Introduction

Mirabegron (trade name: Betmiga) has been approved in Germany since December 2012 for the treatment of overactive bladder in adults.

Women and men with an overactive bladder (irritable bladder) have an increased urge to urinate that is extremely difficult to control. Needing to go more often can have a major impact on everyday activities. The urge to urinate can become so strong that they do not make it to the toilet and wet themselves (incontinence). People with irritable bladder also need to get up at night more frequently (nocturia), making it virtually impossible to sleep through the night.

Overactive bladder is more common in women than in men. One of the main causes is thought to be that the bladder muscles contract too often, but it is not known why this happens.

Health problems like urinary tract infection or neurological disorders may cause similar symptoms. Some medications can also cause an increased urge to urinate. For these reasons, overactive bladder is only diagnosed after these other possible causes have been ruled out.

Mirabegron is designed to relax the bladder muscles and relieve the urge to urinate.

Application

Mirabegron is usually taken once a day in tablets (50 mg).

Other treatments

There are several different drugs available to treat overactive bladder in adults, including trospium chloride, solifenacin, propiverine, darifenacin, and tolterodine.

Assessment

In 2014, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) examined whether mirabegron has an added benefit over tolterodine for treatment of overactive bladder.

What advantages does mirabegron have?

  • Dry mouth: People taking mirabegron reported having a dry mouth less often. Over the time span of a year about 3 in 100 people using mirabegron named dryness of the mouth as a side effect. 9 out of 100 people who took tolterodin had the same problem. But this side effect was not severe. Overall, in both groups fewer than 1 in 100 participants stopped treatment due to mouth dryness.

Where was there no difference?

  • Increased urge to urinate: There was no difference between mirabegron and tolterodine for several typical overactive bladder symptoms. For instance, there were no significant differences between the treatment groups in severity or frequency of the urge to urinate. The groups were also basically the same in terms of how much they were affected by the urge to urinate or by getting up at night to go to the bathroom.
  • Quality of life: People who took mirabegron did not evaulate their quality of life any differently than those who used tolterodine.
  • Severe side effects: There were no differences between mirabegron and tolterodine in terms of severe side effects either. For both drugs, about 5 out of 100 participants reported a severe side effect.

What questions remain unanswered?

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of this review and the hearings received, G-BA passed a resolution on the added benefit of mirabegron (Betmiga).

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