This was a very interesting posting which brings to light some important points regarding the current status of LABAs (Long Acting Beta Agonist such as Serevent and Foradil, also referred to as Long Acting Bronchodilators).
Interestingly, the recently published (2007) and publically available NIH guidelines for managing asthma, continue to have medications which contain LABAs (combination: LABA and inhaled steroid) positioned as preferred medications for patients with moderate to severe persistent asthma. The panel of asthma experts emphasize the importance of not using LABAs alone, to control asthma. As well, they should not be used as reliever medications (not for as needed use to reduce chest symptoms).
Advair has been utilized in numerous studies comparing it to other controller agents such as Cromolyn, Theophylline and Singulair. These studies have consistently shown Advair to be better at reducing asthma symptoms and attacks. The evidence is so overwhelming that the NIH panel and World Health Organization support and advocate the use of medications like Advair for managing asthma, not adequately responsive to low or medium dose inhaled steroids.
The 4000 deaths attributed to Salmeterol, mentioned in the Annals article, was actually a terrible misconception. There are currently just over 4000 deaths from asthma in the United States annually, overall. There are no published reports I am aware of suggesting or stating that any significant portion of the deaths related to asthma in this country are a result of, or associated with patients taking Salmeterol, Advair or related inhalants. Evidence for this statement in the article was not referenced and has been criticized in scientific forums.
Finally, I often discuss the Black Box Warnings with my patients on Advair or Symbicort and explain to them that the medication that prompted the warnings was used separately in the SMART study (Advair was not used in the SMART study). Patients in the study were instructed to continue taking their controller medications over the 28 weeks. They were not followed up (no follow-up doctor visits) to assure that they continued their controller medications (e.g. inhaled steroids). In fact, less than half of the patients were on inhaled steroids. This may explain why the same tendency (to have worsening asthma or life threatening attacks) has not been seen as a trend in clinical trials of patients on Advair or Symbicort. In these medications, again, you get your inhaled steroid with each puff, along with the LABA.
With appropriate monitoring of patients, any medication that fails to improve asthma control or worsens it will be identified and stopped.
I continue to widely prescribe Advair or Symbicort, both of which have Black Box Warnings (because of the LABA in it). I have experienced very satisfying results with the majority of my patients.
The most striking data implicating Salmeterol in the SMART study was on African-Americans. Many asthma experts (including me) think the association was higher in blacks because this subgroup had more severe asthma going into the study, and as well were less often on inhaled steroids. Review of study data supports this observation (blacks in the study had more severe asthma at the start). I continue to manage many of my African-American patients with Advair or Symbicort (if the disease severity level warrants it).
Because of the Black Box Warnings, relative to Salmeterol (brand- Serevent), I no longer prescribe this medication (Serevent) for use alone (only as a combination inhaler, with inhaled steroid) in asthma treatment.
I completely agree with your concluding statements. Thanks for addressing this important topic.
James T.
This was a very interesting posting which brings to light some important points regarding the current status of LABAs (Long Acting Beta Agonist such as Serevent and Foradil, also referred to as Long Acting Bronchodilators).
Interestingly, the recently published (2007) and publically available NIH guidelines for managing asthma, continue to have medications which contain LABAs (combination: LABA and inhaled steroid) positioned as preferred medications for patients with moderate to severe persistent asthma. The panel of asthma experts emphasize the importance of not using LABAs alone, to control asthma. As well, they should not be used as reliever medications (not for as needed use to reduce chest symptoms).
Advair has been utilized in numerous studies comparing it to other controller agents such as Cromolyn, Theophylline and Singulair. These studies have consistently shown Advair to be better at reducing asthma symptoms and attacks. The evidence is so overwhelming that the NIH panel and World Health Organization support and advocate the use of medications like Advair for managing asthma, not adequately responsive to low or medium dose inhaled steroids.
The 4000 deaths attributed to Salmeterol, mentioned in the Annals article, was actually a terrible misconception. There are currently just over 4000 deaths from asthma in the United States annually, overall. There are no published reports I am aware of suggesting or stating that any significant portion of the deaths related to asthma in this country are a result of, or associated with patients taking Salmeterol, Advair or related inhalants. Evidence for this statement in the article was not referenced and has been criticized in scientific forums.
Finally, I often discuss the Black Box Warnings with my patients on Advair or Symbicort and explain to them that the medication that prompted the warnings was used separately in the SMART study (Advair was not used in the SMART study). Patients in the study were instructed to continue taking their controller medications over the 28 weeks. They were not followed up (no follow-up doctor visits) to assure that they continued their controller medications (e.g. inhaled steroids). In fact, less than half of the patients were on inhaled steroids. This may explain why the same tendency (to have worsening asthma or life threatening attacks) has not been seen as a trend in clinical trials of patients on Advair or Symbicort. In these medications, again, you get your inhaled steroid with each puff, along with the LABA.
With appropriate monitoring of patients, any medication that fails to improve asthma control or worsens it will be identified and stopped.
I continue to widely prescribe Advair or Symbicort, both of which have Black Box Warnings (because of the LABA in it). I have experienced very satisfying results with the majority of my patients.
The most striking data implicating Salmeterol in the SMART study was on African-Americans. Many asthma experts (including me) think the association was higher in blacks because this subgroup had more severe asthma going into the study, and as well were less often on inhaled steroids. Review of study data supports this observation (blacks in the study had more severe asthma at the start). I continue to manage many of my African-American patients with Advair or Symbicort (if the disease severity level warrants it).
Because of the Black Box Warnings, relative to Salmeterol (brand- Serevent), I no longer prescribe this medication (Serevent) for use alone (only as a combination inhaler, with inhaled steroid) in asthma treatment.
I completely agree with your concluding statements. Thanks for addressing this important topic.
James T.