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Top Clinical Issues Eltanya A. Patterson, MD

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Top Clinical Issues. Eltanya A. Patterson, MD. Heart Failure Guidelines. Eltanya A. Patterson, MD. Definition. Complex clinical syndrome Any structural or functional impairment of ventricular filling or ejection of blood Cardinal s/ sx Dyspnea and fatigue Fluid retention - PowerPoint PPT Presentation

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Page 1: Top Clinical Issues

Top Clinical Issues

Eltanya A. Patterson, MD

Page 2: Top Clinical Issues

Heart Failure Guidelines

Eltanya A. Patterson, MD

Page 3: Top Clinical Issues

Definition

0Complex clinical syndrome0Any structural or functional impairment of ventricular

filling or ejection of blood0Cardinal s/sx

0 Dyspnea and fatigue0 Fluid retention0 Pts may c/o exercise intolerance with little fluid

retention.0 Others may c/o the peripheral edema, SOB, or fatigue

Page 4: Top Clinical Issues

Etiology

0The clinical syndrome of HF may result from0 disorders of the pericardium, myocardium,

endocardium, heart valves, or great vessels, 0 or from certain metabolic abnormalities, 0 but most patients with HF have symptoms due to

impaired left ventricular (LV) myocardial function.

Page 5: Top Clinical Issues

Definition

0 Some patients present without s/sx of fluid overload, therefore, the term “HEART FAILURE” is preferred over “CONGESTIVE HEART FAILURE.”

0 No single diagnostic test for HF.0 HF is largely a clinical diagnosis based on a careful history

and physical examination. 0 **HF is not synonymous with either cardiomyopathy or LV

dysfunction; these latter terms describe possible structural or functional reasons for the development of HF.

0 is preferable to use the terms preserved or reduced EF over preserved or reduced systolic function.

Page 6: Top Clinical Issues

New Terminology

0 HFrEF = Heart Failure with reduced Ejection Fraction0 HFpEF = Heart Failure with preserved Ejection Fraction

0 Most pts with HF with have systolic and diastolic.0 Reasons why EF is important

0 Demographics0 Comorbidities0 Prognosis0 Response to therapies0 **Most clinical trials selected pts based on EF

Page 7: Top Clinical Issues

Definition: Redefining HF

Classification EF Description

HFrEF ≤ 40% Synonymous with systolic HF. Demonstrated efficacious therapy.

HFpEF ≥ 50% Synonymous with diastolic HF. No efficacious therapy.

HFpEF, borderline 41-49% Intermediate/borderline group. Characteristics, treatment, and outcome similar to HFpEF.

HFpEF, improved > 40% Pertains to subset of pts who were prev HFrEF. These pts have recovered their EF. Further studies needed.

Page 8: Top Clinical Issues

ACCF/AHA Stages of HF Stage Description

A At high risk for HF but without structural heart None disease or symptoms of HF

B Structural heart disease but without signs or symptoms of HF

C Structural heart disease with prior or current symptoms of HF

D Refractory HF requiring specialized interventions

Page 9: Top Clinical Issues

NYHA Functional Classification

Classification Description

I No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF.

II Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF.

III Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF.

IV Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest.

Page 10: Top Clinical Issues

020% lifetime risk for Americans ≥ 40 yo.0 Incidence stable over last several decades.

0 >650,000 new diagnoses yearly0Prevalence: ~5.1 million.01 in 5 will be >65 yo by 2050.

0 Highest HF prevalence.

Epidemiology

Page 11: Top Clinical Issues

0Blacks - highest risk for HF. 0White women – lowest incidence.0Black men – highest incidence.05-year mortality rate – blacks > whites.0Prevalence:

0 Non-Hispanic black males - 4.5%0 Non-Hispanic females – 3.8%0 Non-Hispanic white males - 2.7% 0 Non-Hispanic white females - 1.8%

Disparities Identified

Page 12: Top Clinical Issues

0 Initial laboratory evaluation 0 CBC, CMP, Magnesium, FLP, TSH, urinalysis. (C)

0Serial monitoring0 Serum electrolytes and renal function. (C)

0 Initial 12-lead electrocardiogram. (C)

Diagnostic Tests: Class I

Page 13: Top Clinical Issues

0Screening:0 Hemochromatosis or HIV - reasonable in selected

patients. (C)0Other tests:

