ACCP Cardiology PRN Journal Clubaccpcardsprnjournalclub.pbworks.com/w/file/fetch... · Presenter...

ACCP Cardiology PRNJournal Club

10/23/2019

Moderator: Ashley Kasper, PharmD

Mentor Bio

• Dr. Vicki Groo is a Clinical Associate Professor and Clinical Pharmacist at the University of Illinois Chicago Colleges of Pharmacy and Medicine. She graduated with a BS in Pharmacy from University of Toledo and earned her PharmD from The Ohio State University. She completed a specialty residency in Cardiology and Critical Care at the University of Illinois Chicago. Currently, Dr. Groo practices in the area of heart failure at the UI Health Heart Center and her teaching and research focuses in the area of ambulatory cardiology.

Presenter Bio

• Dr. Wilson Pace is a PGY2 Cardiology Pharmacy Resident at Utah Valley Hospital in Provo, Utah. He graduated from the University of Utah College of Pharmacy and completed his PGY1 Pharmacy Residency at Intermountain Medical Center. His current practice interests include heart failure, mechanical circulatory support, and thrombosis. After residency, Dr. Pace plans to obtain a position as a cardiology clinical pharmacist.

Dapagliflozin in Patients with Heart Failure and Reduced

Ejection Fraction (DAPA-HF)

Wilson D. Pace, PharmDPGY2 Cardiology Resident, Intermountain Healthcare

Disclosure

• Neither the presenter nor the presentation mentor have conflicts of interest to disclose

Cause of Death in T2DM

CV Death

Non-CVDeath

Unknown

SuddenDeath

AcuteMI/Stroke

HF Death

PresumedCV/Other

Diabetes Care, 40(12), 1763-1770.

FDA Guidance – 2008

FDA expectation that pharmaceutical companies evaluate cardiovascular outcomes for T2DM drugs

• Prospective adjudication of CV events by an independent committee

• Events should include CV mortality, MI, Stroke

• May also include ACS hospitalization, Urgent revascularization, Others

• Not legally binding

• Similar guidance from European Medicines Agency

Cardiovascular diabetology, 16(1), 35; FDA. Guidance for Industry. (2008); International Journal of Risk & Safety in Medicine, 24(2), 73-80; European Heart Journal-Cardiovascular Pharmacotherapy, 2(1), 32-43.

Diabetes care, 41(1), 14-31.

SGLT-2 Inhibitors

Mechanism• Inhibit activity of SGLT2 channel, which reduces re-absorption of

glucose in the kidney and leads to increase glucose secretion

Canagliflozin Dapagliflozin Empagliflozin

Dosing 100 mg – 300 mg daily 5 mg – 10 mg daily 10 mg – 25 mg daily

Renal Dose Adjustment

CrCl < 60 mL/min 100 mg daily Use not recommended No dose adjustment

CrCl <45 mL/min Use not recommended Use not recommended Use not recommended

Diabetes Therapy, 5(2), 355-366.Invokana (canagliflozin) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals; October 2018.Farxiga (dapagliflozin) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2019.Jardiance (empagliflozin) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; October 2018.

SGLT2i CVOTs – Study Characteristics

EMPA-REG OUTCOME CANVAS Program DECLARE-TIMI 58

Treatment Empagliflozin vs placebo Canagliflozin vs placebo Dapagliflozin vs placebo

A1C (baseline) 7.0 – 10.0 7.0 – 10.5 6.5 – 12.0

Age (years) 63.1 63.3 63.9

BMI (kg/m2) 30.7 32 32

Diabetes duration (years) 57 % > 10 yr 13.5 10.5

CVD (%) 99 65.6 40.7

CHF (%) 10 14.4 10.1

Statin use (%) 77 75 74.9

New England Journal of Medicine, 380(4), 347-357; The New England journal of medicine, 374(11), 1094; Circulation, 137(4), 323-334;

