Drug updated on 4/17/2024
| Dosage Form | Tablet (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 Class | Angiotensin 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.
Summary
- Valsartan and hydrochlorothiazide USP (Diovan HCT) is indicated for the treatment of hypertension, particularly in patients not adequately controlled with monotherapy or those likely to need multiple drugs to achieve their blood pressure goals.
- Two systematic reviews/meta-analyses provided insights into Diovan HCT's safety and effectiveness compared to other antihypertensive medications.
- The first study highlighted that ARB/CCB combinations are highly effective in managing both systolic and diastolic blood pressures. However, it also noted that ARB/thiazide combinations like Diovan HCT can be beneficial too.
- According to the second study, fixed-dose combinations of an ARB with a high dose of hydrochlorothiazide significantly increase the risk of hypokalemia compared to placebo. But when valsartan was combined with a 12.5 mg dose of hydrochlorothiazide, there was no significant alteration in the risk of hypokalemia from placebo.
- This suggests that Diovan HCT could be a safer option regarding dyskalemia risk compared to its components used as monotherapies or higher dose combinations for initial antihypertensive treatment.
- In terms of population types and subgroup considerations, these studies suggest potential efficacy across wide demographics including individuals with uncontrolled essential hypertension as well as uncomplicated hypertensive patients who may benefit from initial treatments where managing electrolyte balance is important.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Diovan HCT (valsartan and hydrochlorothiazide USP) Prescribing Information. | 2011 | Novartis Pharmaceuticals Corporation., East Hanover, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy of single-pill combination in uncontrolled essential hypertension: A systematic review and network meta-analysis. | 2023 | Clinical Cardiology |
| Dyskalemia risk associated with fixed-dose anti-hypertensive medication combinations. | 2021 | Journal of Human Hypertension |