0 Rheumatologic diseases.0 Amyloidosis.0 Pheochromocytoma.0 Reasonable if clinical suspicion. (C)

Diagnostic Tests: Class IIa

Page 14: Top Clinical Issues

0Ambulatory patients with dyspnea, it is useful to measure B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP). It supports clinical decision. Especially if uncertain.(A)

0Measure BNP or NT-proBNP to establish prognosis or disease severity in chronic HF. (A)

Outpatient Biomarkers: Class I

Page 15: Top Clinical Issues

0Well-structured HF disease management program: BNP- or NT-proBNP−guided HF therapy can be useful to achieve optimal dosing of GDMT in select clinically euvolemic patients. (B)

Outpatient Biomarkers: Class IIa

Page 16: Top Clinical Issues

0Serial BNP:0 Usefulness in reducing hospitalization or mortality is

not well established. (B)

0Other clinically available tests 0 Biomarkers of myocardial injury or fibrosis - additive for

risk stratification in chronic HF. (B)

Outpatient Biomarkers: Class IIb

Page 17: Top Clinical Issues

0Measurement of BNP or NT-proBNP0 Useful to support clinical judgment for the diagnosis of

acutely decompensated HF. (A)0Measurement of BNP or NT-proBNP and/or cardiac

troponin0 Useful for establishing prognosis or disease severity in

acutely decompensated HF. (A)

Hospitalized/Acute: Class I

Page 18: Top Clinical Issues

0Usefulness of BNP- or NT-proBNP−guided therapy for acutely decompensated HF is not well established. (C)

Hospitalized/Acute: Class IIb

Page 19: Top Clinical Issues

0Patients with suspected or new-onset HF, or those presenting with acute decompensated HF, should undergo 0 CXR - to assess heart size and pulmonary congestion and

to detect alternative cardiac, pulmonary, and other diseases that may cause or contribute to the patient’s symptoms. (C)

02D echocardiogram with Doppler 0 Initial evaluation to assess ventricular function, size,

wall thickness, wall motion, and valve function. (C)

Noninvasive Cardiac Imaging: Class I

Page 20: Top Clinical Issues

0Repeat measurement of EF and severity of structural remodeling is useful when:0 There’s significant change in clinical status; 0 In those who have experienced or recovered from a

clinical event; 0 In those who have received treatment that might have

had a significant effect on cardiac function0 Those who may be candidates for device therapy0 (Level of Evidence: C)

Noninvasive Cardiac Imaging: Class I

Page 21: Top Clinical Issues

0Routine repeat measurement of LV function in pt w/o a change in clinical status or treatment interventions should not be performed. (B)

Noninvasive Cardiac Imaging: Class IIINo Benefit

Page 22: Top Clinical Issues

0Treat Hypertension and Hyperlipidemia, according to guidelines, to lower the risk of HF. (A)

0Control or avoid other conditions that may lead to or contribute to HF0 Obesity0 Diabetes mellitus0 Tobacco use0 Known cardiotoxic agents0 (Level of Evidence: C)

Treatment of Stage A to D: Recommendations: Stage A Class I

Page 23: Top Clinical Issues

0 Recent or remote h/o MI or ACS and reduced EF = ACEI. (A)

0 ACEI prevent symptomatic HF and reduce mortality.0 If intolerant to ACEIs ARBs. (A)0 Beta blockers to reduce mortality. (B)0 In recent or remote history of MI or ACS statins to

prevent symptomatic HF and cardiovascular events. (A)0 ACE inhibitors in all patients with a reduced EF to

prevent symptomatic HF, regardless of history of MI. (A)

Treatment of Stage A to D: Recommendations: Stage B Class I

Page 24: Top Clinical Issues

0Beta blockers in all patients with a reduced EF to prevent symptomatic HF, even if no history of MI. (C)

Treatment of Stage A to D: Recommendations: Stage B Class I

Page 25: Top Clinical Issues

0Placement of an implantable cardioverter-defibrillator (ICD)0 To prevent sudden death0 Is reasonable in patients with

0asymptomatic ischemic cardiomyopathy 0who are at least 40 days post-MI, 0have an LVEF of 30% or less, 0are on appropriate medical therapy, 0and have reasonable expectation of survival 0with a good functional status for more than 1 year.

