Interview with Alejandro Hoberman M.D., Dept. of Pediatrics, University of Pittsburgh School of Medicine
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AO/Beck: Good Morning Dr. Hoberman. I'd like to start this discussion by getting a little information on you. Where do you practice?
Hoberman: I am in the Department of Pediatrics at the University of Pittsburgh School of Medicine, and I'm on the faculty of the Children's Hospital in Pittsburgh.
AO/Beck: Would you please summarize your recent findings regarding Augmentin ES?
Hoberman: First of all it is important to emphasize that drug resistant ear infections have increased some 300 percent over the past five years, according to the Centers for Disease Control (CDC). This is a staggering increase. Additionally, as you can imagine, and as you witness in your clinical practice, children's ear infections have become progressively more difficult to treat.
AO/Beck: What is the most recent number you have regarding how many visits to the physician are prompted by otitis media in children across the USA.
Hoberman: Currently, we use the number - 30 million patient visits per year in the USA. Additionally, we know that middle ear infections are highly prevalent and certainly not all children with middle ear infections are brought to the office, so the actual incidence could be higher. Also, the 30 million includes the total number of children brought to either the ER, the pediatrician, the otolaryngologist and all combined medical visits.
AO/Beck: What are the primary symptoms you look for to make the diagnosis?
Hoberman: The primary symptoms of acute OM include; otalgia, including unaccustomed tugging or rubbing of the ear, hearing loss, and certainly there can be associated fever and cold like symptoms. However, acute OM can also be present in asymptomatic children. OM impacts more than just the child. Most often the family is inconvenienced too, due to time off from work to take care of the child, the costs of the medicines and the costs of medical care.
AO/Beck: Specifically, with regards to your new study, what did you find?
Hoberman: We looked at 521 children, aged 3 to 48 months in a multi-center trial. We cultured fluid from their middle ears via tympanocentesis, to determine the pathogen. Of those with bacterial infections, Augmentin ES eradicated 96 percent of the penicillin-resistant S. pneumoniae, and Augmentin ES eradicated 100 percent of the penicillin-susceptible S. pneumoniae. In addition, other common bacteria were also eradicated in the 95 to 100 percent range, including; H. influenzae and M. catarrhalis.
AO/Beck: Dr. Hoberman, is the new Augmentin essentially the same as the earlier version of Augmentin, just a higher dose?
Hoberman: Yes, the new version and the original contain the same amount of clavulanic acid. The new formulation is called ES, or extra strength, because it contains twice the amount of amoxicillin. The original version has been available for some 16 years now.
AO/Beck: What are the contraindications for Augmentin ES?
Hoberman: The contraindications for ES are the same as for the standard product. Certainly if a child is allergic to penicillin, they cannot be treated with either Augmentin product.
AO/Beck: What are the side effects associated with Augmentin ES?
Hoberman: The side effects are essentially the same as the side effects for any penicillin derived medicine. About 10 to 12 percent of the patients will experience some diarrhea. Overall, Augmentin is an extremely safe drug, it is well tolerated and they ES version has maintained the safety profile of the earlier formulation.
AO/Beck: Doctor Hoberman, are you concerned that with Augmentin ES we may actually be increasing the overall rate of drug resistant 'superinfections?'
Hoberman: Nobody can predict the future, but there is no direct evidence to support that hypothesis. Importantly, there is some evidence that when you kill bacteria (both susceptible and resistant strains) with a highly efficacious drug, repopulation occurs with susceptible strains because they are more common. When you use less efficacious drug, you might be only killing susceptible strains, and accordingly selecting resistant strains. In other words, if you have a beast around that is threatening you, you don't go around poking at it, the goal is to chop it's head off! That's what this antibiotic is doing.
AO/Beck: Are there any topical varieties of this drug, or other ear drops with similar success rates?
Hoberman: No, this is strictly available as an oral medicine.
AO/Beck: What percentage of all episodes of OM are indeed bacterial? That is, with respect to viral versus bacterial infections, what percentage of all cases of OM are indeed bacterial and can be successfully treated with Augmentin ES?
Hoberman: We did not look at that in the context of this study. It has been well documented in other studies that viral upper respiratory infections, via eustachian tube dysfunction, predispose to acute otitis media. Children followed in this study were the ones proven to have bacterial infections, based on tympanocentesis results. Nonetheless, the way I think about this issue is that viruses predispose children with acute OM to bacterial infection. That is, once you have true OM, which is the presence of middle-ear effusion plus findings of acute inflammation (ear pain, bulging or distinct erythema of the tympanic membrane), there is usually a bacterial pathogen causing it.