SGLT2i CVOTs – Results

EMPA-REG OUTCOME CANVAS Program DECLARE-TIMI 58

Treatment Empagliflozin vs placebo Canagliflozin vs placebo Dapagliflozin vs placebo

Primary Outcome* 0.86 (0.74 – 0.99) 0.86 (0.75 – 0.97) 0.93 (0.84 – 1.03)

CV Death 0.62 (0.49 – 0.77) 0.96 (0.77 – 1.18) 0.98 (0.82 – 1.17)

MI 0.87 (0.70 – 1.09) 0.89 (0.73 – 1.09) 0.89 (0.77 – 1.01)

Stroke 1.18 (0.89 – 1.56) 0.87 (0.69 – 1.09) 1.01 (0.84 – 1.21)

HF Hospitalization 0.65 (0.50 – 0.85) 0.67 (0.52 – 0.87) 0.73 (0.61 – 0.88)

All-Cause Mortality 0.68 (0.57 – 0.82) 0.87 (0.74 – 1.01) 0.93 (0.82 – 1.04)

New England Journal of Medicine, 380(4), 347-357; The New England journal of medicine, 374(11), 1094; Circulation, 137(4), 323-334;

*Primary outcome = 3-point MACE (CV death, Non-fatal stroke, Non-fatal MI)

Dapagliflozin in Patients with Heart Failure and Reduced

Ejection Fraction (DAPA-HF)

Trial Design

• Prospective

• International

• Multi-center

• Double-blind

• Placebo-controlled

• Randomized controlled trial

New England Journal of Medicine. DOI: 10.1056/NEJMoa1911303.

Purpose

• Evaluate effect of dapagliflozin vs placebo in addition to standard of care on worsening heart failure and cardiovascular death, regardless of presence of diabetes.


Methods – Key Inclusion / Exclusion Criteria

Inclusion

• 18 years old

• HF for 2 months

• NYHA II – IV

• EF ≤ 40%

• Optimal RX / Device treatment of HF

• NT pro-BNP ≥ 600 pg/mL

Exclusion

• Recent SGLTi treatment / intolerance

• Type 1 DM

• Hypotension (Symptoms or SBP < 95 mmHg)

• Recent CV / HF events

• eGFR < 30 mL/min/1.73m2


Methods – Concomitant Medications

• Heart Failure• Guideline-directed medications; stable for at least 4 weeks

• ACEi / ARB / ARNI

• Beta Blocker

• MRA

• Diuretic - titrated according to weight, signs + symptoms of fluid overload

• Diabetes• Continue current therapy

• Dose of insulin / sulfonylurea may be lowered for hypoglycemia


Methods - Statistics

• Sample size• Assumed HR 0.80

• Two-sided alpha 0.05

• 844 events needed for 90% power

• Event rate of 11% = 4500 subjects

• Calculations• Hierarchical testing of primary / secondary endpoints

• Time-to-event data: Kaplan-Meier/Cox proportional-hazards

• Hazard ratios: Cox models

• Adverse events: Fisher’s exact


• Composite: Worsening heart failure (hospitalization or urgent visit requiring IV therapy) OR CV deathPrimary

• HFH OR CV death

• Total # HFH and CV deaths

• 8-month change in KCCQ questionnaire

• Renal composite: ≥ 50% decline in eGFR, ESRD, Renal death

• All-cause mortality

Secondary

• Composite: Worsening HF outcomes

• Change in NYHA class from baseline

• New atrial fibrillation

• Hypo- / Hyperkalemia

• Total # events with SCr doubling

Exploratory


Endpoints

Baseline CharacteristicsCharacteristic Dapagliflozin (n=2,373) Placebo (n=2,371)

