# Long‐Term Safety of Desmopressin Orally Disintegrating Tablets in Men With Nocturia due to Nocturnal Polyuria: Final Results of a Specified Drug Use‐Results Survey in Japan

## TL;DR

This study evaluated the long-term safety of desmopressin tablets in Japanese men with nocturia, finding hyponatremia as the most common side effect.

## Contribution

The study provides real-world safety data on desmopressin ODT in elderly Japanese men with nocturia due to nocturnal polyuria.

## Key findings

- Hyponatremia was the most common adverse drug reaction, affecting 13.3% of patients.
- Age ≥75 years, benign prostatic hyperplasia history, and low baseline sodium levels were risk factors for hyponatremia.
- Only 0.7% of patients experienced serious adverse drug reactions.

## Abstract

This report presents the final results of a post‐marketing surveillance evaluating the safety of desmopressin orally disintegrating tablets (ODT) in Japanese men with nocturia due to nocturnal polyuria (NP).

In total, 1113 Japanese men who received desmopressin ODT for the first time to treat nocturia due to NP were enrolled in a central registry. Of the 1087 patients for which case report forms were collected, 38 did not meet the safety eligibility criteria of the survey. Consequently, the remaining 1049 patients were included in the analysis. The participants were followed for up to 52 weeks.

The mean age of the total population was 75.0 ± 9.6 years. A total of 351 adverse drug reactions (ADRs) were reported in 259 patients, including 11 serious ADRs in 7 patients (0.7%). The most common ADR was hyponatremia, which occurred in 140 patients (13.3%). Among the 19 patients (13.6%) presenting hyponatremia related symptoms, no reports of confusion, seizures, stupor, or coma was recorded. Multivariate analysis identified age ≥ 75 years, a history of benign prostatic hyperplasia, and a lower serum sodium level before treatment as risk factors for the development of hypernatremia after the treatment with desmopressin ODT.

The survey provides insights into the safety profile of desmopressin ODT in real‐clinical practice in Japan. Patients aged ≥ 75 years, those with underlying medical conditions, and those with abnormal clinical laboratory values, such as reduced renal function or a baseline serum sodium level of < 140 mmol/L, should be closely monitored for the development of hyponatremia during desmopressin treatment for nocturia due to NP.