Amit Acharya1, Ingrid Glurich2, Scott Hetzel3, KyungMann Kim3, Matthew C Tattersall3, David L DeMets3, Charles H Hennekens4. 1. Marshfield Clinic Research Institute, Marshfield, WI; University of Wisconsin School of Medicine and Public Health, Madison, WI. 2. Marshfield Clinic Research Institute, Marshfield, WI. 3. University of Wisconsin School of Medicine and Public Health, Madison, WI. 4. Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL. Electronic address: PROFCHHMD@prodigy.net.
Abstract
BACKGROUND: Inflammation is intimately involved in the pathogenesis of atherosclerosis and is accurately measured by high-sensitivity C-reactive protein (hs-CRP), a sensitive marker for future risk of cardiovascular disease. The Correlation between Oral Health and Systemic Inflammation (COHESION) trial was designed to test the hypothesis that PlaqueHD, a plaque-identifying toothpaste, reduces hs-CRP. METHODS: The trial was designed initially to include 132 subjects with hs-CRP between 2.0 and 10.0 mg/L but instead randomized 112 between 0.5 and 10.0, of which 103 had baseline and follow-up data and comprised the intention-to-treat sample. Of these, a prespecified subgroup analysis included 40 with baseline hs-CRP >2.0 and all hs-CRP <10. Because the distribution of hs-CRP was skewed toward higher values, to achieve normality assumptions, the significance of changes in hs-CRP between groups over time was tested on log-transformed data using a mixed effects analysis of variance. RESULTS: The intention-to-treat analysis showed no significant differences between the PlaqueHD and placebo group (P = .615). The prespecified subgroup analysis showed a significant difference between the PlaqueHD and placebo group (P = .047). Results of the analysis showed a reduction in hs-CRP at follow-up of 0.58 in the PlaqueHD and an increase of 0.55 in the placebo group. CONCLUSIONS: These findings are compatible with those of a prior pilot trial that also suggested benefits only in subjects with baseline elevations. Future trials targeting reductions of hs-CRP levels should randomize subjects with baseline hs-CRP between 2.0 and 10.0 mg/L.
RCT Entities:
BACKGROUND:Inflammation is intimately involved in the pathogenesis of atherosclerosis and is accurately measured by high-sensitivity C-reactive protein (hs-CRP), a sensitive marker for future risk of cardiovascular disease. The Correlation between Oral Health and Systemic Inflammation (COHESION) trial was designed to test the hypothesis that PlaqueHD, a plaque-identifying toothpaste, reduces hs-CRP. METHODS: The trial was designed initially to include 132 subjects with hs-CRP between 2.0 and 10.0 mg/L but instead randomized 112 between 0.5 and 10.0, of which 103 had baseline and follow-up data and comprised the intention-to-treat sample. Of these, a prespecified subgroup analysis included 40 with baseline hs-CRP >2.0 and all hs-CRP <10. Because the distribution of hs-CRP was skewed toward higher values, to achieve normality assumptions, the significance of changes in hs-CRP between groups over time was tested on log-transformed data using a mixed effects analysis of variance. RESULTS: The intention-to-treat analysis showed no significant differences between the PlaqueHD and placebo group (P = .615). The prespecified subgroup analysis showed a significant difference between the PlaqueHD and placebo group (P = .047). Results of the analysis showed a reduction in hs-CRP at follow-up of 0.58 in the PlaqueHD and an increase of 0.55 in the placebo group. CONCLUSIONS: These findings are compatible with those of a prior pilot trial that also suggested benefits only in subjects with baseline elevations. Future trials targeting reductions of hs-CRP levels should randomize subjects with baseline hs-CRP between 2.0 and 10.0 mg/L.
Authors: Thomas A Pearson; George A Mensah; R Wayne Alexander; Jeffrey L Anderson; Richard O Cannon; Michael Criqui; Yazid Y Fadl; Stephen P Fortmann; Yuling Hong; Gary L Myers; Nader Rifai; Sidney C Smith; Kathryn Taubert; Russell P Tracy; Frank Vinicor Journal: Circulation Date: 2003-01-28 Impact factor: 29.690
Authors: Paul M Ridker; Brendan M Everett; Tom Thuren; Jean G MacFadyen; William H Chang; Christie Ballantyne; Francisco Fonseca; Jose Nicolau; Wolfgang Koenig; Stefan D Anker; John J P Kastelein; Jan H Cornel; Prem Pais; Daniel Pella; Jacques Genest; Renata Cifkova; Alberto Lorenzatti; Tamas Forster; Zhanna Kobalava; Luminita Vida-Simiti; Marcus Flather; Hiroaki Shimokawa; Hisao Ogawa; Mikael Dellborg; Paulo R F Rossi; Roland P T Troquay; Peter Libby; Robert J Glynn Journal: N Engl J Med Date: 2017-08-27 Impact factor: 91.245
Authors: Paul M Ridker; Eleanor Danielson; Francisco A H Fonseca; Jacques Genest; Antonio M Gotto; John J P Kastelein; Wolfgang Koenig; Peter Libby; Alberto J Lorenzatti; Jean G MacFadyen; Børge G Nordestgaard; James Shepherd; James T Willerson; Robert J Glynn Journal: N Engl J Med Date: 2008-11-09 Impact factor: 91.245