Andrew (Drew) Rhoades , 2025-05-05 15:32:00
Key takeaways:
- New drugs for hypertension, UTIs and menopause symptoms are promising additions to the treatment armamentarium in primary care.
- However, costs and prescribing challenges may hinder their use.
NEW ORLEANS — Recently approved medications for resistant hypertension, uncomplicated UTIs and menopausal hot flashes show potential as first- or second-line options, a speaker said.
At the ACP Internal Medicine Meeting, Gerald W. Smetana, MD, MACP, a professor of medicine at Harvard Medical School, discussed these new drugs, which he said work “by a completely different mechanism than anything we’ve used before.”
New drugs recently approved by the FDA for hypertension, UTIs and menopause symptoms are promising additions to the treatment armamentarium in primary care. Image: Adobe Stock
Aprocitentan for resistant hypertension
According to Smetana, 45% of Americans have hypertension, among whom 12% have resistant hypertension, defined as high BP that is not adequately controlled despite three drugs that include a diuretic.
“This is an important public health burden and a big part of what we do,” he said.
One promising approach to this issue is aprocitentan (Tryvio, Idorsia), a joint endothelin A/endothelin B receptor antagonist that was approved by the FDA in March 2024.
Smetana said the key analysis that led to aprocitentan’s approval was the PRECISION trial, which showed that the drug was superior vs. placebo for BP lowering among patients with resistant hypertension.
However, he added that the absolute effect of the drug “was relatively modest,” with aprocitentan lowering systolic and diastolic BP by a mean 4 mm Hg when compared with placebo.
A downside of aprocitentan is its price, as the 30-day supply cost for aprocitentan 12.5 mg ($800) is substantially more than those of other medications for resistant hypertension such as minoxidil or hydralazine, which cost approximately $10 per month.
Smetana also pointed out that aprocitentan is a known teratogen. As a result, “this makes it very challenging to prescribe in practice,” he said, because prescribers must enroll in a Risk Evaluation and Mitigation Strategies (REMS) program through manufacturer websites, while the drug can only be dispensed through the Walgreens specialty pharmacy program.
Smetana said that while aprocitentan is a potential fourth-line treatment for resistant hypertension, “for all these reasons, I consider it to be less desirable” vs. existing treatments like spironolactone and labetalol.
Sulopenem etzadroxil and probenecid for uncomplicated UTIs
UTIs are common in younger women. At least 40% of women younger than 40 years have had at least one UTI, and 15% of these women will go on to have recurrent UTIs — at least three yearly — Smetana said.
A possibly effective antibiotic for uncomplicated UTIs — that is, UTIs in people with no symptoms or examination findings of upper tract infection — is sulopenem etzadroxil and probenecid (Orlynvah, Iterum Therapeutics), approved by the FDA in October 2024.
Smetana said that previous trials showed sulopenem etzadroxil and probenecid was non-inferior to quinolones like ciprofloxacin for uncomplicated UTI and was superior to quinolones for drug-resistant UTIs.
He underlined that the FDA “made a very specific narrow labeling recommendation” for the drug, which is uncomplicated UTIs due to Escherichia coli, Proteus mirabilis or Klebsiella pneumoniae in patients “with limited or no other alternative antibiotic options.”
“They did not approve it for complicated UTI,” he said.
Smetana added that the cost of the drug, which is not yet available in pharmacies, is currently unknown and may be a barrier down the line.
Still, “I’m giving this a thumbs-up as it does offer a new option for highly resistant organisms or in patients with multiple drug allergies,” he said.
Fezolinetant for menopausal hot flashes
Menopausal hot flashes occur in around 80% of perimenopausal women and are frequently severe and disabling, Smetana said.
Oral fezolinetant (Veozah, Astellas Pharma), a neurokinin 3 receptor antagonist, was approved by the FDA for such hot flashes in 2023.
Smetana highlighted results from the SKYLIGHT 1 and 2 trials, which indicated that fezolinetant reduced the overall severity and frequency of symptoms while the benefits were maintained for at least a year.
He also pointed out that fezolinetant was tied to improved sleep quality and that its adverse effects “did not differ substantially from placebo” aside from gastrointestinal events like diarrhea.
Last year, the FDA warned that using fezolinetant may cause rare but serious liver injury and changed its recommendations for the frequency of liver functioning testing, adding monthly testing for the following 2 months after the start of treatment and then at months 3, 6 and 9 of treatment as was recommended previously.
“[This] would make it a little more burdensome to prescribe in order to adhere to the FDA requirements,” Smetana said.
He concluded that fezolinetant “would probably still be a second-line option among nonhormonal treatments” like gabapentin or selective serotonin reuptake inhibitors because of the need for liver functioning monitoring while using the drug and its cost.
