COPD and Alpha-1

Chronic obstructive pulmonary disease (COPD) is an umbrella name for a handful of lung diseases, including bronchitis and emphysema.1 COPD is a leading cause of illness and death worldwide.2 In the United States, COPD is the third leading cause of death.3 Approximately 24 million adults in the United States have airway obstruction or COPD.4

Alpha-1 is the most common genetic risk factor for COPD. Approximately 1 to 3% of all people diagnosed with COPD could have undiagnosed Alpha-1. Because of this fact, the World Health Organization (WHO), the American Thoracic Society (ATS), and the European Respiratory Society (ERS) recommend that patients with COPD that isn't controlled with one of the usual treatments be tested for Alpha-1.6,7

Is it COPD due to Alpha-1?

COPD is the most prevalent clinical disorder associated with Alpha-1.8

Alpha-1 is often not diagnosed in patients with COPD because the symptoms are similar.

  • Shortness of breath
  • Wheezing
  • Chronic cough
  • Recurring chest colds

Testing for Alpha-1

The average Alpha patient experiences symptoms for more than 8 years and sees 3 doctors before being correctly diagnosed with Alpha-1.7 This delay is too long, especially considering the destruction of lung tissue prior to diagnosis. Alpha-1 is easily diagnosed with simple blood tests.

Ask your doctor about a free Grifols AlphaKit that can tell if you have Alpha-1.

PROLASTIN®-C (alpha1-proteinase inhibitor [human]) is indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI (alpha1-antitrypsin deficiency).

The effect of augmentation therapy with any alpha1-proteinase inhibitor (alpha1-PI), including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C are not available.

PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established.

PROLASTIN-C is contraindicated in IgA-deficient patients with antibodies against IgA due to the risk of severe hypersensitivity and in patients with a history of anaphylaxis or other severe systemic reactions to alpha1-PI.

Hypersensitivity reactions, including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. Should hypersensitivity symptoms be observed, promptly stop infusion and begin appropriate therapy. Have epinephrine and other appropriate therapy available for the treatment of any acute anaphylactic or anaphylactoid reaction.

PROLASTIN-C may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.

The most common drug-related adverse reaction observed at a rate of >5% in subjects receiving PROLASTIN-C was upper respiratory tract infection. The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in 1 subject.

Because PROLASTIN-C is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens.

Please click here for full Prescribing Information for PROLASTIN-C.


References

  1. American Thoracic Society, European Respiratory Society. Standards for the Diagnosis and Management of Patients With COPD. 2004. http://www.thoracic.org/sections/copd/resources/copddoc.pdf. Accessed June 18, 2008.
  2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2007. Available at: www.goldcopd.org. Accessed February 18, 2008.
  3. DL Hoyert, JQ Xu. Deaths: preliminary data for 2011. Natl Vital Stat Rep Hyattsville, MD: National Center for Health Statistics2012. 2012;61:1-65.
  4. Mannino DM. COPD: epidemiology, prevalence, morbidity and mortality, and disease heterogeneity. Chest. 2002;121(5 suppl):121S-126S.
  5. Ranes J, Stoller JK. A review of alpha 1 antitrypsin deficiency. Semin Respir Crit Care Med. 2005;26(2):154-166.
  6. Alphas, Friends, and Family: Alpha-1 Lung Disease. http://www.alphaone.org/alphas/?c=03-Alpha-1-Lung-Disease. Accessed September 29, 2009.
  7. Campos MA, Wanner A, Zhang G, Sandhaus RA. Trends in the diagnosis of symptomatic patients with alpha-1 antitrypsin deficiency between 1968 and 2003. Chest. 2005;128(3):1179-1186.
  8. World Health Organization. Bulletin: Alpha1-antitrypsin deficiency: memorandum from a WHO meeting. 1997;75(5):397-415.