Natpara May Help in Maintaining Heart Health, Trial Data Show

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Adults with hypoparathyroidism given long-term treatment with Natpara are less likely to experience heart-related health problems, according to an analysis of data from three clinical trials.

Natpara “may confer cardiovascular benefits to patients with chronic hypoparathyroidism, and further research is warranted to understand the relationship better in a real-world setting,” the researchers wrote.

The study, “Lower Risk of Cardiovascular Events in Adult Patients with Chronic Hypoparathyroidism Treated with rhPTH(1–84): A Retrospective Cohort Study,” was published in the journal Advances in Therapy. The work was funded by Takeda, which markets Natpara.

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Hypoparathyroidism is characterized by abnormally low levels of the parathyroid hormone or PTH. Natpara, which contains a lab-made version of this hormone, is widely approved to treat hypoparathyroidism, though it is not currently available in the U.S. due to issues with its packaging that led to a recall in 2019.

Natpara may aid heart via mineral levels in blood

A number of studies have illustrated that people with hypoparathyroidism are at increased risk of cardiovascular disease. Here, scientists at Takeda and other institutions conducted an analysis to assess Natpara’s effect on heart health.

“This study set out to assess the impact of treatment with [Natpara] on cardiovascular outcomes in patients with chronic hypoparathyroidism,” the team wrote.

Analyses utilized data from three clinical trials of Natpara — REPLACE (NCT00732615), RELAY (NCT01268098), and RACE (NCT01297309)  — as well as historical data. In total, the analysis included 113 hypoparathyroidism patients who had been treated with Natpara, as well as 618 other patients who did not receive the treatment as a control group.

Compared with controls, significantly fewer patients in the Natpara group used cholesterol-controlling medicines called statins, or had type 2 diabetes or high blood-fat levels. Patients using Natpara also were generally less likely to have acute manifestations of hypoparathyroidism.

Over five years of follow-up, four (3.5%) of the Natpara-treated patients experienced a cardiovascular event, broadly defined as any form of heart failure or cardiovascular disease. By comparison, cardiovascular events were reported in 101 (16.3%) controls.

Statistical analyses illustrated that Natpara’s use reduced the risk of any cardiovascular event by about 75%. Mathematical adjustments to account for the other differences between Natpara-treated patients and controls generally yielded similar results.

“The results show that individuals treated with [Natpara] had a 75% lower risk of developing a cardiovascular event compared with a historical control group treated with conventional therapy without PTH replacement. … The lower risk of new cardiovascular events in the [Natpara] cohort remained even after adjusting for baseline variables including CKD [chronic kidney disease], diabetes, hypertension, and statin use,” the scientists concluded.

Since prior data have illustrated that Natpara treatment can help to normalize the levels of calcium and phosphate disrupted by hypoparathyroidism, the researchers speculated that “the lower cardiovascular risk associated with treatment with [Natpara] may be the result of better restoration of mineral homeostasis [regulation] compared with conventional therapy alone.”

The scientists noted that this study is limited by a relatively small size, reflecting the rarity of hypoparathyroidism. They also noted that patients given Natpara in clinical trials may have been receiving more medical scrutiny than untreated controls, which could have influenced the results.

“Future studies involving larger samples would be helpful to support the findings of this study,” they wrote.