Adempas in CTEPH therapy

  • ADEMPAS demonstrated efficacy for patients with:
    • Persistent/recurrent CTEPH post-PEA
    • Inoperable CTEPH
  • ADEMPAS has demonstrated improvement in end points such as WHO FC, exercise capacity (as measured by 6MWD), and selected hemodynamic parameters

Set goals for your CTEPH patients

Ghofrani et al. N Engl J Med. 2013;369(4):319–329.

6MWD, 6-minute walk distance

CTEPH, chronic thromboembolic pulmonary hypertension

PEA, pulmonary endarterectomy

WHO FC, World Health Organization functional class


adempas package

Baseline to End of Week 16 in Selected End Pointsa


Adempas was studied in a multicenter, double blind, randomized, placebo-controlled study of 261 patients with inoperable CTEPH (independently assessed) or persisting/recurring PH after PEA called CHEST-1.

Select results are presented below.

adempas package

Adapted from CHEST-1: Ghofrani et al., N Engl J Med.. 2013;369(4):319-328

aPlus-minus values are means ±SD. The changes from baseline to the end of week 16 are arithmetic means. The leastsquares mean difference was calculated by analysis of covariance for the change from baseline to the last visit. NTproBNP denotes N-terminal pro-brain natriuretic peptide, and Pao2 partial pressure of arterial oxygen.

bP values were calculated with use of the stratified Wilcoxon test for the change from baseline to the last visit.

cThe primary end point was analyzed in the modified intention-to-treat population as the change from baseline to the last observed value (not including follow-up) among patients who completed the study or withdrew; the worst value (0m) was imputed in the case of death or clinical worsening without a termination visit or without a measurement at thetermination visit.

dThe change in the WHO functional class was analyzed with the use of a stratified Wilcoxon test.


CHEST-1 Study Design

Multicenter, double-blind, randomized, placebo-controlled study of 261 patients with inoperable CTEPH (independently assessed) or persisting/recurrent PH after PEA. Study involved 89 centers across 26 countries in Europe, South America, North America, Asia, and Australia. Of 261 randomized patients

who received at least one dose of study drug, 88 were assigned to placebo and 173 were assigned to ADEMPAS® (riociguat) 2.5 mg tid daily. Patients were individually titrated up to 2.5 mg tid based upon blood pressure response and signs or symptoms of hypotension. The primary end point in this

study was the change from baseline in the 6MWD at the end of week 16. Those completing the study without ongoing study drug-related serious adverse events were given the option to enroll in a long-term extension study, CHEST-2.

6MWD, 6-minute walk distance

CTEPH, chronic thromboembolic pulmonary hypertension

NT-proBNP, n-terminal prohormone of brain natriuretic peptide

PEA, pulmonary endarterectomy

PH, pulmonary hypertension

WHO, World Health Organization

Baseline data from CHEST-1

adempas

Ghofrani et al. N Engl J Med. 2013;369(4):319–329.

6MWD, 6-minute walk distance

CO, cardiac output

CTEPH, chronic thromboembolic pulmonary hypertension

NT-proBNP, n-terminal prohormone of brain natriuretic peptide

PAP, pulmonary arterial pressure

PVR, pulmonary vascular resistance

Assessment Resultsa

adempas

Safety

Ghofrani et al. N Engl J Med. 2013;369(4):319-329.


SSI


ADEMPAS® (riociguat) antihypertensiva medel för pulmonell arteriell hypertension, (Rx (F); SPC 02/2019), tabletter 0,5mg, 1,0 mg, 1,5 mg, 2,0 mg, 2,5 mg.

Indikationer:

  • Kronisk tromboembolisk pulmonell hypertension (CTEPH) - Vuxna med WHO funktionsklass II till III med inoperabel CTEPH, kvarstående eller återkommande CTEPH efter kirurgisk behandling.
  • Pulmonell arteriell hypertension (PAH) - Som monoterapi eller i kombination med endotelinreceptorantagonister, hos vuxna patienter med PAH med WHO funktionsklass II till III, för att förbättra fysisk arbetsförmåga. Effekt har visats hos en PAH-population, som inkluderade etiologier av idiopatisk eller hereditär PAH eller PAH associerad med bindvävssjukdom

Kontraindikationer:

Samtidig administrering med PDE-5-hämmare (såsom sildenafil, tadalafil, vardenafil). Gravt nedsatt leverfunktion (Child-Pugh C). Överkänslighet mot den aktiva substansen eller mot något hjälpämne. Samtidig administrering med alla former av nitrater och kväveoxidgivare (såsom amylnitrit) inklusive partydroger, så kallade ”poppers”. Patienter med systoliskt blodtryck <95 mmHg vid behandlingsstart. Graviditet. Patienter med pulmonell hypertension associerad med idiopatiska interstitiella pneumonier (PH-IIP).

Fertilitet, Graviditet, Amning:
Fertilitet: Fertila kvinnor måste använda effektiv preventivmetod under behandling med ADEMPAS.
Graviditet: ADEMPAS är kontraindicerat under graviditet.
Amning: Amning ska avbrytas under behandling med ADEMPAS.
Villkor för subvention: ADEMPAS Subventioneras vid behandling av inoperabel eller återkommande CTEPH. Subventioneras även vid behandling av PAH till patienter där sildenafil eller tadalafil inte haft tillräcklig effekt.
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INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING: Bayer AG, 513 68 Leverkusen,

Tyskland

SE-ADE-00005