Bayer’s Riociguat showed statistically significant results in patients of Pulmonary Arterial Hypertension
Riociguat pill, an experimental drug by Bayer HealthCare, has shown promising results against the life-threatening form of high blood pressure in the lungs.
This drug showed better results in patients suffering from pulmonary arterial hypertension (PAH), a gradually deteriorating condition that can overstrain the heart, in the Phase-III trial to improve heart function and better tolerate physical exercise. PAH affects only 52 in a million people in the world and its cause is still unknown.
Researchers worked on 443 participants and checked how far they could walk in six minutes before and after 12 weeks of three-times-daily riociguat or a placebo pill. Bayer said that the patients who took riociguat showed improvement in walking distance by 36 meters on average as compared to the control group which showed no improvement from an initial 330-350 meters. Patients talking the trial medicine also showed improved cardiovascular readings.
“The improvements were not limited to treatment naïve patients receiving riociguat monotherapy, but were also statistically significant for those who received combination treatment with an endothelin receptor antagonist or a non-iv prostanoid.” said Professor Ardeschir Ghofrani, University Hospital Giessen and Marburg, Germany and Principal Investigator of the PATENT study.
Bayer reported that the side effects included headache, dizziness, swollen limbs and nausea that are well tolerated overall.
The results will be presented at this week’s annual meeting of the American College of Chest Physicians (ACCP) in Atlanta.
Bayer has planned to apply for the marketing approval of riociguat in the United States, the European Union and Japan simultaneously in the first part of the next year while the market launch would take place in the mid-2014.
“We are optimistic about the potential of riociguat to add a much needed treatment option for PAH,” said Kemal Malik, member of the Bayer HealthCare Executive Committee and Head of Global Development.
This drug is thought to pose a greater challenge to the treatments presented by Actelion and Gilead.