Risk Factors & Impact

Serious Disease with Serious Consequences

COPD: A Leading Cause of Death

Although it has been difficult to quantify the prevalence of Chronic Obstructive Pulmonary Disease (COPD) due to the variable definitions of the disease, lack of clear recognition and under-diagnosing, COPD is known to be one of the leading causes of death, worldwide.1,16,17,21

In some countries, under-reporting may occur in patients with mild COPD because they may have no symptoms or their symptoms of chronic cough and sputum may not be perceived to be indicators of COPD.1 Countries that use spirometry or other standardized methods to diagnose patients report that nearly one-fourth of adults aged 40 years and older may have airflow limitations caused by COPD.1

COPD: Death Rate Climbing 16,17,21

* Rates are age-adjusted to the 2000 U.S. standard population.

By the year 2020, The Global Burden of Disease Study has projected that COPD will rank as the third leading cause of death.1

Identifying Risk Factors

Understanding the risk factors and reducing exposure to risk factors are important considerations when devising an effective COPD treatment strategy for your patients. Smoking is the most commonly encountered (and studied) risk factor for COPD.1 Reduction of exposure to tobacco smoke, occupational dusts and chemicals, and indoor and outdoor pollutants, including smoke from cooking over biomass fueled fires, are important goals to prevent the onset and progression of COPD.1 Additional risk factors include:1

  • Genetic factors (alpha -1 antitrypsin [AAT] deficiency—a severe deficiency and rare recessive trait commonly seen in individuals of Northern European origin)
  • Inhalation exposures
  • Gender
  • Infection
  • Socioeconomic status

Comorbidities

There are numerous comorbidities associated with COPD, which occur with greater frequency in patients of increasing age.1 It is estimated that 25% of patients over 65 years of age suffer from at least two of the five most chronic conditions, including COPD.1 These comorbidities can severely impact your patients' quality of life.1,18

Comorbidities Associated with COPD1,18

Impact: Financial Burden of COPD

COPD carries a very heavy financial burden that is measured in direct costs (diagnosis and management) and indirect costs (missed work, premature mortality, caregiver/family costs resulting from illness).1 As the severity of COPD progresses, so do the corresponding costs of care.1

  • Exacerbations, which are very common, affecting about 20% of patients with moderate-to-severe COPD, are the most expensive burden of COPD, in developed countries, in both direct and indirect costs1,5
    • $18 billion accounted for direct costs of COPD in the U.S., in 20021
    • $14 billion accounted for indirect costs of COPD in the U.S., in 20021
  • In Europe, COPD is responsible for 56% of the cost of respiratory infections, which accounts for 6% of the burden of health care1

Impact: Treatment Burden of COPD

Twice-daily dosing with a nebulized LABA can reduce the treatment burden associated with more frequent dosing with short-acting beta2-agonists (SABA) that patients use several times throughout the day.1

Impact: Long-term Care

Prevalence of diagnosed COPD in nursing home residents is rising—nearly one-fifth of the residents are diagnosed with COPD. In addition, from 2002 to 2009, COPD in nursing homes increased by 20%.19

Patients with COPD in long-term care settings are typically prescribed inhalers for symptom management. However, many patients have physical and/or cognitive challenges that may make it difficult for them to perform the activities of daily living or comply with the administration requirements of inhalers.4,10,11 The ability to use an inhaler can be impaired by these physical conditions, which are common among elderly nursing home residents, such as:3

  • Arthritis (33%)1,19
  • Stroke (20%)
  • Parkinson's disease (6%)
  • Hearing difficulty (28%)

Nebulization may address the needs of those who are cognitively impaired or physically challenged.2,3 There is an important long-term solution for patients with COPD in long-term care—twice-daily nebulization with PERFOROMIST® Inhalation Solution.

Please see accompanying full Prescribing Information, including Boxed Warning.

Indication

PERFOROMIST® (formoterol fumarate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Important Limitations for Use:

  • It is not indicated to treat acute deteriorations of COPD
  • It is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol, the active ingredient in PERFOROMIST Inhalation Solution.
The safety and efficacy of PERFOROMIST in patients with asthma have not been established. All LABA, including PERFOROMIST, are contraindicated in patients with asthma without use of a long-term asthma control medication.

Important Safety Information

PERFOROMIST Inhalation Solution like other LABAs is contraindicated in patients with asthma without use of a long term asthma control medication.

PERFOROMIST Inhalation Solution should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. PERFOROMIST Inhalation Solution should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

As with other inhaled beta2-agonists, PERFOROMIST Inhalation Solution can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, PERFOROMIST Inhalation Solution should be discontinued immediately and alternative therapy instituted.

PERFOROMIST Inhalation Solution should not be used more often, at higher doses than recommended, or in conjunction with other inhaled, long-acting beta2-agonists, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

PERFOROMIST Inhalation Solution should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

PERFOROMIST Inhalation Solution, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, systolic and/or diastolic blood pressure, and/or symptoms.

PERFOROMIST Inhalation Solution, like other sympathomimetic amines, should be used with caution. Doses of the related beta2-agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Beta agonist medications may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Immediate hypersensitivity reactions may occur after administration of PERFOROMIST Inhalation Solution, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.

PERFOROMIST Inhalation Solution, as with other beta2-agonists, should be used with extreme caution in patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.

Beta-blockers and formoterol fumarate may inhibit the effect of each other when administered concurrently. Therefore, patients with COPD should not normally be treated with beta-blockers except under certain circumstances e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-blockers in patients with COPD.

Concomitant treatment with Xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of adrenergic agonists. The EKG changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, so caution is advised in the co-administration.

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.