TOPLINE

One in three older men had little or no symptom benefit from tamsulosin; however, a smaller group worsened after stopping it.

METHODOLOGY

• Researchers conducted a double-blind randomized trial to identify which older men on tamsulosin showed little benefit and might be candidates for deprescribing.
• They included 31 men aged 55-80 years (mean age, 68.5 years) with lower urinary tract symptoms attributed to benign prostatic hyperplasia who had taken tamsulosin for at least 1 year at urology clinics between over a nearly year-long period in 2021.
• Each patient started with placebo for 1 week and then completed four, 2-week periods of tamsulosin or placebo in a random order, separated by a 1-week washout period.
• The researchers collected daily scores for symptoms ranging from 0 to 35 and daily scores for adverse events; they classified each man as having minimal/none, moderate, or strong response based on changes in symptom scores with tamsulosin vs placebo.
• In a substudy, researchers confirmed whether 1-week washouts cleared tamsulosin.

TAKEAWAY

• Overall, 26 men completed all periods, 36.7% of those had minimal or no response in symptoms from tamsulosin vs placebo, 36.7% had a moderate response, 13.3% had a strong response, and 13.3% could not tolerate the switch to placebo.
• Men had 2.96 fewer daily symptom points on average with tamsulosin than placebo.
• Most men (92.3%) who completed the full protocol reported at least 1 day of a possible adverse drug reaction. The mean number of affected days was 34.
• Individual-level treatment effects did not vary by the sequence of treatment or by the baseline score of symptoms. The 1-week washout period was adequate to clear the drug.

IN PRACTICE

“[The] study highlights the need to counsel patients on the heterogeneity of tamsulosin treatment effects and supports the clinical use of empiric tamsulosin trials rather than lifelong therapy,” the researchers wrote.

SOURCE

The study was led by Scott R. Bauer, MD, ScM, of University of California, San Francisco. It was published online on July 6 in JAMA Network Open.

LIMITATIONS

Researchers assessed only one treatment and washout schedule. They lacked measures of urodynamics or prostate measurements.

DISCLOSURES

The study received support from the University of California, San Francisco, Academic Senate Committee Resource Allocation Program; the National Center for Advancing Translational Sciences; the National Institute of Diabetes and Digestive and Kidney Diseases; and the National Institute on Aging. Several authors reported receiving stock options, research grants, or personal fees from commercial and noncommercial entities.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.