References
1. Hempenius L, Slaets JP, Boelens MA, et al. Inclusion of frail elderly patients in clinical trials: solutions to the problems. J Geriatr Oncol 2013; 4 (1): 26-31.
2. Lindley RI. Drug trials for older people. J Gerontol A Biol Sci Med Sci 2012; 67 (2): 152-7.
3. Hilmer SN, Wu H, Zhang M. Biology of frailty: Implications for clinical pharmacology and drug therapy in frail older people. Mech Ageing Dev 2019; 181 : 22-8.
4. Hubbard RE, O’Mahony MS, Woodhouse KW. Medication prescribing in frail older people. European Journal of Clinical Pharmacology2013; 69 (3): 319-26.
5. Wynne HA, Yelland C, Cope LH, Boddy A, Woodhouse KW, Bateman DN. The association of age and frailty with the pharmacokinetics and pharmacodynamics of metoclopramide. Age Ageing 1993;22 (5): 354-9.
6. Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. The Lancet 2013; 381 (9868): 752-62.
7. Ambrosius WT, Sink KM, Foy CG, et al. The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: the Systolic Blood Pressure Intervention Trial (SPRINT). Clin Trials 2014; 11 (5): 532-46.
8. Pajewski NM, Williamson JD, Applegate WB, et al. Characterizing Frailty Status in the Systolic Blood Pressure Intervention Trial.Journals of Gerontology Series A-Biological Sciences & Medical Sciences 2016; 71 (5): 649-55.
9. Williamson JD, Supiano MA, Applegate WB, et al. Intensive vs Standard Blood Pressure Control and Cardiovascular Disease Outcomes in Adults Aged >/=75 Years: A Randomized Clinical Trial. Jama2016; 315 (24): 2673-82.
10. Pitt B, Pfeffer MA, Assmann SF, et al. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med 2014;370 (15): 1383-92.
11. Sanders NA, Supiano MA, Lewis EF, et al. The frailty syndrome and outcomes in the TOPCAT trial. European Journal of Heart Failure2018; 20 (11): 1570-7.
12. McMurray JJV, Solomon SD, Inzucchi SE, et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med 2019; 381 (21): 1995-2008.
13. Butt JH, Dewan P, Merkely B, et al. Efficacy and Safety of Dapagliflozin According to Frailty in Heart Failure With Reduced Ejection Fraction : A Post Hoc Analysis of the DAPA-HF Trial. Ann Intern Med 2022; 175 (6): 820-30.
14. Solomon SD, McMurray JJV, Claggett B, et al. Dapagliflozin in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med 2022; 387 (12): 1089-98.
15. Butt JH, Jhund PS, Belohlavek J, et al. Efficacy and Safety of Dapagliflozin According to Frailty in Patients With Heart Failure: A Prespecified Analysis of the DELIVER Trial. Circulation 2022;146 (16): 1210-24.
16. McNeil JJ, Woods RL, Nelson MR, et al. Effect of Aspirin on Disability-free Survival in the Healthy Elderly. N Engl J Med2018; 379 (16): 1499-508.
17. McNeil JJ, Nelson MR, Woods RL, et al. Effect of Aspirin on All-Cause Mortality in the Healthy Elderly. New England Journal of Medicine 2018; 379 (16): 1519-28.
18. Ryan J, Espinoza S, Ernst ME, et al. Validation of a Deficit-Accumulation Frailty Index in the ASPirin in Reducing Events in the Elderly Study and Its Predictive Capacity for Disability-Free Survival. J Gerontol A Biol Sci Med Sci 2022; 77 (1): 19-26.
19. Okumura K, Akao M, Yoshida T, et al. Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation. N Engl J Med 2020;383 (18): 1735-45.
20. Akashi S, Oguri M, Ikeno E, et al. Outcomes and Safety of Very-Low-Dose Edoxaban in Frail Patients With Atrial Fibrillation in the ELDERCARE-AF Randomized Clinical Trial. JAMA Netw Open 2022;5 (8): e2228500.
21. Patel A, MacMahon S, Chalmers J, et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med 2008; 358 (24): 2560-72.
22. Study rationale and design of ADVANCE: action in diabetes and vascular disease–preterax and diamicron MR controlled evaluation.Diabetologia 2001; 44 (9): 1118-20.
23. Nguyen TN, Harris K, Woodward M, et al. The Impact of Frailty on the Effectiveness and Safety of Intensive Glucose Control and Blood Pressure-Lowering Therapy for People With Type 2 Diabetes: Results From the ADVANCE Trial. Diabetes Care 2021; 44 (7): 1622-9.
24. Andrieu S, Guyonnet S, Coley N, et al. Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet neurol 2017; 16 (5): 377-89.
25. Tabue-Teguo M, Barreto de Souza P, Cantet C, et al. Effect of Multidomain Intervention, Omega-3 Polyunsaturated Fatty Acids Supplementation or their Combinaison on Cognitive Function in Non-Demented Older Adults According to Frail Status: Results from the MAPT Study. J Nutr Health Aging 2018; 22 (8): 923-7.
26. Ridda I, Macintyre CR, Lindley R, et al. Immunological responses to pneumococcal vaccine in frail older people. Vaccine 2009;27 (10): 1628-36.
27. DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Efficacy and immunogenicity of high-dose influenza vaccine in older adults by age, comorbidities, and frailty. Vaccine 2015;33 (36): 4565-71.
28. Bringhen S, D’Agostino M, Paris L, et al. Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 randomized trial.Haematologica 2020; 105 (7): 1937-47.
29. Mateos M-V, Dimopoulos MA, Cavo M, et al. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. New England Journal of Medicine 2017; 378 (6): 518-28.
30. Mateos M-V, Cavo M, Blade J, et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial.The Lancet 2020; 395 (10218): 132-41.
31. Mateos MV, Dimopoulos MA, Cavo M, et al. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE. Clin Lymphoma Myeloma Leuk2021; 21 (11): 785-98.
32. Auner HW, Gavriatopoulou M, Delimpasi S, et al. Effect of age and frailty on the efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma.Am J Hematol 2021; 96 (6): 708-18.
33. Facon T, Kumar S, Plesner T, et al. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med 2019;380 (22): 2104-15.
34. Facon T, Cook G, Usmani SZ, et al. Daratumumab plus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: frailty subgroup analysis of MAIA. Leukemia 2022; 36 (4): 1066-77.
35. Rizka A, Setiati S, Harimurti K, Sadikin M, Mansur IG. Effect of Alfacalcidol on Inflammatory markers and T Cell Subsets in Elderly with Frailty Syndrome: a Double Blind Randomized Controlled Trial. Acta Med Indones 2018; 50 (3): 215-21.
36. Hanlon P, Butterly E, Lewsey J, Siebert S, Mair FS, McAllister DA. Identifying frailty in trials: an analysis of individual participant data from trials of novel pharmacological interventions. BMC Medicine 2020; 18 (1): 309.
37. Rockwood K, Andrew M, Mitnitski A. A comparison of two approaches to measuring frailty in elderly people. Journals of Gerontology - Series A Biological Sciences and Medical Sciences 2007; 62 (7): 738-43.
38. Rockwood K, Mitnitski A. Frailty Defined by Deficit Accumulation and Geriatric Medicine Defined by Frailty. Clinics in Geriatric Medicine 2011; 27 (1): 17-26.