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Polyneuropathy and
statins part-II
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Table 1: Definition of diagnosis of polyneuropathy
Description
|
Definition
|
| Definite |
Adequate work up and
tested for exclusion
diagnoses and conditions,
and no apparent cause of
neuropathy established |
| Probable |
Only sufficient
information to rule out
alcohol overuse, diabetes
and renal insufficiency |
| Possible |
Information not
sufficient to ascertain
presence or absence of any
exclusion diagnosis |
For each case, all
inhabitants of the same sex
and age were used to
randomly choose 25 control
subjects per case.
Results
There were 166 cases (mean
age 59 years) of first time
diagnosis of polyneuropathy
in the five years, of which
35 were definite, 54
probable, and 77 possible.
Of these nine (5.4%) had a
previous exposure to statins
(eight current users), with
a median duration of 2.8
years. There were 4,150
controls, of whom 66 (1.6%)
had exposure to statins (49
current users).
The relative risk of
polyneuropathy for current
users was 4.6 (2.1 to 10)
for all cases with current
use, and 16 (5.7 to 45) for
definite cases with current
use (Table 2). Odds ratios
were higher for more than
two years of use compared
with less than two years,
and for larger numbers of
doses than smaller numbers.
Table 2: Statin exposure in all cases and definite cases of
polyneuropathy
|
Statin exposure
|
Cases
|
Controls
|
Odds ratio
(95%CI)
|
All cases
|
|
Never use |
157 |
4084 |
1 |
|
Current use |
8 |
49 |
4.6 (2.1 to 10) |
Definite cases
|
|
Never use |
27 |
854 |
|
|
Current use |
7 |
17 |
16 (5.7 to 45) |
The number needed to harm
(NNH) based on all patients
was calculated as 5,500
(2,200 to 18,500). In those
over 50 the incidence of
polyneuropathy in the
background population was
1.7 per 10,000 person years,
with an excess rate of 4.5
per 10,000 person years
among those exposed to
statins. That is roughly one
excess case of
polyneuropathy for every
2,200 (880 to 7,300) person
years of statin use.
Comment
In 1998 about 1% of the
Danish population used a
statin. It's probably more
now, both in Denmark and
elsewhere. If a PCO with
100,000 inhabitants had 1%
taking statins, a case of
polyneuropathy might be
expected every second year.
That's twice as frequent as
a case of myopathy.
In primary care in England
in 2001 there were about 13
million prescriptions for
statins, at a cost of about
£420 million. It is not
possible to extrapolate too
much from that, other than
to conclude that with so
much statin use, these rare
adverse events will occur
and should be noticed.
Awareness of that may be
important in limiting their
impact.
This is a powerful and
interesting paper,
demonstrating how good
government information
systems can be used for the
good of its population. It
is important in
understanding risk, though
not of causation nor
mechanism. Papers in the
journal Neurology are
available free on the
Internet. If you think you
want to read this one, then
read also an thoughtful
accompanying editorial [3].
References:
- D Gaist et al.
Lipid-lowering drugs and
risk of myopathy: a
population-based
follow-up study.
Epidemiology 2001 12:
565-569.
- D Gaist et al.
Statins and risk of
polyneuropathy. A
case-control study.
Neurology 2002 58:
1333-1337.
- M Donaghy. Assessing
the risk of drug-induced
neurologic disorders.
Neurology 2002 58:
1321-1322.
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