Ramipril

證據等級: L5 預測適應症: 10

目錄

  1. Ramipril
  2. Ramipril: From Hypertension to Pulmonary Hypertension due to Lung Disease and/or Hypoxia
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. Denmark Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## 藥師評估報告

Ramipril: From Hypertension to Pulmonary Hypertension due to Lung Disease and/or Hypoxia

One-Sentence Summary

Ramipril is an ACE inhibitor publicly known for treating hypertension and related cardiovascular/renal conditions, though this specific Evidence Pack contains no confirmed original-indication or MOA data. The TxGNN model predicts a possible role in Pulmonary Hypertension due to Lung Disease and/or Hypoxia (WHO Group 3), but this is currently supported by 0 clinical trials and 20 publications that are all unrelated to ramipril or pulmonary hypertension treatment — the evidence base is essentially absent.


Quick Overview

Item Content
Original Indication Not available in the Danish regulatory record (drug not currently marketed in Denmark); publicly known as an ACE inhibitor for hypertension
Predicted New Indication Pulmonary Hypertension due to Lung Disease and/or Hypoxia (WHO Group 3)
TxGNN Prediction Score 99.93%
Evidence Level L5
Denmark Market Status Not marketed
Number of Marketing Authorisations 0
Recommended Decision Hold

Why is This Prediction Reasonable?

Detailed mechanism-of-action data for this record is a data gap (original_moa: [Data Gap]), and no original indication is registered for Denmark. Based on the drug’s known pharmacological class — referenced within this Evidence Pack’s own analysis — ramipril is an ACE inhibitor that suppresses the renin-angiotensin-aldosterone system (RAAS), a mechanism with established benefit in hypertension and, per the REIN study literature, in renal protection for chronic kidney/diabetic nephropathy.

For the top-ranked predicted indication, however, the mechanistic rationale supplied with this evidence pack is cautionary rather than supportive: WHO Group 3 pulmonary hypertension arises from chronic hypoxia/lung disease, where hypoxic pulmonary vasoconstriction (HPV) is a protective compensatory mechanism. Systemic vasodilators — including ACE inhibitors — may worsen ventilation-perfusion mismatch and aggravate hypoxemia, which is why current clinical guidelines do not recommend this drug class for Group 3 PH.

The 20 attached publications are all general hypoxia-biology papers (neurodegeneration, tumour metabolism, multiple sclerosis, altitude physiology) and do not address ramipril or pulmonary hypertension treatment. Combined with the mechanistic concern above, this prediction should be treated as a knowledge-graph association rather than a therapeutically actionable signal.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

PMID Year Type Journal Key Findings
40347693 2025 Basic research Redox Biology Hypoxia’s role in multiple sclerosis pathology; not related to ramipril or PH
40815459 2025 Basic research Rev Med Inst Mex Seguro Soc Hypobaric hypoxia and high-altitude acclimatisation; not drug-related
37915135 2023 Basic research BMB Reports CMGC kinase regulation by hypoxia in tumours; not related to ramipril or PH
37572528 2023 Basic research Neurobiology of Aging Hypoxia link between Alzheimer’s disease and cancer; unrelated to ramipril/PH
37328448 2023 Basic research Advanced Science Hypoxia tolerance mechanism in gastric cancer glycolysis; unrelated to ramipril/PH
36100192 2022 Basic research J Control Release Hypoxia-targeted nanomedicine for tumours; unrelated to ramipril/PH
34618295 2022 Review Metabolic Brain Disease Cognitive impairment from hypoxia; unrelated to ramipril/PH
33862277 2021 Review Ageing Research Reviews Hypoxia’s role in brain aging/neurodegeneration; unrelated to ramipril/PH
34535359 2021 Review Clinical Oncology Therapeutic modification of tumour hypoxia (radiotherapy context); unrelated to ramipril/PH
33278780 2021 Basic research Redox Biology Glucose metabolism in keloid fibroblasts under hypoxia; unrelated to ramipril/PH

Note: None of the above literature discusses ramipril or its use in pulmonary hypertension. These are general hypoxia-biology papers that surfaced through keyword overlap (“hypoxia”) rather than direct evidence for this repurposing hypothesis.


Denmark Market Information

Ramipril has no marketing authorisations recorded for Denmark in this Evidence Pack (0 licenses; market status: Not marketed).


Safety Considerations

Please refer to the approved Summary of Product Characteristics (SmPC) for safety information. No key warnings, contraindications, or drug-interaction data were found in this Evidence Pack (DDI query status: not found).


Conclusion and Next Steps

Decision: Hold

Rationale: The predicted indication (Group 3 pulmonary hypertension) conflicts with established clinical concern that ACE inhibitors may worsen hypoxemia by blunting protective hypoxic pulmonary vasoconstriction. No clinical trials exist, and all 20 attached publications are unrelated to ramipril or pulmonary hypertension. Evidence level is L5 (model prediction only), and the drug is not currently marketed in Denmark.

To proceed, the following is needed:

  • SmPC warnings/contraindications from the manufacturer (currently blocking safety assessment — DG001)
  • Confirmed mechanism of action and original indication data (DG002)
  • A clinical or preclinical rationale specifically evaluating ACE inhibition in Group 3 PH, rather than general hypoxia biology
  • Drug interaction (DDI) data, currently unavailable
  • If pursued despite the above: a pharmacology review addressing the HPV-blunting concern before any further evaluation stage

    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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