What parameters should be monitored in patients initiating Entresto (sacubitril/valsartan) therapy?

Monitoring Parameters for Patients Initiating Entresto (Sacubitril/Valsartan) Therapy

When initiating Entresto (sacubitril/valsartan) therapy, patients should be monitored for blood pressure, renal function, serum electrolytes (especially potassium), and signs of angioedema, with follow-up assessments at 1 week, 1 month, 3 months, and 6 months after starting treatment or dose adjustments.

Key Parameters to Monitor

Before Initiation

• Blood pressure - ensure systolic BP ≥100 mmHg before starting
• Renal function (serum creatinine, eGFR)
• Serum electrolytes (particularly potassium and sodium)
• Pregnancy test in women of childbearing potential (contraindicated in pregnancy)
• Medication review to ensure no concurrent ACE inhibitor use (must wait 36 hours after discontinuing ACE inhibitor) 1

After Initiation

• Blood pressure - monitor for hypotension, especially in:

  • Volume-depleted patients
  • Patients on high-dose diuretics
  • Elderly patients
  • Patients with baseline SBP 100-110 mmHg 2

• Renal function and electrolytes:

  • Check within 1 week of starting treatment 3, 1
  • Recheck 1 week after any dose increase 3
  • Monitor at 1,3, and 6 months after achieving maintenance dose 3
  • Continue monitoring every 6 months thereafter 3

• Signs of angioedema:

  • Swelling of face, lips, tongue, glottis, or larynx
  • Higher risk in Black patients and those with prior history of angioedema 1

• Symptoms of heart failure - to assess therapeutic response

Dosing and Titration Monitoring

• Starting dose:

  • 24/26 mg twice daily for patients not currently taking an ACE inhibitor or ARB
  • 49/51 mg twice daily for patients previously on low doses of ACE inhibitor or ARB
  • 97/103 mg twice daily for patients previously on high doses of ACE inhibitor or ARB 1

• Titration schedule:

  • Consider gradual up-titration over 6 weeks rather than rapid 3-week titration, especially in patients with baseline SBP 100-110 mmHg 2
  • Target dose: 97/103 mg twice daily

• Dose adjustment considerations:

  • If hypotension occurs, consider reducing diuretic dose before reducing Entresto 1
  • For patients who develop renal impairment or hyperkalemia, down-titration or temporary discontinuation may be necessary 1

Special Monitoring Considerations

• Patients with renal impairment:

  • More frequent monitoring of renal function
  • No initial dose adjustment needed for mild to moderate renal impairment
  • Reduced starting dose (24/26 mg twice daily) for severe renal impairment 1

• Patients with hepatic impairment:

  • No dose adjustment needed for mild hepatic impairment
  • Starting dose of 24/26 mg twice daily recommended for moderate hepatic impairment
  • Not recommended in severe hepatic impairment 1

• Elderly patients:

  • Monitor closely for hypotension
  • No initial dose adjustment required based on age alone 1

Common Adverse Effects to Monitor

• Hypotension (most common) - monitor for dizziness, lightheadedness 1
• Hyperkalemia - especially in patients with renal impairment, diabetes, or on potassium-sparing medications 1
• Renal dysfunction - particularly in patients with pre-existing renal impairment 1
• Hyponatremia - has been reported in some cases 4
• Angioedema - requires immediate discontinuation if it occurs 1

Practical Monitoring Schedule

1. Baseline: Complete blood work including renal function, electrolytes, and blood pressure measurement
2. Week 1: Recheck renal function, electrolytes, and blood pressure
3. Week 2-4: Consider dose up-titration if initial dose tolerated; recheck parameters 1 week after any dose change
4. Month 1: Comprehensive assessment of all parameters
5. Month 3: Follow-up assessment
6. Month 6: Follow-up assessment
7. Every 6 months thereafter: Routine monitoring

By following this monitoring protocol, clinicians can optimize the safety and efficacy of Entresto therapy while minimizing the risk of adverse events.