0 (Level of Evidence: B)

Treatment of Stage A to D: Recommendations: Stage B Class IIa

Page 26: Top Clinical Issues

0Nondihydropyridine calcium channel blockers with negative inotropic effects may be harmful in asymptomatic patients with low LVEF and no symptoms of HF after MI. (Level of Evidence: C)

Treatment of Stage A to D: Recommendations: Stage B Class III Harm

Page 27: Top Clinical Issues

Oral Anticoagulants

Page 28: Top Clinical Issues

Anticoagulants

0Heparins0Vitamin K Antagonists0Fondaparinux0Direct Thrombin Inhibitors (DTI)0Direct Factor Xa Inhibitors (DFXaI)

Page 29: Top Clinical Issues

Thrombin

0Final enzyme in clotting cascade that produces fibrin.0Activates other procoagulant factors.0Active in both circulating and clot-bound forms.0DTI block action of both forms of thrombin.0Heparins only inactivate thrombin in fluid phase via

antithrombin

Page 30: Top Clinical Issues

Factor Xa

0Acts at convergence point of intrinsic and extrinsic coagulation pathway.

0One molecule of factor 10a can cleave over 1000 molecules of prothrombin to thrombin.

0Active in circulating and clot-bound forms.0DXa inhibitors block the action in both forms.0 Indirect Factor Xa inhibitors (heparin and

fondaparinux) only able to inactivate Xa in the fluid phase.

Page 31: Top Clinical Issues

Anticoagulant Terminology

0Anithrombotic Agent0 Antiplatelet0 anticoagulant

0Antiplatelet0 ASA0 Clopidogrel

0Anticoagulant 0 DTI0 DFXaI

Page 32: Top Clinical Issues

Anticoagulant Terminology

0Other Acronyms0TSOACs0DOACs0ODI0NOACs0Newer0Nonvitamin K antagonists

Page 33: Top Clinical Issues

Comparison

0Anticoagulants differ in efficacy depending on clinical setting.

0There are differences in dosing, monitoring, cost, and risk.

0Advantages and disadvantages of each agent must be individualized.

Page 34: Top Clinical Issues

ComparisonCoumadin TSOACs

Dose Once daily Once or twice daily

Diet Vitamin K foods Rivaroxaban: take with food

Monitor - Therapy PT/INR plus None required

Drug Interactions Numerous Rivaroxaban – CYP-3A4 and P-glycoprotein inh

Therapeutic Time

Reversal Agents Vitamin K, FFP, PCC, rFVIIa

None. PCC for life-threatening bleeding

Monitor - Reversal PT/INR TT – dabigatranAnti-factor Xa - apixaban

Comorbid Conditions Renal functions affects phrmacokineticsUnclear dosing for those with obesity

Page 35: Top Clinical Issues

Contraindications

0Pregnancy0Prosthetic Heart Valve0Renal Impairment0Compliance0GI Disease

Page 36: Top Clinical Issues

Indications

0DVT prophylaxis and treatment0Afib0Unstable angina0MI0Coronary Stenting0Heparin –Induced Thrombocytopenia

Page 37: Top Clinical Issues

Bleeding

0Warfarin - Vitamin K0Dabigatran – Clotting factor products, i.e. FFP0Rivaroxaban - Clotting factor products, i.e. FFP0Apixaban - Clotting factor products, i.e. FFP

Page 38: Top Clinical Issues

Surgery/Invasive Procedure

0Warfarin - Stopped 5 days before surgery0Dabigatran – Stopped 2-3 days before surgery0Rivaroxaban - Stopped 2-3 days before surgery0Apixaban - Stopped 2-3 days before surgery

Page 39: Top Clinical Issues

Dabigatran – Overview

0Orally administered prodrug. Converted in the liver.0Active DTI0 Inhibits clot-bound and circulating thrombin0T1/2 ~12 to 17 hours0Max anticoag effect @ 2-3 hrs of ingestion0Renal excretion. Not used if CrCl <150 **Capsules in original bottle only!!!0Used within 4 months.

