BOSTON, Oct. 5 (Reuters) - Spiriva, marketed by Pfizer (PFE.N) and Boehringer Ingelheim, offered no advantage over an inhaled placebo for moderate-to-very-severe chronic obstructive pulmonary disease, or COPD, researchers reported on Sunday.
They were looking for some sign that the drug could improve lung function over the long term for COPD, which includes chronic bronchitis and emphysema.
But researchers did document improvement in some secondary measures such as quality of life over four years. The drug also seemed to forestall some worsening of the the disease, they told a European Respiratory Society meeting in Berlin.
The results, also released online by the New England Journal of Medicine, are the latest in a series of reports about the drug that have offered mixed findings.
Analysts at Morgan Stanley said last month the results of the study were “highly likely” to influence what doctors do.
A study published Sept. 23 in the Journal of the American Medical Association showed that patients who took Spiriva or Boehringer’s older medication, Atrovent, for at least a month were 58 percent more likely to have heart attacks, strokes or to die from other forms of heart disease.
Two days later, the manufacturers disclosed some findings from the study, called Uplift, showing a similar rate of serious adverse events between Spiriva and placebo and, more importantly for them, a 16 percent reduction in the risk of death.
But that reduction was barely statistically significant and Uplift did not compare Spiriva to any other medication.
For its part, GlaxoSmithKline cited findings from the another study showing that Advair could slow progression of COPD over three years, something that Spiriva did not do.
The Uplift results show that people taking the drug had less congestive heart failure, fewer heart attacks and less respiratory failure than volunteers taking a placebo, but had no impact on the rate of chest pain or angina, a heart arrhythmia called atrial fibrillation or pneumonia.
The Uplift results show that Spiriva should not be prescribed in hopes of changing the progression of COPD, but only for the alleviation of symptoms, Dr. John Reilly of the University of Pittsburgh School of Medicine wrote in a commentary.
The company-financed test of Spiriva, known generically as tiotropium, involved nearly 6,000 people in 37 countries.
The Uplift researchers assessed lung capacity with a test that gauged the amount of air patients could blow out in one second.
Spiriva had sales of $2.65 billion in 2007, while Advair generated $6.51 billion. COPD, stroingly linked with smoking, affects 12 million people in the United States alone. (Editing by Maggie Fox)