Spyridon Deftereos1, Georgios Giannopoulos2, Vasiliki Panagopoulou3, Georgios Bouras3, Konstantinos Raisakis3, Charalampos Kossyvakis4, Sofia Karageorgiou3, Charalampos Papadimitriou3, Maria Vastaki3, Andreas Kaoukis3, Christos Angelidis3, Stamatina Pagoni5, Vlasios Pyrgakis3, Dimitrios Alexopoulos6, Antonis S Manolis7, Christodoulos Stefanadis7, Michael W Cleman8. 1. Department of Cardiology, Athens General Hospital "G. Gennimatas", Athens, Greece; Section of Cardiovascular Medicine, Yale University School of Medicine, Yale University, New Haven, Connecticut. 2. Department of Cardiology, Athens General Hospital "G. Gennimatas", Athens, Greece; Section of Cardiovascular Medicine, Yale University School of Medicine, Yale University, New Haven, Connecticut; Hellenic Center of Disease Control and Prevention Athens, Greece. Electronic address: ggiann@med.uoa.gr. 3. Department of Cardiology, Athens General Hospital "G. Gennimatas", Athens, Greece. 4. Department of Cardiology, Athens General Hospital "G. Gennimatas", Athens, Greece; Hellenic Center of Disease Control and Prevention Athens, Greece. 5. Third Department of Internal Medicine, Athens General Hospital "G. Gennimatas," Athens, Greece. 6. Department of Cardiology, University of Patras Medical School, Patras, Greece. 7. First Department of Cardiology, University of Athens Medical School, Athens, Greece. 8. Section of Cardiovascular Medicine, Yale University School of Medicine, Yale University, New Haven, Connecticut.
Abstract
OBJECTIVES: The purpose of this study was to test the efficacy of a 6-month course of anti-inflammatory treatment with colchicine in improving functional status of patients with stable chronic heart failure (CHF). BACKGROUND:CHF has been shown to be associated with inflammatory activation. Inflammation has been designated as a therapeutic target in CHF. METHODS:Patients with stable CHF were randomly assigned to colchicine (0.5 mg twice daily) or placebo for 6 months. The primary endpoint was the proportion of patients achieving at least one-grade improvement in New York Heart Association class. RESULTS:Two hundred sixty-seven patients were available for final evaluation of the primary endpoint: its rate was 11% in the control group and 14% in the colchicine group (odds ratio: 1.40; 95% confidence interval: 0.67 to 2.93; p = 0.365). The rate of the composite of death or hospital stay for heart failure was 9.4% in the control group, compared with 10.1% in the colchicine group (p = 0.839). The changes in treadmill exercise time with treatment were insignificant and similar in the 2 groups (p = 0.938). C-reactive protein and interleukin-6 were both significantly reduced in the colchicine group (-5.1 mg/l and -4.8 pg/ml, respectively; p < 0.001 for both, compared with the control group). CONCLUSIONS: According to this prospective, randomized study, anti-inflammatory treatment with colchicine in patients with stable CHF, although effective in reducing inflammation biomarker levels, did not affect in any significant way patient functional status (in terms of New York Heart Association class and objective treadmill exercise tolerance) or the likelihood of death or hospital stay for heart failure.
RCT Entities:
OBJECTIVES: The purpose of this study was to test the efficacy of a 6-month course of anti-inflammatory treatment with colchicine in improving functional status of patients with stable chronic heart failure (CHF). BACKGROUND:CHF has been shown to be associated with inflammatory activation. Inflammation has been designated as a therapeutic target in CHF. METHODS:Patients with stable CHF were randomly assigned to colchicine (0.5 mg twice daily) or placebo for 6 months. The primary endpoint was the proportion of patients achieving at least one-grade improvement in New York Heart Association class. RESULTS: Two hundred sixty-seven patients were available for final evaluation of the primary endpoint: its rate was 11% in the control group and 14% in the colchicine group (odds ratio: 1.40; 95% confidence interval: 0.67 to 2.93; p = 0.365). The rate of the composite of death or hospital stay for heart failure was 9.4% in the control group, compared with 10.1% in the colchicine group (p = 0.839). The changes in treadmill exercise time with treatment were insignificant and similar in the 2 groups (p = 0.938). C-reactive protein and interleukin-6 were both significantly reduced in the colchicine group (-5.1 mg/l and -4.8 pg/ml, respectively; p < 0.001 for both, compared with the control group). CONCLUSIONS: According to this prospective, randomized study, anti-inflammatory treatment with colchicine in patients with stable CHF, although effective in reducing inflammation biomarker levels, did not affect in any significant way patient functional status (in terms of New York Heart Association class and objective treadmill exercise tolerance) or the likelihood of death or hospital stay for heart failure.
Authors: Antonio Abbate; Stefano Toldo; Carlo Marchetti; Jordana Kron; Benjamin W Van Tassell; Charles A Dinarello Journal: Circ Res Date: 2020-04-23 Impact factor: 17.367