Page 40: Top Clinical Issues

Dabigatran - Indicator

0DVT prophylaxis and treatment.0Stroke prevention in Afib0PE

Page 41: Top Clinical Issues

Dabigatran vs Coumadin

0Meta-analyses an dlarge observational studies0Overall bleeding rates are similar0Dabigatran may be assoc’d with a slightly lower rate

of ICH and death0Dabigatran may be assoc’d with a slightly higher rate

of GIB0Lacks a specific antidote0Dyspepsia – common SE

Page 42: Top Clinical Issues

Rivaroxaban - Overview

0 DFXaI0 T1/2 ~7 to 17 hours0 Indicator: DVT prophylaxis and treatment and stroke

prevention in Afib.0 Contraindicated in pregnancy, prosthetic heart valve0 Taken with food0 Not recommended for use in CrCl <30. Not used if CrCl <15

or significant hepatic impairment (Child-Pugh Class B and C with coagulopathy)

0 Rivaroxaban interacts with CYP-3A4 and P-glycoprotein inh0 Drug levels are relatively predictable

Page 43: Top Clinical Issues

Apixaban - Overview

0DFXaI0T1/2 ~5 to 9 hours0 Indicator: DVT prophylaxis and treatment and stroke

prevention in Afib.0Contraindicated in pregnancy or those with prosthetic

heart valve0Drug levels are relatively predictable

Page 44: Top Clinical Issues

CYP-3A4 and P-glycoprotein inh

0Ketoconazole0 Itraconazole0Voriconazole0Posaconazole0Ritonavir

Page 45: Top Clinical Issues

2013 ACC/AHA Blood Cholesterol Guideline

Page 46: Top Clinical Issues

Purpose

0The American College of Cardiology (ACC) and the American Heart Association (AHA) have collaborated with the National Heart, Lung, and Blood Institute (NHLBI) and stakeholder and professional organizations to:0 to provide a strong evidence-based foundation for the

treatment of cholesterol 0 for the primary and secondary prevention of ASCVD in

women and men.

Page 47: Top Clinical Issues

ASCVD

0Atherosclerotic cardiovascular disease 0ASCVD includes

0 coronary heart disease (CHD)0 stroke0 peripheral arterial disease

Page 48: Top Clinical Issues

The Research

0 Based on the highest quality evidence available. 0 Expert panel did not consider evidence beyond 2011. 0 Recommendations were derived from randomized trials,

meta-analyses, and observational studies evaluated for quality.

0 A limited number of expert opinion recommendations were made only when RCT evidence was not present and after a thorough consideration of what the Expert Panel had learned from the RCTs.

0 Plan to begin updating these guidelines starting in 2014.

Page 49: Top Clinical Issues

Lipid Lowering Strategies

0Strategies for using drug therapy 0 Treat-to-cholesterol target0 Lower cholesterol is better0 Risk-based treatment approaches.

0Only 1 approach evaluated in multiple RCTs0 Using fixed doses of cholesterol-lowering drugs to

reduce the ASCVD risk. 0Bulk of evidence from statin trials0Expert Panel focused on statin RCTs to develop the

evidence-based guidelines

Page 50: Top Clinical Issues

RCTs

0Either compared fixed doses of statins with placebo or untreated controls,

0Or compared fixed doses of higher-intensity statins with moderate-intensity statins.

0The trials were not designed to evaluate the effect of titrated (dose-adjusted) statin treatment to achieve a specific LDL–C or non-HDL–C.

Page 51: Top Clinical Issues

RCTs

0No RCT evidence to support titrating cholesterol- lowering drug therapy to achieve target LDL–C or non-HDL-C levels (as recommended by ATP III).

0No RCT evidence that use of therapy (e.g., niacin) to additionally lower non-HDL–C, once an LDL–C target was achieved, further reduce ASCVD.

0Extensive RCT evidence that the appropriate intensity of statin therapy should be used to reduce ASCVD risk in those most likely to benefit.

Page 52: Top Clinical Issues

0The difficulty of giving up the treat-to-goal paradigm was deliberated extensively over a 3-year period.

Page 53: Top Clinical Issues

Example

0FH with LDL–C >190 mg/dL.0 Individuals with FH are unable to achieve an LDL–C

goal <100 mg/dL. 0They may only achieve an LDL–C of 120 mg/dL despite

use of 3 cholesterol-lowering drugs. 0Did this patient fall short of the 100 mg/dL goal?0No, they have decreased their LDL–C by >50%.0May have started from an untreated LDL–C level of

~325-400 mg/dL. 0Not treatment failures.

