Study Stopped for Pulmonary Hypertension in Patients with Sickle Cell Disease Due to Safety Concerns

A public announcement has been made in a press release from the National Institutes of Health regarding the cessation of a study investigating potential treatments of pulmonary hypertension for patients who also suffer with sickle cell disease. The study was stopped by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health due to safety concerns for participants in the study.

This study, known as walk-PHaSST, administered the drug sildenafil to investigate possible relief of primary pulmonary hypertension (PPH) symptoms. Symptoms were investigated during a test where patients walked, giving the name of the study. The common problem among participants not in the placebo group was episodes of severe pain called sickle cell crises resulting in hospitalization. Fortunately, no deaths have been reported.

“The increase in sickle cell medical problems is concern enough for us to stop this clinical trial to protect the safety of our patients,” said NHLBI Director Elizabeth G. Nabel, M.D. in the press release. “We will continue to look into the possible causes of these preliminary results.” It is of great interest to advance the treatment of pulmonary hypertension because of the great risks of this pulmonary disease. The NHLBI is taking the results of this study very seriously.

Brief Overview of Primary Pulmonary Hypertension (PPH)
This public announcement also provided a brief overview of primary pulmonary hypertesnion (PPH) that may be useful and so is summarized here. PPH is a serious and debilitating condition of high blood pressure in the arteries that carry blood to the lungs. This complication can lead to heart failure and even death. This condition also makes many everyday activities extremely difficult for those who suffer from this pulmonary disease.

Hope for Future of PPH Treatment
Since the medical problems that were encountered in this study were complications specific to sickle cell disease, “The findings of the walk-PHaSST study should not be applied to other groups of patients with pulmonary hypertension where the drug has been found to be safe and effective,” Nabel added in this report. Ongoing analyses of participants conditions in this study are being conducted. Researchers in this study remain hopeful in approaches to treating PPH. It is extremely important to inspire hope among those who suffer from PPH and to show that there are many advocates for those who suffer from this condition on the medical front and the legal front. The report issued this quote from Mark Gladwin, M.D., lead investigator of this study and director of the Vascular Medicine Institute at the University of Pittsburgh:

“Although these preliminary results are disappointing, we expect that the study’s results, once fully analyzed, will provide important insights into the role of pulmonary hypertension in sickle cell disease.”

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