Exclusion of Older Adults from Ongoing Clinical Trials About Type 2 Diabetes Mellitus

Cruz-Jentoft, Alfonso J.; Carpena-Ruiz, Marina; Montero‐Errasquín, Beatriz; Sánchez-Castellano, C.; García, Elena Martín

doi:10.1111/jgs.12215

Cited by 110 publications

(105 citation statements)

References 25 publications

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“…The majority of studies concern themselves with identifying forms of discrimination in diagnosis , Rudd et al 2007, Bond et al 2003, discrimination in treatment and management (Koch and Webb 1996;Chambaere et al 2012;Pedersen and Mehlsen 2011;Grant et al 2000;Gnavi et al 2007;Austin et al 2013), discrimination in access to research and clinical trials (Cruz-Jentoft et al 2013;Briggs et al 2012) and differences in survival rates (Peake et al 2003;Grant et al 2000). The cognitive component, mainly addressed in qualitative studies, is generally reflected in research on the stereotypes and assumption about older patients not belonging in specific care institutions (Parke and Chappell 2010), about symptoms that are "normal" at more advanced ages (Iliffe et al 2005;Makris et al 2015) and about expected responses to treatment (Skirbekk and Nortvedt 2014).…”

Section: Comparison Of Research On Ageism In Health and Long-term Carementioning

confidence: 99%

“…Here, evidence of ageism is related to "the extent of exclusion of older individuals from ongoing clinical trials regarding type 2 diabetes mellitus" (Cruz-Jentoft et al 2013;p. 734) and "(...)"whether exclusion of older people was prevalent in research proposals submitted to Dublin teaching hospitals" (Briggs et al 2012, p.311).…”

Section: Ageism In Health Carementioning

confidence: 99%

“…Similarly, in the health care setting, studies of ageism are also based on registry data (Cruz-Jentoft et al 2013), on analysis of case documentation and files (Bond et al 2003;Peake et al 2003), on auditing of clinical research proposals (Briggs et al 2012), on the analysis of death certificates (Chambaere et al 2013) and of hospital and other regional medical databases (Gnavi et al 2007;Grant et al 2000;Rudd et al 2007). Due to the lack of coordinated data collection efforts, among other constraints, such studies are rendered virtually impossible and in fact, lack completely, from the empirical literature on ageism in long-term care.…”

Section: Quantitative Approachesmentioning

confidence: 99%

See 2 more Smart Citations

Researching Ageism in Health-Care and Long Term Care

Buttiġieġ

Ilinca

Jose

et al. 2018

International Perspectives on Aging

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Section: Comparison Of Research On Ageism In Health and Long-term Carementioning

confidence: 99%

Section: Ageism In Health Carementioning

confidence: 99%

Section: Quantitative Approachesmentioning

confidence: 99%

See 1 more Smart Citation

Researching Ageism in Health-Care and Long Term Care

Buttiġieġ

Ilinca

Jose

et al. 2018

International Perspectives on Aging

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“…Few studies specifically in older adults with type 2 diabetes exist, limiting the applicability of the evidence to older, complex patients (11)(12)(13)(14)(15)(16). In recognition of the particular pathophysiologic features of older patients with diabetes, the International Diabetes Federation (IDF) and the American Diabetes Association (ADA) developed guidelines specifically for the older population.…”

