PRIMO study (statin treatment and muscle related (myalgia) symptoms)

PRIMO study

• study sought to characterize the risk factors, rate of occurrence, onset, nature and impact of mild to moderate muscular symptoms with high-dosage HMG-CoA reductase inhibitor (statin) therapy in general practice
  
  
• the Prédiction du Risque Musculaire en Observationnel (Prediction of Muscular Risk in Observational conditions, PRIMO) survey was an observational study of muscular symptoms in an unselected population of 7924 hyperlipidemic patients receiving high-dosage statin therapy in a usual care, outpatient setting in France
  
  
• multivariate analysis revealed the strongest predictors for muscular symptoms to be a personal history of muscle pain during lipid-lowering therapy (odds ratio, OR, 10.12, 95% CI 8.23-12.45; P < 0.0001), unexplained cramps (OR 4.14; 95% CI 3.46-4.95; P < 0.0001) and a history of creatine kinase (CK) elevation (OR 2.04; 95% CI 1.55-2.68; P < 0.0001)
  
  
  • muscular symptoms were reported by 832 patients (10.5%), with a median time of onset of 1 month following initiation of statin therapy
    
    
  • muscle-related symptoms occurred with the various regimens as follows:
    • Fluvastatin XL 40 mg - 5.1%
    • Pravastatin 40 mg- 10.9%
    • Atorvastatin 40 to 80 mg- 14.9%
    • Simvastatin 40 to 80 mg- 18.2%
      
      
  • thus the PRIMO study suggests that fluvastatin and pravastatin have less muscle related symptoms compared to other statins in this particular study

Reference:

• 1) Bruckert E et al. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients--the PRIMO study. Cardiovasc Drugs Ther. 2005 Dec;19(6):403-14.