title: Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy.
abstract: OBJECTIVE
  Statin-induced myopathy (SIM) has been partially attributed to deficiency of dolichol and coenzyme Q10 (CoQ10). We aimed to test the safety and efficacy of plant polyprenols in combination with CoQ10 for alleviation of SIM.
  
  
  METHODS
  In an open-label, one-center prospective pilot study patients with SIM received conifer-tree needle polyprenols (4mg/day) and CoQ10 (100mg/day) for 8 weeks. Symptoms and safety were evaluated according to symptom severity score (0-10), creatine kinase (CK) levels, exercise test, dynamometry, complete blood count, clinical biochemistry and electrocardiography.
  
  
  RESULTS
  Of the 14 patients, 11 completed the study per protocol. Two patients withdrew consent due to travels abroad, and it was discontinued for one patient with stage 3 chronic kidney disease due to asymptomatic elevations of liver enzymes at week 4. No safety parameters changed significantly in per protocol group. Non-significant increase of CK levels was observed (P=0.231). Muscle pain (n=10) and weakness (n=7) scores improved significantly (P<0.001 and P=0.018, respectively). Muscle pain completely disappeared in 2 patients, weakness resolved in 3 patients and cramps disappeared in two patients. Four patients assessed improvement strong enough to consider increase of statin dose. No changes were observed in exercise test or dynamometry.
  
  
  CONCLUSIONS
  Conifer-tree polyprenols in combination with CoQ10 may be generally safe in patients with SIM, but caution should be exercised in patients with glomerular filtration rate <60mL/min and routine monitoring of the liver enzymes and CK is advocated in all patients. The observed efficacy provides the rationale for a larger, double-blind controlled study with polyprenols.
authors: Latvian Center Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia; Faculty of Medicine, University of Latvia, Riga, Latvia; Latvian Institute of Cardiology and Regenerative Medicine, University of Latvia, Riga, Latvia. Electronic address: gustavs.latkovskis@lu.lv.
authors: Gustavs
authors: G
authors: Latkovskis
authors: Latvian Center Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors: Vita
authors: V
authors: Saripo
authors: Latvian Center Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors: Emma
authors: E
authors: Sokolova
authors: Latvian Center Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors: Dana
authors: D
authors: Upite
authors: Pharma and Chemistry Competence Center of Latvia Ltd., Riga, Latvia.
authors: Ilona
authors: I
authors: Vanaga
authors: Pharma and Chemistry Competence Center of Latvia Ltd., Riga, Latvia.
authors: Ugis
authors: U
authors: Kletnieks
authors: Latvian Center Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia; Faculty of Medicine, University of Latvia, Riga, Latvia; Latvian Institute of Cardiology and Regenerative Medicine, University of Latvia, Riga, Latvia.
authors: Andrejs
authors: A
authors: Erglis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D005080:Exercise Test; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D018908:Muscle Weakness / Q000139:chemically induced* / Q000188:drug therapy*; D063806:Myalgia / Q000139:chemically induced* / Q000188:drug therapy*; D010147:Pain Measurement; D010865:Pilot Projects; D011446:Prospective Studies; D013729:Terpenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D064028:Tracheophyta; D016896:Treatment Outcome; D014451:Ubiquinone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D015415:Biomarkers; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D013729:Terpenes; D014451:Ubiquinone; C024989:coenzyme Q10
keywords: Coenzyme Q10; Myopathy; Polyprenols; Statins; Ubiquinone