Vibegron After 65: 4 Findings From Two Trials

Half of one subgroup had substantially fewer urge leaks

In EMPOWUR’s 12-week analysis, 628 patients were 65 or above. Among participants with urge leakage, 50.0% on vibegron 75 mg daily had at least a 75% reduction, versus 29.8% on placebo. The denominators were 192 and 168, respectively; this was not a cure rate.¹

The oldest subgroup and drug comparisons need care

Only 179 participants were 75 or above. The age subgroups were not separately powered to detect differences. Investigators also made no formal efficacy comparison with tolterodine, the active control; this analysis cannot establish superiority over that medicine.¹

The blood-pressure result came from a separate population

A 28-day trial randomized 214 adults aged 40–75; 197 had usable baseline and follow-up ambulatory readings. The adjusted difference versus placebo in daytime systolic pressure change was 0.8 mmHg, with a 90% confidence interval of −0.9 to 2.5. It did not show a significant average increase.²

The trial excluded pressure above 160 systolic or 95 diastolic, recent major cardiovascular events and certain rhythm abnormalities. Its short duration and age ceiling limit what it says about people outside those criteria. An average result also does not promise that an individual’s readings cannot rise.²

Both studies were funded by Urovant Sciences.¹²

A favorable pressure result does not remove other precautions

The current U.S. GEMTESA label recommends 75 mg once daily and warns about urinary retention, particularly with bladder outlet obstruction or concurrent antimuscarinic bladder medicines. Trouble emptying deserves prompt clinical attention.³

The label also warns about potentially dangerous face or airway swelling and requires digoxin monitoring before, during and after treatment. Severe liver impairment and end-stage kidney disease require additional prescribing consideration; GEMTESA is not recommended in those groups. Our digoxin monitoring guide covers that specific interaction.³

Bring comparable diary entries to the review

Ask which outcome will guide the decision: urge-leak episodes, urgent trips or time between bathroom visits. Bring dated entries from before treatment and the period before your review, alongside side effects and your medicine list.

The “What to Say in the Room” section of Laugh, Sneeze, Jump pairs earlier and current three-day bladder records with a medicine list and an agreed check-in date.