Page 54: Top Clinical Issues

Age

0A person aged 70 years without other risk factors will receive statin treatment on the basis of age alone.

0The estimated 10-year risk is still ≥7.5%, a risk threshold for which a reduction in ASCVD risk events has been demonstrated in RCTs.

0Most ASCVD events occur after age 70 years, giving individuals >70 years of age the greatest potential for absolute risk reduction.

Page 55: Top Clinical Issues

Lifestyle Modification

0Emphasized 0Adhering to a heart healthy diet0Regular exercise0Avoidance of tobacco products0Maintenance of a healthy weight0Critical component of health promotion and ASCVD

risk reduction0Before and with the use of cholesterol- lowering drug

therapy

Page 56: Top Clinical Issues

Statin Therapy

Page 57: Top Clinical Issues

Statins

03 types of statin therapy0 High-intensity0 Moderate-intensity0 Lower-intensity

0Designations were developed from RCTs0 Evidence: The relative reduction in ASCVD risk is related

to the degree LDL-C is lowered.0High-intensity > Moderate-intensity > lower-intensity

Page 58: Top Clinical Issues

Comparison of Statin Intensity

0 Bold statins and doses = Evaluated in RCTs.0 Italic statins and doses = Approved by FDA, not tested in RCTs that were reviewed.

High-Intensity Moderate-Intensity Lower-Intensity

Lowering of LDL-C

≥ 50% 30% to <50% <30%

Statins Atorvastatin 40-80mgRosuvastatin 20 (40) mg

Atorvastatin 10 (20) mgRosuvastatin (5) 10mgSimvastatin 20-40mgPravastatin 40 (80) mgLovastatin 40mgFluvastatin XL 80mgFluvastatin 40mg bidPitavastatin 2-4mg

Simvastatin 10mgPravastatin 10-20mgLovastatin 20mgFluvastatin 20-40mg Pitavastatin 1mg

Page 59: Top Clinical Issues

Primary Prevention

0Adult ≥21 yo with LDL-C ≥190mg/dL0 High lifetime risk for ASCVD events0 Initiate High-intensity statin0 Goal: to achieve at least 50% reduction0 May require nonstatin cholesterol-lowering medication

also.0 Consider screening family members0 Screen for secondary causes

Page 60: Top Clinical Issues

Secondary CausesElev LDL-C Elev TG

Diet Fats (saturated or trans), weight gain, anorexia

Excessive alcohol intake, high amt of refined carbs, very low fat diets, weight gain

Drugs Diuretics, cyclosporine, glucocorticoids, amiodarone

Oral estrogens, glucocorticoids, bile acid sequestrants, protease inhibitors, retinoic acid, anabolic steroids, sirolimus, raloxifene, tamoxifen, BB (not carvedilol), thiazides

Diseases Biliary obstruction, nephrotic syndrome, hypothyroidism, obesity, pregnancy

Nephrotic syndrome, CRF, lipodystrophies, DM (uncontrolled) hypothyroidism, obesity, pregnancy

Page 61: Top Clinical Issues

Primary Prevention

040-75yo with DM and LDL-C 70-189mg/dL0 Moderate-intensity statin is indicated. (A/Strong)0 High-intensity statin is reasonable if 10-yr ASCVD risk

≥7.5% - unless contraindicated. (E)0<40 or >75yo with DM and LDL-C 70-189mg/dL

0 Individualize therapy0 Evaluate for ASCVD benefits0 Evaluate for AE0 Discuss with patient0 (E)

Page 62: Top Clinical Issues

Primary Prevention

040-75yo without DM and LDL-C 70-189mg/dL0 Statin initiation is based on 10-yr ASCVD risk (E)0 If risk ≥7.5% moderate to high-intensity statin (A)0 If risk is 5% - <7.5% moderate-intensity is reasonable

(C/Weak)

Page 63: Top Clinical Issues

Secondary Prevention

0≤ 75yo with clinical ASCVD High-intensity (A/Strong)0 If already on statin at a lower intensity, increase the

intensity.0 Consider:

0History of intolerance0Drug-drug interactions0Patient preference

0>75yo with clinical ASCVD Moderate-intensity (E)

Page 64: Top Clinical Issues

** Note **

0No recommendation for or against specific LDL-C or non-HDL-C targets, irregardless of primary or secondary prevention.

