Patients report size, number of phosphate binder pills as barriers to use

ByJill Rollet

Fact checked byRichard Smith

Key takeaways:

Of survey respondents, 47% said large number and large size of pills were among top phosphate binder adherence barriers.
An investigational agent is smaller, swallowed whole and dosed with fewer pills.

BOSTON — Patients on kidney dialysis reported better adherence to an investigational phosphate-binding agent designed to be smaller, swallowed whole and dosed with fewer pills than available oral therapies, according to survey data.

Results of two surveys about patients’ experiences with therapies for hyperphosphatemia, a common condition among patients with chronic kidney disease on dialysis, were presented at the National Kidney Foundation Spring Clinical Meetings.

If approved, the investigational medication, oxylanthanum carbonate (Unicycive Therapeutics), “will share substantially the same product label and prescribing information as the reference-listed drug Fosrenol (lanthanum carbonate [Takeda]), with the exception that oxylanthanum carbonate tablets are smaller in size and swallowed whole with water and not chewed,” according to the company website.

Hyperphosphatemia is asymptomatic but can lead to vascular calcification and CVD, according to Shalabh Gupta, MD, founder, CEO, president and chairman of Unicycive Therapeutics. It is treated with oral phosphate-binding agents.

Shalabh Gupta, MD

“The worst thing is that these large size pills have to be chewed, and when you chew them, they taste like metal because they are metal,” Gupta told Healio. “If they don’t chew the pill, these drugs do not get absorbed. ... The three main [compliance] challenges are large number of pills, large size pills and large pills that have to be chewed.”

In a study conducted by Unicycive in conjunction with NKF, researchers collected responses to a 20-minute online survey. Respondents were recruited through the NKF email list, were aged 40 years or older and on dialysis, and 126 answered questions about barriers to phosphate binder adherence.

Forgetting to take the medication was listed as the top issue by 63% of respondents and as among their top three issues by 89%. Forty-seven percent of respondents said large number and large size of pills were among their top three barriers.

In a separate survey as part of an open-label, single-arm, multidose study of oxylanthanum carbonate, Gupta and colleagues assessed patient satisfaction with and adherence to oral phosphate-binding agents. The 80 patients who completed the survey had CKD and were on dialysis. At baseline, they had a mean serum phosphate level between 4 mg/dL and 7 mg/dL for at least 8 weeks. The patients underwent a washout period for phosphate binders and then received oxylanthanum carbonate during a 6-week titration period and a 4-week maintenance period with a maximum dose of 1,000 mg per day.

At baseline, patients reported taking six pills per day of their prescribed phosphate-binding medication; 58% reported consistent therapy adherence. At the end of the study, patients reported taking three oxylanthanum carbonate pills per day, 70% reported consistent therapy adherence, and 79% said they preferred the study treatment to their previous prescriptions.

“Almost all patients — 98% — agreed that [oxylanthanum carbonate] was easy to take, and most patient — 89% — reported they were satisfied with [oxylanthanum carbonate] treatment,” Gupta said.

“People are just overwhelmed with the number of pills they have to take,” he said. “[Hyperphosphatemia] doesn’t cause a symptom. People don’t feel chest pain. They don’t feel headaches, and it doesn’t affect them overnight.”