Table 1 Design and description of trials of aspirin therapy included in systematic review and meta-analysis
Study and Year | Study design | Patient Population | ASA Dose | Duration of ASA therapy (years) | Exclusively enrolled patients with DM | # of people with DM (% of sample) | Duration of DM | Mean HbA1C % | Primary outcome measures |
|---|---|---|---|---|---|---|---|---|---|
PHS 1989 | Randomized, double blind*, placebo controlled trial | Male physicians | 325 mg every other day | 5 | No | 533 (2.4) | NR | NR | CV mortality |
ETDRS 1992 | Randomized, double blind*, placebo controlled trial | Men and women with type 1 or type 2 DM | 650 mg every day | 5 | Yes | 3711 (100) | Greater than 80% for >10 years | >40% with HbA1C >10% | All cause mortality |
HOT 1998 | Randomized, double blind*, placebo controlled trial## | Men and women with hypertension | 75 mg every day | 3.8 | No | 1501 (8) | NR | NR | Composite endpoint of CV death, MI, or stroke |
PPP 2003 | Randomized, open label trial with 2 × 2 factorial design | Men and women with DM age >50 with ≥ 1 RF for CVD | 100 mg every day | 3.6 | Yes | 1031 (100) | NR | 7.6, 7.6 | Composite end point CV death, MI, or stroke |
WHS 2005 | Randomized, double blind*, 2 × 2 factorial, placebo controlled trial | Women | 100 mg every other day | 10.1 | No | 1027 (2.6) | NR | NR | Composite end point of non-fatal MI, non-fatal stroke, death from CVD |
POPADAD2008 | Randomized, double blind*, 2 × 2 factorial, placebo controlled trial | Men and Women with type 1 or 2 DM and an ABI ≤ 0.99 but no symptomatic CVD | 100 mg every day | 6.7 ** | Yes | 1276 (100) | Greater than 6 years in each group | 7.9-8.0 | Death from CHD or stroke, non-fatal MI or stroke, or amputation above ankle for critical limb ischemia and death from CHD |
JPAD 2008 | Randomized, open label controlled trial | Men and women with type 2 DM without history of atherosclerotic disease | 81 or 100 mg every day | 4.4 | Yes | 2539 (100) | 7.3, 6.7*** | 7.1, 7.0 | Atherosclerotic events including fatal or non-fatal heart disease, fatal or non-fatal stroke, and PAD |