Rosuvastatin
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Rosuvastatin: From Dyslipidaemia to Cholesterol-Ester Transfer Protein Deficiency
One-Sentence Summary
Rosuvastatin is a statin (an HMG-CoA reductase inhibitor) used to lower cholesterol. The SAHPRA records supplied contain no indication text, so this original use comes from the published literature. The TxGNN model predicts it may be effective for cholesterol-ester transfer protein (CETP) deficiency, but this prediction is supported by 0 clinical trials and only 2 case reports, so the evidence is very weak.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Dyslipidaemia / hypercholesterolaemia (from the literature; not stated in the SAHPRA records supplied) |
| Predicted New Indication | Cholesterol-ester transfer protein deficiency |
| TxGNN Prediction Score | 99.54% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 5 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. Based on known information, rosuvastatin inhibits HMG-CoA reductase, which lowers cholesterol synthesis and LDL-C. Its efficacy in hypercholesterolaemia is well established.
The link to CETP deficiency is weak. CETP deficiency mainly causes markedly raised HDL-C, so a statin has little clear therapeutic role. The high graph score (99.54%) reflects the model’s network similarity between lipid disorders. It is not backed by any disease-specific clinical data.
The two publications found are case reports on other rare lipid disorders (apo A-I deficiency and hepatic lipase deficiency). Neither reports rosuvastatin treatment outcomes in CETP deficiency.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21122686 | 2010 | Case report / Review | J Clin Lipidol | Complete apo A-I deficiency in an Iraqi Mandaean family. Describes a new APOA1 nonsense mutation and differing clinical presentations. No rosuvastatin outcome data. |
| 22798447 | 2010 | Case report | BMJ Case Rep | Hepatic lipase deficiency in a Middle-Eastern-Arabic male. First report of CETP activity and mass in this setting. No rosuvastatin outcome data. |
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 46/7.5/0222 | Rostor | Tablet | Not stated in the record supplied |
| Reg. No. 47/7.5/0900 | Rosuvastatin 5 Pharmc | Film-coated tablet | Not stated in the record supplied |
| Reg. No. 55/7.5/0563 | Lypovas 5 | Tablet | Not stated in the record supplied |
| Reg. No. 55/7.5/0779 | Lypstaplus 10 Mg/10 Mg | Tablet | Not stated in the record supplied |
| Reg. No. 54/7.5/0693 | Reguchole 10/5Mg | Tablet | Not stated in the record supplied |
All five products are oral tablets. Some product names suggest fixed-dose combinations, but the record does not list their ingredients. Essential Medicines List (EML) status was not included in the data.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone. The only literature is two case reports on related but different disorders, there are no trials, and CETP deficiency is characterised by high HDL-C, so a statin has a weak therapeutic rationale.
Two other predictions in the same Evidence Pack, familial hypercholesterolaemia and hyperlipidaemia, have Level 1 evidence. They are most likely established uses of rosuvastatin rather than true repurposing, and should be confirmed against the regulatory record.
To proceed, the following is needed:
- SAHPRA Professional Information (PI) with approved indications, warnings and contraindications
- Mechanism of action data from DrugBank
- Any disease-specific clinical data (case series or registry data) on statin use in CETP deficiency
- Confirmation of the original indication from the regulatory record
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.