Hydroxy-methylglutaryl CoA reductase inhibitors or statins are associated with an increased incidence of myalgia or muscle pain. These symptoms may affect medication adherence and increase risk of injury in older adults. The true incidence of myalgia has ranged from 1% in pharmaceutical trials to 10% to 25% of patients in non–industry-funded trials. Muscle fatigue and weakness are occasionally reported during statin therapy, but weakness has rarely been documented because few studies have examined whether measureable weakness accompanies statin myalgia. In The Effect of STatins On Skeletal Muscle Function and Performance (STOMP) study, 18 subjects with confirmed statin myalgia taking atorvastatin demonstrated decreases in muscle strength (5 of 14 variables) compared with asymptomatic subjects (0 of 14 variables). This rate was not different from muscle strength decreases in placebo myalgic subjects (4 of 14 variables) compared with asymptomatic subjects on placebo (4 of 14 variables). However, this study excluded subjects with previous statin use and therefore could not investigate strength in patients with statin muscle intolerance. Consequently, we assessed muscle strength and self-reported physical activity in clinical patients with statin intolerance to determine if statin myalgia is associated with changes in muscle performance in this population.

Materials and Methods

Patients (n = 11, 7 men and 4 women, 63.2 ± 7.8 years, body mass index = 28.9 ± 5.3 kg/m ² ) from the Hartford Hospital Cholesterol Clinic who reported a history of statin-associated muscle complaints (i.e., muscle cramps, fatigue, and weakness) were asked to participate. Patients were either on (n = 4) or off (n = 7) cholesterol-lowering medication at visit 1 ( Table 1 ). In the latter group, patients had not taken their statin for 2 months to 1 year. Patients on statins at enrollment performed strength and metabolic testing, stopped their statin for 2 months, and repeated the testing. Patients off their statin at enrollment performed strength and metabolic testing, started statin therapy, and repeated the testing after 2 months of treatment or when their muscle complaints returned. Strength and metabolic testing included administration of the Brief Pain Inventory—Short Form, question 8 of the Paffenbarger Physical Activity Questionnaire, height and weight measurements, handgrip and leg strength, leg endurance, and a fasted metabolic assessment of respiratory exchange ratio (RER). RER was determined using TrueOne 2400 metabolic measurement system (Parvo Medics, Inc., Sandy, Utah). Informed written consent was obtained from all patients, and the study was approved by the Hartford Hospital Institutional Review Board.

Table 1

Summary of the medication used and absolute respiratory exchange ratio at rest, strength, and daily activity changes in the 11 patients with statin myalgia

Variable	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5	Patient 6	Patient 7	Patient 8	Patient 9	Patient 10	Patient 11
Age (yr)/gender/ethnicity	53/M/AA	56/M/C	56/F/C	57/M/C	58/M/C	62/F/C	65/M/C	70/M/C	71/M/C	72/F/C	75/F/C
Medication/dose (mg)	P20	E10	A10	A80	E10	E10/S20	R2.5	A10	S20	R5	RRY600
Frequency	Daily	3d·wk	3d·wk	Daily	3d·wk	Daily	Daily	Daily	Daily	Daily	Twice daily
Drug order	Off/on	Off/on	On/off	On/off	Off/on	Off/on	Off/on	Off/on	On/off	Off/on	On/off
Resting RER Δ	0.0	−0.2	0.2	—	—	0.1	0.1	0.1	0.0	—	−0.1
Handgrip (kg) Δ	−11.0	3.6	0.4	−3.0	−6.1	−7.4	0.7	−4.0	1.0	0.0	−1.3
Leg strength Δ (N-M)
Isom Ext (APT)	−64.0	44.1	−34.0	−18.0	0.4	−35.0	−3.2	−4.6	29.1	38.1	−3.9
Isom Flex (APT)	−16.0	32.2	−4.1	−3.9	6.9	−16.0	−1.0	−17.0	35.9	8.4	0.3
Isok Ext (AP) @ 60°/sec	2.2	−9.5	−13.0	−33.0	0.0	−18.0	0.2	−7.4	−16.0	0.0	−2.9
Isok Flex (AP) @ 60°/sec	5.7	−0.3	−1.9	−30.0	−6.2	0.0	5.6	−2.9	−2.0	−7.6	−1.8
Isok Ext (AP) @ 180°/sec	−31.0	29.9	−19.0	−54.0	15.0	−34.0	2.4	−8.7	−26.0	6.5	−15.0
Isok Flex (AP) @ 180°/sec	−32.0	37.4	−14.0	−58.0	−35.0	−16.0	22.2	−5.6	10.3	25.4	−11.0
Isok Ext (APT) @ 60°/sec	−10.0	−8.1	−40.0	−51.0	−10.0	−23.0	1.2	−12.0	−21.0	22.4	−2.9
Isok Flex (APT) @ 60°/sec	10.6	3.3	−12.0	−42.0	−11.0	1.4	4.5	0.3	8.6	1.3	−2.6
Isok Ext (APT) @ 180°/sec	−24.0	13.7	−25.0	−28.0	11.0	−16.0	−0.8	−2.4	−15.0	25.7	−5.3
Isok Flex (APT) @ 180°/sec	−18.0	14.6	−15.0	−15.0	−21.0	−7.9	5.3	1.9	12.7	9.7	−6.6
Fatigue index (%)	10	−13.0	0.0	9.3	—	−1.6	−1.8	−0.7	−16.0	−2.8	−9.4
Brief Pain Inventory-SF Δ
Pain severity score	5.3	−1.0	0.0	−1.8	—	1.8	1.8	1.0	0.0	0.0	0.0
Pain interference score	6.6	−0.3	1.6	−1.3	—	3.6	−0.3	0.71	0.29	0.0	0.0
PPAQ question 8 Δ (hr·d)
Vigorous activity	2.4	2.6	1.7	0.0	—	−1.3	0.0	0.0	−0.6	0.0	1.0
Moderate activity	1.5	−0.7	−0.6	3.4	—	−3.7	−1.3	0.0	−1.4	4.0	−1.7
Light activity	−0.9	−0.6	−3.1	2.7	—	5.3	−2.0	1.0	0.3	−3.0	1.1
Sitting	−3.1	−3.0	2.0	−2.9	—	0.6	3.3	0.0	2.4	−1.0	−0.4
Sleeping/reclining	0.1	1.7	0.0	−1.0	—	0.0	0.0	−1.0	0.0	0.0	0.0

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