Age (yr) 66.2 66.5

Female Sex (%) 23.8 23.0

BMI 28.2 28.1

NYHA classification (%)IIIIIIV

67.731.50.8

67.431.71.0

LVEF (%) 31.2 30.9

Medical History (%)HFHAtrial FibrillationDiabetes mellitus

47.438.641.8

47.538.041.8

Estimated GFR (mL/min/1.73m2 66.0 65.5


Background HF Therapy

DAPA-HF PARADIGM SHIFT ATMOSPHERE

Beta Blocker 96% 93% 90% 92%

ACEi / ARB / ARNI 95% 100% 92% 100%

Diuretic 93% 80% 83% 80%

MRA 71% 52% 59% 37%

Digoxin 19% 29% 22% 32%

4,744 Subjects Randomized

Dapagliflozinn=2,373

Discontinuation: 249Incomplete follow-up: 14Did not receive drug: 5

Placebon=2,371

Discontinuation: 258Incomplete follow-up: 22Did not receive placebo: 3

Completed treatmentn=2,039

Completed treatmentn=1,993

Day -14Enrollment

Day 0Randomization

Day 14Visit 3

Day 60Visit 4

Day 120Visit 5

Every 120 daysVisit 6, 7, 8,

etc.

Mean follow-up duration: 18.2 months

8,134 Subjects ScreenedExcluded: 3390Ineligible: 3279Declined: 84Adverse event: 15Death: 12


Results

Outcome Dapagliflozinn=2,373

Placebon=2,371

Hazard / Rate Ratio / Difference (95% CI)

P Value

Primary

Worsening HF or CV Death

383 (16.3) 502 (21.2) 0.74 (0.65 – 0.85) <0.001

Secondary

HFH or CV Death 382 (16.1) 495 (20.9) 0.75 (0.65 – 0.85) <0.001

KCCQ score change 6.1 ± 18.6 3.3 ± 19.2 1.18 (1.11 – 1.26) <0.001

Worsening renal function

28 (1.2) 39 (1.6) 0.71 (0.44 – 1.16) N/A

All-cause death 276 (11.6) 329 (13.9) 0.83 (0.71 – 0.97) N/A


Safety

Outcome Dapagliflozin n=2,368

Placebon=2,368

P Value

Discontinuation due to adverse event

111 (4.7) 116 (4.9) 0.79

Volume depletion 178 (7.5) 162 (6.8) 0.40

Renal adverse event 153 (6.5) 170 (7.2) 0.36

Fracture 49 (2.1) 50 (2.1) 1.00

Amputation 13 (0.5) 12 (0.5) 1.00

Major hypoglycemia 4 (0.2) 4 (0.2) NA

Diabetic ketoacidosis 3 (0.1) 0 NA

Fournier’s gangrene 0 1 (<0.1) NA


Laboratory / Other Measures

Change from baseline to 8 mo. follow-up

Dapagliflozin n=2,368

Placebon=2,368

Hazard / Rate Ratio / Difference (95% CI)

P Value

HbA1c (%) -0.21 ± 1.14 0.04 ± 1.29 -0.24 (-0.34 to -0.13) <0.001

SCr (mg/dL) 0.07 ± 0.24 0.04 ± 0.25 0.02 (0.01 to 0.03) <0.007

Hematocrit (%) 2.31 ± 3.90 -0.19 ± 3.81 2.41 (2.21 to 2.62) <0.001

NT-proBNP (pg/mL) -196 ± 2387 101 ± 2944 -303 (-457 to -150) <0.001

Weight (kg) -0.88 ± 3.86 0.10 ± 4.09 -0.87 (-1.11 to -0.62) <0.001

SBP (mmHg) -1.9 ± 14.92 -0.38 ± 15.27 -1.27 (-2.09 to -0.45) 0.002


Strengths

• Gold-standard trial design

• Meaningful endpoints

• Well-balanced groups

• Meaningful safety endpoints

• Appropriate duration

• Pre-specified sub-analyses

Criticisms

• Small Black / Hispanic representation

• Few elderly subjects

• Only 14% North American subjects

• Use of sacubitril/valsartan low

Study Conclusions

Dapagliflozin significantly reduced worsening HF and CV death

Dapagliflozin had similar safety and tolerability profile to placebo

No worsening renal function

Lower risk of all-cause death

Similar findings in subjects with or without T2DM

Dapagliflozin / SGLT2-i Place in Therapy?