mentioning

confidence: 99%

Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial

Meneilly

Roy-Duval

Alawi³

et al. 2017

Diabetes Care

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OBJECTIVETo evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment. RESEARCH DESIGN AND METHODSIn this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged ‡70 years were randomized to receive once-daily lixisenatide 20 mg or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks. Patients at risk for malnutrition or with moderate to severe cognitive impairment were excluded. The primary end point was absolute change in HbA 1c from baseline to week 24. Secondary end points included change from baseline to week 24 in 2-h postprandial plasma glucose (PPG) and body weight. RESULTSA total of 350 patients were randomized. HbA 1c decreased substantially with lixisenatide (20.57% [6.2 mmol/mol]) compared with placebo (+0.06% [0.7 mmol/mol]) from baseline to week 24 (P < 0.0001). Mean reduction in 2-h PPG was significantly greater with lixisenatide (25.12 mmol/L) than with placebo (20.07 mmol/L; P < 0.0001). A greater decrease in body weight was observed with lixisenatide (21.47 kg) versus placebo (20.16 kg; P < 0.0001). The safety profile of lixisenatide in this older population, including rates of nausea and vomiting, was consistent with that observed in other lixisenatide studies. Hypoglycemia was reported in 17.6% of patients with lixisenatide versus 10.3% with placebo. CONCLUSIONSIn nonfrail older patients uncontrolled on their current antidiabetic treatment, lixisenatide was superior to placebo in HbA 1c reduction and in targeting postprandial hyperglycemia, with no unexpected safety findings.

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“…randomized controlled trials (RCTs) (3,4) often as a result of study entry criteria, including 1) setting arbitrary caps on participant age and 2) discouraging or disallowing participants with confounding comorbidities, frailty, or polypharmacy (common in the elderly). The justification for these criteria is a concern that including such subjects may complicate study interpretation (5).…”

mentioning

confidence: 99%

Efficacy and Safety of Saxagliptin in Older Participants in the SAVOR-TIMI 53 Trial

Leiter

Teoh²,

Braunwald

et al. 2015

Diabetes Care

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OBJECTIVETo examine the safety and cardiovascular (CV) effects of saxagliptin in the predefined elderly ( ‡65 years) and very elderly ( ‡75 years) subpopulations of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) trial. RESEARCH DESIGN AND METHODSIndividuals ‡40 years (n = 16,492; elderly, n = 8,561; very elderly, n = 2,330) with HbA 1c ‡6.5% (47.5 mmol/mol) and £12.0% (107.7 mmol/mol) were randomized (1:1) to saxagliptin (5 or 2.5 mg daily) or placebo in a double-blind trial for a median follow-up of 2.1 years. RESULTSThe hazard ratio (HR) for the comparison of saxagliptin versus placebo for the primary end point (composite of CV mortality, myocardial infarction, or ischemic stroke) was 0.92 for elderly patients vs. 1.15 for patients <65 years (P = 0.06) and 0.95 for very elderly patients. The HRs for the secondary composite end points in the entire cohort, elderly cohort, and very elderly cohort were similar. Although saxagliptin increased the risk of hospitalization for heart failure in the overall saxagliptin population, there was no age-based treatment interaction (P = 0.76 for elderly patients vs. those <65 years; P = 0.34 for very elderly patients vs. those <75 years). Among saxagliptin-treated individuals with baseline HbA 1c ‡7.6% (59.6 mmol/mol), the mean change from baseline HbA 1c at 2 years was 20.69%, 20.64%, 20.66%, and 20.66% for those ‡65, <65, ‡75, and <75 years old, respectively. The incidence of overall adverse events (AEs) and serious AEs was similar between saxagliptin and placebo in all cohorts; however, hypoglycemic events were higher for saxagliptin versus placebo regardless of age. CONCLUSIONSThe SAVOR-TIMI 53 trial supports the overall CV safety of saxagliptin in a robust number of elderly and very elderly participants, although the risk of heart failure hospitalization was increased irrespective of age category. AEs and serious AEs as well as glycemic efficacy of saxagliptin in elderly patients are similar to those found in younger patients.Estimates place the global prevalence of diabetes in individuals between 60 and 79 years old at ;19%, with the number of these individuals projected to almost double by 2035 (1). Despite ongoing emphasis on the importance of practicing evidencebased medicine (2), older patients have been underrepresented in type 2 diabetes

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Exclusion of Older Adults from Ongoing Clinical Trials About Type 2 Diabetes Mellitus

Cited by 110 publications

References 25 publications

Researching Ageism in Health-Care and Long Term Care

Researching Ageism in Health-Care and Long Term Care

Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial

Efficacy and Safety of Saxagliptin in Older Participants in the SAVOR-TIMI 53 Trial

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