Effect of Simvastatin-Ezetimibe Compared With Simvastatin Monotherapy After Acute Coronary Syndrome Among Patients 75 Years or Older: A Secondary Analysis of a Randomized Clinical Trial.
Richard G. Bach,Christopher P. Cannon,Robert P. Giugliano,Jennifer White,Yuliya Lokhnygina,Erin A. Bohula,Robert M. Califf,Eugene Braunwald,Michael A. Blazing +8 more
TLDR
In IMPROVE-IT, patients hospitalized for ACS derived benefit from higher-intensity therapy to lower lipid levels with simvastatin-ezetimibe compared with simVastatin monotherapy, with the greatest absolute risk reduction among patients 75 years or older.Abstract:
Importance Limited evidence is available regarding the benefit and hazard of higher-intensity treatment to lower lipid levels among patients 75 years or older. As a result, guideline recommendations differ for this age group compared with younger patients. Objective To determine the effect on outcomes and risks of combination ezetimibe and simvastatin compared with simvastatin monotherapy to lower lipid levels among patients 75 years or older with stabilized acute coronary syndrome (ACS). Design, Setting, Participants In this prespecified secondary analysis of the global, multicenter, prospective clinical randomized Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), outcomes and risks were compared by age among patients 50 years or older after a hospitalization for ACS. Data were collected from October 26, 2005, through July 8, 2010, with the database locked October 21, 2014. Data were analyzed May 29, 2015, through March 13, 2018, using Kaplan-Meier curves and Cox proportional hazards models. Interventions Double-blind randomized assignment to combined simvastatin and ezetimibe or simvastatin and placebo with follow-up for a median of 6 years (interquartile range, 4.3-7.1 years). Main Outcomes and Measures The primary composite end point consisted of death due to cardiovascular disease, myocardial infarction (MI), stroke, unstable angina requiring hospitalization, and coronary revascularization after 30 days. Individual adverse ischemic and safety end points and lipid variables were also analyzed. Results Of 18 144 patients enrolled (13 728 men [75.7%]; mean [SD] age, 64.1 [9.8] years), 5173 (28.5%) were 65 to 74 years old, and 2798 (15.4%) were 75 years or older at randomization. Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction). The rate of adverse events did not increase with simvastatin-ezetimibe vs simvastatin-placebo among younger or older patients. Conclusions and Relevance In IMPROVE-IT, patients hospitalized for ACS derived benefit from higher-intensity therapy to lower lipid levels with simvastatin-ezetimibe compared with simvastatin monotherapy, with the greatest absolute risk reduction among patients 75 years or older. Addition of ezetimibe to simvastatin was not associated with any significant increase in safety issues among older patients. These results may have implications for guideline recommendations regarding lowering of lipid levels in the elderly. Trial Registration ClinicalTrials.gov identifier:NCT00202878read more
Citations
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2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation
Jean-Philippe Collet,Holger Thiele,Emanuele Barbato,Olivier Barthelemy,Johann Bauersachs,Deepak L. Bhatt,Paul Dendale,Maria Dorobantu,Thor Edvardsen,Thierry Folliguet,Chris P Gale,Martine Gilard,Alexander Jobs,Peter Jüni,Ekaterini Lambrinou,Basil S. Lewis,Julinda Mehilli,Emanuele Meliga,Béla Merkely,Christian Mueller,Marco Roffi,Frans H. Rutten,Dirk Sibbing,George C.M. Siontis +23 more
TL;DR: A correction has been published: European Heart Journal, ehaa895, https://doi.org/10.1093/eurheartj/ehaa-895.
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Efficacy and safety of lowering LDL cholesterol in older patients: a systematic review and meta-analysis of randomised controlled trials
Baris Gencer,Nicholas A Marston,KyungAh Im,Christopher P. Cannon,Peter S. Sever,Anthony C Keech,Eugene Braunwald,Robert P. Giugliano,Marc S. Sabatine +8 more
TL;DR: In patients aged 75 years and older, lipid lowering was as effective in reducing cardiovascular events as it was in patients younger than 75 years, and guideline recommendations for the use of lipid-lowering therapies, including non-statin treatment, in older patients should strengthen.
Journal ArticleDOI
Familial hypercholesterolaemia: evolving knowledge for designing adaptive models of care.
