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7. Efficacy of ivabradine in heart failure patients with a high‐risk profile (analysis from the SHIFT trial).

Author

Abdin, Amr, Komajda, Michel, Borer, Jeffrey S., Ford, Ian, Tavazzi, Luigi, Batailler, Cécile, Swedberg, Karl, Rosano, Giuseppe M.C., Mahfoud, Felix, and Böhm, Michael

Subjects
HEART failure patients, IVABRADINE, SYSTOLIC blood pressure, VENTRICULAR ejection fraction, HEART beat
Abstract

Aims: Early start and patient profile‐oriented heart failure (HF) management has been recommended. In this post hoc analysis from the SHIFT trial, we analysed the treatment effects of ivabradine in HF patients with systolic blood pressure (SBP) < 110 mmHg, resting heart rate (RHR) ≥ 75 b.p.m., left ventricular ejection fraction (LVEF) ≤ 25%, New York Heart Association (NYHA) Class III/IV, and their combination. Methods and results: The SHIFT trial enrolled 6505 patients (LVEF ≤ 35% and RHR ≥ 70 b.p.m.), randomized to ivabradine or placebo on the background of guideline‐defined standard care. Compared with placebo, ivabradine was associated with a similar relative risk reduction of the primary endpoint (cardiovascular death or HF hospitalization) in patients with SBP < 110 and ≥110 mmHg [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.74–1.08 vs. HR 0.80, 95% CI 0.72–0.89, P interaction = 0.34], LVEF ≤ 25% and >25% (HR 0.85, 95% CI 0.72–1.01 vs. HR 0.80, 95% CI 0.71–0.90, P interaction = 0.53), and NYHA III–IV and II (HR 0.83, 95% CI 0.74–0.94 vs. HR 0.81, 95% CI 0.69–0.94, P interaction = 0.79). The effect was more pronounced in patients with RHR ≥ 75 compared with <75 (HR 0.76, 95% CI 0.68–0.85 vs. HR 0.97, 95% CI 0.81–0.1.16, P interaction = 0.02). When combining these profiling parameters, treatment with ivabradine was also associated with risk reductions comparable with patients with low‐risk profiles for the primary endpoint (relative risk reduction 29%), cardiovascular death (11%), HF death (49%), and HF hospitalization (38%; all P values for interaction: 0.40). No safety concerns were observed between study groups. Conclusions: Our analysis shows that RHR reduction with ivabradine is effective and improves clinical outcomes in HF patients across various risk indicators such as low SBP, high RHR, low LVEF, and high NYHA class to a similar extent and without safety concern. [ABSTRACT FROM AUTHOR]

Published
2023
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9. Medical Misinformation: Vet the Message!

Author

Hill, Joseph A., Agewall, Stefan, Baranchuk, Adrian, Booz, George W., Borer, Jeffrey S., Camici, Paolo G., Chen, Peng-Sheng, Dominiczak, Anna F., Erol, Çetin, Grines, Cindy L., Gropler, Robert, Guzik, Tomasz J., Heinemann, Markus K., Iskandrian, Ami E., Knight, Bradley P., London, Barry, Lüscher, Thomas F., Metra, Marco, Musunuru, Kiran, Nallamothu, Brahmajee K., Natale, Andrea, Saksena, Sanjeev, Picard, Michael H., Rao, Sunil V., Remme, Willem J., Rosenson, Robert S., Sweitzer, Nancy K., Timmis, Adam, and Vrints, Christiaan

Published
2019
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23. Abstract 18347: Prognostic Significance of Activation Delay by Cross Correlation Analysis Using Tissue Doppler Imaging in Patients With Heart Failure and Narrow QRS Duration; an Echocardiography Guided Cardiac Resynchronization Therapy (Echo-CRT) Trial Substudy of Patients Not Randomized to CRT

Author

Tayal, Bhupendar, Gorcsan 3rd, John, Bax, Jeroen, Risum, Niels, Olsen, Niels Thue, Singh, Jagmeet P, Abraham, William T, Borer, Jeffrey S, Dickstein, Kenneth, Gras, Daniel, Krum, Henry, Brugada, Josep, Robertson, Michele, Ford, Ian, Holzmeister, Johannes, Ruschitzka, Frank, and Sogaard, Peter

