update in outpatient medicine jnc 8, hypertension and more

Update in Outpatient MedicineJNC 8, Hypertension and More

March 6th 2015

Robert Gluckman, MD, FACPCMO‐ Providence Health Plans

Disclosures

Stock HoldingsAbbott LabsAbbvieBristol Myers SquibbGEProctor and GambleWalgreens

TopicsHypertension

New GuidelinesApplying treatment targets to individualsProtocols to get to target

Cancer screening in the elderly

Colon Cancer Screening

Benefit and Cost of Supplemental U/S for breast cancer screening women with dense breasts

Cost Effectiveness of Lung Cancer Screening

New Lipid Guidelines

New Agent for CHF

2014 Evidence-Based Guideline for the Management of Hypertension: JNC 8

Evidence based review focused on 3 questions; 9 recommendations

Does initiating pharmacologic therapy at specific BP thresholds improve health outcomes?

Does pharmacologic treatment targeted to a specific BP goal improve health outcomes?

Do various anti-hypertensive drugs/classes differ in comparative benefits/harms for specific health outcomes? JAMA 2014; 311: 507-520


Recommended BP targets and treatment regimens based on age, race, presence of DM/CKD.

General population age ≥ 60 treat to target SBP ≤150, DBP ≤ 90 (Grade A)

Patients currently tolerating treatment with BP ≤140/90 do not require adjustment (Grade E)

General population age < 60 initiate treatment to target DBP <90 (Grade A 30-59. Grade E 18-29)


General population age < 60 initiate treatment to SBP < 140 (Grade E)

In patients age ≥ 18 with DM or CKD initiate treatment to target BP <140/90 (Grade E)

In general population non-black patients, including patients with DM, initiate treatment with thiazide or CCB or ACE or ARB (Grade B)


In patients with CKD, regardless of race or DM, initiate or add ACE or ARB to treatment (Grade B)

In black patients including with DM, initiate treatment with thiazide or CCB (Grade B, DM recommendation Grade C)

In patients not controlled after 1 month of treatment, increase dose or add 2nd medication.

– Patients uncontrolled on 3 agents consider BP med not specified in guideline or refer

Impact of BP Control on Mortality Risk and ESRD

• Retrospective cohort study of 396,419 treated hypertensives from Kaiser Permanente Southern California

Excluded ESRD and CHF

Average age 64

Subgroup analyses for DM, age >70

Follow up 4-5 yearsJACC 2014;64:588-97

BP Lowering in Type 2 DM:A Systematic Review and Meta-analysis

Forty trials deemed of low risk of bias

Stratified results based on patients initial BP

Noted reduced CVA and albuminuria (not other outcomes) if achieved BP lower than 130/80

Individualized targets based on age and co-morbidity may result in better outcomes

JAMA 2015;313:603-615

Treatment with Multiple BP Medications, Achieved BP and Mortality in NH Residents- The PARTAGE Study

• 1127 nursing home residents age > 80• Measured BP over 3 consecutive days• 2 year follow-up• Assessed medication use– Excluded patients without hypertension on

meds for other conditions

JAMA Int Med published online 2/16/2015

Cost Effectiveness of Hypertension Therapy According to 2014 Guidelines

Used a computer simulation model to predict incidence, prevalence, and mortality of CHD and CVA among persons age 35-94.

Categorized patients as Stage 1 SBP 140-159, DBP 90-99Stage 2 or higher SBP ≥ 160, DBP ≥ 100

Estimated 56,000 cardiac events and 13,000 deaths prevented in the US each year

NEJM 2015:372-447-55

Summary- New BP Guidelines and TargetsImplications for Performance Measurement

BP targets raised for patients 60 and older

BP targets raised for patients with DM, CKD

ACE/ARB preference removed for hypertensive patients with DM unless CKD or albuminuria

Drug choices differ by race, (use thiazide or CCB in black patients unless CKD

Performance measures allow looser controlImportant to remember to individualize approach

Younger patients with DM, CKD consider more aggressive target, Relax treatment in old, frail patients

Improved BP Control with a Large Scale Hypertension Program

652,763 patients in KPNC registry compared to other California insurers participating in NCQA

5 components to programDevelopment of a registrySharing of performance metricsEvidence based guidelinesMA BP visitsSingle pill combination therapy (diuretic plus ACE)

