ADEMPAS DELIVERS SIGNIFICANT IMPROVEMENTS ACROSS 4 CRITICAL PARAMETERS1
exercise-capacity
Improvement in 6MWD
who-fc
Improvement in WHO FC
clinical-worsening
Improvement in time to clinical worsening*
hemodynamics
Improvement in PVR and NT-proBNP

6MWD = 6-minute walking distance; NT-proBNP = n-terminal prohormone of brain natriuretic peptide; PVR = pulmonary vascular resistance; WHO FC = World Health Organization Functional Class.

*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 FC.

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.

Patients with PAH
Patients with PAH - Mobile
Base Line
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 FC: II (42%); III (54%)

Mean 6MWD baseline: 363 m

Exclusions: Patients with SBP <95 mm Hg

Treatment
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

DOSING CHARACTERISTICS
DOSING CHARACTERISTICS

Initiation: 1 mg 3x daily

Groups: Adempas at 2.5 mg 3x daily; Adempas at 1.5 mg 3x daily; placebo

Titration: ~75% were titrated to 2.5 mg 3x daily 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 (6MWD)
START WITH A TREATMENT THAT SHOWED EARLY IMPROVEMENT IN EXERCISE CAPACITY AND SIGNIFICANT RESULTS AT WEEK 121

Improvement in 6MWD was observed at 2 weeks and continued through 12 weeks1

SIGNIFICANT IMPROVEMENT IN 6MWD AT WEEK 121
EXERCISE CAPACITY
PATIENT SUBGROUPS
START WITH ADEMPAS FOR PROVEN RESULTS ALONE OR IN COMBINATION WITH AN ERA OR PCA1

Adempas demonstrated improvements in 6MWD

  • As monotherapy
  • In combination with ERAs
  • In combination with PCAs

 

6MWD AT WEEK 12 BASED ON PATIENT CHARACTERISTIC1
PATIENT SUBGROUPS
WHO FUNCTIONAL CLASS (FC) IMPROVEMENT
START WITH A TREATMENT THAT PROVIDED STRONG IMPROVEMENT IN WHO FC1

50% more patients improved WHO FC vs placebo1

CHANGE IN WHO FC IN THE 12-WEEK PATENT-1 STUDY1
WHO FC IMPROVEMENT
CLINICAL WORSENING
START WITH A TREATMENT THAT SIGNIFICANTLY DELAYED TIME TO CLINICAL WORSENING1*
CLINICAL WORSENING
ADEMPAS SIGNIFICANTLY REDUCED EVENTS ASSOCIATED WITH CLINICAL WORSENING1*

In just 12 weeks, patients receiving Adempas demonstrated significantly fewer events of clinical worsening than those receiving placebo*†‡

ANY CLINICAL WORSENING EVENT*†‡
clinical worsening
HEMODYNAMICS (PVR AND NT-proBNP)
START WITH A TREATMENT THAT DELIVERED STRONG IMPROVEMENTS IN PVR AND NT-proBNP1
HEMODYNAMICS
LONG-TERM DATA
MORE THAN 90% OF ADEMPAS PATIENTS SURVIVED AT 2 YEARS1
probability of survival
MOST COMMON ADVERSE EVENTS
ADVERSE REACTIONS (FROM POOLED DATA)1||
ADVERSE EVENTS

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

 

dosage

LEARN ABOUT PERSONALIZED DOSING FOR YOUR PATIENTS

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. Galiè N, Humbert M, Vachiery JL, et al; ESC Scientific Document Group. 2015 ESC/ERS guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2016;37(1):67-119.

  4. McLaughlin VV, Gaine SP, Howard LS, et al. Treatment goals of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25):D73-D81.

 

Efficacy pah