• Recommend as first-line therapy for T2DM in HF patients (with or without metformin)

• Consider as additional therapy in HFrEF in addition to GDMT

• Unanswered questions• Only 10% of patients with ARNI – Safe/effective in combination?• Majority of patients with moderate heart failure – Safe/effective in severe?

Mild?• Unknown doses of HF meds – Titrate current HF meds vs add additional?• Safe in patients with lower blood pressure?• Will FDA grant new indication?• Will 3rd party payers cover therapy?

Future Directions?

• Third party coverage

• Pharmacoeconomic analysis of dapagliflozin in HFrEF patients

• Other studies• 2020 EMPORER-Reduced: Empagliflozin in HFrEF (with or without diabetes)

• 2020 EMPORER-Preserved: Empagliflozin in HFpEF (with or without diabetes)

• 2021 SOLOIST-WHF: Sotagliflozin in HF patients with diabetes

• 2021 DELIVER: Dapagliflozin in HFpEF (with or without diabetes)

https://clinicaltrials.gov/ct2/show/NCT03057951: Accessed 10/11/2019https://clinicaltrials.gov/ct2/show/NCT03057977: Accessed 10/11/2019https://clinicaltrials.gov/ct2/show/NCT03521934: Accessed 10/11/2019https://clinicaltrials.gov/ct2/show/NCT03619213: Accessed 10/11/2019

https://clinicaltrials.gov/ct2/show/NCT03057951




Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction (DAPA-HF)

Wilson D. Pace, PharmDPGY2 Cardiology Resident, Intermountain Healthcare

[email protected]

Questions?

Presenter Bio

• Dr. Hetal Patel is a PGY2 Cardiology Pharmacy Resident at AdventHealth Orlando in Orlando, Florida, where she also completed her PGY1 Pharmacy Residency. She graduated from Nova Southeastern University in West Palm Beach, Florida. Her current practice interests include advanced heart failure, cardiac transplant and cardiothoracic surgery. After residency, Dr. Patel plans to pursue a position as a cardiology clinical pharmacist at an academic medical center or a tertiary community hospital.

Presenter Bio

• Dr. Kimberly San Agustin is a PGY2 Cardiology Pharmacy Resident at AdventHealth Orlando in Orlando, Florida. She graduated from the University of California, San Diego Skaggs School of Pharmacy and completed her PGY1 Pharmacy Residency at the University of Arizona/Banner - University Medical Center Tucson. Her current practice interests include cardiac transplant, electrophysiology, and mechanical circulatory support. After residency, Dr. San Agustin plans to pursue a position as a cardiology clinical pharmacist at an academic medical center.

Angiotensin-neprilysin inhibition in heart failure with preserved

ejection fraction (PARAGON-HF)

Berwanger O, et al. JAMA Cardiol. 2018;3(5):391-399.

Hetal Petal, PharmDPGY2 Cardiology Pharmacy Resident at

AdventHealth Orlando

Kimberly San Agustin, PharmDPGY2 Cardiology Pharmacy Resident at

AdventHealth Orlando

Disclosure statement

• Hetal Patel has no conflicts of interest to disclose

• Kimberly San Agustin has no conflicts of interest to disclose

Background

Diagnosis of HFpEF

2013 ACCF/AHA HF guidelines 2016 ESC HF guidelines

• Symptoms ± Signs • Symptoms ± Signs

• LVEF ≥ 50% • LVEF ≥ 50%

• Elevated levels of natriuretic peptides

• At least one additional criteria:

• Relevant structural heart disease (LVH and/or LAE)

• Diastolic dysfunctionJACC 2013;62(16):1495-1539.EHJ 2016;37:2129-2200.

