Boehringer Ingelheim Welcomes New 2023 GOLD Report Positioning LAMA/LABA as the Preferred Treatment for the Majority of Patients with COPD

• The 2023 GOLD Report recommends LAMA, LABA or LAMA+LABA therapy as the initial treatment for patients with COPD
• Based on GOLD criteria, a LAMA/LABA, such as STIOLTO^® RESPIMAT^®, is now the optimal first-line treatment for most patients with COPD

RIDGEFIELD, Conn. and NORWALK, Conn., Nov. 17, 2022 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals Inc. welcomes the updated 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Report recommending long‐acting muscarinic antagonist (LAMA) plus long‐acting beta‐agonist (LABA) as the optimal first-line treatment option for most patients with COPD (chronic obstructive pulmonary disease), regardless of exacerbation risk. According to GOLD, LAMA, LABA or LAMA+LABA therapy should be used as the initial treatment for the majority of patients with COPD, regardless of exacerbation risk. Based on GOLD criteria, a LAMA/LABA, such as STIOLTO^® RESPIMAT^®, is now the preferred treatment for the majority of patients with COPD.

These updates are essential to help provide optimal treatment to patients with COPD, who are facing one of the top three causes of death worldwide. For healthcare providers, these updates confirm LAMA/LABAs are central to COPD disease management across most patient groups.

"It is crucial that healthcare providers have the latest information to offer their patients the best possible care," said Brian DiDonato, Vice President, Respiratory & Established Brands. "As a company with over 100 years in Respiratory, we keep patients at the center of everything we do. We applaud the continued effort from GOLD to better the lives of patients with COPD by providing a framework for treatment approaches based on the latest evidence."

The recommendations provide healthcare providers with more clarity on how to optimize treatment for their patients with COPD. With the 2023 Report, GOLD no longer encourages the use of a LABA+ICS combination in COPD.

"From a physician's perspective, we are always grateful to receive well-vetted and informed recommendations on how we can best utilize available treatment options to provide the most benefit to our patients," said Antonio Anzueto, M.D., Professor of Medicine, Pulmonary Critical Care, University of Texas Health San Antonio. "The new 2023 GOLD recommendations represent a meaningful change for the treatment of COPD by prioritizing the utilization of a fixed LAMA/LABA combination."

These recommendations reflect results from the large-scale, Phase III TOviTO^® clinical trial program showing 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.

APPROVED USE for STIOLTO RESPIMAT (tiotropium bromide and olodaterol) Inhalation Spray  

STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs 1 time 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 is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms.

STIOLTO is not for asthma.

IMPORTANT SAFETY INFORMATION for STIOLTO RESPIMAT

Do not use STIOLTO if you have asthma. People with asthma who take long-acting beta₂-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death.

Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO.

Call your healthcare provider or get emergency medical care if you experience symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing. 

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.

Do not use STIOLTO more often than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics.

Do not use STIOLTO for treating sudden breathing problems.  Always have a rescue inhaler with you to treat sudden symptoms.

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.

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, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle 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 STIOLTO 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 STIOLTO and call your doctor right away.

The most common side effects of STIOLTO are runny nose, cough, and back pain.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. STIOLTO and certain other medicines may affect each other.

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. Your vision may become blurred and your pupils may become larger (dilated). 

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 full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT.

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. Learn more at www.boehringer-ingelheim.com.

About the Respimat Inhaler

The RESPIMAT inhaler was designed to get the medicine deep into patients' lungs. The RESPIMAT inhaler operates independent of inspiratory effort and the slow-moving mist helps patients inhale the medicine.

As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as coordination between actuation of the inhaler and inspiration through the delivery system. The duration of inhalation should be at least as long as the spray duration (1.5 seconds).

Boehringer Ingelheim's RESPIMAT family of products includes five FDA-approved medicines for respiratory diseases.

CONTACT:
Tyler Rescigno
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.