JAMA 2013;310-699-705

Improved BP Control with a Large Scale Hypertension Program

4 step drug therapyThiazide or Thiazide plus ACEIThiazide plus ACEICCB (i.e. amlodipine)Spironolactone or beta blocker

MA visit 2-4 weeks after med changeNo co-payAllowed more rapid treatment intensification

JAMA 2013;310:699-705

PHP201370.1%

Epidural Steroids for Spinal Stenosis 400 patients age ≥ 50 with lumbar central spinal stenosis and moderate to severe leg pain and disability

Randomized to receive epidural injections of glucocorticoid plus lidocaine vs. lidocaine alone

Received one or two injections before outcome evaluation 6 weeks after first injection

Primary OutcomeRoland-Morris Disability QuestionnaireRating intensity of leg pain (0-10)

Epidural Steroids for Spinal Stenosis

Epidural Steroids for Spinal StenosisTreatment of lumbar spinal stenosis with

glucocorticoid plus lidocaine injections offered minimal to no benefit at 6 weeks

Although sham injections were not performed, there is no evidence to support injections for the treatment of spinal stenosis.

Consider behavioral/PT programs for non-surgicalcandidates

Cancer Screening in Patients with Limited Life Expectancies

Retrospective cohort analysis of 27,911 patients aged 65 and older

Data derived from the National Health Interview Survey, self reported cancer screening rates

Mortality index developed and patients grouped into low (<25%), intermediate (25-49%), high(50-74%, or very high (>75%) mortality in 5 and 9 years.

JAMA IM 2014;174(10):1558-65

Estimating Prognosis for Elderswww.eprognosis.ucsf.edu

Charlson Co-Morbidity Index Calculatorhttp://farmacologiaclinica.info/scales/Charlson_Comorbidity/

Should CRC Screening be Considered in Previously Unscreened Elderly Persons

Microsimulation modeling study using observational and experimental studies

One time screening with colonoscopy, sigmoidoscopy, or FIT in previously unscreened persons aged 76-90 with no, moderate, severe comorbid conditions

Cost effectiveness threshold $100,000 per QALY

Ann Intern Med 2014;160:750-759

Multi-target Stool DNA Testing for CRC Screening

12,776 patients age 50-84 at average risk for CRC enrolled at 90 sites

Excluded patients with previous colonoscopy within 9 years, + fecal blood in past 6 months.

9989 participants could be fully evaluated1168 did not undergo colonoscopy723 had insufficient stool or other sample issues304 had incomplete colonoscopy

Multi-target Stool DNA Testing for CRC Screening

Specificity for stool DNA lower in patients over 65 Lower cutoffs for positive FIT (20µg/g produces similar sensitivity/specificity to stool DNA

Multi-target Stool DNA Testing for CRC ScreeningMultitargeted Stool DNA testing is significantly more

sensitive than FIT for colorectal cancer detection

FIT is more specific for colorectal cancer detection than multitargeted stool DNA testing

Lowering threshold of a positive FIT may result in equivalent performanceBaseline risk is an important consideration in

determining the best test for patients

Multitargeted DNA may be appropriate in previously unscreened patients who refuse colonoscopy or have co-morbiditiesFIT may be more appropriate for older patients with previous negative colonoscopy where colonoscopy may pose higher risks and lower benefit

Long Term CRC Mortality After Adenoma Removal

Cohort study Cancer Registry and Cause of Death Registry of Norway

40,826 patients followed median 7.7 years after adenoma removal

Norwegian standard of care10 year surveillance for high risk adenoma5 year surveillance for 3 or more adenomasNo surveillance for low risk adenomas or for patients > 74 years old

CRC mortality primary endpoint

Reviewed 442 pathology reports and reclassified8.2% of cases from highto low risk and 30.2% from low risk to high risk

Thus the risk may havebeen overstated in both cohorts if patients were correctly classified.

