Response to Letter Regarding Article, “Heart Failure, Saxagliptin and Diabetes Mellitus: Observations From the SAVOR-TIMI 53 Randomized Trial”
2015; Lippincott Williams & Wilkins; Volume: 132; Issue: 6 Linguagem: Inglês
10.1161/circulationaha.115.015511
ISSN1524-4539
AutoresBenjamin M. Scirica, Eugene Braunwald, Itamar Raz, Matthew A. Cavender, David A. Morrow, Petr Jarolı́m, Jacob A. Udell, Ofri Mosenzon, KyungAh Im, Amarachi Umez-Eronini, Pia S. Pollack, Boaz Hirshberg, Robert Frederich, Basil S. Lewis, Darren K. McGuire, Jaime A. Davidson, Philippe Gabríel Steg, Deepak L. Bhatt,
Tópico(s)Heart Failure Treatment and Management
ResumoHomeCirculationVol. 132, No. 6Response to Letter Regarding Article, "Heart Failure, Saxagliptin and Diabetes Mellitus: Observations From the SAVOR-TIMI 53 Randomized Trial" Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBResponse to Letter Regarding Article, "Heart Failure, Saxagliptin and Diabetes Mellitus: Observations From the SAVOR-TIMI 53 Randomized Trial" Benjamin M. Scirica, MD, MPH and Eugene Braunwald, MD Itamar Raz, MD Matthew A. Cavender, MD, MPH and David A. Morrow, MD, MPH Petr Jarolim, MD, PhD Jacob A. Udell, MD, MPH Ofri Mosenzon, MD KyungAh Im, PhD and Amarachi A. Umez-Eronini, MPH Pia S. Pollack, MD and Boaz Hirshberg, MD Robert Frederich, MD Basil S. Lewis, MD Darren K. McGuire, MD, MHSc Jaime Davidson, MD, PhD Gabriel Steg, MD Deepak L. Bhatt, MD, MPH Benjamin M. SciricaBenjamin M. Scirica TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA and Eugene BraunwaldEugene Braunwald TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA Itamar RazItamar Raz Diabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel Matthew A. CavenderMatthew A. Cavender TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA and David A. MorrowDavid A. Morrow TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA Petr JarolimPetr Jarolim Department of Pathology, Brigham and Women's Hospital, Boston, MA Jacob A. UdellJacob A. Udell Cardiovascular Division, Women's College Hospital and Toronto General Hospital, University of Toronto, Toronto, Canada Ofri MosenzonOfri Mosenzon Diabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel KyungAh ImKyungAh Im TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA and Amarachi A. Umez-EroniniAmarachi A. Umez-Eronini TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA Pia S. PollackPia S. Pollack AstraZeneca Research and Development, Wilmington, DE and Boaz HirshbergBoaz Hirshberg AstraZeneca Research and Development, Wilmington, DE Robert FrederichRobert Frederich Bristol-Myers Squibb, Princeton, NJ Basil S. LewisBasil S. Lewis Cardiovascular Research Institute, Lady Davis Carmel Medical Center and Ruth and Bruce Rappaport School of Medicine Technion-IIT, Haifa, Israel Darren K. McGuireDarren K. McGuire Cardiovascular Medicine, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX Jaime DavidsonJaime Davidson Division of Endocrinology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX Gabriel StegGabriel Steg Département Hospitalo-Universitaire FIRE, INSERM U-1148, Université Paris-Diderot, Hôpital Bichat, AP-HP, Paris, France, NHLI Imperial College, ICMS, Royal Brompton Hospital, London, UK Deepak L. BhattDeepak L. Bhatt TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA Originally published11 Aug 2015https://doi.org/10.1161/CIRCULATIONAHA.115.015511Circulation. 2015;132:e121–e122We thank Drs Muskiet, Tonneijck, and van Raalte for calling attention to the potentially detrimental consequences of simultaneous inhibition of dipeptidyl peptidase 4 and angiotensin-converting enzyme (ACE).1,2 They note correctly that in Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications (SAVOR-TIMI 53), more patients treated with ACE inhibitors at baseline were subsequently hospitalized for heart failure. However, this observation alone is likely a result of confounding by indication, because patients at highest risk of heart failure are more likely to be treated with this class of drug in the first place. A similar observation was seen with β-blockers.3Despite elegant physiological studies suggesting a potential hemodynamic interaction between dipeptidyl peptidase 4 inhibitors and ACE inhibitors, there were no differences in heart or blood pressure changes after randomization according to baseline ACE inhibitor use in patients treated with saxagliptin or placebo (all P for interaction >0.10). Nor were there any clinical consequences of baseline ACE inhibitor use on the primary end point of cardiovascular death, myocardial infarction, or ischemic stroke (baseline ACE inhibitor: saxagliptin, 7.3% versus placebo, 7.5%; hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.81–1.09; P=0.41 in comparison with no baseline ACE inhibitor: saxagliptin, 7.3% versus placebo, 6.9%; HR, 1.08; 95% CI, 