(Circulation. 2007;116:II_847.)
Abstract 3725: Simvastatin but Not Pravastatin Affects Sleep: Findings
from the UCSD Statin Study
Beatrice A Golomb; Edwin K Kwon; Michael H Criqui; Joel E Dimsdale
Univ of California, San Diego, La Jolla, CA
Background: Case reports have suggested possible effects of lipophilic
statins on sleep in some subjects. Most randomized studies evaluating
the effect of statins on sleep have had small sample size and short
duration ( 6 weeks). Whether statins affect sleep on average,
favorably or adversely, has been unclear.
Goal: To assess the effects of lipophilic and hydrophilic statins on
sleep.
Subjects: 1016 adult men and women without diabetes or heart disease,
with LDL-cholesterol 115-190mg/dL.
Design: Randomized double blind placebo-controlled trial of
simvastatin 20mg, pravastatin 40mg or placebo for 6 months. Sleep was
a prespecified secondary outcome. It was assessed by both an
adaptation of the Leeds sleep scale (a visual analog scale of sleep
quality); and a rating scale of sleep problems. Both items were
measured at baseline and on-treatment.
Analysis: Baseline comparability of randomization groups including
sleep measures was affirmed. T-test of mean on-treatment sleep scores
across randomization groups was performed. This complemented
regression analyses, adjusted for baseline values of the respective
sleep assessment.
Results: Groups were comparable at baseline on variables including
both sleep measures. Simvastatin use was associated with significantly
worse sleep quality, and significantly greater reported sleep problems
than either pravastatin or placebo, by t-test and regression analyses.
Pravastatin did not differ significantly from placebo on any sleep
outcome.
Conclusion: Findings were compatible with the hypothesis that statins
may impair sleep in some subjects, and that this impairment may arise
selectively with lipophilic statins.
http://circ.ahajournals.org/cgi/content/meeting_abstract/116/16_MeetingAbstracts
/II_847?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=golomb&searchid=1&FIRS
TINDEX=0&volume=116&issue=16+Supplement&resourcetype=HWCIT
Cholesterol Drug Tied to Sleep Disturbances
11.07.07, 12:00 AM ET
WEDNESDAY, Nov. 7 (HealthDay News) -- Lowering your cholesterol could
interrupt your slumber.
A new report found that the statin Zocor disrupts sleep patterns in
some users.
"The study suggests that simvastatin [Zocor] is more likely to have
sleep disruption," said Dr. Sidney Smith, past president of the
American Heart Association and director of the Center for
Cardiovascular Science and Medicine at the University of North
Carolina School of Medicine. "The extent to which this would be a
significant problem for patients is uncertain, but this should raise
awareness that symptoms could be related to therapy."
The findings were presented Wednesday at the American Heart
Association's annual meeting, in Orlando, Fla.
A growing number of Americans now take statins to reduce their
cholesterol levels, as a way to prevent heart attack or stroke.
"There had long been concerns about statins adversely affecting sleep
in case reports and case series dating back to at least 1990, just
after the release of statins," said study author Dr. Beatrice Golomb,
of the University of California, San Diego, School of Medicine's
Department of Medicine. "The rub is that they used sample sizes that
were tiny and follow-ups of only four to six weeks. The sample sizes
were less than 20 or 30 -- not enough typically to show an effect
unless the effect was huge," Golomb noted.
The new study, funded by the U.S. National Institutes of Health, is
the largest of its kind and involved 1,106 healthy adult men and women
who were randomly chosen to receive 20 milligrams of Zocor
(simvastatin), 40 milligrams of Pravachol (pravastatin), or a placebo
for six months. The two dosages of the two statins are considered
approximately equivalent.
"We were looking at the impact of the most hydrophilic [Pravachol] and
most lipophilic [Zocor] statins on a range of non-cardiac endpoints
with sleep as a pre-specified secondary outcome," Golomb explained.
Lipophilic means the drug is soluble in fat, while hydrophilic means
it is soluble in water. Previous research had implicated lipophilic
statins in sleep disturbances.
"Simvastatin is fat-soluble, and can penetrate and cross into the
brain," Smith explained.
Golomb said: "We did show significant worsening in both sleep quality
outcome and sleep problem categories in patients taking simvastatin.
Less sleep quality and more sleep problems."
Those participants who had worse sleep also showed a worsening in
their aggression scores, compared to people in the other two study
groups.
This doesn't mean that patients experiencing sleep problems should
take themselves off Zocor or another statin, Smith said. "The broader
benefit of decreasing heart attack and stroke must be taken into
account," he said.
And patients who find themselves truly sleep-deprived can also talk to
their doctor about finding an alternate statin, he said.