HFpEF trials

Trial Drug Population Findings

CHARM-Preserved

CandesartanHFpEF EF≥40%, NYHA class II-IV

Candesartan did not reduce mortality but did reduce HF hospitalizations

SENIORS NebivololHF (~35% had EF > 35%)

Nebivolol reduced mortality and CV hospitalizations irrespective of EF

PEP-CHF PerindoprilDiastolic HF (EF >50%)

Improved symptoms, exercise capacity, and fewer hospitalizations with perindopril

TOPCAT Spironolactone HFpEF EF≥45%Spironolactone did not reduce mortality but the rate of HF hospitalizations was lower

TOPCAT post-hoc analysis

Spironolactone HFpEF EF≥45%Possible clinical benefits with spironolactone in patients from Americas

Lancet. 2003; 362:777-81.Eur Heart J. 2005;26(3):215-25.Eur Heart J. 2006;27:2338-2345.

N Engl J Med. 2014; 370:1383-92.Circulation. 2015;131:34-42.

PARAMOUNT trial, 2012

• Double blind parallel group multicenter phase II trial

• Population: HFpEF (EF≥ 45%, NYHA Class II-III)

• Intervention: LCZ696 titrated to 200 mg twice daily or valsartan titrated to 160 mg twice daily (Follow up: 36 weeks)

• Findings: LCZ696 reduced NT-proBNP to a greater extent than did valsartan at 12 weeks and was well tolerated.

Lancet 2012; 380: 1387–1395.

Study Objective:

To test whether sacubitril-valsartan would result in a lower rate of a composite outcome of total hospitalizations for heart failure and death from

cardiovascular causes compared to valsartan

Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction

PARAGON HF trial

Published on September 1, 2019, at NEJM.org. DOI: 10.1056/NEJMoa1908655

Study population

Study design: Randomized, double-blind, active-comparator trial

• Inclusion:

• Age 50+

• Signs/symptoms of heart failure

• NYHA II to IV

• EF ≥45% in past 6 months

• Elevated natriuretic peptides

• Evidence of structural heart disease

• Diuretic therapy

• Exclusion:

• EF <40%

• SCr > 5.2 mEq/l

• ACS, cardiac surgery, PCI in past 3 months

• Any event within 6 months prior to visit that would have reduced EF

• Liver, kidney, artery or valvular disease


Study Procedure

• Valsartan 40mg or 80mg BID

• 40mg to 80mg in 1 week

• N=5,746

Single blind run -in phase 1

(1-2 weeks)**

• Sacubitril/ valsartan 49/51mg BID

• N=5,205

Single blind run -in phase 2

(2-4 weeks)**• Sacubitril/ valsartan

97/103mg BID or valsartan 160mg BID

• N=4,822

Randomized 1:1 to double blind

treatment**

** All background medications except RAAS inhibitors continued


N=4,822

Sacubitril-valsartan

97/103mg BID

N=2407

Valsartan 160mg BID

N=2389

• Power: 1847 primary events for 95% power to detect 22% lower rate in sacubitril-valsartan group and 80% power to detect overall 19% lower rate

• Intention to treat analysis

Randomization Statistics


Study Outcomes

• Primary endpoint: composite of total hospitalizations for heart failure + death from cardiovascular causes

• Secondary endpoints:

• Change from baseline to 8 months in:

• Clinical summary score on KCCQ

• NYHA class

• First occurrence of decline in renal function

• Death from any cause

• Safety endpoints: hypotension, renal dysfunction, hyperkalemia, angioedema


Results

Baseline characteristics

• NYHA Class II >>> III > I > IV

• On other heart failure therapies

• Slight differences:

• Mineralocorticoid-receptor antagonist use

• Ischemic causes of heart failure

Median duration of follow-up: 35 months


Results – Primary Endpoint

Primary composite endpoint

Sacubitril-valsartan(N = 2407)

Valsartan(N = 2389)

Ratio or Difference(95% CI)

Total hospitalizations for heart failure and death from cardiovascular causes

894 1009P=0.06

RR 0.87 (0.75-1.01)

Total hospitalizations for heart failure

690 797 RR 0.85 (0.72-1.00)

