Phase IV Trial Data for Pulmonary Arterial Hypertension Drug Now Available

According to a story from, the pharmaceutical company Bayer has recently announced the release of results from its phase IV trial. This trial evaluated the effects of the drug riociguat (marketed as Adempas®) for people living with intermediate risk pulmonary arterial hypertension (PAH). These patients had transitioned to the drug after seeing an insufficient response to treatment with PDE5i therapy.

About Pulmonary Arterial Hypertension

Pulmonary arterial hypertension is a condition in which the blood pressure in the arteries of the lungs is abnormally high. The cause of pulmonary arterial hypertension is often unknown in many cases. However, there are a variety of potential causes, such as certain heritable genetic mutations, exposure to certain toxins, and drug use (ex. methamphetamine). It can also appear as a symptom or complication in a number of other diseases, such as heart disease, connective tissue disease, and infection with HIV. The arteries in the lungs are often inflamed. Symptoms of this condition include rapid heartbeat, poor exercise tolerance, shortness of breath, fainting, leg swelling, fatigue, and chest pain. Treatment may include a number of medications and surgical operations, including lung transplant. A transplant can cure the condition, but it can cause many complications. Survival rate is often only about two or three years without treatment, but the latest drugs can prolong life by several years or more. Click here to learn more about pulmonary arterial hypertension.

About The Trial

The study included a total of 226 patients, lasted for 24 weeks, and included 81 total trial sites in 22 different countries. The primary endpoint in this trial was clinical improvement by the end of the study in the absence of clinical worsening, and 41 percent of patients that received Adempas achieved this endpoint, compared to just 20 percent of the placebo group. Overall, the study reaffirmed the efficacy of the drug for these patients, while seeing no changes to the safety profile demonstrated in earlier trials.

About Phase IV Clinical Trials

Phase IV trials are conducted after a drug has been approved for market use. Also called a postmarketing surveillance trial, these studies are meant to continue monitoring technical support and the safety profile of the therapy. Adempas was first approved in 2013; new drugs are often surveilled for several years after their approval in phase IV studies. These trials can monitor long term impacts of a drug and other aspects not covered in other types of trials, such as cost effectiveness of quality of life impacts. 

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