Data Impact Challenge II Question 7

Question 7: Is there a difference in outcomes for patients with diabetes and those who do not have diabetes using ACE or ARBs?

Rationale
Angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) are widely prescribed medications. A 2014 recent Cochrane review of randomized controlled trials found no evidence of a difference in total mortality or cardiovascular outcomes (e.g. cardiovascular events) for ARBs as compared with ACE inhibitors for patients prescribed these medications for primary hypertension. However, whether this translates to non-study populations is not well understood. Is there a difference in all-cause mortality and cardiovascular outcomes for patients with diabetes and those who do not have diabetes using these medications irrespective of indication?

Guiding Specifications

    a) Comparison for patients without diabetes

  1. All-cause 5-year mortality and (separately) cardiovascular events for patients without diabetes on ACE inhibitors.
    • Numerator: Of those individuals in the denominator, number of individuals without diabetes on ACE inhibitors that experience death or a cardiovascular event within a 5-year period.
    • Denominator: Number of individuals without diabetes on ACE inhibitors at a given point(s) in time.
  2. All-cause 5-year mortality and (separately) cardiovascular events for patients without diabetes on ARBs.
    • Numerator: Of those individuals in the denominator, number of individuals without diabetes on ARBs that experience a cardiovascular event or death within a 5-year period.
    • Denominator: Number of individuals without diabetes on ARBs at a given point(s) in time.
    b) Comparison for patients with diabetes

  1. Total mortality and cardiovascular events for patients with diabetes on ACE inhibitors.
    • Numerator: Of those individuals in the denominator, number of individuals with diabetes on ACE inhibitors that experience a cardiovascular event or death within a 5-year period.
    • Denominator: Number of individuals with diabetes on ACE inhibitors at a given point(s) in time.
  2. Total mortality and cardiovascular outcomes for patients with diabetes on ARBs.
    • Numerator: Of those individuals in the denominator, number of individuals with diabetes on ARBs that experience a cardiovascular event or death within 5-year period.
    • Denominator: Number of individuals with diabetes on ARBs at a given point(s) in time.

Sample: Minimum sample size of 5,000 users of ACE inhibitors and 5,000 users of ARBs.
Timeframe: Data should follow users for at least five years.