Death from cardiovascular causes

204 (8.5%) 212 (8.9%) HR 0.95 (0.79-1.16)


Results – Secondary Endpoints

Secondary endpointsSacubitril-valsartan

(N = 2407)Valsartan(N = 2389)

Ratio or Difference(95% CI)

Change in NYHA class OR 1.45 (1.13-1.86)

Improved 347 (15%) 289 (12.6%)

Unchanged 1767 (76.3%) 1792 (77.8%)

Worsened 202 (8.7%) 221 (9.6%)

Change in KCCQ Clinical Summary Score

-1.6±0.4 -2.6±0.4 Difference 1.0 (0.0-2.1)

Renal composite outcome 33 (1.4%) 64 (2.7%) HR 0.50 (0.33-0.77)

Death from any cause 342 (14.2%) 349 (14.6%) HR 0.97 (0.84-1.13)


Results – Safety Endpoints

Adverse EventSacubitril-valsartan

(N = 2407)Valsartan(N = 2389)

P-Value

Hypotension (SBP <100 mmHg) 15.8% 10.8% <0.001

Elevated SCr

≥2.0 mg/dL 10.8% 13.7% 0.002

≥2.5 mg/dL 4.0% 4.6% NS

≥3.0 mg/dL 1.6% 1.7% NS

Elevated serum K

≥5.5 mmol/L 13.2% 15.3% 0.048

>6.0 mmol/L 3.1% 4.3% 0.04

Angioedema 0.6% 0.2% 0.02

Liver-related AE 6.3% 7.5% NS


Results – Subgroup Analysis

Subgroup Rate Ratio 95% CI

Sex

Male 1.03 0.85-1.25

Female 0.73 0.59-0.90

Left ventricular ejection fraction

≤Median (57%) 0.78 0.64-0.95

>Median (57%) 1.00 0.81-1.23

All subgroup analyses in favor of sacubitril-valsartan


Conclusions

• No significant difference in primary composite outcome

• Trend towards fewer hospitalizations with sacubitril-valsartan

• Adverse effects

• Sacubitril-valsartan: hypotension, angioedema

• Valsartan: hyperkalemia, elevated SCr

• Greater benefit of sacubitril-valsartan in:

• Ejection fraction <57%

• Women


Discussion

Lancet. 2003; 362:777-81.N Engl J Med. 2014; 370:1383-92.Circulation. 2015;131:34-42.

Strengths Limitations

Proportion of female patients Proportion of black patients

Definition of HFpEF Lack of placebo control group

NYHA Class Rate of discontinuation of study drug

Run-in period

Practice Implications

Defining HFpEF

• Ejection fraction cutoffs

• Pathophysiology

Females with HFpEF

• Further research

• Therapy considerations


Acknowledgements

Journal Club Mentors

Vicki Groo, PharmD

• Clinical Pharmacist Cardiology І Clinical Associate Professor

• Colleges of Pharmacy and Medicine, University of Illinois, Chicago

Kyle Thorner, PharmD, BCPS

• Cardiology Pharmacy Clinical Specialist

• AdventHealth-Heart Success Center І AdventHealth Orlando, Orlando

ACCP Cardiology PRN Journal Club Coordinator

Ashley Kasper, PharmD

• Cardiology Clinical Specialist

• Department of Pharmacy І Cleveland Clinic

Angiotensin-neprilysin inhibition in heart failure with preserved ejection fraction (PARAGON-HF)

Hetal Petal, PharmDPGY2 Cardiology Pharmacy Resident at

AdventHealth [email protected]

Kimberly San Agustin, PharmDPGY2 Cardiology Pharmacy Resident at

AdventHealth [email protected]

Questions?

mailto:[email protected]

mailto:[email protected]

November Journal Club

• Presentations by PGY2 Cardiology Pharmacy Residents from UPMC Presbyterian Shadyside and UMass Memorial Medical Center

• November 18th at 3:00 PM EST (tentatively)

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