Does Hypertension and Age 55 Qualify as Additional Cardiac Risk Factors for Vascepa in a Diabetic Patient?
Yes, hypertension alone qualifies as an additional cardiovascular risk factor that, combined with diabetes mellitus, meets the criteria for Vascepa (icosapent ethyl) therapy in patients with elevated triglycerides on statin treatment.
Understanding Vascepa Indication Criteria
The REDUCE-IT trial, which established Vascepa's cardiovascular benefit, enrolled patients with either:
- Established cardiovascular disease (secondary prevention), OR
- Diabetes mellitus PLUS at least one additional cardiovascular risk factor (primary prevention) 1
Hypertension definitively counts as an additional cardiovascular risk factor in diabetic patients for Vascepa consideration 1. The presence of hypertension in your 55-year-old diabetic patient satisfies the "diabetes plus one additional risk factor" criterion.
Recognized Additional Cardiovascular Risk Factors
Beyond hypertension, other qualifying risk factors include 2:
- Age ≥55 years in men (your patient meets this threshold)
- Age ≥65 years in women
- Smoking (current or recent)
- Dyslipidemia (LDL ≥100 mg/dL despite statin therapy)
- Chronic kidney disease (eGFR <60 mL/min/1.73 m²)
- Albuminuria (≥30 μg albumin/mg creatinine)
- Family history of premature atherosclerotic cardiovascular disease
- Retinopathy or neuropathy
Your Patient's Specific Situation
Your 55-year-old male patient with diabetes and hypertension meets criteria through two pathways:
Hypertension as the additional risk factor: This alone, combined with diabetes, qualifies him for Vascepa if triglycerides remain 135-499 mg/dL on statin therapy 1
Age ≥55 years: Being 55 years old is itself recognized as an additional cardiovascular risk factor in diabetic men 2
Complete Eligibility Requirements for Vascepa
To prescribe Vascepa for cardiovascular risk reduction, your patient must meet ALL of the following 1:
- Diabetes mellitus (which he has) ✓
- At least one additional cardiovascular risk factor (hypertension and/or age ≥55) ✓
- Elevated triglycerides 135-499 mg/dL (verify this level)
- Already on statin therapy (confirm he's taking a statin)
- Controlled LDL cholesterol (typically 40-100 mg/dL on statin)
Clinical Evidence Supporting Use
The REDUCE-IT trial demonstrated that icosapent ethyl 4 g daily reduced the primary composite cardiovascular endpoint by 25% in high-risk patients 1. Women with diabetes showed particularly robust responses, with 21.5% triglyceride reduction and improvements in multiple atherogenic lipid parameters without increasing LDL cholesterol 3.
Importantly, benefits were consistent across all kidney function categories, with patients having eGFR <60 mL/min/1.73 m² showing the largest absolute risk reduction (primary endpoint: 21.8% vs 28.9% placebo; HR 0.71, P=0.0002) 1.
Common Pitfall to Avoid
Do not wait for additional risk factors to accumulate. Hypertension alone is sufficient when combined with diabetes. The presence of age ≥55 years provides additional justification but is not required when hypertension is already present 2, 1.
Safety Monitoring Considerations
While prescribing Vascepa, monitor for 1:
- Atrial fibrillation/flutter: Increased risk, particularly in patients with reduced kidney function (4.2% vs 3.0% placebo in eGFR <60 group)
- Bleeding events: Slightly elevated risk (5.4% vs 3.6% placebo in eGFR <60 group), though hazard ratios were similar across all eGFR categories
- These risks did not outweigh cardiovascular benefits in the trial population