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EFFICACY + SAFETY RESULTS

Set goals for your adult patients with inoperable and persistent/recurrent CTEPH (WHO Group 4). Consider Adempas.

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:

efficacy checkmark

EXERCISE CAPACITY

(as measured by 6MWD)

efficacy checkmark

WHO FUNCTIONAL CLASS

efficacy checkmark

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
baseline icon

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

treatment icon

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)

dosing icon

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
*PEA, also known as pulmonary thromboendarterectomy (PTE).

Exercise Capacity (6MWD)

ADEMPAS SIGNIFICANTLY IMPROVED 6MWD AT WEEK 161

RESULTS IN CTEPH: 6MWD OVER 16 WEEKS

Line graph

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 CTEPH (WHO Group 4).

Patient Subgroups

CTEPH PATIENTS WALKED FARTHER WITH ADEMPAS1

PRESPECIFIED SUBGROUP: MEAN CHANGE FROM BASELINE

Hemodynamics (PVR and NT-proBNP)

ADEMPAS IMPROVED PVR AND NT-proBNP AT WEEK 161,2‡

CTEPH CLINICAL STUDY POPULATION AT WEEK 16

Hemodynamics

Right-heart catheterization was performed at the beginning and end of the study period in 233 patients.

Adempas, n=173; placebo, n=88

WHO Functional Class Improvement

50% MORE PATIENTS IMPROVED WHO FUNCTIONAL CLASS VS PLACEBO1

CHANGE IN WHO FUNCTIONAL CLASS IN THE 16-WEEK TRIAL

WHO

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)

Long-Term Data

MORE THAN 90% OF ADEMPAS PATIENTS SURVIVED AT 2 YEARS1

PROBABILITY OF SURVIVAL DATA FOR CTEPH PATIENTS

Long term data

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.

Most Common Adverse Events

ADVERSE REACTIONS, FROM POOLED DATA

Advertse Event

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
Pill bottle

Help your patients take Adempas properly.

Learn more here.

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EFFICACY + SAFETY RESULTS

Set goals for your adult patients with inoperable and persistent/recurrent CTEPH (WHO Group 4). Consider Adempas.

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:

efficacy checkmark

EXERCISE CAPACITY

(as measured by 6MWD)

efficacy checkmark

WHO FUNCTIONAL CLASS

efficacy checkmark

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
baseline icon

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

treatment icon

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)

dosing icon

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 (6MWD)
    ADEMPAS SIGNIFICANTLY IMPROVED 6MWD AT WEEK 161
    RESULTS IN CTEPH: 6MWD OVER 16 WEEKS
    Line graph Mobile

    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).

    Patient Subgroups
    CTEPH PATIENTS WALKED FARTHER WITH ADEMPAS1
    PRESPECIFIED SUBGROUP:
    MEAN CHANGE FROM BASELINE
    Hemodynamics (PVR and NT-proBNP)
    ADEMPAS IMPROVED PVR AND NT-proBNP AT WEEK 161,2‡
    CTEPH CLINICAL STUDY
    POPULATION AT WEEK 16
    Hemodynamics Mobile

    Right-heart catheterization was performed at the beginning and end of the study period in 233 patients.

    Adempas, n=173; placebo, n=88

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

    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)

    Long-Term Data
    MORE THAN 90% OF ADEMPAS PATIENTS SURVIVED AT 2 YEARS1
    PROBABILITY OF SURVIVAL
    DATA FOR CTEPH PATIENTS
    Long term data Mobile

    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.

    Most Common Adverse Events
    ADVERSE REACTIONS, FROM POOLED DATA
    Advertse Event Mobile

    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
    Pill bottle

    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., 2021.
    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.