IF YOUR PATIENTS AREN’T AT GOAL, CONSIDER ADEMPAS

Adempas demonstrated efficacy for PAH adult patients in both WHO functional class II and III by 4 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)

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DELAYED TIME TO
CLINICAL WORSENING*

*Time to clinical worsening was a combined endpoint defined as death (all-cause mortality), heart/lung transplantation, atrial septostomy, hospitalization due to persistent worsening of pulmonary hypertension, start of new PAH-specific treatment, persistent decrease in 6-minute walk distance (6MWD) and persistent worsening of WHO functional class.

NT-proBNP=N-terminal pro-brain natriuretic peptide; PVR=pulmonary vascular resistance

PATENT-1 STUDY DESIGN1,2

Pulmonary Arterial Hypertension Soluble Guanylate Cyclase–Stimulator Trial 1 (PATENT-1)
was a randomized, double-blind, multinational, multicenter, placebo-controlled, 12-week phase 3 study.

Patient with PAH
Patient with PAH
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Baseline characteristics

Mean age: 51 years (~80% female)

PAH cause: Idiopathic (61%), familial (2%), associated with connective tissue disease (25%), congenital heart disease (8%), portal hypertension (3%), or anorexigen/amphetamine use (1%)

WHO functional class: II (42%); III (54%)

Mean 6MWD baseline: 363 m

Exclusions: Patients with SBP <95 mm Hg

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Treatment characteristics

Treatment status: Treatment-naïve (50%), pretreated with endothelin receptor antagonist (ERA) (44%), and pretreated with prostacyclin analog (PCA) (6%)

Pretreatment definition: On stable treatment for 3 months with an ERA or PCA; Adempas was combined with these therapies

Concomitant medications: Oral anticoagulants, diuretics, digitalis, calcium channel blockers, and oxygen were allowed

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Dosing characteristics

Initiation: 1 mg 3x a day

Groups: Adempas @ 2.5 mg 3x a day; Adempas @ 1.5 mg 3x a day; placebo

Titration: ~75% were titrated to 2.5 mg 3x a day by Week 12

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

 

FC=functional class; mPAP=mean pulmonary arterial pressure; SBP=systolic blood pressure

EXERCISE CAPACITY
Exercise Capacity (6MWD)
ADEMPAS SIGNIFICANTLY IMPROVED 6MWD AT WEEK 121
RESULTS IN PAH: 6MWD OVER 12 WEEKS
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36 m improvement (mean) in 6-minute walk distance (6MWD) over placebo at Week 12 (95% confidence interval (CI): 20 m-52 m; p<0.0001) for adults with PAH (WHO Group 1).

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PATIENT SUBGROUPS
Patient Subgroups
ADEMPAS CAN BE USED AS MONOTHERAPY AND IN COMBINATION WITH AN ERA OR PCA1,3
ADEMPAS DEMONSTRATED
IMPROMENTS IN 6MWD
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HEMODYNAMICS
Hemodynamics (PVR and NT-proBNP)
ADEMPAS IMPROVED PVR AND NT-proBNP AT WEEK 121,2*
PAH CLINICAL STUDY POPULATION
AT WEEK 12
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Right-heart catheterization was performed at the beginning and end of the study period in 339 patients.

Adempas, n=254; placebo, n=126

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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 12-WEEK TRIAL
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Deteriorated:

4% for Adempas (n=9/254)
14% for placebo (n=18/125)

Stable:

76% for Adempas (n=192/254)
71% for placebo (n=89/125)

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CLINICAL WORSENING
Clinical Worsening
ADEMPAS SIGNIFICANTLY DELAYS TIME TO CLINICAL WORSENING1
TIME TO CLINICAL WORSENING
WITHIN 12 WEEKS
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Time to clinical worsening was a combined endpoint defined as death (all-cause mortality), heart/lung transplantation, atrial septostomy, hospitalization due to persistent worsening of pulmonary hypertension, start of new PAH-specific treatment, persistent decrease in 6MWD and persistent worsening of WHO functional class.

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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 PAH PATIENTS
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An open-label extension PATENT-2 study included 396 patients who had completed PATENT-1. At the cut-off date in the PATENT-2 study, the mean treatment duration for the total population was 1146 days (±479). Without a control group, these data must be interpreted cautiously.

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ADVERSE EVENTS
Most Common Adverse Events
ADVERSE REACTIONS, FROM POOLED DATA1†
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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, Galiè N, Grimminger F, et al. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013;369(4):330-340.
  3. Data on file, 2018. Bayer.

Efficacy PAH