Olmesartan
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Olmesartan: From Hypertension to Prinzmetal Angina
One-Sentence Summary
Olmesartan is an angiotensin II receptor blocker (ARB). The data compiled for this report do not list an approved indication text for it in Singapore. The TxGNN model predicts it may be effective for Prinzmetal angina, but no clinical trials and no publications currently support this prediction. It is a model prediction only. The most evidence-supported alternative candidate in this analysis is migraine disorder, with 3 publications and no registered trials.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available in the Singapore license data (the drug class is ARB, generally used for hypertension) |
| Predicted New Indication | Prinzmetal angina |
| TxGNN Prediction Score | 99.84% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 7 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available. Based on known information, olmesartan is an angiotensin II type 1 (AT1) receptor antagonist. Blocking this receptor reduces vascular tone and endothelial dysfunction, which may in theory be relevant to vascular spasm.
However, Prinzmetal (vasospastic) angina is mainly managed with calcium channel blockers and nitrates. The high TxGNN score (99.84%) is not supported by any clinical data retrieved, so this prediction should be treated as a hypothesis only.
Other candidates reviewed:
- Migraine disorder (score 99.64%, L3): Modulating the renin-angiotensin system may reduce migraine frequency through effects on vascular tone, sympathetic activity and neuroinflammation. Olmesartan-specific reports from 2006 in hypertensive or prehypertensive patients suggest a possible benefit, and a 2019 systematic review covers ACE inhibitors and ARBs for prevention. The evidence is small, comes from hypertensive populations or is class-level, and study designs are inferred from titles and need verification. This is the best-supported candidate and is framed as a research question.
- Pulmonary hypertension (score 99.61%, L4): Angiotensin II drives pulmonary vascular remodelling. Rat models show olmesartan effects, supporting biological plausibility, but there is no human efficacy evidence.
- Open-angle glaucoma (score 99.40%, L4): The renin-angiotensin system exists in ocular tissue, but the only item retrieved is a general glaucoma review that is not specific to olmesartan.
- Hair disorders (hypotrichosis simplex of the scalp, alopecia, congenital hypotrichosis milia, diffuse alopecia areata), migraine with brainstem aura, and kyphoscoliotic heart disease: Prediction only, with no known mechanistic link or retrieved evidence. These likely reflect knowledge-graph proximity rather than biology.
Clinical Trial Evidence
Currently no related clinical trials registered for Prinzmetal angina.
For reference, the only trial retrieved across the candidates was for pulmonary hypertension and is not directly relevant:
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT04330300 | Phase 4 | Suspended | 2414 | CORONACION: ACE inhibitor/ARB continuation in COVID-19. It does not study pulmonary hypertension, so the link is incidental. |
Literature Evidence
Currently no related literature available for Prinzmetal angina.
For reference, the most relevant publications for the best-supported alternative (migraine disorder):
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 16618270 | 2006 | Clinical study (design to be verified) | Headache | Effects of olmesartan on migraine frequency and severity in patients with hypertension or prehypertension |
| 31515634 | 2019 | Systematic review | Current Pain and Headache Reports | ACE inhibitors and ARBs for preventing episodic migraine in adults (class-level); aims to identify research gaps |
| 16942482 | 2006 | Commentary/Letter | Headache | Commentary on olmesartan, migraine and blood pressure |
Preclinical publications for pulmonary hypertension:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 18209564 | 2008 | Preclinical | J Cardiovasc Pharmacol | Olmesartan medoxomil tested in the rat monocrotaline model of pulmonary hypertension |
| 16336959 | 2005 | Preclinical | Eur J Pharmacol | Olmesartan medoxomil in chronic hypoxic rats, evaluating efficacy against hypoxic pulmonary hypertension |
| 17089097 | 2006 | Preclinical | Naunyn-Schmiedeberg's Arch Pharmacol | Olmesartan effects on hypoxia-induced ERK1/2 activation and pro-inflammatory signals in mouse lung |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN15528P | OLMEZEN Film-Coated Tablet 40mg | Film-coated tablet | Not listed |
| SIN13018P | Olmetec Tablet 40mg | Film-coated tablet | Not listed |
| SIN13016P | Olmetec Tablet 20mg | Film-coated tablet | Not listed |
| SIN15530P | OLMEZEN Film-Coated Tablet 20mg | Film-coated tablet | Not listed |
| SIN13964P | Azoren Film-Coated Tablet 20mg/5mg | Film-coated tablet | Not listed |
All 7 licenses are valid (oral film-coated tablets). Two more Azoren strengths (SIN13966P, SIN13965P) are not shown here.
Safety Considerations
- Drug Interactions: 94 interactions were identified. Major interactions include potassium bicarbonate and potassium chloride, which carry a hyperkalaemia risk. Moderate interactions include hydrocortisone, eluxadoline, exenatide, polyethylene glycol (3350 with electrolytes) and many insulin products (human, aspart, degludec, detemir, glargine, glulisine, lispro and others).
Please refer to the package insert for warnings and contraindications. A case report in the retrieved literature also notes that ARBs are contraindicated in pregnancy because of fetal renin-angiotensin system suppression.
Conclusion and Next Steps
Decision: Hold
Rationale: The top prediction, Prinzmetal angina, rests on a model score alone, with no trials or publications, and vasospastic angina already has established first-line therapies. Among the other candidates, migraine disorder has the most supportive literature (L3), but it is limited and mostly based on hypertensive or class-level data, so it is best handled as a separate research question.
To proceed, the following is needed:
- Package insert warnings and contraindications from HSA (currently a blocking gap for safety screening)
- Detailed mechanism of action data (e.g., from DrugBank)
- Approved indication text for the Singapore licenses
- For migraine: verification of the study designs of the 2006 reports and a review of olmesartan-specific data, followed by a controlled trial design in the relevant population
- For Prinzmetal angina: any mechanistic or clinical evidence beyond the model prediction, and comparison against calcium channel blockers and nitrates
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.