IF YOUR PATIENTS AREN’T AT GOAL, CONSIDER ADEMPAS

Adempas demonstrated efficacy for CTEPH adult patients in both WHO functional class II and III by 3 parameters1:

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EXERCISE CAPACITY

(as measured by 6MWD)

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WHO FUNCTIONAL CLASS
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HEMODYNAMICS

(PVR, NT-proBNP)

6MWD=6-minute walk distance; CTEPH=chronic thromboembolic pulmonary hypertension; NT-proBNP=N-terminal pro-brain natriuretic peptide; PVR=pulmonary vascular resistance; WHO=World Health Organization

CHEST STUDY DESIGN1,2

Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase–Stimulator Trial 1 (CHEST-1) was a randomized, double-blind, multinational, multicenter, placebo-controlled, 16-week phase 3 study.

CTPEH Case
CTPEH Case
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BASELINE CHARACTERISTICS

Mean age: 59 years (range: 18-80)

CTEPH: Inoperable for PEA* with PVR >300 dyn-sec-cm-5, mPAP >25 mm Hg measured at least 90 days after the start of full anticoagulation, or recurrent/persisting PH with PVR >300 dyn-sec-cm-5 measured at least 180 days following PEA

Type of CTEPH: Inoperable (72%), recurrent or persisting PH following PEA (28%)

WHO functional class: II (31%); III (64%)

Mean 6MWD baseline: 347 m

Exclusions: Patients with SBP <95 mm Hg

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TREATMENT CHARACTERISTICS

Concomitant medications: Stable dosages of oral anticoagulants, diuretics, digitalis, calcium channel blockers, and oxygen were allowed, but not NO donors, ERAs, PCAs, specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil), and nonspecific PDE inhibitors (for example, dipyridamole or theophylline)

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Dosing characteristics

Initiation: 1 mg 3x a day

Groups: Adempas @ 2.5 mg 3x a day; Adempas @ 1 mg 3x a day; placebo

Titration: 77% were titrated to 2.5 mg 3x day by Week 16

Adempas titrated every 2 weeks based on SBP and signs and symptoms of hypotension

ERA=endothelin receptor antagonist; FC=functional class; mPAP=mean pulmonary arterial pressure; NO=nitric oxide; PCA=prostacyclin analog; PDE-5=phosphodiesterase type 5; PH=pulmonary hypertension; SBP=systolic blood pressure

EXERCISE CAPACITY
Exercise Capacity (6MWD)
ADEMPAS SIGNIFICANTLY IMPROVED 6MWD AT WEEK 161
RESULTS IN CTEPH: 6MWD OVER 16 WEEKS
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46 m improvement (mean) in 6-minute walk distance (6MWD) over placebo at Week 16 (95% confidence interval (CI): 25 m-67 m; p<0.0001) for adults with CTPH (WHO Group 4).

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PATIENT SUBGROUPS
Patient Subgroups
CTEPH PATIENTS WALKED FARTHER WITH ADEMPAS1
PRESPECIFIED SUBGROUP:
MEAN CHANGE FROM BASELINE
cteph prescribed subgroup
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HEMODYNAMICS
Hemodynamics (PVR and NT-proBNP)
ADEMPAS IMPROVED PVR AND NT-proBNP AT WEEK 161,2‡
CTEPH CLINICAL STUDY
POPULATION AT WEEK 16
Hemodynamics
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Right-heart catheterization was performed at the beginning and end of the study period in 233 patients.

Adempas, n=173; placebo, n=88

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WHO FC IMPROVEMENT
WHO Functional Class Improvement
50% MORE PATIENTS IMPROVED WHO FUNCTIONAL CLASS VS PLACEBO1
CHANGE IN WHO FUNCTIONAL CLASS
IN THE 16-WEEK TRIAL
WHO
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Deteriorated:

5% for Adempas (n=9/173)

7% for placebo (n=6/87)

Stable:

62% for Adempas (n=107/173)

78% for placebo (n=68/87)

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LONG-TERM DATA
Long-Term Data
MORE THAN 90% OF ADEMPAS PATIENTS SURVIVED AT 2 YEARS1
PROBABILITY OF SURVIVAL
DATA FOR CTEPH PATIENTS
Long term data
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An open-label extension CHEST-2 study included 237 patients who had completed CHEST-1. At the cut-off date in the CHEST-2 study, the mean treatment duration for the total population was 1077 days (±433). Without a control group, these data must be interpreted cautiously.

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ADVERSE EVENTS
Most Common Adverse Events
ADVERSE REACTIONS, FROM POOLED DATA
Advertse Event
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Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were:

  • Palpitations
  • Nasal congestion
  • Epistaxis
  • Dysphagia
  • Abdominal distention
  • Peripheral edema
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Help your patients take Adempas properly.

Learn more here.

MORE IMPORTANT SAFETY INFORMATION LESS IMPORTANT SAFETY INFORMATION
References:
  1. Adempas Prescribing Information. Whippany, NJ. Bayer Pharmaceuticals Inc., 2018.
  2. Ghofrani HA, D’Armini AM, Grimminger F, et al. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl Med. 2013;369(4):319-329.
  3. Data on file, 2018. Bayer.

Efficacy CTEPH