Valsartan and hydrochlorothiazide USP

(Diovan HCT®)

Valsartan and hydrochlorothiazide USP

Drug updated on 9/5/2024

Dosage FormTablet (oral; valsartan/HCTZ: 80 mg /12.5 mg, 160 mg /12.5 mg, 160 mg /25 mg, 320 mg /12.5 mg, 320 mg /25 mg)
Drug ClassAngiotensin II receptor blockers and diuretics
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

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

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Summary
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  • Diovan HCT (valsartan and hydrochlorothiazide USP) is indicated for the treatment of hypertension to lower blood pressure in patients not adequately controlled with monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Blood Pressure Reduction: Valsartan/HCTZ was included but not ranked, with ARB/CCB combinations such as Irbesartan/amlodipine and Amlodipine/losartan ranking first for systolic and diastolic blood pressure reduction (SUCRA: 92.2% and 95.1%, respectively).
  • Blood Pressure Control and Diastolic Response: Valsartan/HCTZ was included but not ranked, with Telmisartan/amlodipine and Amlodipine/losartan achieving the highest ranks in blood pressure control rates and diastolic response (SUCRA: 83.5% and 84.5%, respectively).
  • Comparative Effectiveness: Single-pill combinations, including Valsartan/HCTZ, are more effective than monotherapy for reducing systolic and diastolic blood pressure, achieving better blood pressure control rates, and improving diastolic response rates.
  • Hypokalemia Risk: Valsartan combined with 25 mg HCTZ shows a higher hypokalemia risk difference compared to placebo (2.52% [95% CI: 1.17, 4.38%]), whereas the combination with 12.5 mg HCTZ does not show a significant risk difference (-0.03% [-0.80, 0.71%]).
  • Hyperkalemia Risk: ARB monotherapy is associated with a higher hyperkalemia risk difference from placebo (1.3% [0.3, 3.6%]), but Valsartan combined with HCTZ (at any dose) does not show a significant risk difference (0.06% [-1.48, 1.64%]).
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Diovan HCT (valsartan and hydrochlorothiazide USP) Prescribing Information.2011Novartis Pharmaceuticals Corporation., East Hanover, NJ

Systematic Reviews / Meta-Analyses