Olodaterol [Striverdi Respimat] approved to treat chronic obstructive pulmonary disease
Last Updated on January 26, 2016 by Joseph Gut – thasso
July 31, 2014 – Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time.
COPD is a serious lung disease that makes breathing difficult and worsens over time. Symptoms can 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 FDA’s 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 bronchospasm).
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 effects.
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).
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Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.
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thasso post is all about genetic influences on causing diseases, responding to therapies, and developing adverse drug reactions (ADRs). Very often, confounding factors such as lifestyle, are mentioned which actually modify a patient’s behavior (phenotype) despite a seemingly definite genotype (i.e., genetic background). With COPD most likely being a multifactorial disease it would not come as a surprise if some patients would get some relief with drugs like Olodaterol, and others would not. In your case, there may well be a genetic background (together with other, confounding, factors) that led you have a great therapy response with the Emphysema herbal formula, while other patients may not experience the same. As with synthetic drugs, there will be genetic constellations that allow some patients to have great response to ingredients of herbal formulations; unfortunately, this is not too much researched for, and not sufficiently validated in patient studies. Fortunately, in thasso post, you find once in a while articles that address the issue.
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