Desmopressin ODT Shows Favorable Long-Term Safety in Men With Nocturia: Japan Surveillance Study
Japan: A large post-marketing surveillance study in Japan has provided important real-world insights into the long-term safety of desmopressin orally disintegrating tablets (ODT) in men with nocturia caused by nocturnal polyuria. The findings, published in Low Urinary Tract Symptoms, highlight both the tolerability of the drug and key risk factors that clinicians should consider when treating patients.
Desmopressin, an antidiuretic hormone analogue, is commonly prescribed to reduce nighttime urine production. While its efficacy is well established, concerns around safety—particularly electrolyte imbalance—have prompted the need for long-term observational data in routine clinical settings. To address this, Yoshimasa Ogawa and colleagues conducted a post-marketing surveillance study involving Japanese men initiating desmopressin ODT therapy for the first time.
The study enrolled 1,113 patients into a centralized registry, of whom 1,049 were included in the final safety analysis after exclusions. Participants were followed for up to one year, offering a comprehensive view of adverse events over extended use. The average age of the study population was 75 years, reflecting the condition’s higher prevalence among older adults.
The key findings were as follows:
- A total of 351 adverse drug reactions were reported in 259 patients.
- Serious ADRs were rare, occurring in only 7 patients (0.7%).
- Hyponatremia was the most common adverse event, observed in 13.3% of patients.
- Some patients with hyponatremia experienced related symptoms; however, no cases of severe neurological complications such as seizures, confusion, stupor, or coma were reported.
- Age ≥75 years was identified as a significant risk factor for developing hyponatremia.
- A history of benign prostatic hyperplasia was associated with an increased risk.
- Lower baseline serum sodium levels prior to treatment also increased susceptibility to hyponatremia.
- These findings highlight the need for careful patient selection and close monitoring during treatment.
The study also emphasized the need for vigilance in patients with underlying comorbidities or abnormal laboratory parameters, such as impaired renal function or baseline serum sodium levels below 140 mmol/L. Regular monitoring of sodium levels during treatment is particularly critical in these populations to mitigate potential risks.
Overall, the results support the acceptable safety profile of desmopressin ODT in routine clinical practice when used appropriately. However, they also reinforce that individualized risk assessment and ongoing monitoring are essential, especially in elderly patients and those with predisposing conditions.
These real-world findings provide valuable guidance for clinicians managing nocturia due to nocturnal polyuria, helping to balance therapeutic benefits with patient safety in long-term care.
Reference:
Ogawa Y, Kuramoto K, Nakano A. 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. Low Urin Tract Symptoms. 2026 Mar;18(2):e70052. doi: 10.1111/luts.70052. PMID: 41844238; PMCID: PMC12995508.
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