0.91–1.27; P=0.39; P for interaction=0.23), the secondary end point, which included the primary end point plus hospitalization for unstable angina, heart failure, or coronary revascularization (baseline ACE inhibitor: saxagliptin, 12.9% versus placebo, 13.2%; HR, 0.95; 95% CI, 0.85–1.07; P=0.41 in comparison with no baseline ACE inhibitor: saxagliptin, 12.7% versus placebo, 11.5%; HR, 1.11; 95% CI, 0.98–1.27; P=0.11; P for interaction=0.08), or hospitalization for heart failure alone (baseline ACE inhibitor: saxagliptin, 3.6% versus placebo, 3.1%; HR, 1.19; 95% CI, 0.95–1.49; P=0.14 in comparison with no baseline ACE inhibitor: saxagliptin, 3.3% versus placebo, 2.4%; HR, 1.39; 95% CI, 1.06–1.83, P=0.02; P for interaction=0.38).Benjamin M. Scirica, MD, MPHEugene Braunwald, MDTIMI Study GroupCardiovascular DivisionBrigham and Women's HospitalBoston, MAItamar Raz, MDDiabetes UnitDivision of Internal MedicineHadassah Hebrew University HospitalJerusalem, IsraelMatthew A. Cavender, MD, MPHDavid A. Morrow, MD, MPHTIMI Study GroupCardiovascular DivisionBrigham and Women's HospitalBoston, MAPetr Jarolim, MD, PhDDepartment of PathologyBrigham and Women's HospitalBoston, MAJacob A. Udell, MD, MPHCardiovascular DivisionWomen's College Hospital and Toronto General HospitalUniversity of TorontoToronto, CanadaOfri Mosenzon, MDDiabetes UnitDivision of Internal MedicineHadassah Hebrew University HospitalJerusalem, IsraelKyungAh Im, PhDAmarachi A. Umez-Eronini, MPHTIMI Study GroupCardiovascular DivisionBrigham and Women's HospitalBoston, MAPia S. Pollack, MDBoaz Hirshberg, MDAstraZeneca Research and DevelopmentWilmington, DERobert Frederich, MDBristol-Myers SquibbPrinceton, NJBasil S. Lewis, MDCardiovascular Research InstituteLady Davis Carmel Medical Center and Ruth and Bruce Rappaport School of Medicine Technion-IITHaifa, IsraelDarren K. McGuire, MD, MHScCardiovascular MedicineDepartment of Internal MedicineUniversity of Texas Southwestern Medical CenterDallas, TXJaime Davidson, MD, PhDDivision of EndocrinologyDepartment of Internal MedicineUniversity of Texas Southwestern Medical CenterDallas, TXGabriel Steg, MDDépartement Hospitalo-Universitaire FIREINSERM U-1148Université Paris-DiderotHôpital Bichat, AP-HPParis, FranceNHLI Imperial CollegeICMS, Royal Brompton HospitalLondon, UKDeepak L. Bhatt, MD, MPHTIMI Study GroupCardiovascular DivisionBrigham and Women's HospitalBoston, MASources of FundingSAVOR-TIMI 53 was funded by AstraZeneca and Bristol-Myers Squibb.DisclosuresSAVOR-TIMI 53 was supported by a research grant from AstraZeneca and Bristol-Myers Squibb. Dr Scirica reports research grants via the TIMI Study and Brigham and Women's Hospital from AstraZeneca and Bristol-Myers Squibb, Daichi-Sankyo, GlaxoSmithKline, Johnson and Johnson, Bayer Healthcare, Gilead, Eisai, Merck. Consulting fees from AstraZeneca, Gilead, Lexicon, Arena, Eisai, St. Jude's Medical, Bristol-Myers Squibb, Forest Pharmaceuticals, Boston Clinical Research Institute, Decision Resources, University of Calgary, Elsevier Practice Update Cardiology, Forest Pharmaceuticals. Dr Braunwald reports grants from Astra Zeneca, grants from Bristol Myers Squibb, during the conduct of the study; grants from Johnson & Johnson, grants from Merck & Co., grants from Sanofi Aventis, grants from Daiichi Sankyo, grants from Glaxo Smith Kline, grants from Beckman Coulter, grants from Roche Diagnostics, grants from Pfizer, grants from Eli Lilly, grants from Duke University, personal fees from Eli Lilly, personal fees from Merck, personal fees from CVRx, personal fees from CV Therapeutics, now Gilead, personal fees from Daiichi Sankyo, personal fees from Menarini International, personal fees from Medscape, personal fees from Bayer, personal fees from Genzyme, personal fees from Medicines Company, personal fees from Sanofi Aventis, outside the submitted work. Dr Raz reports grants from Astra Zeneca, grants from Bristol Myers Squibb, during the conduct of the study; scientific board membership from Novo Nordisk, MSD, Eli Lilly, Sanofi, Medscape, Andromeda, Insuline; Payment for lectures including service on speakers bureaus for lectures from Eli Lilly, Novo Nordisk, Johnson and Johnson, Sanofi, MSD, Novartis; stock options in Insuline. Dr Morrow reports grants from AstraZeneca during the conduct of the study; consultancy fees from Abbott Laboratories, BG Medicine, Critical Diagnostics, Daiichi Sankyo, Genetech, Gilead, Instrumentation Laboratories, Johnson & Johnson, Konica Minolta, Merck, Novartis, Provenchio, Roche Diagnostics, Servier; grants from Abbott Laboratories, Beckman Coulter, BG Medicine, Critical Diagnostics, Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, Novartis, Roche Diagnostics, Sanofi Aventis, Gilead. Dr Jarolim reports grants from Abbott, AstraZeneca, Daiichi Sankyo, Merck, Roche Diagnostics and Waters Technologies; consultancy fees from Biosystems and Quanterix. Dr Mosenzon reports grants from AstraZeneca and Bristol-Myers Squibb, during the conduct of the study; consulting fees from AstraZeneca and Bristol-Myers Squibb; support for travel to meetings for the study from AstraZeneca and Bristol-Myers Squibb; scientific advisory board membership from Novo Nordisk, Eli Lilly, Sanofi, Norvartis, speakers bureaus for Novo Nordisk, Eli Lilly, Sanofi, Norvartis, Mercj, Sharpe and Dohme. A. A. Dr Pollack reports employment by AstraZeneca and having stock/stock option in AstraZeneca. Dr Hirshberg reports employment by AstraZeneca and having stock/stock option in AstraZeneca. Dr Frederich reports employment by Bristol-Myers Squibb and having stock/stock option in Bristol-Myers Squibb. Dr Lewis reports grants from AstraZeneca during the conduct of the study; scientific advisory board membership from MSD and AstraZeneca; grants from Bayer Healthcare, Amylin, Amgen, GDK, MSD, Eli Lilly, Sanofi. Dr McGuire reports grants from Brigham and Women's Hospital, personal fees from Brigham and Women's Hospital, during the conduct of the study; personal fees from Boehringer Ingelheim, personal fees from Janssen Research and Development LLC, personal fees from Sanofi Aventis Groupe, personal fees from Genentech, Inc., personal fees from Merck Sharp and Dohme Corp., personal fees from Medscape Cardiology, personal fees from Pri-Med Institute, personal fees from The Brigham and Women's Hospital, Inc, personal fees from Duke Clinical Research Institute, personal fees from The Cleveland Clinic Coordinating Center for Clinical Research, personal fees from The University of Oxford, personal fees from Daiichi Sankyo, Inc., personal fees from Lilly USA, personal fees from Novo Nordisk, personal fees from F. Hoffmann La Roche, nonfinancial support from Gilead Sciences, personal fees from Axio Research, personal fees from Premier Research, personal fees from INC Research LLC, personal fees from Glaxo Smith Kline, personal fees from Takeda Pharmaceuticals North America, personal fees from Bristol-Myers Squibb, personal fees from Eisai, personal fees from Omthera, personal fees from Regeneron, outside the submitted work Dr Davidson reports personal fees from TIMI Group during the conduct of the study. Dr Steg reports personal fees from AstraZeneca, during the conduct of the study; personal fees from Amarin, personal fees from Bayer, personal fees from Boehringer-Ingelheim, personal fees from Bristol-Myers-Squibb, personal fees from Daiichi-Sankyo, personal fees from GlaxoSmithKline, personal fees from Lilly, personal fees from Merck-Sharpe-Dohme, personal fees from Novartis, personal fees from Otsuka, personal fees from Pfizer, personal fees from Roche, personal fees from The Medicines Company, grants and personal fees from Sanofi, grants and personal fees from Servier, personal fees from Vivus, outside the submitted work. Dr Bhatt discloses the following relationships: Advisory Board: Elsevier Practice Update Cardiology, Medscape Cardiology, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care; Chair: American Heart Association Get With The Guidelines Steering Committee; Data Monitoring Committees: Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, Population Health Research Institute; Honoraria: American College of Cardiology (Editor, Clinical Trials, Cardiosource), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor in Chief, Journal of Invasive Cardiology), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), Journal of the American College of Cardiology (Section Editor, Pharmacology); Research Grants: Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Medtronic, Roche, Sanofi Aventis, The Medicines Company; Unfunded Research: FlowCo, PLx Pharma, Takeda. The other authors report no conflicts.References1. Devin JK, Pretorius M, Nian H, Yu C, Billings FT, Brown NJ. Substance P increases sympathetic activity during combined angiotensin-converting enzyme and dipeptidyl peptidase-4 inhibition.Hypertension. 2014; 63:951–957. doi: 10.1161/HYPERTENSIONAHA.113.02767.LinkGoogle Scholar2. Marney A, Kunchakarra S, Byrne L, Brown NJ. Interactive hemodynamic effects of dipeptidyl peptidase-IV inhibition and angiotensin-converting enzyme inhibition in humans.Hypertension. 2010; 56:728–733. doi: 10.1161/HYPERTENSIONAHA.110.156554.LinkGoogle Scholar3. Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg PG, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators*. 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August 11, 2015Vol 132, Issue 6 Advertisement Article InformationMetrics © 2015 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.115.015511PMID: 26260506 Originally publishedAugust 11, 2015 PDF download Advertisement SubjectsCongenital Heart DiseaseDiabetes, Type 2
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