title: The influence of a triclosan toothpaste on adverse events in patients with cardiovascular disease over 5-years.
abstract: Adverse effects of long-term usage of triclosan-containing toothpaste in humans are currently unknown. We assessed the effect of long-term use of 0.3% triclosan-toothpaste on serious adverse events (SAEs) in patients with cardiovascular disease (CVD). 438 patients with a history of stable CVD were entered into the 5-year longitudinal Cardiovascular and Periodontal Study at Prince Charles Hospital, Brisbane, Australia and randomised into test (triclosan) or placebo groups. There were no significant differences in demographics or clinical features between the groups. Patients were examined at baseline, and annually for 5-years. SAEs were classified according to the System Organ Classes defined by MedDRA (Medical Dictionary for Regulatory Activities). Results were analysed using chi square and Kaplan Meier analysis. Overall, 232 patients (123 in the triclosan group; 109 in the placebo group) experienced 569 SAEs (288 in the triclosan group and 281 in the placebo group). There was no significant difference between the groups in numbers of patients experiencing SAEs (p=0.35) or specific cardiovascular SAEs (p=0.82), nor in time to the first SAE or first cardiovascular SAE, irrespective of gender, age or BMI after adjusting for multiple comparisons (p>0.05). The adjusted odds of experiencing an SAE were estimated to increase by 2.7% for each year of age (p=0.02) and the adjusted odds of experiencing a cardiovascular SAE were estimated to increase by 5.1% for each unit increase in BMI (p=0.02). Most cardiovascular events were related to unstable angina or myocardial infarcts, 21 were associated with arrhythmia and 41 were vascular events such as aortic aneurysm and cerebrovascular accident. Within the limitations of the present study the data suggest that the use of triclosan-toothpaste may not be associated with any increase in SAEs in this CVD population. The long-term impact of triclosan on hormone-related disease, such as cancer, in humans remains to be determined.
authors.affiliation: School of Medicine, University of Queensland, Prince Charles Hospital, Rode Road, Chermside, Queensland 4032, Australia; Sir John Walsh Research Institute, University of Otago, 310 Great King Street, Dunedin 9016, New Zealand. Electronic address: m.cullinan@uq.edu.au.
authors.forename: Mary P
authors.initials: MP
authors.lastname: Cullinan
authors.affiliation: School of Medicine, University of Queensland, Prince Charles Hospital, Rode Road, Chermside, Queensland 4032, Australia. Electronic address: j.palmer@uq.edu.au.
authors.forename: Janet E
authors.initials: JE
authors.lastname: Palmer
authors.affiliation: Metro North Hospital and Health Service, Prince Charles Hospital, Rode Road, Chermside, Queensland 4032, Australia. Electronic address: Anne_Carle@health.qld.gov.au.
authors.forename: Anne D
authors.initials: AD
authors.lastname: Carle
authors.affiliation: School of Medicine, University of Queensland, Prince Charles Hospital, Rode Road, Chermside, Queensland 4032, Australia. Electronic address: malcolm.west@uq.edu.au.
authors.forename: Malcolm J
authors.initials: MJ
authors.lastname: West
authors.affiliation: School of Medicine, University of Queensland, Prince Charles Hospital, Rode Road, Chermside, Queensland 4032, Australia. Electronic address: airgard@mgard.com.au.
authors.forename: Bill
authors.initials: B
authors.lastname: Westerman
authors.affiliation: School of Medicine, University of Queensland, Prince Charles Hospital, Rode Road, Chermside, Queensland 4032, Australia; Sir John Walsh Research Institute, University of Otago, 310 Great King Street, Dunedin 9016, New Zealand. Electronic address: gregory.seymour@otago.ac.nz.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Seymour
mesh_terms: D000891:Anti-Infective Agents, Local / Q000009:adverse effects*; D001315:Australia / Q000453:epidemiology; D002318:Cardiovascular Diseases / Q000453:epidemiology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014100:Toothpastes / Q000009:adverse effects*; D014260:Triclosan / Q000009:adverse effects*
chemical_list: D000891:Anti-Infective Agents, Local; D014100:Toothpastes; D014260:Triclosan
keywords: Adverse events; Cardiovascular disease; Randomised controlled trial; Toothpaste; Triclosan