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Medicina is published by MDPI from Volume 54 Issue 1 (2018). Articles in this Issue were published by another publisher in Open Access under a CC-BY (or CC-BY-NC-ND) licence. Articles are hosted by MDPI on mdpi.com as a courtesy and upon agreement with Lithuanian Medical Association, Lithuanian University of Health Sciences, and Vilnius University.
Open AccessArticle

Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy

1
Latvian Center Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia
2
Faculty of Medicine, University of Latvia, Riga, Latvia
3
Latvian Institute of Cardiology and Regenerative Medicine, University of Latvia, Riga, Latvia
4
Pharma and Chemistry Competence Center of Latvia Ltd., Riga, Latvia
*
Author to whom correspondence should be addressed.
Medicina 2016, 52(3), 171-179; https://doi.org/10.1016/j.medici.2016.05.002
Received: 6 November 2015 / Revised: 22 April 2016 / Accepted: 10 May 2016 / Published: 30 May 2016
Background and 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.
Materials and methods: In an open-label, one-center prospective pilot study patients with SIM received conifer-tree needle polyprenols (4 mg/day) and CoQ10 (100 mg/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 <60 mL/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.
Keywords: Statins; Myopathy; Polyprenols; Coenzyme Q10; Ubiquinone Statins; Myopathy; Polyprenols; Coenzyme Q10; Ubiquinone
MDPI and ACS Style

Latkovskis, G.; Saripo, V.; Sokolova, E.; Upite, D.; Vanaga, I.; Kletnieks, U.; Erglis, A. Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy. Medicina 2016, 52, 171-179.

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