Researchers question safety of mist inhalers for delivering common drug for chronic lung disease

People who use a mist inhaler to deliver a drug widely prescribed in more than 55 countries to treat chronic obstructive pulmonary disease (COPD) may be 52 percent more likely to die, new Johns Hopkins-led research suggests.

The findings, published by BMJ, the , raise concerns not only about the mist inhaler -- a device that delivers the soluble form of the medication tiotropium -- but also about the drug itself. The mist inhaler has not yet gained regulatory approval in the United States, but the drug in its powdered form is commonly used to treat COPD here.

"What we think is going on is that the mist inhaler is delivering a higher concentration of tiotropium than it should be and that may be increasing the risk of death," says Sonal Singh, M.D., M.P.H., an assistant professor of general internal medicine at the Johns Hopkins University School of Medicine and the lead author of the study.

COPD, the fourth leading cause of death worldwide, includes the chronic lung diseases and bronchitis, which are usually due to decades of smoking. Tiotropium is routinely given to COPD patients with symptoms such as , and those with hospitalizations as a result of their .

Singh says the increased deaths linked to the inhaler are primarily from cardiovascular disease. Anticholinergics, the class of drugs that includes tiotropium, increase the risk of (arrhythmias), especially among those with existing .

In the United States and throughout the world, the medication is available in a powdered form and sold under the brand name Spiriva. Fifty-five countries now allow tiotropium to also be administered using the mist inhaler. Overseas, people with poor manual dexterity tend to be prescribed the mist inhaler because it is easier to use.

For the study, Singh and his colleagues from the United States and the United Kingdom reviewed and analyzed published findings comparing treatment with the mist inhaler containing tiotropium to treatment with a mist inhaler containing a placebo. They looked at five randomized, controlled trials, which included data on more than 6,500 participants. Both the drug and the placebo were delivered with the Respimat Soft Mist Inhaler. The results show a 52 percent increased risk of death among those who used the mist inhaler with tiotropium, as compared to the mist inhaler with placebo. Singh says his new research shows one excess death due to the mist inhaler for every 124 patients with chronic obstructive lung disease treated for one year.

What concerns Singh now is that there is a large, 17,000-patient, multicenter study underway in several countries, including the United States, comparing the two devices using the same drug.

"I'm worried about the participants assigned to the use of the mist inhaler," he says. "They are not fully informed about what could be serious safety issues with the device."

Singh emphasizes that while the current study only focused on tiotropium delivered through mist inhaler, the findings also raise serious questions about whether the drug tiotropium, in particular, and the class of inhaled anticholinergics, in general, are safe for COPD patients, particularly those with known heart problems. The shortness of breath caused by COPD can be treated with other long-acting bronchodilators, such as the long-acting beta-agonists. The risk of additional hospitalizations for these chronic lung diseases can be reduced somewhat by other COPD inhalers. At this point, Singh recommends that patients discuss the risks and benefits of COPD treatments with their doctors.

In New Zealand, a warning about a possible link between cardiovascular death and the mist inhaler has been included in the package insert for the device. In the United Kingdom, health officials advise caution in prescribing the mist inhaler to patients with arrhythmias.

Provided by Johns Hopkins Medical Institutions

not rated yet

Related Stories

Beta blockers may help COPD sufferers

May 12, 2011

(Medical Xpress) -- Beta blockers, the group of drugs commonly prescribed to patients with heart diseases, may also have considerable benefits for sufferers of diseases such as chronic bronchitis and emphysema, according ...

Nano-particle research will benefit inhaler-users

Apr 29, 2005

Patients suffering from conditions as diverse as asthma and diabetes could benefit from research at Cardiff University to improve the effectiveness of drugs taken through spray inhalers. Scientists in the Welsh School of ...

Recommended for you

Recorded Ebola deaths top 7,000

19 hours ago

The worst Ebola outbreak on record has now killed more than 7,000 people, with many of the latest deaths reported in Sierra Leone, the World Health Organization said as United Nations Secretary-General Ban ...

Liberia holds Senate vote amid Ebola fears (Update)

Dec 20, 2014

Health workers manned polling stations across Liberia on Saturday as voters cast their ballots in a twice-delayed Senate election that has been criticized for its potential to spread the deadly Ebola disease.

Evidence-based recs issued for systemic care in psoriasis

Dec 19, 2014

(HealthDay)—For appropriately selected patients with psoriasis, combining biologics with other systemic treatments, including phototherapy, oral medications, or other biologic, may result in greater efficacy ...

Bacteria in caramel apples kills at least four in US

Dec 19, 2014

A listeria outbreak believed to originate from commercially packaged caramel apples has killed at least four people in the United States and sickened 28 people since November, officials said Friday.

Steroid-based treatment may answer needs of pediatric EoE patients

Dec 19, 2014

A new formulation of oral budesonide suspension, a steroid-based treatment, is safe and effective in treating pediatric patients with eosinophilic esophagitis (EoE), according to a new study in Clinical Gastroenterology and Hepatology, the official clinical practice journal ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.