Page 65: Top Clinical Issues

HF and HD

0No recommendation made in regards to initiating or discontinuing statin therapy in those individuals with NYHA class II-IV ischemic systolic HF or patients currently on HD

Page 66: Top Clinical Issues

Risk Assessment

0For identification of candidates for statin therapy0http://my.americanheart.org/cvriskcalculator0http://www.cardiosource.org/science-and-quality/pr

actice-guidelines-and-quality-standards/2013-prevention-guideline-tools.aspx

0App from iTunes or Google Play or launch from website

0Age, gender, race, HDL, TC, SBP, HTN/DM/Smoker

Page 67: Top Clinical Issues

Statin Maintenance

0 If predisposed to AE, initiate therapy with the nextv lower intensity level. (A)

0To avoid unnecessary discontinuation of statins, obtain a history of prior or current muscle symptoms to establish a baseline before initiating statin therapy. (E)

0 If unexplained severe muscle symptoms or fatigue develop during statin therapy, promptly discontinue the statin and address the possibility of rhabdomyolysis by evaluating CK, creatinine, and a urinalysis for myoglobinuria. (E)

Page 68: Top Clinical Issues

Statin Maintenance0 If mild to moderate muscle symptoms develop during statin therapy:

0–  Discontinue the statin until the symptoms can be evaluated.

0–  Evaluate the patient for other conditions that might increase the risk for muscle symptoms

0 If muscle symptoms resolve, and if no contraindication exists, give the patient the original or a lower dose of the same statin to establish a causal relationship between the muscle symptoms and statin therapy.

0–  If a causal relationship exists, discontinue the original statin. Once muscle symptoms resolve, use a low dose of a different statin.

0–  Once a low dose of a statin is tolerated, gradually increase the dose as tolerated.

0–  If persistent muscle symptoms are determined to arise from a condition unrelated to statin therapy, or if the predisposing condition has been treated, resume statin therapy at the original dose. (E)

Page 69: Top Clinical Issues

Predisposing Characteristics

0Multiple or serious comorbidities, including impaired renal or hepatic function.

0History of previous statin intolerance or muscle disorders.

0Unexplained ALT elevations >3 times ULN. 0Patient characteristics or concomitant use of 0drugs affecting statin metabolism. 0>75 years of age. 0History of hemorrhagic stroke. 0Asian ancestry.

Page 70: Top Clinical Issues

4 Major Statin Groups

0 Individuals with clinical ASCVD0 Individuals with primary elevations of LDL–C >190

mg/dL0 Individuals with diabetes aged 40 to 75 years with

LDL– C 70 to189 mg/dL and without clinical ASCVD 0 Individuals without clinical ASCVD or diabetes with

LDL–C 70 to189 mg/dL and estimated 10-year ASCVD risk >7.5%

Page 71: Top Clinical Issues

Labwork - Initiation

0Fasting lipid panel (FLP) is preferred.0 If nonfasting TG >500, a FLP is required.0ALT0CK (if necessary)0Hemoglobin A1c (If not DM)

Page 72: Top Clinical Issues

Labwork - Maintenance

0Do not routinely measure CK. (A)0Baseline CK is reasonable if concerns. (E)0Measure CK and hepatic function when AE is

suspected. (E)0Consider decreasing statin dose when 2 consecutive

LDL-C <40mg/dL. (C/Weak)0 Initial FLP0F/U in 4-12 weeks0Then every 3 to 12 months as clinically indicated.

Page 73: Top Clinical Issues

Further Studies

0To determine the optimal age for initiation of therapy0To determine duration of therapy

Page 74: Top Clinical Issues

DEA

Page 75: Top Clinical Issues

Hydrocodone Combination Products (HCPs)

0Previously listed as schedule III0Now listed as schedule II

Page 76: Top Clinical Issues

History of Change

02004 – DEA received petition requesting a schedule change for HCPs.

0DEA submitted request for “HHS to provide the DEA with a scientific and medical evaluation of available information and a scheduling recommendation for HCPS.”

02008 – HHS provided DEA with necessary info – recommendation for HCPs to remain as they were in schedule III.

