Adverse effects of low-dose aspirin in a healthy elderly population

Abstract

The adverse effects of low-dose aspirin (100 mg daily) in the elderly were studied over a 12-month period in a double-blind, randomized, placebo-controlled trial of 400 subjects who were 70 years of age or older and had no preexisting major vascular diseases at the time of entry. Subjects were randomized so that 200 subjects received low-dose enteric-coated aspirin (100 mg daily) and 200 subjects received placebo. Compliance with medication, assessed by pill count, was 86%. Gastrointestinal symptoms were reported by 18% (n = 36) of participants receiving aspirin and 13% (n = 26) of those receiving placebo. Clinically evident gastrointestinal bleeding occurred in 3% (n = 6) of subjects receiving aspirin and none receiving placebo. Aspirin-treated subjects had a significant decrease in mean hemoglobin levels of 0.33 gm/dl during the 12-month study period, which was significantly greater than the decrease in the placebo-treated group (0.11 gm/dl; p < 0.05). These rates of unwanted symptoms are comparable with previous studies that used higher doses of aspirin. Until the risk-benefit trade-off from the use of low-dose aspirin in the elderly is established with an appropriate clinical trial, caution should be exercised when this compound is used for primary prevention of cardiovascular disease in this age group.

The MAGIC Study and the Gastrointestinal Effects of Low-Dose Aspirin

“…The study will also be able to relate gastric mucosal injury to dose and measure the frequency of clinical evident bleeding over 12 months. In previous studies where bleeding has been carefully documented its incidence has been surprisingly high [2][3][4][5] and it will be interesting to establish if this study confirms these observations. The investigators are also planning to assess any differences between a variety of subgroups based on such factors as the presence or absence of H. pylori infection or co-prescription of anti-secretory drugs (e.g.…”

Review article: gastrointestinal bleeding with low‐dose aspirin – what's the risk?

“…[23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] 'Major' bleeding is based on definitions in individual studies or includes GI bleeding episodes that were fatal or required hospitalization or transfusion. The mean or median duration of 12 studies comprising 97.5% of the patients in the 14 studies ranged from 12 to 76 months, while the other 2.5% of the patients were from two studies with 3 months median duration.…”

Adherence to Secondary Stroke Prevention Strategies – Results from the German Stroke Data Bank

“…Non-compliance accounted for more than half of the drug failures under antihypertensive treatment [19]. Adherence to a prescribed drug, moreover, is perhaps related to other factors such as patient’s education and attitude to disease [20], perceived or experienced side effects [21, 22], patient specific reminders [23], medical regimen with a convenient intake frequency [24], adherence control and physician’s attitude regarding therapy [23]. Major problems also include potential side effects and the patient’s non-verbalized anxiety towards any chemical agent [23].…”