Esomeprazole and aspirin fixed combination for the prevention of cardiovascular events

Figures & data

Table 1 Potential long-term adverse effect of proton pump inhibitors^36–45

Decreased bone mineral density

Increased risk of fractures: hip, vertebral, and wrist

Increased risk of infections

Enteric infections (eg, Clostridium difficile)

Respiratory infections (community-acquired and hospital-acquired pneumonia)

Nutritional deficiencies

Calcium

Iron

Vitamin B12

Magnesium

Increased risk of gastric and colon cancer

Table 2 Summary of recommendations on aspirin use for the prevention of cardiovascular events^10,11,56

Population	Recommendation	Level of evidence
US preventative services task force
Men 45–79 years old	Encourage use of ASA* (75 mg/day) when potential benefit of a reduction in MI outweighs the potential harm of an increase in GI hemorrhage	A
Women 55–79 years old	Encourage use of ASA* (75 mg/day) when potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in GI hemorrhage	A
Men and Women > 80 years old	Insufficient evidence to assess the balance of benefit and harm for CV disease prevention	I
Women < 55 years old and Men < 45 years old	Do not encourage the use of ASA* for CV disease prevention	D
AHA/ACCF scientific statement 2010: primary prevention		ACCF/AHA
Adults with DM and a 10-year CVD risk > 10% who are not at increased risk for bleeding	Consider low dose ASA* therapy (75 to 162 mg/day)	B
Adults with DM and a 10-year CVD risk < 5%	Not recommended	C
Adults with DM and a 10-year CVD risk of 5%–10%	Consider using low dose ASA* (75 to 162 mg/day) until further research is available	C
ADA 2011 guidelines		ADA
High CVD risk: 10-year risk > 10% Type 1 and 2 DM	Consider ASA* therapy at 75 to 162 mg/day	C
Low CVD risk 10-year risk < 5%	Risk of bleed outweighs benefit; not recommended	C
Moderate CVD risk 10-year risk 5%–10%	Clinical judgment of risk versus benefit required	E
Secondary prevention: all patients with DM and history of CVD	Use ASA* 75–162 mg/day	A
Documented ASA* allergy in patients with DM and h/o CVD	Use clopidogrel 75 mg/day	B
Patients with DM and ACS	Combination therapy with ASA* (75–162 mg/day) and clopidogrel 75 mg/day) up to one year	B

Notes: ASA* is contraindicated in patients <21 years old due to the risk of Reye’s syndrome. A: benefit is substantial; B: benefit is moderate; C: benefit is small; D: Harm outweighs benefit; I: Insufficient evidence. ACCF/AHA – A: data from many large, randomized controlled trials; B: data from fewer, smaller randomized controlled trials, non-randomized studies or observational registries; C: expert consensus. ADA – A: clear evidence randomized controlled trial or meta-analysis; B: supportive evidence from cohort studies; C: supportive evidence from poorly controlled or uncontrolled studies; E: expert consensus.

Abbreviations: ACCF, American College of Cardiology Fellows; ACS, acute coronary syndrome; ADA, American Diabetes Association; AHA, American Heart Association; ASA, aspirin; CVD, cardiovascular disease; DM, diabetes mellitus; GI, gastrointestinal; h/o, history of; MI, myocardial infarction.

Table 3 Risk factors for gastrointestinal bleeding^7,18

History of gastrointestinal bleeding

Peptic ulcer disease

Upper gastrointestinal tract pain

Concomitant medications

Nonsteroidal anti-inflammatory drugs

Anticoagulants (warfarin, dabigatran, rivaroxaban, low molecular weight heparin, fondaparinux)

Antiplatelets (clopidogrel, ticagrelor, prasugrel, ticlopidine, cilostazol, dipyridamole)

Steroids

Advanced age

Male gender

Uncontrolled hypertension

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