Pravastatin
| Evidence Level: L4 | Predicted Indications: 6 |
Table of Contents
Pravastatin: HIV infectious disease
One-Sentence Summary
Pravastatin is a statin originally used for hyperlipidemia, atherosclerosis and stroke-related disorders. The TxGNN model predicts it may be effective for HIV infectious disease, but the data compiled for this report contain 1 clinical trial (which tests a different drug, alirocumab) and 12 publications (mostly reviews on other lipid-lowering agents), so direct evidence for pravastatin is weak.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | HIV infectious disease |
| TxGNN Prediction Score | 0.9974 |
| Evidence Level | L4 |
| 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?
Currently, detailed mechanism of action data is not available in the compiled data. Based on general pharmacology, pravastatin inhibits HMG-CoA reductase, which reduces cholesterol synthesis in the liver and upregulates hepatic LDL receptors, increasing LDL clearance from the blood.
This is also an extension of an existing lipid-lowering use rather than true repurposing.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03510715 | Phase 3 | Completed | 18 | Open-label study of alirocumab (a PCSK9 inhibitor) in children and adolescents aged 8–17 with homozygous FH. Pravastatin is not the studied drug, so this is background on the treatment landscape only. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 28685504 | 2017 | Systematic Review | Cochrane Database Syst Rev | Statins for children with familial hypercholesterolemia (general FH, not homozygous-specific) |
| 31696945 | 2019 | Systematic Review | Cochrane Database Syst Rev | Updated Cochrane review of statins in children with FH |
| 28437620 | 2017 | Guideline | Endocr Pract | AACE/ACE guidelines for dyslipidemia management and cardiovascular prevention |
| 28416195 | 2017 | Randomized trial | Lancet HIV | Pitavastatin vs pravastatin in HIV-infected adults with dyslipidaemia (not an FH population) |
| 15532136 | 2004 | Commentary | Prescrire Int | Notes simvastatin and pravastatin are reference statins for heterozygous FH, and that statins are not very effective in homozygous FH |
| 12269853 | 2002 | Review | Drugs | Rosuvastatin review; superior to pravastatin in lipid improvement in hypercholesterolaemia |
| 15531000 | 2004 | Review | Clin Ther | Rosuvastatin is indicated in homozygous FH |
| 14727947 | 2003 | Review | Am J Cardiovasc Drugs | Ezetimibe reduces LDL-C via inhibition of intestinal cholesterol absorption |
| 14647533 | 2003 | Review | Cardiovasc Drug Rev | Ezetimibe as a novel cholesterol absorption inhibitor |
| 9129869 | 1997 | Review | Drugs | Atorvastatin pharmacology and therapeutic potential in hyperlipidaemias |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02243824 | PRO-PRAVASTATIN | Not specified | Not specified |
| 02432056 | MAR-PRAVASTATIN | Not specified | Not specified |
| 02330954 | JAMP-PRAVASTATIN | Not specified | Not specified |
| 02389746 | PRAVASTATIN | Not specified | Not specified |
| 02535661 | NRA-PRAVASTATIN | Not specified | Not specified |
These are 5 of 20 valid single-ingredient licences; none are cancelled.
Safety Considerations
- Contraindication-related conditions (from the knowledge graph, not label text): kidney disease, liver disease, gallbladder disease, thrombocytopenia, peptic ulcer disease, myopathy and other muscle diseases, rhabdomyolysis, gout, hemophilia, anemia, nephrolithiasis, hypercalcemia, sarcoidosis, hyperparathyroidism, and substance abuse/dependence, among others.
- Drug Interactions: 100 interactions were recorded. Moderate-level ones include metronidazole, clarithromycin, eluxadoline, naltrexone, pectin, rosuvastatin, simvastatin and tinidazole. Others, such as calcitriol, acarbose, sucralfate, prednisone and vancomycin, are of unknown severity.
Please refer to the package insert for the official warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The only trial listed tests alirocumab, not pravastatin, and the literature consists mostly of reviews on other lipid-lowering drugs. Mechanistically, statin efficacy is expected to be limited when LDL receptor function is severely impaired. The high TxGNN score reflects a model prediction rather than direct clinical evidence.
To proceed, the following is needed:
- Pravastatin-specific clinical data in homozygous FH patients (trials or case series)
- Mechanism of action data for pravastatin
- Health Canada package insert warnings and contraindications (currently missing, which blocks safety screening)
- Review of the 100 recorded drug interactions before any co-prescription
Note on other predictions: HIV-associated dyslipidemia (L2) is a research question with small trials. The remaining predictions have little or no supporting evidence.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.