2019 Update on Recent Guideline Releases for Diabetes ...

2019 Update on Recent Guideline Releases for Diabetes, Hypertension, and Dyslipidemia:

Can We, Please, All Just Get on the Same Page?!

Jeremy L. Johnson, PharmD, BCACP, CDE, BC-ADM

Assistant Professor, SWOSU College of Pharmacy

Ambulatory Care Pharmacist, OSU Internal Medicine

2019 OSHP Annual Meeting OSU Center for Health Sciences. Tulsa, OK

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April 12, 2019

Disclosures

Under guidelines established by the Accreditation Council for Pharmacy Education, disclosure must be made regarding financial relationships with commercial interests within the last 12 months.

I, Jeremy Johnson, have no relevant financial relationships or affiliations with commercial interests to disclose.

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Pharmacist Objectives

? At the completion of this activity, pharmacists will be able to:

? Recognize inconsistencies between clinical practice guidelines released over the past 10-15 years

? Identify clinical practice guideline updates for diabetes, hypertension, and dyslipidemia

? Apply updates from new clinical practice guidelines to patient-care practices

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Technician Objectives

? At the completion of this activity, pharmacy technicians will be able to:

? Discuss pharmacology of medications for diabetes, hypertension and dyslipidemia and their therapeutic roles according to updated guidelines

? Identify common adverse effects of medications for treatment of diabetes, hypertension and dyslipidemia

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Overview

? Relevance of diabetes, hypertension, and dyslipidemia in modern ambulatory care practice

? Diabetes guideline updates and the impact of Cardiovascular Outcomes Trials (CVOTs) among antihyperglycemic agents

? History of hypertension and dyslipidemia guidelines ? Hypertension guideline updates ? Dyslipidemia guideline updates ? Implications for patient care

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The DM Epidemic

? 30.3 million in US have DM

? 9.4% of population ? Only 23.1 million have been diagnosed

? ~95% have Type 2 DM

What is Coming ? 84.1 million in US have Prediabetes

? 33.9% of US adults

CDC National Diabetes Statistics Report, 2017. .

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Complications of DM

? Microvascular

? Retinopathy ? Nephropathy ? Neuropathy

? Macrovascular

? CVD ? Stroke ? Heart Failure (HF)

In 2014, 1.5 million hospitalizations in US among adults with diabetes due to CVD. (70.4 per 1,000 patients with diabetes)

CDC National Diabetes Statistics Report, 2017. .

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Cardiovascular Disease and DM

? ~65% of deaths are due to CVD

? Risk of death from ASCVD 2- to 4-fold ? Stroke risk 2- to 4-fold ? Heart failure 2- to 5-fold

CDC National Diabetes Fact Sheet. .

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CVD Risk Reduction in DM

? Statins

? Ezetimibe ? PCSK-9 inhibitors

? Aspirin ? ACE/ARB

? Antihyperglycemic agents

Do not use drugs that could increase CVD risk!

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WHY THE SUDDEN INCREASE IN CARDIOVASCULAR OUTCOMES TRIALS

Among New Antihyperglycemic Agents

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Rosiglitazone Controversy

? 2007 meta-analysis associated rosiglitazone with increased ischemic events

? REMS on rosiglitazone

? Mixed findings in other studies

? Data determined "inconclusive"

? FDA lifted restricted prescribing program in December 2015

Conclusions: "Rosiglitazone was associated with a significant increase in the risk of myocardial infarction (OR 1.43 (95% CI, 1.03 to 1.98; P=0.03) and with an increase in the risk of death from cardiovascular causes (OR 1.64; 95% CI, 0.98 to 2.74; P=0.06) that had borderline significance."

Nissen SE. N Engl J Med. 2007;356:2457-2471

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FDA Response

? 2008 FDA mandate requiring RCT assessment of cardiovascular safety of all new antihyperglycemic agents

? Cardiovascular Outcomes Trials (CVOT)

? Must demonstrate "non-inferiority" vs placebo for association with major adverse cardiovascular events (MACE)

? Patients must be "high-risk"

? Primary endpoint: "composite of cardiovascular death, nonfatal MI, and nonfatal stroke"

? If shown non-inferior to placebo, may test for superiority

FDA. Guidance for Industry Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic

Therapies to Treat Type 2 Diabetes .

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gen/documents/document/ucm071627.pdf . Accessed September 20, 2018.

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CARDIOVASCULAR OUTCOMES TRIALS (CVOT) SINCE 2008 FDA MANDATE

DPP-4 Inhibitors, GLP-1 Receptor Agonists, SGLT2 Inhibitors

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Class

DPP-4 Inhibitors

GLP-1 Agonists

SGLT2 Inhibitors

CVOT Trials

Drug

Trial

Final

Saxagliptin Alogliptin Sitagliptin Linagliptin Linagliptin

SAVOR TIMI-53 EXAMINE TECOS CAROLINA CARMELINA

2013 2013 2015 2018 2018

Lixisenatide Liraglutide Semaglutide Exenatide Dulaglutide

ELIXA LEADER SUSTAIN-6 EXSCEL REWIND

2015 2016 2016 2017 2018

Empagliflozin Canagliflozin Dapagliflozin Ertugliflozin

EMPA-REG CANVAS Program DECLARE TIMI-58 VERTIS CV

2015 2017 2019 2020

DPP-4 Inhibitors: Non-Inferior Not Superior

GLP-1 Agonists: Non-Inferior Mixed findings for Superiority

SGLT2 Inhibitors: Non-Inferior Superior

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GLP-1 Receptor Agonists

? Glucagon-Like Peptide-1 Receptor Agonists ? Injectable: twice daily, once daily, or once weekly ? AE: Nausea, pancreatitis, thyroid tumors (animal

studies--avoid if history or family history) ? Titrate doses gradually to reduce/avoid nausea

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GLP-1 RA CVOT: LEADER

? Liraglutide 1.8 mg vs placebo

? n=9340 with type 2 DM and high CV risk

? Non-inferiority/superiority study ? Primary outcome: composite of CV death, nonfatal MI,

nonfatal stroke

? 13% vs 14.9%; HR 0.87, 95%CI 0.78-0.97; p ................
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