Published
2017

38. Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium

Author

Stone, Gregg W., Vahanian, Alec S., Adams, David H., Abraham, William T., Borer, Jeffrey S., Bax, Jeroen J., Schofer, Joachim, Cutlip, Donald E., Krucoff, Mitchell W., Blackstone, Eugene H., Généreux, Philippe, Mack, Michael J., Siegel, Robert J., Grayburn, Paul A., Enriquez-Sarano, Maurice, Lancellotti, Patrizio, Filippatos, Gerasimos, and Kappetein, Arie Pieter

Published
2015
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42. Evaluation of the Relationship Between Serum Urate Levels, Clinical Manifestations of Gout, and Death From Cardiovascular Causes in Patients Receiving Febuxostat or Allopurinol in an Outcomes Trial.

Author

Saag, Kenneth G., Becker, Michael A., White, William B., Whelton, Andrew, Borer, Jeffrey S., Gorelick, Philip B., Hunt, Barbara, Castillo, Majin, Gunawardhana, Lhanoo, Lloyd, Eric, Wigfield, Simon, Gwynne, Lauren, and Johnson, Danielle

Subjects
CARDIOVASCULAR disease related mortality, CAUSES of death, DRUG efficacy, RESEARCH, GOUT suppressants, ALLOPURINOL, CARDIOVASCULAR diseases, DESCRIPTIVE statistics, URIC acid, STATISTICAL sampling, GOUT, SECONDARY analysis, SYMPTOMS, DISEASE complications
Abstract

Objective: To investigate whether serum urate levels, number of gout flares, and tophi burden are related to death from cardiovascular (CV) causes after treatment with febuxostat or allopurinol in patients with gout from the Cardiovascular Safety of Febuxostat or Allopurinol in Patients With Gout and Cardiovascular Comorbidities (CARES) trial. Methods: Patients were randomly assigned to receive febuxostat (40 mg or 80 mg once daily, according to serum urate levels at week 2) or allopurinol titrated in 100‐mg increments from 200–400 mg or 300–600 mg (with dose determined according to kidney function). Changes from baseline in serum urate level, gout flares, and tophus resolution were key exploratory efficacy parameters in the overall population and in subgroups of patients who died and those who did not die from a CV‐related cause. The latter subgroup included patients who died due to non‐CV causes and those who did not die due to any cause. Results: Patients received treatment with febuxostat (n = 3,098) or allopurinol (n = 3,092) for a median follow‐up period of 32 months (for a maximum of 85 months). In the overall population, mean serum urate levels were lower in those receiving febuxostat compared with those receiving allopurinol at most study visits. There were no associations between serum urate levels and death from CV causes with febuxostat. The number of gout flares requiring treatment was higher within 1 year of treatment with febuxostat compared with allopurinol (mean incidence of gout flares per patient‐years of exposure 1.33 versus 1.20), but was comparable thereafter and decreased overall throughout the study period (mean incidence of gout flares per patient‐years of exposure 0.35 versus 0.34 after 1 year of treatment; overall mean incidence 0.68 versus 0.63) irrespective of whether the patient died from a CV‐related cause. Overall, 20.8% of patients had ≥1 tophus at baseline; tophus resolution rates were similar between treatment groups, with cumulative resolution rates of >50%. Conclusion: In the CARES trial, febuxostat and allopurinol (≤600 mg doses) had comparable efficacy in patients with gout and CV disease, and there was no evidence of a relationship between death from CV causes and serum urate levels, number of gout flares, or tophus resolution among the patients receiving febuxostat. [ABSTRACT FROM AUTHOR]

Published
2022
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48. Heart rate: a prognostic factor and therapeutic target in chronic heart failure. The distinct roles of drugs with heart rate-lowering properties

Author

Dobre, Daniela, Borer, Jeffrey S., Fox, Kim, Swedberg, Karl, Adams, Kirkwood F., Cleland, John G.F., Cohen-Solal, Alain, Gheorghiade, Mihai, Gueyffier, Francois, OʼConnor, Christopher M., Fiuzat, Mona, Patak, Athul, Piña, Ileana L., Rosano, Giuseppe, Sabbah, Hani N., Tavazzi, Luigi, and Zannad, Faiez

Published
2014
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