News | Hypertension | January 04, 2016

Positive Results for New Oral Drug for Pulmonary Hypertension

Largest study ever shows effectiveness of first orally available selective prostacyclin IP receptor agonist

January 4, 2016 — Living with pulmonary arterial hypertension (PH) is challenging, but the chore of treating the rare heart disease may change following promising clinical trial data published in the Dec. 24 issue of the New England Journal of Medicine.

Data from the largest study ever of pulmonary hypertension shows the oral medication Selexipag led to a 40 percent reduction in hospitalizations and worsening symptoms among patients with pulmonary hypertension.

Selexipag targets a well-known disease pathway that opens blood vessels to the lungs and improves heart function and is easier to use than PH treatments delivered with infusions or injections.

“For more than two decades we’ve targeted the prostacyclin pathway to induce vasodilation in these blood vessels in the lung,” said senior study author Vallerie McLaughlin, M.D., director of the University of Michigan Pulmonary Hypertension Program.

“But because of the cumbersome nature of treatment, patients would often wait until late stages to begin therapy. Having an oral medication to attack the disease pathway will be a major advancement because less ill patients will be willing to begin this therapy,” McLaughlin said.

Selexipag demonstrated effectiveness while its most frequent adverse events were headache, diarrhea, nausea, muscle pain and joint pain. The side effects were considered consistent with prostacyclin therapy.

The medication is not commercially available. Following the phase 3 clinical trial, the U.S. Food and Drug Administration is evaluating the drug.

Pulmonary hypertension, which is high blood pressure in the loop of blood vessels connecting the heart and lungs, can make everyday activities exhausting. It often leads to life-threatening heart failure as the heart works harder to pump blood to the lungs.

The greatest number of cases is reported in women between ages 21 and 40 who most often experience fatigue and shortness of breath.

While a rare disease, research of causes and treatment of pulmonary hypertension is growing. The GRIPHON study is a standout because of its size and scope, enrolling 1,156 patients with pulmonary hypertension from 181 centers from 39 countries in North and South America, Europe, Asia-Pacific and Africa.

Collaborators from the U.S. and Europe led the GRIPHON study, which was sponsored by Actelion Pharmaceuticals.

McLaughlin is a consultant to Actelion and served on the steering committee for the GRIPHON study.

For more information: www.med.umich.edu


Related Content

News | Cardiovascular Clinical Studies

October 14, 2022 — Heart Initiative, the sponsor of the STRONG-HF (Safety, Tolerability and efficacy of Rapid ...

Home October 14, 2022
Home
News | Cardiovascular Clinical Studies

October 11, 2022 — The preliminary results of the first-in-human (FIH) trials for the innovative ELANA Heart Bypass ...

Home October 11, 2022
Home
News | Cardiovascular Clinical Studies

October 4, 2022 — Lexicon Pharmaceuticals, Inc. announced that a new analysis of results from the SOLOIST-WHF Phase ...

Home October 04, 2022
Home
News | Cardiovascular Clinical Studies

September 8, 2022 — A clinical trial led by investigators from Brigham and Women’s Hospital has found that the long-term ...

Home September 08, 2022
Home
News | Cardiovascular Clinical Studies

August 17, 2022 — A study carried out by scientists at the Centro Nacional de Investigaciones Cardiovasculares (CNIC) ...

Home August 17, 2022
Home
News | Cardiovascular Clinical Studies

August 12, 2022 — Older adults with atrial cardiopathy (a major, often undetected cardiac cause of stroke) may be at ...

Home August 12, 2022
Home
News | Cardiovascular Clinical Studies

August 8, 2022 — Two years ago, University of Alabama at Birmingham researchers and colleagues reported that reductive ...

Home August 08, 2022
Home
News | Cardiovascular Clinical Studies

July 22, 2022 — BioSig Technologies, Inc. a medical technology company advancing electrophysiology workflow by ...

Home July 22, 2022
Home
News | Cardiovascular Clinical Studies

July 18, 2022 — scPharmaceuticals Inc., a pharmaceutical company focused on developing and commercializing products that ...

Home July 19, 2022
Home
News | Cardiovascular Clinical Studies

July 15, 2022 — Imagine, if scientists had a map of the heart, so granular in its accuracy that it even profiled details ...

Home July 15, 2022
Home
Subscribe Now