Riociguat (Adempas) for the treatment of chronic thromboembolic pulmonary hypertension (high blood pressure)

Introduction

Riociguat (trade name: Adempas) has been approved in Germany since March 2014 for the treatment of pulmonary hypertension (high blood pressure) in adults. It can be used alone or in combination with other blood-pressure-lowering (antihypertensive) medications.

The right side of the heart pumps blood that is low in oxygen through the pulmonary artery into the lungs. The blood picks up oxygen in the lungs and then travels through the pulmonary vein to the left side of the heart. From there, oxygen-rich blood is pumped into the body. This part of the blood circulatory system is called pulmonary circulation. In chronic thromboembolic pulmonary hypertension (CTEPH), the pulmonary (lung) vessels are narrowed, increasing the blood pressure within the pulmonary circulation. This makes it harder for the heart to pump blood through the lungs. As a result, there is more strain on the heart, less oxygen is absorbed by the lungs, and too little oxygen reaches the body. CTEPH may occur if people have frequently recurring pulmonary embolisms and the blood clots don't fully dissolve, causing the pulmonary vessels to become narrower.

CTEPH has four stages:

  • Stage 1: Patients have an increased pulmonary blood pressure, but have no symptoms during normal physical activity.
  • Stage II: During physical activity, patients have symptoms such as trouble breathing, , chest pain or feeling faint. These symptoms stop when resting.
  • Stage III: Even light physical activity causes severe symptoms, but there are no symptoms at rest.
  • Stage IV: Symptoms occur even at rest and physical activity is severely limited. There is also a risk of heart failure.

Riociguat is a treatment option for people with functional class II or III CTEPH. The drug aims to widen the blood vessels and decrease the strain on the heart.

Application

Riociguat is available in tablet form, in doses of 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg. Riociguat is taken three times a day. Depending on the blood pressure, the daily dose is gradually increased to 7.5 mg at the most.

Other treatments

The standard treatment for CTEPH is best supportive care (BSC). This treatment should be tailored to the patient’s individual needs, relieve symptoms such as pain, and improve their quality of life.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of riociguat compared to the standard treatments for CTEPH.

But the manufacturer didn’t provide any suitable data with which to do the assessment.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of riociguat (Adempas).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Riociguat (CTEPH) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-30. June 10, 2020. (IQWiG reports; Volume 928).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on July 2, 2020
Next planned update: 2023

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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