The use of antihypertensive therapies — medications that lower high blood pressure — is not linked to a decrease in the frequency of clinical events associated with vascular Ehlers-Danlos Syndrome, data from a pilot study suggest.
The findings were presented in a poster titled, “Pilot Study to Evaluate Effect of Antihypertensive Therapy on the Rates of Clinical Events in Patients with Vascular Ehlers-Danlos Syndrome (vEDS),” at the Society for Vascular Medicine (SVM) 2019 Annual Scientific Sessions, May 29–June 1 in McLean, Virginia.
Ehlers-Danlos Syndrome (EDS) is a connective tissue disorder caused by defects in a protein called collagen. Vascular EDS (vEDS), one of the most severe forms of the disorder, is characterized by blood vessel fragility, easy bruising, and bleeding episodes.
Although there are no approved medications to treat vEDS in the U.S., some physicians prescribe antihypertensive medications in the hope they will lower blood pressure and reduce the strain on blood vessels, minimizing the chances of vEDS complications.
The main goal of the study, carried out by Acer Therapeutics, was to evaluate whether the use of antihypertensive medications might be associated with a decrease in the rate of vEDS clinical events, including aneurysms, intestinal perforation, arterial rupture, and intracranial (brain) hemorrhage.
Researchers performed a retrospective study based on insurance claims from Truven MarketScan to identify vEDS patients between Jan. 1, 2014, and Dec. 31, 2017.
After identifying vEDS patients, investigators divided them into two groups: those who had never been prescribed any antihypertensive medications, and those who had been prescribed any type of antihypertensive therapy. The team then compared the frequency of vEDS clinical events in each group.
From the 3,614 vEDS patients who were identified, 2,371 (65.6%) had never received a prescription for antihypertensive medications, while the remaining 1,243 (34.4%) had already been prescribed these medications, namely beta blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or calcium channel blockers.
Results showed, however, that there were no statistically significant differences in the frequency of vEDS clinical events between patients who had never been treated with antihypertensive drugs and those who had — 15.6% versus 16.5%, respectively.
“Over the four-year period being evaluated, 15.9% of vEDS patients had at least one clinical event at an average rate of 1.19 events per year,” the researchers said. They added, however, that “there was no statistically significant difference between rate of clinical events in patients in any of the medication groups compared to patients on no antihypertensive medication.”
The findings of Acer’s pilot study will also be published in the online and print versions of SVM’s journal, called Vascular Medicine.
“While some physicians prescribe antihypertensive medications as possible preventative therapy in vEDS patients, the pilot study indicates that there is no evidence of their benefit in vEDS,” William Andrews, MD, chief medical officer of Acer, said in a press release.
“While we recognize the limitations of drawing clinical conclusions from a pilot study based on retrospective analysis of insurance claims databases, we believe these results, along with the high incidence of major complications in vEDS patients, underscore the serious need for an approved, safe and effective therapy for this disease,” Andrews said.
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