02009 – DEA requested a re-evaluation from HHS

Page 77: Top Clinical Issues

History of Change

0 July 9, 2012 – President Obama signed the FDA Safety and Innovation Act0 “Directed” FDA to have public hearing on HCPs0 Required the Secretary to engage stakeholders

0 Health benefits and risks0 Potential for abuse0 Impact of up-scheduling

0 January 24-25, 2013 – Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM)0 DEA0 NIDA (Nat’l Institute on Drug Abuse)0 CDC0 General Public0 Vote 19/10

Page 78: Top Clinical Issues

History of Change

0Dec 16, 2013 – HHS submitted recommendation for schedule II.

0Stated reasons for recommendation.0 HCPs are taken in amounts enough to create a safety

hazard for themselves, others, and the community0 Significant diversion0 Individuals take HCPs on their own accord rather than

as advised by their physician

Page 79: Top Clinical Issues

History of Change

0Feb 27, 2014 – Notification of proposed change in Federal Register.0 Comments were solicited and reviewed.

0Mcv sdf – HCPs officially became schedule II0 Cannot be called over the phone.

Page 80: Top Clinical Issues

Tramadol

0DEA concluded that:0 Tramadol has low potential for abuse when compared to

drugs and substances in schedule III.0 Abuse potential is more aligned with those in schedule

IV0 Tramadol is currently accepted for medical use and

approved for marketing for treatment of moderate to severe pain.

0 Abuse may lead to limited physical or psychological dependence comparable to schedule III.

Page 81: Top Clinical Issues

Tramadol

0DEA decision:0 Tramadol to be placed in schedule IV.0 Effective: August 18, 2014

Page 82: Top Clinical Issues

USPSTF2014 Updates

Page 83: Top Clinical Issues

USPSTF GradingGrade Definition Suggestions for Practice

A Service recommended. High certainty net benefit is substantial.

Offer or provide this service.

B Service recommended. Moderate to high certainty the net benefit is moderate to substantial.

Offer or provide this service.

C Selective recommendation based on professional judgment and patient preferences. At least moderate certainty net benefit is small.

Offer or provide this service for selected patients depending on individual circumstances.

D Recommendation against the service. High or moderate certainty the service has no net benefit or that harms outweigh the benefits.

Discourage the use of this service

I Conclusion: current evidence insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.

If the service is offered, patients should understand the uncertainty about the balance of benefits and harms.

Page 84: Top Clinical Issues

Abdominal Aortic Aneurysm Screening

Population Recommendation Grade

Men Ages 65 to 75 Years who Have Ever Smoked

One-time screening for AAA with US.  B

Men Ages 65 to 75 Years who Have Never Smoked

To selectively offer screening for AAA with US. C

Women Ages 65 to 75 Years who Have Ever Smoked

Current evidence is insufficient to assess the balance of benefits and harms of screening for AAA.

I

Women Who Have Never Smoked

Against. D

Release Date: June 2014

Page 85: Top Clinical Issues

Carotid Artery Stenosis: Screening

Population Recommendation Grade

General Adult Population The USPSTF recommends against screening for asymptomatic carotid artery stenosis in the general adult population.

D

Release Date: July 2014

Page 86: Top Clinical Issues

Chlamydia and Gonorrhea: Screening

Population Recommendation Grade

Sexually Active Women Screening for chlamydia in sexually active women age 24 years and younger and in older women who are at increased risk for infection.

B

Sexually Active Women Screening for gonorrhea in sexually active women age 24 years and younger and in older women who are at increased risk for infection.

B

Sexually Active Men Current evidence is insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men.

I

Release Date: September 2014

Page 87: Top Clinical Issues

Sexually Transmitted Infections: Behavioral Counseling

Population Recommendation Grade

Sexually Active Adolescents and Adults

Intensive behavioral counseling for ALL sexually active adolescents and for adults who are at increased risk for sexually transmitted infections (STIs).

B

Release Date: September 2014

Page 88: Top Clinical Issues

Cognitive Impairment in Older Adults: Screening

Population Recommendation Grade

Older Adults Current evidence is insufficient to assess the balance of benefits and harms of screening for cognitive impairment.

I

Release Date: March 2014

Page 89: Top Clinical Issues

Dental Caries in Children from Birth Through Age 5 Years:

ScreeningPopulation Recommendation Grade

Children From Birth Through Age 5 Years

Prescribe oral fluoride supplementation starting at age 6 months for children whose water supply is deficient in fluoride.

