Spiriva, marketed by Pfizer 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 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 September 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% 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% reduction in the risk of death.
But that reduction was barely statistically significant and Uplift
did not compare Spiriva to any other medication.
Nonetheless, that news prompted analysts at Morgan Stanley to
predict that Spiriva would capture some market share from
GlaxoSmithKline's respiratory drug Advair.
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.
