Captopril

Evidence Level: L5 Predicted Indications: 3

Table of Contents

  1. Captopril
    1. Pharmacist Assessment Report
    2. Captopril: ACE inhibitor → malignant hypertensive renal disease
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. India Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Captopril: ACE inhibitor → malignant hypertensive renal disease

One-Sentence Summary

Captopril is an angiotensin-converting enzyme (ACE) inhibitor sold in India as single-ingredient tablets. The TxGNN model predicts it may be effective for malignant hypertensive renal disease, but the data compiled for this report contain no clinical trials and only 1 publication, a diagnostic case report that does not show therapeutic benefit.


Quick Overview

Item Content
Original Indication Not recorded in the local data
Predicted New Indication malignant hypertensive renal disease
TxGNN Prediction Score 0.9928
Evidence Level L5
India Market Status Listed in a compiled Indian medicine price dataset (7 of 7) – CDSCO approval status is not included in this data
Number of Listed Products 7 (valid: 7)
Recommended Decision Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the data compiled for this report. Captopril belongs to the ACE inhibitor class, which lowers activity of the renin-angiotensin system (RAS) by blocking the conversion of angiotensin I to angiotensin II.

Malignant hypertensive renal disease (malignant nephrosclerosis) involves RAS activation. Blocking this system with an ACE inhibitor therefore offers a plausible mechanistic basis, and captopril is also linked to kidney-protective effects in diabetic nephropathy. This is a theoretical link only.

The one retrieved publication is a case report on captopril renography, a diagnostic test. It describes a renal cell carcinoma that produced a false-positive result, and it does not show that captopril treats this disease. The prediction is therefore essentially model-based.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

PMID Year Type Journal Key Findings
28902735 2017 Case report Clinical Nuclear Medicine Positive captopril renography in a patient with a large chromophobe renal cell carcinoma and intact renal arteries; hypertension resolved after nephrectomy. Diagnostic use only, not therapeutic evidence.

India Market Information

Authorization Number Product Name Dosage Form Approved Indication
4601 Aceten 25mg Tablet Strip of 10 tablets Not recorded
5570 Angiopril 25mg Tablet Strip of 10 tablets Not recorded
38749 Capotril 12.5mg Tablet Strip of 10 tablets Not recorded
36749 Capotril 25mg Tablet Strip of 10 tablets Not recorded
10076 Aceten 12.5mg Tablet Strip of 10 tablets Not recorded

Safety Considerations

  • Drug Interactions: 245 interactions were found in total. The main ones listed are of moderate level, for example with hydrocortisone, dexamethasone, betamethasone, triamcinolone and budesonide (corticosteroids), metformin, alogliptin, canagliflozin, dapagliflozin and empagliflozin (diabetes drugs), and acetylsalicylic acid, morphine and bupropion. Aluminum hydroxide and calcium carbonate have minor interactions.

For warnings and contraindications, please refer to the package insert.


Conclusion and Next Steps

Decision: Hold

Rationale: The prediction score is high (0.9928), but no clinical trial studies this disease and the only publication is a diagnostic case report. Evidence is limited to a model prediction (L5).

To proceed, the following is needed:

  • Clinical or well-designed preclinical studies of captopril in malignant hypertensive renal disease
  • Detailed mechanism of action data
  • Package insert warnings and contraindications from the Indian regulator
  • A review of how captopril compares with standard treatment for severe hypertension with kidney involvement, including safety in patients with kidney disease

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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