Post by highskier on May 17, 2022 16:49:29 GMT
Teva Announces New Findings Highlighting Potential of ProAir® Digihaler® (albuterol sulfate) Inhalation Powder to Address Asthma Treatment Challenges
Results were presented in a late-breaking oral session at the ATS 2022 annual meeting
TEL AVIV, Israel & PARSIPPANY, N.J., May 17, 2022--(BUSINESS WIRE)--Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced new study findings based on newly established clinical thresholds on short-acting beta agonist (SABA) use that highlight real-world SABA usage among patients with asthma in the U.S. and the potential for ProAir® Digihaler® (albuterol sulfate) inhalation powder, a digital inhaler, to help inform treatment discussions and decisions. The findings were presented in a late-breaking oral session at the American Thoracic Society (ATS) 2022 Annual Meeting.
Among the study findings, nearly one-third of asthma patients made 138 or more inhalations during the 12-week study period, which was equivalent to 600 or more inhalations, or three or more canisters, per year. In this study analysis, valid inhalations are defined as events when the patient inhales at a peak inspiratory flow (PIF) rate between >18 to <120 liters/minute with no errors in use. The findings are the first application of evidence-based clinical statements from an independent U.S. expert consensus that identify risk of asthma exacerbation, including potential for a life-threatening event, based on patients’ SABA overuse. These results suggest digital inhalers may help healthcare professionals identify and address SABA reliever overuse and help inform clinical decision-making based on individual insights from objective patient SABA reliever usage data downloaded directly from their ProAir Digihaler.
"These findings shed important light on patients’ real-world use of SABA and the potential of objective data from digital health tools like ProAir Digihaler to help inform treatment decisions," said Tanisha Hill, Senior Medical Director, Respiratory and Digital Health Medical Lead at Teva. "The findings suggest that, with ProAir Digihaler, accurate and objective data on reliever inhaler use can help facilitate treatment discussions between providers and patients."
"Many patients with poorly controlled asthma rely on SABA when they have an asthma exacerbation," said Njira Lugogo, MD, Clinical Associate Professor, University of Michigan, and lead study author. "Our research shows that there is a gap between clinical recommendations and real-world management of asthma, and shows how digital tools, such as ProAir Digihaler, may help address some of these challenges."
Data on SABA usage among 359 patients downloaded from ProAir Digihaler devices were used to apply and validate clinical action thresholds for risk associated with SABA reliever overuse established by independent expert consensus. Patients made one or more valid inhalations (PIF >18 to <120 with no errors in use) from a ProAir Digihaler device over a 12-week period. Elevated SABA use among sub-optimally controlled asthma patients was found to be more common than previously understood.1 Detailed results include:
89% (319/359) of patients met the consensus threshold of SABA reliever medication use that is ≥100% over baseline during one or more study weeks, and 72% (260/359) met the threshold of SABA reliever medication use ≥200% above baseline. These thresholds were determined by independent consensus to likely indicate impending or ongoing exacerbation.1
17% (62/359) of patients made 25 or more valid inhalations in a week, a level associated with unanimous consensus of likely impending or ongoing exacerbation.1 This included 14% (40/295) of patients who did not have a confirmed exacerbation.1
Nearly one-third of patients (29%, 104/359) exhibited a rate of SABA reliever use over 12 weeks equivalent to three or more canisters per year, which was determined by consensus to be associated with increased risk of asthma exacerbation and death.1 This included 52% (33/64) of patients who had asthma exacerbations during the study period, and 24% (71/295) who did not have confirmed exacerbations.1
About ProAir Digihaler
ProAir Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people ≥4 years of age for the treatment or prevention of bronchospasm in people who have reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
The Digihaler Inhalers are the first family of smart inhalers with built-in sensors that capture personal inhaler data and allow patients to track and share their data. ProAir Digihaler (albuterol sulfate) Inhalation Powder is the first and only breath-actuated, digital short-acting beta agonist (SABA) inhaler with built-in flow sensors that detect, record and store objective data showing how often and how well patients use their rescue inhaler, as measured by inspiratory flow. Patients are able to view their personalized data on the Digihaler app and can share it with a healthcare provider to inform their asthma treatment plan, facilitate dialogue and guide decisions around treatment adjustments. This personal inhaler data can record how well a patient uses their inhaler by measuring the strength of inhalations, indicating when inhaler technique may need improvement. In addition, the data can capture rescue inhaler user patterns over time and show trends indicating when increasing SABA use might be associated with disease worsening.
Important Safety Information About ProAir Digihaler
Contraindications: ProAir Digihaler (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose
Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs.
Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids
Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma
Hypersensitivity Reactions including Anaphylaxis: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler
Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines
Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation
Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting
Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler
Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy
Please read the full Prescribing Information.
TEL AVIV, Israel & PARSIPPANY, N.J., May 17, 2022--(BUSINESS WIRE)--Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced new study findings based on newly established clinical thresholds on short-acting beta agonist (SABA) use that highlight real-world SABA usage among patients with asthma in the U.S. and the potential for ProAir® Digihaler® (albuterol sulfate) inhalation powder, a digital inhaler, to help inform treatment discussions and decisions. The findings were presented in a late-breaking oral session at the American Thoracic Society (ATS) 2022 Annual Meeting.
Among the study findings, nearly one-third of asthma patients made 138 or more inhalations during the 12-week study period, which was equivalent to 600 or more inhalations, or three or more canisters, per year. In this study analysis, valid inhalations are defined as events when the patient inhales at a peak inspiratory flow (PIF) rate between >18 to <120 liters/minute with no errors in use. The findings are the first application of evidence-based clinical statements from an independent U.S. expert consensus that identify risk of asthma exacerbation, including potential for a life-threatening event, based on patients’ SABA overuse. These results suggest digital inhalers may help healthcare professionals identify and address SABA reliever overuse and help inform clinical decision-making based on individual insights from objective patient SABA reliever usage data downloaded directly from their ProAir Digihaler.
"These findings shed important light on patients’ real-world use of SABA and the potential of objective data from digital health tools like ProAir Digihaler to help inform treatment decisions," said Tanisha Hill, Senior Medical Director, Respiratory and Digital Health Medical Lead at Teva. "The findings suggest that, with ProAir Digihaler, accurate and objective data on reliever inhaler use can help facilitate treatment discussions between providers and patients."
"Many patients with poorly controlled asthma rely on SABA when they have an asthma exacerbation," said Njira Lugogo, MD, Clinical Associate Professor, University of Michigan, and lead study author. "Our research shows that there is a gap between clinical recommendations and real-world management of asthma, and shows how digital tools, such as ProAir Digihaler, may help address some of these challenges."
Data on SABA usage among 359 patients downloaded from ProAir Digihaler devices were used to apply and validate clinical action thresholds for risk associated with SABA reliever overuse established by independent expert consensus. Patients made one or more valid inhalations (PIF >18 to <120 with no errors in use) from a ProAir Digihaler device over a 12-week period. Elevated SABA use among sub-optimally controlled asthma patients was found to be more common than previously understood.1 Detailed results include:
89% (319/359) of patients met the consensus threshold of SABA reliever medication use that is ≥100% over baseline during one or more study weeks, and 72% (260/359) met the threshold of SABA reliever medication use ≥200% above baseline. These thresholds were determined by independent consensus to likely indicate impending or ongoing exacerbation.1
17% (62/359) of patients made 25 or more valid inhalations in a week, a level associated with unanimous consensus of likely impending or ongoing exacerbation.1 This included 14% (40/295) of patients who did not have a confirmed exacerbation.1
Nearly one-third of patients (29%, 104/359) exhibited a rate of SABA reliever use over 12 weeks equivalent to three or more canisters per year, which was determined by consensus to be associated with increased risk of asthma exacerbation and death.1 This included 52% (33/64) of patients who had asthma exacerbations during the study period, and 24% (71/295) who did not have confirmed exacerbations.1
About ProAir Digihaler
ProAir Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people ≥4 years of age for the treatment or prevention of bronchospasm in people who have reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
The Digihaler Inhalers are the first family of smart inhalers with built-in sensors that capture personal inhaler data and allow patients to track and share their data. ProAir Digihaler (albuterol sulfate) Inhalation Powder is the first and only breath-actuated, digital short-acting beta agonist (SABA) inhaler with built-in flow sensors that detect, record and store objective data showing how often and how well patients use their rescue inhaler, as measured by inspiratory flow. Patients are able to view their personalized data on the Digihaler app and can share it with a healthcare provider to inform their asthma treatment plan, facilitate dialogue and guide decisions around treatment adjustments. This personal inhaler data can record how well a patient uses their inhaler by measuring the strength of inhalations, indicating when inhaler technique may need improvement. In addition, the data can capture rescue inhaler user patterns over time and show trends indicating when increasing SABA use might be associated with disease worsening.
Important Safety Information About ProAir Digihaler
Contraindications: ProAir Digihaler (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose
Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs.
Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids
Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma
Hypersensitivity Reactions including Anaphylaxis: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler
Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines
Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation
Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting
Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler
Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy
Please read the full Prescribing Information.