Does statin use have a disease modifying effect in symptomatic knee osteoarthritis? Study protocol for a randomised
Yuanyuan Wang1, Andrew Tonkin2, Graeme Jones3
1Department of Epidemiology and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, 3004, Australia. yuanyuan.wang@monash.edu.
Trials
|December 25, 2015
Summary
This study investigates if atorvastatin, a cholesterol-lowering drug, can slow the progression of knee osteoarthritis (OA). Results will determine if atorvastatin offers a new disease-modifying treatment for OA patients.
Area of Science:
- Rheumatology
- Pharmacology
- Biomedical Engineering
Background:
- Osteoarthritis (OA) is a significant health issue with no approved disease-modifying treatments.
- Statins, used for cardiovascular health, may impact OA via lipid metabolism and inflammation.
- This trial assesses atorvastatin's potential disease-modifying effects in knee OA.
Purpose of the Study:
- To determine if atorvastatin reduces structural and symptomatic progression of knee OA over two years.
- To evaluate atorvastatin's efficacy as a novel disease-modifying osteoarthritis drug (DMOAD).
Main Methods:
- A multicentre, randomized, double-blind, placebo-controlled trial involving 350 patients.
- Participants received 40 mg atorvastatin or placebo daily for two years.
- Knee structure (cartilage volume) and symptoms assessed via MRI and validated measures.
Main Results:
- Primary outcome: annual percentage change in knee cartilage volume.
- Secondary outcomes: cartilage defects, bone marrow lesions, pain, and function.
- Analysis by intention-to-treat and per protocol.
Conclusions:
- The study will provide high-quality evidence on atorvastatin's disease-modifying potential in knee OA.
- Positive findings could lead to cost savings in joint replacement surgery and improved quality of life for OA patients.