Gerald F. Watts,Gerald F. Watts,Samuel S. Gidding,Pedro Mata,Jing Pang,David R. Sullivan,David R. Sullivan,Shizuya Yamashita,Frederick J. Raal,Raul D. Santos,Kausik K. Ray +10 more
TL;DR: The latest advances that can inform the development and implementation of new models of care for familial hypercholesterolaemia are summarized, with an emphasis on articles published since 2014.
Journal ArticleDOI
Effect of alirocumab on cardiovascular outcomes after acute coronary syndromes according to age: an ODYSSEY OUTCOMES trial analysis.
Peter Sinnaeve,Gregory G. Schwartz,Daniel Wojdyla,Marco Alings,Deepak L. Bhatt,Vera Bittner,Chern-En Chiang,Roger M Correa Flores,Rafael Diaz,Maria Dorobantu,Shaun G. Goodman,Shaun G. Goodman,J. Wouter Jukema,Yong-Un Kim,Robert Pordy,Matthew T. Roe,Rody G Sy,Michael Szarek,Harvey D. White,Andreas M. Zeiher,Ph. Gabriel Steg,Ph. Gabriel Steg,Odyssey Outcomes Investigators +22 more
TL;DR: In patients with recent ACS, alirocumab improves outcomes irrespective of age, and increasing absolute benefit but not harm with advancing age suggests that LDL-C lowering is an important preventive intervention for older patients after ACS.
Journal ArticleDOI
Step‐by‐step diagnosis and management of the nocebo/drucebo effect in statin‐associated muscle symptoms patients: a position paper from the International Lipid Expert Panel (ILEP)
David Marais,Zeljko Reiner,Matteo Pirro,Manfredi Rizzo,Alexandros Sachinidis,Dan Gaita,Mohsen Mazidi,Daniel Pella,G.B. John Mancini,Stephan von Haehling,Maciej Banach,Julio Acosta,Mutaz Alkhnifsawi,Fahad Alnouri,Fahma Amar,Atanas G. Atanasov,G. Bajraktari,Sonu Bhaskar,Ibadete Bytyçi,Bojko Bjelakovic,Eric Bruckert,Alberto Cafferata,Richard Ceska,Arrigo F G Cicero,Xavier Collet,Magdalena Daccord,Olivier S. Descamps,Dragan Djuric,Ronen Durst,Marat V. Ezhov,Zlatko Fras,Adrian V. Hernandez,Steven P. Jones,Jacek Jerzy Jozwiak,N. Kakauridze,A. Kallel,Niki Katsiki,Amit Khera,Karam Kostner,Raimondas Kubilius,Gustavs Latkovskis,A. David Marais,Seth S. Martin,Julio A. Martínez,Dimitri P. Mikhailidis,Erkin M. Mirrakhimov,André R. Miserez,Olena Mitchenko,N.P. Mitkovskaya,Patrick M. Moriarty,Seyed Mohammad Nabavi,Devaki Nair,Demosthenes B. Panagiotakos,György Paragh,Peter E. Penson,Zaneta Petrulioniene,Arman Postadzhiyan,Raman Puri,Ashraf Reda,Dina Radenkovic,Michael Robert Rakowski,Jemaa Riadh,Dimitri Richter,Massimiliano Ruscica,Amirhossein Sahebkar,Naveed Sattar,Maria-Corina Serban,Abdullah Shehab,Aleksandr B Shek,Cesare R. Sirtori,Claudia Stefanutti,Tomasz Tomasik,Peter P. Toth,Margus Viigimaa,Pedro Valdivielso,Dragos Vinereanu,Branislav Vohnout,Michal Vrablík,Nathan D. Wong,Hung-I Yeh,Ji Zhisheng,Andreas Zirlik +81 more
TL;DR: A step‐by‐step patient‐centred approach to the identification and management of SAMS with a particular focus on strategies to prevent and manage the nocebo/drucebo effect and to improve long‐term compliance with lipid‐lowering therapy is presented.
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Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial
James Shepherd,Gerard J. Blauw,Michael B. Murphy,Edward L.E.M. Bollen,Brendan M. Buckley,Stuart M. Cobbe,Ian Ford,Allan Gaw,Michael E. Hyland,J. Wouter Jukema,Adriaan M. Kamper,Peter W. Macfarlane,A. Edo Meinders,John Norrie,Chris J. Packard,Ivan J. Perry,David J. Stott,Brian Sweeney,Gillian Twomey,Rudi G. J. Westendorp +19 more
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