Prevalence of diabetes treatment effect modifiers: The external validity of trials to older adults

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7 Scopus citations


Background and aims: Potential treatment effect modifiers (TEMs) are specific diseases or conditions with a well-described mechanism for treatment effect modification. The prevalence of TEMs in older adults with type 2 diabetes mellitus (DM) is unknown. Objectives were to 1) determine the prevalence of pre-specified potential TEMs; 2) demonstrate the potential impact of TEMs in the older adult population using a simulated trial; 3) identify TEM combinations associated with number of hospitalizations to test construct validity. Methods: Data are from the nationally-representative United States National Health and Examination Survey, 1999-2004: 8646 Civilian, non-institutionalized adults aged 45-64 or 65+ years, including 1443 with DM. TEMs were anemia, congestive heart failure, liver inflammation, polypharmacy, renal insufficiency, cognitive impairment, dizziness, frequent mental distress, mobility difficulty, and visual impairment. A trial was simulated to examine prevalence of potential TEM impact. The cross-sectional association between TEM patterns and number of hospitalizations was estimated to assess construct validity. Results: The prevalence of TEMs was substantial such that 19.0% (95% CI 14.8-23.2) of middle-aged adults and 38.0% (95% CI 33.4-42.5) of older adults had any two. A simulated trial with modest levels of interaction suggested the prevalence of TEMs could nullify treatment benefit in 3.9-27.2% of older adults with DM. Compared to having DM alone, hospitalization rate was increased by several combinations of TEMs with substantial prevalence. Conclusions: We provide national benchmarks that can be used to evaluate TEM prevalence reported by clinical trials of DM, and correspondingly their external validity to older adults.

Original languageEnglish (US)
Pages (from-to)370-376
Number of pages7
JournalAging - Clinical and Experimental Research
Issue number4
StatePublished - Aug 2012


  • Applicability
  • Clinical trials as topic
  • Comorbidity
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Aging
  • Geriatrics and Gerontology


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