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

Introduction

Riociguat (trade name: Adempas) has been approved in Germany since March 2014 for the treatment of pulmonary arterial hypertension (high blood pressure) in adults. This drug 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 pulmonary arterial hypertension, 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. This type of high blood pressure is usually caused by another heart or lung condition.

There are four stages of pulmonary arterial hypertension (PAH), described by the WHO as "functional classes":

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

Riociguat is an option for people with functional class II or III pulmonary arterial hypertension. The drug aims to widen the blood vessels, decrease the strain on the heart and improve physical performance.

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 pulmonary arterial hypertension depends on what medications have already been used as treatment, among other things. It is individually adjusted by the doctor.

Assessment

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of riociguat compared with the standard treatments for pulmonary arterial hypertension.

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 (pulmonary arterial hypertension) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A20-31. June 10, 2020. (IQWiG reports; Volume 929).

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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