INTRODUCTION:
Statins are benchmark lipid-lowering drugs, reducing blood cholesterol by controlling its synthesis. There are side effects linked to statin use, notably statin-associated muscle symptoms (SAMS) (Thompson et al., 2016). These symptoms typically include myalgia, stiffness, weakness, fatigue and/or cramps. SAMS can lead to an altered health-related quality of life (Peyrel et al., 2023). Moreover, the potential effects of SAMS on sleep remain poorly documented. The objective of this exploratory work was to assess if subjective and objective measures of sleep, as well as functional capacity, improve after drug withdrawal in SAMS self-reporters.
METHODS:
Patients (5 men, 3 women, 44.8±6.3 yr) in primary cardiovascular prevention were divided into two groups: statin users with (SAMS, n=4) or without self-reported symptoms (No SAMS, n=4). The Epworth Sleepiness Scale (ESS) and the Pittsburgh Sleep Quality Index (PSQI) questionnaire were used to assess subjective daytime sleepiness and sleep quality, respectively. Sleep measurements were recorded objectively for one week using actigraphy. The handgrip strength (FOHG) was measured using a handheld dynamometer, and the Six-Minute Walk Test (6MWT) was used to assess functional capacity. Finally, a 10-point visual analog scale (VAS) evaluated the intensity of SAMS. Measures were taken before and after a 2 month-statin withdrawal. Cohens d-values for pairwise comparisons were used to assess effect sizes (ES) of changes within group over time, and ES were considered as trivial (<0.2), small (0.2–0.5), moderate (0.5–0.8), and large (>0.8).
RESULTS:
After statin withdrawal, an improvement of objective sleep quality was observed in the SAMS group (sleep efficiency: +3.8%, ES: 0.33 [small effect]; wake after sleep onset: -15.6%, ES: -0.30 [small effect]; number of awakenings after sleep onset: -12.7%, ES: -0.45 [small effect]), concurrent with a decrease of subjective perception of SAMS intensity (VAS: 4.75 to 2.25, ES: -1.06 [large effect]). A decrease in subjective daytime sleepiness (ESS: 11.3 to 8.3, ES: -0.45 [small effect]) and an increase in subjective sleep quality (PSQI: 7.66 to 6.33, ES: -0.31 [small effect]) were also specifically seen in this group. The No SAMS group did not show any change for the different objective and subjective sleep parameters (ES: -0.08 to 0.15 [trivial effects]). Finally, FOHG increased only in patients with SAMS (left hand, +12.5%, ES: 0.30 [small effect]), while no change was observed for the distance walked at 6MWT.
CONCLUSION:
These preliminary data suggest that in patients who self-report SAMS, a 2-month statin withdrawal may increase their sleep quality, as well as functional capacity illustrated by FOHG.
REFERENCES
Peyrel P et al. Qual Life Res, 2023; 32(7):1943-1954.
Thompson PD et al. J Am Coll Cardiol, 2016; 67(20): 2395-2410.