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FLUVASTATIN SODIUM
Fluvastatin inhibits HMG-CoA reductase, reducing cholesterol synthesis.
Fluvastatin sodium is a marketed HMG-CoA reductase inhibitor aimed at reducing the risk of coronary revascularization. Its key strength lies in its well-established mechanism for reducing cholesterol synthesis, which is crucial for managing cardiovascular risks. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | FLUVASTATIN SODIUM |
|---|---|
| Target | HMG-CoA reductase |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1993 |
Mechanism of action
Fluvastatin works by blocking the action of HMG-CoA reductase, which is the key enzyme in the production of cholesterol. By inhibiting this enzyme, fluvastatin reduces the amount of cholesterol produced in the body.
Approved indications
- Reduce Risk of Coronary Revascularization
- Reduce LDL-C in Primary Hyperlipidemia
- Reduce LDL-C in HeFH
Common side effects
- influenza-like symptoms
- headache
- myalgia
- abdominal pain
- dyspepsia
- sinusitis
- diarrhea
- urinary tract infection
- nausea
- bronchitis
- fatigue
- flatulence
Drug interactions
- Gemfibrozil
- Cyclosporine
- Fluconazole
- Niacin (lipid-modifying doses ≥ 1 g/day)
- Fibrates
- Warfarin
- Glyburide
- Phenytoin
Key clinical trials
- Safety of Fluvastatin-Celebrex Association in Low-grade and High Grade Optico-chiasmatic Gliomas (PHASE1)
- A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients (PHASE1, PHASE2)
- Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy (PHASE1, PHASE2)
- LATAM LOWERS LDL-C (PHASE4)
- Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants (PHASE1)
- Statins in Frail Older Patients with Ischemic Stroke or Transient Ischemic Attack - the Prospective Cohort Study
- StAtins in Frail OldEr Patients with Ischemic Stroke or Transient Ischemic Attack - the Randomized Controlled Trial (PHASE4)
- A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |