A lung drug from Boehringer Ingelheim GmbH and Pfizer Inc. (PFE) helped delay severe episodes in asthma patients, researchers said today in two studies that may result in broader use of the medicine.
Spiriva, known chemically as tiotropium and delivered by the Respimat Soft Mist inhaler, cut the risk of a severe flare- up by 21 percent when given in addition to standard treatments, according to a company-sponsored study presented today at the European Respiratory Society’s meeting in Vienna. The research was published simultaneously in the New England Journal of Medicine.
A standard treatment for chronic obstructive pulmonary disease, or COPD, Spiriva has been on the market for a decade and had 3.15 billion euros ($3.96 billion) in sales last year. Today’s results were a “valuable but intermediate step” toward using drugs like Spiriva safely in asthma patients, Elisabeth Bel, a pulmonologist at the Academic Medical Center in Amsterdam, wrote in an editorial published alongside the trial results today in the NEJM.
“A word of caution seems appropriate,” Bel wrote, adding that the medicine may be risky for patients with a history of heart problems.
Treating asthma may boost sales significantly for drugs like Spiriva, including those from GlaxoSmithKline Plc (GSK) and Novartis AG (NOVN), Sam Fazeli, a London-based analyst for Bloomberg Industries, wrote in a May report.
“Safety over longer time periods is the key question,” Fazeli wrote.
A review of five studies published last year in the British Medical Journal found the use of Spiriva in mist form was associated with a 52 percent increase in mortality risk. Boehringer has said data from those trials is already “appropriately reflected” in Spiriva’s label.
No patients died during the trials published today, and adverse events were similar in patients who got the drug and those who didn’t, the investigators wrote. The two identical studies excluded people with unstable heart disease. They divided a total of 912 patients into groups that got inhaled steroid hormones and long-acting beta-agonists and groups that took tiotropium alongside the other two types of drugs.
“I’m already prescribing tiotropium as an add-on therapy to my patients,” said Richard Russell, one of the study’s U.K.- based investigators and consultant chest physician at Wexham Park Hospital. Still, “if people have a history of cardiac disease and cardiac arrhythmia, I do not give them Spiriva using a Respimat device.”
The results are important because tiotropium helped people who were already getting drugs in high doses, and still had flare-ups, said Huib Kerstjens, a professor at the University of Groningen in the Netherlands and one of the study’s authors.
“And still in this population where we have a problem, we could reduce these exacerbations,” Kerstjens said. “That’s meaningful to patients.”
Even before the study, Kerstjens had prescribed tiotropium off-label for asthma, he told reporters in Vienna today. The next step is to see if tiotropium works in patients with more moderate asthma, he said.
Boehringer is conducting a total of 11 final-stage clinical trials on tiotropium in asthma, Jennifer Haddon, the Ingelheim, Germany-based company’s respiratory medicine adviser, said in a telephone interview. Haddon declined to give details on how soon Boehringer might request regulatory approval to sell tiotropium in asthma or on its sales potential.
Closely held Boehringer markets Spiriva for COPD patients together with New York-based Pfizer.
To contact the editor responsible for this story: Phil Serafino at email@example.com