Tracey Walker

Overactive bladder drug mirabegron was not associated with an increased risk for cardiovascular (CV) events compared with other treatments, according to a study published in 

Recently, mirabegron, the first Î²3-adrenoceptor agonist, has been prescribed to treat overactive bladder more frequently than antimuscarinic agents, according to the 

“Our findings are not meant to endorse preferential use of mirabegron but to support a growing body of evidence that mirabegron is not associated with an excess risk of CV events compared with other treatments in older patients,” the authors wrote.

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Mina Tadrous, PharmD, PhD, scientist at the 

 in Toronto, Ontario, Canada, and colleagues, conducted a matched cohort study using administrative claims data from 38,818 patients aged 66 years or older using overactive bladder treatments. 

The researchers found that patients taking mirabegron did not have an increased risk of irregular heart rates, heart attacks, or stroke compared to patients taking other overactive bladder drugs.

“These findings offer a measure of reassurance for the decision-makers regarding the safety of mirabegron, a drug with growing utilization,” Tadrous told 

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“Real-world data on older patients with overactive bladder who have concomitant cardiovascular comorbidities such as poorly controlled hypertension, arrhythmia, or heart failure is lacking,” he says. “Moreover, there are limited long-term safety data for patients using mirabegron. Real-world evidence is essential for clinicians to make informed decisions.”

The study also found a 79% prevalence of hypertension and 36% prevalence of diabetes in the cohort, substantially higher than that in clinical trials. 

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Patients with overactive bladder taking this OAB drug did not experience an excess risk of CV events compared with other treatments.

Overactive bladder drug not linked to CV events

FDA approved Teva Pharmaceutical’s AirDuo Digihaler (fluticasone propionate 113 Î¼ and salmeterol 14 Î¼) Inhalation Powder, a combination therapy digital inhaler with built-in sensors that connects to a companion mobile application to provide information on inhaler use to people with asthma. 

AirDuo Digihaler has the ability to not only track inhaler uses, but also measures inspiratory flow rates. This product differs from an add-on that is applied to the top of the device as the technology is integrated into the inhaler, according to Teva.

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The inhaler is not meant to be used as a rescue inhaler, according to the company

AirDuo Digihaler has built-in sensors that detect when the inhaler is used and measure inspiratory flow rates. This inhaler-use data is then sent to a companion mobile app using Bluetooth Wireless Technology so patients can review their data over time, and if desired, share it with their healthcare providers. In addition, the device sends reminders to patients’ smartphones to take their medication in accordance with their treatment plan.

The companion app will be available in the Apple App Store and Google Play. Once the app has been downloaded, patients will open it and scan the QR code on top of the inhaler to pair, using the camera on their smartphone. Patients can pair up to 5 Digihaler inhalers to the app. It’s also important to note that AirDuo Digihaler will still deliver medication even if it is not actively connected to the app and if the inhaler and smartphone are not within range of one another, according to Teva.

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Even with advancements in respiratory care, research indicates that 70% to 90% of patients are still not using their inhalers correctly, and despite their best efforts, patients may not always follow their treatment plan, and some have difficulty using their inhalers, according to Teva.

With AirDuo Digihaler, patients can receive reminder notifications from the app to take their medication in accordance with their treatment plan, and the app will notify them if their inhalation technique may need improvement so they can share this information with their physician. Digitally connected devices like AirDuo Digihaler provide patients and/or their caregivers with data about their inhaler use and frequency, which may help inform conversations with their physicians regarding inhaler technique and adherence to these medications, which may impact overall cost of care.

Teva is having ongoing conversations regarding access for both AirDuo Digihaler andProAir Digihaler, which was approved back in December 2018. Although the pharma maker cannot disclose details at this time, the goal in collaborating with payers is to focus on the value for both patients and payers.

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Author | Tracey Walker

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Overactive bladder drug not linked to CV events

FDA approves first sensor-enabled inhaler