Cozaar Availability in the United States
Yes, Cozaar (losartan) is FDA-approved and available in the United States for treating hypertension in adults and children ≥6 years old, reducing stroke risk in hypertensive patients with left ventricular hypertrophy, and treating diabetic nephropathy in type 2 diabetic patients with elevated serum creatinine and proteinuria. 1
FDA-Approved Indications
Losartan has three specific FDA-approved indications in the US:
Hypertension: Approved for adults and pediatric patients 6 years and older to lower blood pressure, which reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction 1
Stroke Risk Reduction: Indicated to reduce stroke risk in patients with hypertension and left ventricular hypertrophy, though evidence suggests this benefit does not apply to Black patients 1, 2
Diabetic Nephropathy: Approved for treating diabetic nephropathy with elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension, where it reduces the rate of progression to doubling of serum creatinine or end-stage renal disease 1, 3
Clinical Evidence Supporting Use
The LIFE study demonstrated that losartan was more effective than atenolol in reducing cardiovascular mortality, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy, primarily due to a 25% reduction in stroke risk 2, 4
The RENAAL trial showed that losartan is superior to conventional antihypertensive therapy in slowing progression of overt type 2 diabetic nephropathy 3, 5
Dosing and Administration
- Losartan can be administered without regard to food 6
- The recommended starting dose is 25-100 mg once daily, with a maximum recommended daily dose of 100 mg 4, 6
- Higher doses (150 mg daily) have shown greater benefit in heart failure, with a 10% relative risk reduction in death or heart failure hospitalization compared to 50 mg daily 4
- For diabetic nephropathy, the optimal dose is 100 mg daily for renoprotection and blood pressure reduction 7
Important Safety Considerations
Monitor renal function and potassium within 2-4 weeks after initiation or dose increase, as losartan can cause renal function deterioration and hyperkalemia 4, 5
- Avoid combining losartan with ACE inhibitors or direct renin inhibitors, as dual blockade increases risks of hypotension, hyperkalemia, and acute renal failure without additional benefit 4, 5
- Contraindicated in pregnancy due to serious fetal toxicity when given in the second and third trimesters 6
- Use caution in patients with bilateral renal artery stenosis or severe heart failure, where worsening renal function can occur 5