and Medicine for Seniors
New Long-Term Treatment for COPD
Approved by FDA
One of nations biggest killers is
most often found in senior citizens, current or former smokers, women
31, 2014 - A new long-term treatment for the third largest killer of
U.S. citizens - chronic obstructive pulmonary disease (COPD) was
approved today by the U.S. Food and Drug Administration. Striverdi
Respimat (olodaterol), an inhalation spray, is for the treatment of
patients with COPD, including chronic bronchitis and emphysema that are
experiencing airflow obstruction. Striverdi Respimat can be used once
daily over a long period of time.
COPD, which is most prevalent among
senior citizens, especially those age 65 to 74, is a serious lung
disease that makes breathing difficult and worsens over time. Symptoms
include wheezing, cough, chest tightness, and shortness of breath.
Cigarette smoking is the leading cause of COPD.
According to the National Heart,
Lung, and Blood Institute, COPD is the third leading cause of death in
the United States.
The availability of this new
long-term maintenance medication provides an additional treatment
options for the millions of Americans who suffer with COPD, said Curtis
Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II
in the FDAs Center for Drug Evaluation and Research.
Striverdi Respimat is a long-acting
beta-adrenergic agonist (LABA) that helps the muscles around the airways
in the lungs stay relaxed to prevent symptoms.
The safety and effectiveness of
Striverdi Respimat was evaluated in 3,104 people diagnosed with COPD.
People who received Striverdi Respimat showed improved lung function
compared to placebo.
The drug carries a boxed warning
that LABAs increase the risk of asthma-related death. The safety and
effectiveness of Striverdi Respimat in people with asthma has not been
established and it is not approved to treat asthma.
Striverdi Respimat should not
be used as a rescue therapy to treat sudden breathing problems (acute
Striverdi Respimat should not
be used in patients with acutely deteriorating COPD and may cause
serious side effects, including narrowing and obstruction of the
respiratory airway (paradoxical bronchospasm) and cardiovascular
The FDA approved Striverdi Respimat
with a patient medication guide that includes instructions for use and
information about the potential risks of taking the drug.
The most common side effects
reported by people using Striverdi Respimat in the clinical study were
nasopharyngitis (runny nose), upper respiratory tract infection,
bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea,
back pain and arthralgia (joint pain).
Striverdi Respimat is distributed
by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.
The FDA, an agency within the U.S.
Department of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and veterinary
drugs, vaccines and other biological products for human use, and medical
devices. The agency also is responsible for the safety and security of
our nations food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco products.
About COPD from
Centers for Disease Control and Prevention (CDC)
Pulmonary Disease, or COPD, refers to a group of diseases that cause
airflow blockage and breathing-related problems. It includes emphysema,
chronic bronchitis, and in some cases asthma.
What causes COPD?
In the United States, tobacco smoke is a key factor
in the development and progression of COPD1,
although exposure to air pollutants in the home and workplace, genetic
factors, and respiratory infections also play a role. In the developing
world, indoor air quality is thought to play a larger role in the
development and progression of COPD than it does in the United States.
Who has COPD?
Chronic lower respiratory disease, primarily COPD,
was the third leading cause of death in the United States in 2011.
Fifteen million Americans report that they have
been diagnosed with COPD.
More than 50% of adults with low pulmonary function
were not aware that they had COPD; therefore the actual number may be
The following groups were more likely to report
People aged 6574 years.
Individuals who were unemployed, retired, or
unable to work.
Individuals with less than a high school
People with lower incomes.
Individuals who were divorced, widowed, or
Current or former smokers.
Those with a history of asthma.
More at CDC