Amlodipine and valsartan

(Exforge®)

Amlodipine and valsartan

Drug updated on 4/17/2024

Dosage FormTablet (oral; amlodipine/valsartan: 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg, 10 mg/320 mg)
Drug ClassDihydropyridine calcium channel blockers and angiotensin II receptor blockers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled on monotherapy.
  • Indicated for the treatment of hypertension as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

Summary
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  • Amlodipine and valsartan (Exforge) is indicated for the treatment of hypertension, particularly in patients not adequately controlled on monotherapy or those likely to need multiple drugs to achieve their blood pressure goals.
  • The information about Exforge was derived from a single study that evaluated 11 single-pill combination antihypertensive drugs for uncontrolled essential hypertension.
  • This study focused on patients with uncontrolled essential hypertension, indicating its relevance for individuals who are not adequately controlled by monotherapy - directly aligning with Exforge's indication.
  • Although the study does not explicitly rank Exforge in terms of systolic or diastolic blood pressure reduction, it implies that combinations like ARB/CCB (to which Exforge belongs), have superior control rates and response rates compared to other drug combinations.
  • The study suggests that Single Pill Combinations (SPCs) such as Exforge are more effective than monotherapies for managing uncontrolled hypertension. It also indicates significant advantages of ARB/CCB combinations over other SPCs regarding various measures of blood pressure management.
  • While promising results were found concerning effectiveness, caution should be exercised due to limitations in available studies related to certain drug combinations. These gaps may affect the comprehensive understanding across different population subgroups and safety profiles.

Product Monograph / Prescribing Information

Document TitleYearSource
Exforge (amlodipine and valsartan) Prescribing Information.2021Novartis Pharmaceuticals Corporation

Systematic Reviews / Meta-Analyses