AO/Beck: Thank you doctor, I appreciate your time this morning.
Hoberman: I am in the Department of Pediatrics at the University of Pittsburgh School of Medicine, and I'm on the faculty of the Children's Hospital in Pittsburgh.
AO/Beck: Would you please summarize your recent findings regarding Augmentin ES?
Hoberman: First of all it is important to emphasize that drug resistant ear infections have increased some 300 percent over the past five years, according to the Centers for Disease Control (CDC). This is a staggering increase. Additionally, as you can imagine, and as you witness in your clinical practice, children's ear infections have become progressively more difficult to treat.
AO/Beck: What is the most recent number you have regarding how many visits to the physician are prompted by otitis media in children across the USA.
Hoberman: Currently, we use the number - 30 million patient visits per year in the USA. Additionally, we know that middle ear infections are highly prevalent and certainly not all children with middle ear infections are brought to the office, so the actual incidence could be higher. Also, the 30 million includes the total number of children brought to either the ER, the pediatrician, the otolaryngologist and all combined medical visits.
AO/Beck: What are the primary symptoms you look for to make the diagnosis?
Hoberman: The primary symptoms of acute OM include; otalgia, including unaccustomed tugging or rubbing of the ear, hearing loss, and certainly there can be associated fever and cold like symptoms. However, acute OM can also be present in asymptomatic children. OM impacts more than just the child. Most often the family is inconvenienced too, due to time off from work to take care of the child, the costs of the medicines and the costs of medical care.
AO/Beck: Specifically, with regards to your new study, what did you find?
Hoberman: We looked at 521 children, aged 3 to 48 months in a multi-center trial. We cultured fluid from their middle ears via tympanocentesis, to determine the pathogen. Of those with bacterial infections, Augmentin ES eradicated 96 percent of the penicillin-resistant S. pneumoniae, and Augmentin ES eradicated 100 percent of the penicillin-susceptible S. pneumoniae. In addition, other common bacteria were also eradicated in the 95 to 100 percent range, including; H. influenzae and M. catarrhalis.
AO/Beck: Dr. Hoberman, is the new Augmentin essentially the same as the earlier version of Augmentin, just a higher dose?
Hoberman: Yes, the new version and the original contain the same amount of clavulanic acid. The new formulation is called ES, or extra strength, because it contains twice the amount of amoxicillin. The original version has been available for some 16 years now.
AO/Beck: What are the contraindications for Augmentin ES?
Hoberman: The contraindications for ES are the same as for the standard product. Certainly if a child is allergic to penicillin, they cannot be treated with either Augmentin product.
AO/Beck: What are the side effects associated with Augmentin ES?
Hoberman: The side effects are essentially the same as the side effects for any penicillin derived medicine. About 10 to 12 percent of the patients will experience some diarrhea. Overall, Augmentin is an extremely safe drug, it is well tolerated and they ES version has maintained the safety profile of the earlier formulation.
AO/Beck: Doctor Hoberman, are you concerned that with Augmentin ES we may actually be increasing the overall rate of drug resistant 'superinfections?'
Hoberman: Nobody can predict the future, but there is no direct evidence to support that hypothesis. Importantly, there is some evidence that when you kill bacteria (both susceptible and resistant strains) with a highly efficacious drug, repopulation occurs with susceptible strains because they are more common. When you use less efficacious drug, you might be only killing susceptible strains, and accordingly selecting resistant strains. In other words, if you have a beast around that is threatening you, you don't go around poking at it, the goal is to chop it's head off! That's what this antibiotic is doing.
AO/Beck: Are there any topical varieties of this drug, or other ear drops with similar success rates?
Hoberman: No, this is strictly available as an oral medicine.
AO/Beck: What percentage of all episodes of OM are indeed bacterial? That is, with respect to viral versus bacterial infections, what percentage of all cases of OM are indeed bacterial and can be successfully treated with Augmentin ES?
Hoberman: We did not look at that in the context of this study. It has been well documented in other studies that viral upper respiratory infections, via eustachian tube dysfunction, predispose to acute otitis media. Children followed in this study were the ones proven to have bacterial infections, based on tympanocentesis results. Nonetheless, the way I think about this issue is that viruses predispose children with acute OM to bacterial infection. That is, once you have true OM, which is the presence of middle-ear effusion plus findings of acute inflammation (ear pain, bulging or distinct erythema of the tympanic membrane), there is usually a bacterial pathogen causing it.
AO/Beck: Thank you doctor, I appreciate your time this morning.
