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2 results

  • Chapter 32 - Diabetes Mellitus

  • from Section III - Care of the Elderly by Organ System
  • Edited by Jan Busby-Whitehead, University of North Carolina, Chapel Hill, Samuel C. Durso, The Johns Hopkins University, Maryland, Christine Arenson, Thomas Jefferson University, Philadelphia, Rebecca Elon, The Johns Hopkins University School of Medicine, Mary H. Palmer, University of North Carolina, Chapel Hill, William Reichel
  • Book:
    Reichel's Care of the Elderly
    Published online:
    30 June 2022
    Print publication:
    21 July 2022, pp 395-406

  • Summary

    Diabetes mellitus (DM) is a dominant chronic disease in the older adult population in the United States as well as in many other countries of the world. The prevalence of DM in the future is only expected to grow with the increase in the population of adults aged 65 and over, the prevalence of obesity, and physical inactivity. Clinicians are faced with many unique challenges when caring for this older diabetic population. The clinician’s major challenges are (1) to avoid symptoms and complications of hyper- and hypoglycemia, (2) to minimize or delay micro- and macrovascular complications, if possible, and (3) to maximize daily functioning. Underlying these challenges is the realization that the geriatric population is a heterogeneous one. Goals of care and treatment decisions may vary, depending more on the patient’s functional abilities and on other comorbidities or coexisting geriatric syndromes, and less on the age of the patient. This chapter will focus on specific aspects of diabetes care in the older adult.

  • Glycated hemoglobin as a surrogate for evaluating the effectiveness of drugs in diabetes mellitus trials: a systematic review and trial-level meta-analysis

  • Paola Andrea Rivera, Milton J. M. Rodríguez-Zúñiga, José Caballero-Alvarado, Fabián Fiestas
  • Journal:
    International Journal of Technology Assessment in Health Care / Volume 38 / Issue 1 / 2022
    Published online by Cambridge University Press:
    22 December 2021, e12
  • Objective

    The objective of this study was to investigate whether glycated hemoglobin (HbA1c) is a valid surrogate for evaluating the effectiveness of antihyperglycemic drugs in diabetes mellitus (DM) trials.

    Methods

    We conducted a systematic review of placebo-controlled randomized clinical trials (RCTs) evaluating the effect of a treatment on HbA1c (mean difference between groups) and clinical outcomes (relative risk of mortality, myocardial infarction, stroke, heart failure, and/or kidney injury) in patients with DM. Then, we investigated the association between treatment effects on HbA1c and clinical outcomes using regression analysis at the trial level. Lastly, we interpreted the correlation coefficients (R) using the cut-off points suggested by the Institute for Quality and Efficiency in Healthcare (IQWiG). HbA1c was considered a valid surrogate if it demonstrated a strong association: lower limit of the 95 percent confidence interval (95 percent CI) of R greater than or equal to .85.

    Results

    Nineteen RCTs were identified. All studies included adults with type 2 DM. None of the associations evaluated was strong enough to validate HbA1c as a surrogate for any clinical outcome: mortality (R = .34; 95 percent CI −.14 to .69), myocardial infarction (R = .20; −.30 to .61), heart failure (R = .08; −.40 to .53), kidney injury (R = −.04; −.52 to .47), and stroke (R = .81; .54 to .93).

    Conclusions

    The evidence from multiple placebo-controlled RCTs does not support the use of HbA1c as a surrogate to measure the effectiveness of antihyperglycemic drugs in DM studies.