I wish to raise awareness about and concern for dental problems that might be complicated by the new Exubera therapy and other therapies employing the dry powder inhaler (DPI) technology as a means of administering therapeutic medications.

My concerns are as follows:

1. Periodontal disease: No mention in any clinical trials indicated that patients involved had a history of periodontal disease. Given that periodontal disease can increase in severity depending on BG control, this should be further evaluated prior to initiating treatment. Since the dry powder coats the soft tissues in the oral cavity, it would be advisable to see if there are any problems with infected or inflamed periodontal tissues (active untreated disease).

2. Interaction with a removable or fixed dental appliance and dental restorative materials: No studies have been or were performed to evaluate potential chemical or mechanical interference of a dry powder material with

• orthodontic wires and brackets made of nickel-titanium; brackets are chemically bonded to enamel tooth structure.
• chemically bonded, light-cured resins used for restorative purposes on teeth.
• physical displacement of a denture or partial denture prostheses during inhalation of a dry powder therapeutic agent. There exists the potential risk of physical interference during inhalation due to displacement of the prosthesis from the oral tissues. Air passage between the prosthesis and tissue increases the likelihood that more of a therapeutic dose would adhere to these items and not reach the intended tissue for absorption.

I have posed several questions and concerns with regard to the use of this type of therapeutic device, in particular, the Exubera inhaler. I am concerned that there exists the potential for further oral health complications and dosing problems with this product and this form of therapy. The development of certain oral health problems is directly related to the level of glycemic control.

Therefore, I wish to have the following dental recommendations be considered and included in the Exubera Patient Guide:

General Dental Recommendations

A diabetes patient should be referred to a dental professional prior to initiation of dry powder inhaler (DPI) therapy. This is to evaluate any existing oral health problems such as dental decay, periodontal disease, salivary gland disorders, oral infections (Candida) and oral pathology.

Based on those findings, the dental professional should advise the patient on how to optimize his or her oral healthcare and manage or eliminate any existing oral health problems prior to initiation of DPI treatment. The patient should have minimal dental problems that would normally be exacerbated by poorly controlled diabetes.

Patients with physical hand impairments have limited ability to maintain oral hygiene goals. All removable dental prostheses should be removed prior to administration of Exubera. Oral health problems and treatment recommendations should be relayed to the patient’s diabetes care team with some level of frequency as to the patient’s oral health status while utilizing this form of therapy.

Frank Varon, DDS
Omaha, Nebraska