Long Term CRC Mortality After Adenoma Removal

Patients with 1-2 low risk adenomas have a lower risk of CRC death than average population

Current guidelines recommend surveillance 5-10 years after resection of low risk adenomas

Difficult to justify surveillance sooner than 10 years in low risk adenoma patients

Surveillance Colonoscopy in Elderly Patients

Retrospective cohort study 27,763 patients age ≥50 undergoing surveillance colonoscopy from 20001 through 2010 at Southern California Kaiser

4834 patients age ≥ 75

Primary outcome- incidence of CRCSecondary outcome- 30 day post procedure hospitalization

Procedure related (i.e. GI bleed, perforation, arrhythmia)Other GI disorderOther

JAMA IM 2014;174(10):1675-82

Low incidence of CRC in elderly possibly explained by previous removalof potentially malignant lesions or death from other comorbid conditions

PHP Colonoscopy Indications in the Elderly

Surveillance colonoscopy in the elderlySurveillance colonoscopy in older patients appears to be low yield

Healthy patients with previous high risk findings likely benefitmost

Risks of colonoscopy increase with age and co-morbidity

Assessing co-morbidities may help guide decisions for individual patients

Surveillance strategies in the elderly should consider opportunity for cancer prevention vs mortality reduction

Stool based surveillance may be a reasonable alternative for selected patients, especially over age 75.

(My opinion: Current guidelines for surveillance in the elderly are based on opinion)

Benefits, Harms, and Cost Effectiveness of Supplemental U/S for Women with Dense Breasts

19 states, including Oregon, require providers to notify patients about their breast density

Evidence is limited but suggests increased cancer detection at the expense of increased biopsies

Used 3 established models to develop estimatesof benefits, harms and cost effectiveness of supplemental U/S in women with dense breasts

Annals of IM published online Dec 9, 2014

Supplemental Screening Strategy

QALY’sGained

Cost perQALY

Biennial Screening Age 50-74

Supplemental ultrasound for BI-RADS 4

1.1 per 1000women

$246,000

Supplemental ultrasound for BI-RADS 3-4

1.7 per 1000women

$325,000

Annual Screening age 40-74

Supplemental ultrasound for BI-RADS 4

3.1 per 1000women

$553,000

Supplemental ultrasound for BI-RADS 3-4

3.0 per 1000women

$728,000

Cost Effectiveness of CT Screening in the NLST

NLST enrolled patients age 55-74 with 30 pack-yr smoking history

Current smokers or quit within 15 yearsUSPTF Grade B recommendation age 55-80Medicare coverage limited to patients age 55-74

Screening consisted of 3 annual low dose CT scans

Benefits are much greater in high risk patientsNNS 161 vs. 5276 in highest vs. lowest risk patients

NEJM 2014;371:1793-1802; NEJM 2013;369:245-54

Lung Cancer Risk Calculator

http://www.brocku.ca/lung-cancer-risk-calculator

Medicare requires shared decision making for coverage of lung cancerscreening.

Further Insight into the Cardiovascular Risk Calculator: Data from the Women’s Health Study

27,542 women free from CV disease with complete ascertainment of lipids and other risks

Followed median 10 years with annual questionnaires

Analyses adjusted for statin use and revascularizationStatin use increased to 37.5% of higher risk women at 10 years1.4% underwent revascularization;5.2% in highest risk patients

JAMA IM 2014;174 (12) 1964-71

Statin Usage In PHP Patients With ASCVD and DM

New Lipid GuidelinesControversy over lipid calculator for primary prevention

Emphasis on statin prescribing at appropriate dose for patients with known CVD or DM

Patient adherence is much lower than can be explained by side effects

Strategies to assess and promote adherence essential

Statin use in risk populations new proposed performance measure

Angotensin-Neprilysin Inhibition vs. Enalapril in Heart Failure

8442 patients with CHF, EF < 40%, NYHA Class II-IV, elevated BNP randomized to LCZ696 vs enalapril

70% NYHA Class II, 30% Class IIIProtocol changed to EF ≤ 35% mid trialExcluded patients with BP <100, CrCl < ml/min

Primary Outcome- Death from CV causes or 1st

hospitalization for worsening CHF

Trial terminated at 27 months due to overwhelming benefit

NEJM 2014;371:993-1004


LCZ696 Enalapril NNT

Total Mortality 17% 19.8% 36

CV mortality or 1st CHF Hosp

21.8% 26.5% 21

1st CHF Hosp 12.8% 15.6% 36

LCZ696 patients had improved symptoms on KCCQ


Combined angiotensin/neprilysin inhibition was superior to angiotensin inhibition in reducing death, CHF hospitalization and symptoms without significant differences in adverse events.

Questions

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