Sacubitril; Valsartan with Aliskiren Interaction Details
Brand Names Associated with Sacubitril; Valsartan
- Entresto®
- Valsartan and Sacubitril
Brand Names Associated with Aliskiren
- Aliskiren
- Tekturna®
- Tekturna® HCT (as a combination product containing Aliskiren, Hydrochlorothiazide)
- Valturna® (as a combination product containing Aliskiren, Valsartan)
Medical Content Editor Dr. Brian Staiger, PharmD
Last updated
Nov 09, 2023
Interaction Effect
An increased risk of hyperkalemia, renal impairment, and hypotension
Interaction Summary
According to interim results of the randomized, double-blind, placebo-controlled ALTITUDE trial (n=8606), the addition of aliskiren to treatment with an ACE inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes at high risk of fatal and nonfatal cardiovascular and renal events was associated with an increased risk of hyperkalemia, hypotension, and renal impairment. Concomitant use of aliskiren and angiotensin II receptor blockers, such as valsartan, is contraindicated in patients with diabetes due to increased risk of hyperkalemia, hypotension, and renal impairment. The combination of aliskiren with valsartan should also be avoided in patients with renal impairment (GFR less than 60 mL/min) . Concomitant use of 2 agents that block the renin-angiotensin system (RAS) does not provide any additional benefit compared with monotherapy and should generally be avoided. Close monitoring of blood pressure, renal function and electrolytes is recommended for patients receiving valsartan and other agents that affect the RAS .
Severity
Contraindicated
Onset
Unspecified
Evidence
Probable
How To Manage Interaction
Concomitant use of aliskiren and angiotensin II receptor blockers, such as valsartan, is contraindicated in patients with diabetes due to increased risk of hyperkalemia, hypotension, and renal impairment. The combination of aliskiren with valsartan should also be avoided in patients with renal impairment (GFR less than 60 mL/min). Concomitant use of 2 agents that block the renin-angiotensin system (RAS) does not provide any additional benefit compared with monotherapy and should generally be avoided. Close monitoring of blood pressure, renal function and electrolytes is recommended for patients receiving valsartan and other agents that affect the RAS .
Mechanism Of Interaction
Additive effects
Literature Reports
A) In patients with diabetes and renal disease who received either an ACE inhibitor or an angiotensin II receptor blocker, treatment with aliskiren 300 mg daily resulted in higher risk of hyperkalemia, hypotension, and renal impairment compared with placebo, according to interim results of the randomized, double-blind, placebo-controlled Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE; n=8606). The primary composite endpoint was the first occurrence of cardiovascular death, resuscitated sudden death, nonfatal myocardial infarction, nonfatal stroke, unplanned hospitalization for heart failure, doubling of baseline serum creatinine concentration to above ULN (for a period of 1 month), or onset of ESRD or renal death. Hyperkalemia was reported in 36.9% of aliskiren-treated patients (1.1% were rated as serious adverse events), compared with 27.1% of those treated with placebo (0.3% were rated as serious). Renal impairment (12.4% vs 10.4%) and hypotension (18.6% vs 14.8%) were also increased in the aliskiren group compared with the placebo group, respectively. The study was terminated after a median followup of approximately 27 months due to lack of efficacy .
Sacubitril; Valsartan Overview
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The combination of valsartan and sacubitril is usually used in combination with other medications to lower the risk of death and hospitalization in adults with certain types of heart failure. The combination of valsartan and sacubitril is also used to treat certain types of heart failure in children 1 year of age and older. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently. Sacubitril is in a class of medications called neprilysin inhibitors. It works to help control blood volume.
Aliskiren Overview
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Aliskiren is used alone or in combination with some medications to treat high blood pressure. Aliskiren is in a class of medications called direct renin inhibitors. It works by decreasing certain natural chemicals that tighten the blood vessels, so blood vessels relax and the heart can pump blood more efficiently.
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High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
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Definitions
Severity Categories
Contraindicated
These drugs, generally, should not be used together simultaneously due to the high risk of severe adverse effects. Combining these medications can lead to dangerous health outcomes and should be strictly avoided unless otherwise instructed by your provider.
Major
This interaction could result in very serious and potentially life-threatening consequences. If you are taking this drug combination, it is very important to be under close medical supervision to minimize severe side effects and ensure your safety. It may be necessary to change a medication or dosage to prevent harm.
Moderate
This interaction has the potential to worsen your medical condition or alter the effectiveness of your treatment. It's important that you are monitored closely and you potentially may need to make adjustments in your treatment plan or drug dosage to maintain optimal health.
Minor
While this interaction is unlikely to cause significant problems, it could intensify side effects or reduce the effectiveness of one or both medications. Monitoring for changes in symptoms and your condition is recommended, and adjustments may be made if needed to manage any increased or more pronounced side effects.
Onset
Rapid: Onset of drug interaction typically occurs within 24 hours of co-administration.
Delayed: Onset of drug interaction typically occurs more than 24 hours after co-administration.
Evidence
Level of documentation of the interaction.
Established: The interaction is documented and substantiated in peer-reviewed medical literature.
Theoretical: This interaction is not fully supported by current medical evidence or well-documented sources, but it is based on known drug mechanisms, drug effects, and other relevant information.
How To Manage The Interaction
Provides a detailed discussion on how patients and clinicians can approach the identified drug interaction as well as offers guidance on what to expect and strategies to potentially mitigate the effects of the interaction. This may include recommendations on adjusting medication dosages, altering the timing of drug administration, or closely monitoring for specific symptoms.
It's important to note that all medical situations are unique, and management approaches should be tailored to individual circumstances. Patients should always consult their healthcare provider for personalized advice and guidance on managing drug interactions effectively.
Mechanism Of Interaction
The theorized or clinically determined reason (i.e., mechanism) why the drug-drug interaction occurs.
Disclaimer: The information provided on this page is for informational purposes only and should not be considered medical advice. Always consult with a qualified healthcare professional regarding your specific circumstances and medical conditions.
Where Does Our Information Come From?
Information for our drug interactions is compiled from several drug compendia, including:
The prescribing information for each drug, as published on DailyMED, is also used.
Individual drug-drug interaction detail pages contain references specific to that interaction. You can click on the reference number within brackets '[]' to see what reference was utilized.
The information posted is fact-checked by HelloPharmacist clinicians and reviewed quarterly.