However efficient drugs may be for treating one condition,
it is no longer a secret that they can have harmful effects on other parts of our
body. This is also the case of inhaler drugs, one of the most commonly
prescribed treatments for chronic obstructive pulmonary disease (COPD).
According to a study published in the September 24 issue of the Journal of the
American Medical Association, these drugs appear to increase the risk of heart
attacks and even death.
COPD is often caused by smoking and is the fourth-leading
cause of death in the United
States, affecting more than 24 million
people and killing more than 100,000 each year. The disease is characterized by
emphysema and chronic bronchitis, which obstructs airflow to the lungs. There
is no cure for this deadly disease and the current drugs do not slow its
progression.
The drugs under scrutiny are tiotropium, sold as Spiriva Handihaler by
Boehringer Ingelheim Pharmaceuticals, Inc., and Pfizer and ipratropium,
available generically and also sold by Boehringer under the brand name
Atrovent.
Spiriva was approved in 2004 while Atrovent in 1998 and they
both are used to relax muscles and open lung airways. Eight million patients
worldwide have used the Spiriva since its approval.
Dr. Sonal Singh, assistant professor of internal medicine at
Wake Forest
University Baptist
Medical Center
in Winston-Salem, N.C. and colleagues conducted a
meta-analysis of available studies on inhaled anticholinergic drugs that had
been used for the treatment of COPD for at least 30 days. There were 17 studies
involving almost 15,000 patients. The studies followed the patients for six
weeks to five years.
The researchers found a 58 percent increased risk of
cardiovascular death, heart attack or stroke in participants receiving inhaled
anticholinergics.
“We found a 58 percent increased risk of cardiac death, heart attack or
stroke” in people using these inhalers. “In absolute terms, what it means is
that if you were to use these drugs for a year, your absolute risk of
developing an additional cardiac death would be one in 40,” Dr. Singh said.
Overall, the use of Spiriva and Atrovent drugs increased the risk of a heart
attack by 53 percent, cardiovascular death by 80 percent and stroke by 46
percent. This is not new, considering the fact that earlier in March the US
Food and Drug Administration said Spiriva may raise the risk of stroke, citing
a pooled analysis of 13,500 patients. The researchers couldn’t tell for sure
what exactly increased the risk of heart attack in the drugs’ composition, but
they believe damaging proteins involved in inflammation are involved in both
COPD and heart disease.
Leaving aside this analysis, a Veterans Affairs study published last week
linked Atrovent with an increased risk for heart-related deaths in men.
On the other hand, Boehringer and Pfizer released a statement saying that
their analysis of 30 studies involving 19,545 patients found no increased risk
of heart attack, stroke or death from any cause among the chronic lung-disease
patients taking Spiriva.
“We strongly disagree with the conclusion reached by Singh et al. We have
disclosed to regulatory authorities worldwide this important information, which
is part of a very robust analysis of all our double-blind, placebo-controlled,
parallel group trials with a duration of at least 4 weeks. Our analysis, which
includes data from the four-year UPLIFT trial, supports the safety profile of
Spiriva. Patients and physicians can be confident that Spiriva is a safe and
effective medication,” Dr. Andreas Barner, vice chairman of the board of
managing directors at Boehringer Ingelheim, said in the statement.