Valsartan
| Evidence Level: L4 | Predicted Indications: 6 |
Table of Contents
- Valsartan
- Pharmacist Assessment Report
- Valsartan: Malignant hypertensive renal disease
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Conclusion and Next Steps
- Other Predictions Reviewed
- Disclaimer
Valsartan: Malignant hypertensive renal disease
One-Sentence Summary
Valsartan is an angiotensin II receptor blocker originally used to treat hypertension. The TxGNN model predicts it may be effective for malignant hypertensive renal disease, but no clinical trials and only 1 publication (a preclinical study of a different drug) currently support this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Malignant hypertensive renal disease |
| TxGNN Prediction Score | 0.9997 |
| Evidence Level | L4 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known information, valsartan is an angiotensin II type 1 (AT1) receptor blocker. Its efficacy in hypertension is established, and mechanistically it may be applicable to hypertensive kidney injury.
Angiotensin II is thought to drive vascular and kidney damage in severe hypertension. A 2001 animal study found that AT1 receptor blockade prevented lethal malignant hypertension, partly through effects on kidney inflammation. That study concerns the drug class rather than valsartan itself, so it supports the mechanism only indirectly.
The only paper retrieved for this exact prediction (PMID 24368192) studied avosentan, an endothelin antagonist, in a rat model of hypertensive nephropathy. It offers no direct evidence for valsartan. Because valsartan is already used for hypertension, the added value of this specific indication is also limited.
Clinical Trial Evidence
Currently no related clinical trials registered for this indication.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24368192 | 2014 | Preclinical | Pharmacological Research | Avosentan (not valsartan) protected against hypertensive nephropathy in transgenic rats at doses that did not cause fluid retention |
Related class-level evidence: 11560862 (Circulation, 2001, preclinical) showed that AT1 receptor blockade prevented lethal malignant hypertension in an animal model.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 13383J | Dilart | Tablet 320 mg | Not stated in the data compiled for this report |
Safety Considerations
- Contraindications flagged in the knowledge graph (drug-disease links, not product label text): liver failure and liver disease, pancreatitis, gallbladder disease, angioedema (including hereditary, acquired and RAAS-blocker-induced forms), systemic lupus erythematosus, diabetes mellitus and diabetic ketoacidosis, potassium deficiency, hypotensive disorder, anuria, impaired renal function, renal artery obstruction, gout, neutropenia and agranulocytosis, hepatic encephalopathy, hypercalcaemia, hyperparathyroidism and neonatal jaundice. These should be checked against the TGA Product Information.
- Drug Interactions (100 interactions recorded; main ones listed):
- Major: potassium chloride and potassium bicarbonate (risk of hyperkalaemia).
- Moderate: insulin products (many formulations), exenatide, hydrocortisone, eluxadoline and polyethylene glycol 3350 with electrolytes.
Please refer to the TGA-approved Product Information (PI) for full warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high, but the evidence is only L4. There are no clinical trials, and the sole retrieved paper tests a different drug. Valsartan already covers hypertension, so a separate indication for malignant hypertensive renal disease would add little without direct evidence.
To proceed, the following is needed:
- Valsartan-specific preclinical or clinical data in malignant hypertensive kidney disease
- Mechanism of action data, which is currently missing
- Product Information warnings and contraindications from the TGA, plus the approved indication text for the ARTG entry
- Renal safety monitoring plan, covering potassium and renal function, for patients with severe hypertension and kidney impairment
Other Predictions Reviewed
For context, the other predictions had weaker or less direct support:
| Predicted Indication | Score | Evidence Level | Comment |
|---|---|---|---|
| Pulmonary hypertension owing to lung disease and/or hypoxia | 0.9997 | L5 | Preclinical papers, mostly on the sacubitril/valsartan combination; no trials |
| Pulmonary hypertension with unclear multifactorial mechanism | 0.9997 | L5 | Prediction only |
| Braddock syndrome | 0.9996 | L5 | Prediction only |
| Chronic pulmonary heart disease | 0.9958 | L3 | Indirect heart failure data on sacubitril/valsartan; the one registered trial (NCT02966665, Phase 1, 420 participants, recruiting) is an exercise and vascular function study in hypertension, not a valsartan test |
| Prinzmetal angina | 0.9945 | L5 | Single paper is not relevant |
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.