Valsartan
| Evidence Level: L5 | Predicted Indications: 6 |
Table of Contents
Valsartan: Malignant hypertensive renal disease
One-Sentence Summary
Valsartan is an angiotensin II type 1 receptor blocker (ARB) that is marketed in Canada. The TxGNN model predicts it may be useful for malignant hypertensive renal disease. No clinical trials and no studies of valsartan in this disease are available, so the evidence level is L5 (model prediction only).
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 | L5 |
| Canada Market Status | Marketed (marketed DINs on record: at least 20) |
| Number of DINs | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Valsartan belongs to the angiotensin receptor blocker class, which blocks the AT1 receptor of the renin-angiotensin-aldosterone system (RAAS). Mechanistically, RAAS blockade lowers blood pressure and may protect the kidney in hypertensive kidney injury, so the prediction is biologically plausible.
However, this link is a hypothesis only. The one publication attached to this prediction (PMID 24368192) tested avosentan, an endothelin receptor antagonist, in a rat model of hypertensive nephropathy. It did not study valsartan or malignant hypertensive renal disease in patients, so it offers only indirect support. No clinical trials are registered.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 24368192 | 2014 | Preclinical (different drug: avosentan) | Pharmacological Research | Avosentan protected against hypertensive nephropathy in transgenic rats at doses that did not cause fluid retention; valsartan was not studied. |
Canada Market Information
At least 20 valid single-ingredient valsartan licences are recorded in the local data; the list may be partial. Dosage form and indication text are not recorded for these licences.
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02244782 | DIOVAN 160MG TABLETS | Not listed | Not listed |
| 02244781 | DIOVAN 80MG TABLETS | Not listed | Not listed |
| 02289504 | DIOVAN | Not listed | Not listed |
| 02356643 | TEVA-VALSARTAN | Not listed | Not listed |
| 02356759 | SANDOZ VALSARTAN | Not listed | Not listed |
Safety Considerations
- Drug Interactions (100 interactions found in the interaction database; main ones shown):
- Major: potassium chloride and potassium bicarbonate (risk of raised blood potassium).
- Moderate: insulins and exenatide (effects on blood glucose), hydrocortisone, eluxadoline, and polyethylene glycol with electrolytes.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high and RAAS blockade is mechanistically plausible for hypertensive kidney injury. However, no clinical trial or study of valsartan in malignant hypertensive renal disease exists in the data compiled for this report, so the evidence level is L5.
To proceed, the following is needed:
- Clinical or observational studies of valsartan, or other ARBs, in malignant hypertensive renal disease
- Mechanism-of-action data for valsartan
- Warnings and contraindications from the Health Canada package insert
- A safety plan covering potassium monitoring, renal function, and interacting drugs
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.