Boehringer Ingelheim Welcomes Central Role of LAMA/LABA Therapy within 2017 GOLD Strategy for COPD
- Treatment recommendations are tailored to patient needs based on symptoms and exacerbation history
- LABA/LAMA therapy identified as an important option for people with moderate to very severe COPD (GOLD stage B-D)
- ICS-containing pharmaceutical regimens no longer recommended as first-choice treatments for COPD of any severity
RIDGEFIELD, Conn., November 17, 2016 – Boehringer Ingelheim Pharmaceuticals Inc. welcomes the updated 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Strategy, which identifies a significant role for a combination of a LAMA (long-acting anticholinergic) and a LABA (long-acting beta2-agonist) within the treatment algorithms for people with moderate to very severe chronic obstructive pulmonary disease (COPD). The updated GOLD Strategy recognizes that LABA/LAMA therapy helps to improve airflow and symptoms, while reducing the risk of exacerbations. With its focus on individualized therapy, the updated GOLD Strategy also provides clear guidance on the limitations of inhaled corticosteroids (ICS) or ICS/LABA combinations in the treatment of all severities of COPD.
“The new GOLD Strategy represents a significant change compared to previous GOLD guidelines, and we applaud this important effort to provide healthcare providers with new recommendations that are informed by the latest evidence and that seek to improve the care of COPD,” said Danny McBryan, MD, Head, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “The updated GOLD Strategy offers healthcare providers a new framework for their patients – including when to consider LABA/LAMA therapy and how ICS therapy should have a limited role.”
The 2017 GOLD Global Strategy for the Diagnosis, Management and Prevention of COPD reflects the latest evidence from published scientific research,which has shown the added benefits of treatment with a LABA/LAMA, compared to the monocomponents alone.
This latest evidence includes results from the large-scale, Phase III TOviTO® clinical trial program, which showed that a LABA/LAMA, STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray, significantly improved lung function and health-related quality of life for people with COPD across all levels of disease severity, compared to tiotropium alone.
About COPD
Chronic obstructive pulmonary disease (COPD) is a term that includes chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.
The most common symptom of COPD is shortness of breath, especially with physical activities. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.
INDICATION for STIOLTO RESPIMAT
STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, two puffs once each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
STIOLTO contains the anticholinergic, tiotropium, and the long-acting beta2-adrenergic agonist (LABA), olodaterol. STIOLTO works by helping the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath.
STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, contact your healthcare provider to have one prescribed for you.
Do not use STIOLTO if you have asthma. STIOLTO is approved to treat COPD only.
IMPORTANT SAFETY INFORMATION
People with asthma who take long-acting beta2-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), have an increased risk of death from asthma problems. It is not known if LABA medicines, such as olodaterol (one of the medicines in STIOLTO), increase the risk of death in people with COPD. STIOLTO has been approved for chronic obstructive pulmonary disease (COPD) only. STIOLTO is NOT to be used in asthma.
Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO. Symptoms of a serious allergic reaction may include rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction. Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
Do not use STIOLTO more often or at higher doses than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO.
Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines (including eye drops), vitamins, and herbal supplements. STIOLTO may interact with other medicines which may cause serious side effects.
STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, high blood sugar, or low blood potassium that may cause muscle spasms or weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help.
STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away.
STIOLTO can cause new or worsened urinary retention. Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking your medicine and call your doctor right away.
STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler.
Do not spray STIOLTO into your eyes.
The most common side effects of STIOLTO are runny nose, cough, and back pain.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler.
Please see accompanying Medication Guide, Instructions for Use, and Full Prescribing Information, including boxed WARNING.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.
For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.
PC-00960