| 2044 VA Dental Diabetes Study: Adverse events report | ||
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L.C. MCCOY1, R.I. GARCIA2, E.A. KRALL2, M.A. PUCCIO1, S.E. RICH1, C.L. CHRISTIANSEN3, D.R. MILLER3, J. ROTHENDLER3, and J.A. JONES4, 1VA Medical Center, Bedford, MA, USA, 2Boston University School of Dental Medicine, MA, USA, 3VA Medical Center, Bedford & Boston University, MA, USA, 4VA Medical Center, Bedford & Boston University Schools of Dental Medicine and Public Health, MA, USA Objectives: An important feature of clinical trials is an evaluation of adverse events. Poorly controlled diabetics (HbA1c>9) were randomized into four groups in a trial of the efficacy of periodontal therapy on glycemic control. This paper reports on adverse events encountered to date. Methods: The PI reviewed all participants' health records prior to participation. A questionnaire and detailed health history were completed by each patient prior to the clinical examination. Ultrasonic periodontal scaling was performed with 0.12% chlorhexidine gluconate (CHX) lavage. CHX was also used twice daily for four months. Doxycycline 100mg orally was prescribed daily for 14 days. Participants were informed of possible side effects and given drug information sheets derived from MicroMedex® software. Questionnaires assessed adverse events, with follow-up questionnaires administered verbally to participants who experienced adverse events. Results: Thirty-nine patients have received treatment in this study (mean age=60.2 years). Of those, eleven (28%) have experienced mild to severe adverse events, (mean age=62.9 years). Seven participants, (18%), experienced mild to severe gastro-intestinal irritations or rashes from doxycycline. Two participants (5%) experienced events with CHX including mild to severe wheezing, rash, swollen face, lips and tongue, and gastro-intestinal irritations. One participant had a rash unrelated to the medicines and one had a reaction following a study procedure. Conclusions: Adverse events were common in older, medically compromised, poorly controlled diabetics treated with doxycycline and CHX in a clinical trial of periodontal care and glycemic control. Careful monitoring of persons taking medications for treatment of periodontal disease is warranted, particularly among poorly controlled diabetics. Supported by VA HSR&D QUERI DII-99.206 and NIH grant K24 DE00419. mccoyl@bu.edu | ||
| Seq #191 - Systemic Health Issues in Geriatric Oral Health 11:00 AM-12:15 PM, Friday, 8 March 2002 San Diego Convention Center Exhibit Hall C | ||
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