What are the criteria for stopping Diovan (Valsartan) therapy?

Criteria for Stopping Diovan (Valsartan) Therapy

Valsartan should be discontinued immediately if pregnancy is detected, and should be stopped or withheld if clinically significant hypotension, acute renal failure, or severe hyperkalemia develops that cannot be managed with dose adjustment. 1

Absolute Indications for Discontinuation

Pregnancy

• Discontinue valsartan as soon as pregnancy is detected 1
• Valsartan causes fetal toxicity during the second and third trimesters, including fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and neonatal complications (skull hypoplasia, anuria, hypotension, renal failure, and death) 1

Severe Hypotension

• Permanent discontinuation is warranted if symptomatic hypotension persists despite supportive measures 1
• In post-myocardial infarction patients, hypotension led to permanent discontinuation in 1.4% of valsartan-treated patients 1
• Place patient supine and administer IV normal saline if excessive hypotension occurs; if blood pressure cannot be stabilized, discontinue therapy 1

Clinically Significant Renal Dysfunction

• Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function 1
• Monitor renal function periodically, especially in high-risk patients (renal artery stenosis, chronic kidney disease, severe heart failure, volume depletion) 1
• In clinical trials, discontinuation occurred in 0.5% of patients due to creatinine elevations 1

Severe Hyperkalemia

• Dosage reduction and/or discontinuation may be required if hyperkalemia develops 1
• Discontinuation occurred in 0.5% of valsartan-treated patients due to potassium elevations in heart failure trials 1
• Monitor serum potassium, particularly in patients with pre-existing renal impairment or heart failure 1

Relative Indications for Discontinuation

Intolerable Adverse Effects

• Discontinuation due to side effects was required in 2.3% of hypertensive patients, most commonly for headache and dizziness 1
• In heart failure trials, 10% of valsartan patients discontinued for adverse reactions versus 7% on placebo 1

Lack of Efficacy in Hypertension

• While not explicitly stated in guidelines for valsartan, general principles suggest reassessing therapy if blood pressure targets are not achieved after adequate titration and duration (typically 2-4 weeks at target dose) 2, 3
• Consider switching to alternative therapy rather than continuing ineffective treatment 4

Common Pitfalls to Avoid

Do Not Discontinue for Minor Creatinine Increases

• Some increase in creatinine is expected and often not clinically significant 2
• Only discontinue for clinically significant decreases in renal function 1

Do Not Stop Abruptly Without Cause

• In heart failure patients achieving at least 50% of target dose (160 mg daily), continuation provides optimal cardiovascular benefits 2
• Transient hypotensive responses are not contraindications to further treatment once blood pressure stabilizes 1

Avoid Premature Discontinuation in Heart Failure

• The therapeutic benefits in heart failure and post-MI patients are substantial 5
• Valsartan was as effective as captopril at reducing mortality and cardiovascular morbidity in post-MI patients with heart failure or left ventricular systolic dysfunction 5