B

Children From Birth Through Age 5 Years

Apply fluoride varnish to the primary teeth of all infants and children starting at the age of primary tooth eruption.

B

Children From Birth Through Age 5 Years

Current evidence is insufficient to assess the balance of benefits and harms of routine screening examinations for dental caries performed by primary care clinicians in children from birth to age 5 years.

I

Release Date: May 2014

Page 90: Top Clinical Issues

Drug Use, Illicit: Primary Care Interventions for Children and

Adolescents

Population Recommendation Grade

Children and Adolescents without a Substance Use Disorder

Current evidence is insufficient to assess the balance of benefits and harms of primary care–based behavioral interventions to prevent or reduce illicit drug or nonmedical pharmaceutical use in children and adolescents.

I

Release Date: March 2014

Page 91: Top Clinical Issues

Gestational Diabetes Mellitus, Screening

Population Recommendation Grade

Asymptomatic Pregnant Women, After 24 Weeks of Gestation

Screen. B

Asymptomatic Pregnant Women, Before 24 Weeks of Gestation

Current evidence is insufficient to assess the balance of benefits and harms of screening.

I

Release Date: January 2014

Page 92: Top Clinical Issues

Healthy Diet and Physical Activity: Counseling Adults with

High Risk of CVD

Population Recommendation Grade

Adults Who Are Overweight or Obese and Have Additional CVD Risk Factors

Offer or refer to intensive behavioral counseling interventions to promote a healthful diet and physical activity for CVD prevention.

B

Release Date: August 2014

Page 93: Top Clinical Issues

Hepatitis B Virus Infection: Screening, 2014

Population Recommendation Grade

Persons at High Risk for Infection

Screen for hepatitis B virus (HBV) infection in persons at high risk for infection.

B

Release Date: May 2014

Page 94: Top Clinical Issues

Low-Dose Aspirin Use for the Prevention of Morbidity and

Mortality From Preeclampsia: Preventive Medication

Population Recommendation Grade

Pregnant Women Who Are At High Risk for Preeclampsia

Use of low-dose ASA (81 mg/d) as preventive medication after 12 weeks of gestation in women who are at high risk for preeclampsia.

B

Release Date: September 2014

Page 95: Top Clinical Issues

Suicide Risk in Adolescents, Adults and Older Adults:

Screening

Population Recommendation Grade

Adolescents, Adults, and Older Adults

Current evidence is insufficient to assess the balance of benefits and harms of screening.

I

Release Date: May 2014

Page 96: Top Clinical Issues

Vitamin Supplementation to Prevent Cancer and CVD:

CounselingProducts Recommendation Grade

Use of Multivitamins to Prevent Cardiovascular Disease or Cancer

Current evidence is insufficient to assess the balance of benefits and harms.

I

Single- or Paired-Nutrient Supplements for Prevention of Cardiovascular Disease or Cancer

Current evidence is insufficient to assess the balance of benefits and harms (except -βcarotene and vitamin E) for the prevention of cardiovascular disease or cancer. 

I

Use of -carotene or βVitamin E for Prevention of Cardiovascular Disease or Cancer

Against the use of -carotene or vitamin E βsupplements for the prevention of cardiovascular disease or cancer. 

D

Release Date: May 2014

Page 97: Top Clinical Issues

References0 Federal Register. http://www.gpo.gov/fdsys/pkg/FR-2014-08-22/pdf/2014-19922.

pdf. Accessed October 2014.0 Federal Register. http://www.gpo.gov/fdsys/pkg/FR-2014-07-02/pdf/2014-15548.

pdf. Accessed October 2014.0 Leung, Lawrence LK. Anticoagulation with direct thrombin inhibitors and direct

factor Xa inhibitors. www.uptodate.com. Updated 10/07/2014. Accessed 10/17/2014.

0 Stone, NJ, et al. 2013 ACC/AHA Blood Cholesterol Guideline.http://circ.ahajournals.org/content/early/2013/11/11/01.cir.0000437738.63853.7a.full.pdf. Downloaded 10/19/2014.

0 USPSTF. http://www.uspreventiveservicestaskforce.org/BrowseRec/Index. Accessed 10/24/2014.

0 Yancey et al. 2013 ACCF/AHA Heart Failure Guideline: Executive Summary. http://circ.ahajournals.org/content/128/16/e240. Downloaded October 24, 2014.