboratory in the presence of a wide range of patient, environmental, and pharmacologic factors. A clinical evaluation was conducted in which 296 patients and healthcare professionals (HCPs) performed glucose testing using OneTouch Verio test strips and OneTouch VerioIQ meters. RESULTS In the laboratory study, OneTouch Verio test strip results achieved a high level of performance over a wide range of hematocrit (19-61%), temperature (5-45(°)C), humidity (10-90% relative humidity), and altitude (0-3,048 m) conditions. Performance was not affected by 22 of 23 chemical compounds. In the clinical study, 100% (31/31) of lay-user test results were within ±10 mg/dL of reference values for blood glucose <75 mg/dL. At blood glucose ≥75 mg/dL, 99.2% (243/245) were within ±15% of reference values. A feature of the VerioIQ meter, PatternAlert(™) Technology, was correctly used and positively evaluated by >98% of lay users. CONCLUSIONS OneTouch Verio test strips are accurate and precise over a wide range of patient, environmental, and pharmacologic conditions. In addition, lay-users were able to successfully use the OneTouch VerioIQ PatternAlert Technology without HCP training.

The effect of volanesorsen treatment on the burden associated with familial chylomicronemia syndrome: the results of the ReFOCUS study

ABSTRACT Background: Volanesorsen, an investigational inhibitor of apoC-III synthesis, significantly reduced triglyceride levels in clinical trials in patients with familial chylomicronemia syndrome (FCS), a rare genetic disorder characterized by marked chylomicronemia leading to a spectrum of symptoms, including recurrent abdominal pain and episodes of potentially fatal acute pancreatitis (AP). Objective: To determine the effect of volanesorsen on burden of disease on patients with FCS Methods: ReFOCUS was a retrospective global web-based survey open to patients with FCS who received volanesorsen for ≥3 months in an open-label extension study. The survey included questions about patients’ experiences before and after volanesorsen treatment. Results: Twenty-two respondents had received volanesorsen for a median of 222 days. Volanesorsen significantly reduced the number of symptoms per patient across physical, emotional, and cognitive domains. Significant reductions from baseline were reported for steatorrhea, pancreatic pain, and constant worry about an attack of pain/AP. Respondents reported that volanesorsen improved overall management of symptoms and reduced interference of FCS with work/school responsibilities. Reductions in the negative impact of FCS on personal, social, and professional life were also reported. Conclusions: Treatment with volanesorsen has the potential to reduce disease burden in patients with FCS through modulation of multiple symptom domains.