Statins and neuromuscular degenerative disease (Lou Gehrig's like syndrome)
- From: Susan <nevermind@xxxxxxxxxx>
- Date: Fri, 22 Jun 2007 20:55:03 -0400
x-no-archive: yes
Drug Saf. 2007;30(6):515-25. LinkOut
Statins, neuromuscular degenerative disease and an amyotrophic lateral
sclerosis-like syndrome: an analysis of individual case safety reports
from vigibase.Edwards IR, Star K, Kiuru A.
The WHO Foundation Collaborating Centre for International Drug
Monitoring, the Uppsala Monitoring Centre (UMC), Uppsala, Sweden.
BACKGROUND: The WHO Foundation Collaborating Centre for International
Drug Monitoring (Uppsala Monitoring Centre [UMC]) has received many
individual case safety reports (ICSRs) associating HMG-CoA reductase
inhibitor drug (statin) use with the occurrence of muscle damage,
including rhabdomyolysis, and also peripheral neuropathy. A new signal
has now appeared of disproportionally high reporting of upper motor
neurone lesions.
AIM AND SCOPE: The aim of this paper is to present the upper motor
neurone lesion cases, with other evidence, as a signal of a
relationship between statins and an amyotrophic lateral sclerosis
(ALS)-like syndrome. The paper also presents some arguments for
considering that a spectrum of severe neuromuscular damage may be
associated with statin use, albeit rarely. The paper does not do more
than raise the signal for further work and analysis of what must be
regarded as a potentially very serious and perhaps avoidable or
reversible adverse reaction, though it also suggests action to be
taken if an ALS-like syndrome should occur in a patient using
statins.
METHODS: The 43 reports accounting for the disproportional reports in
Vigibase (the database of the WHO Programme for International Drug
Monitoring) are summarised and analysed for the diagnosis of an ALS-
like syndrome. The issues of data quality and potential reporting bias
are considered. RESULTS: 'Upper motor neurone lesion' is a rare
adverse event reported in relationship to drugs in Vigibase (a
database containing nearly 4 million ICSRs). Of the total of 172 ICSRs
on this reported term, 43 were related to statins, of which 40 were
considered further: all but one case was reported as ALS. In 34/40
reports a statin was the sole reported suspected drug. The diagnostic
criteria were variable, and seven of the statin cases also had
features of peripheral neuropathy. Of a total of 5534 ICSRs of
peripheral neuropathy related to any drug in Vigibase, 547 were on
statins. The disproportional reporting of statins and upper motor
neurone lesion persisted after age stratification, and such
disproportionality was not seen for statins and Parkinson's disease,
Alzheimer's disease, extrapyramidal disorders, or multiple sclerosis-
like syndromes. DISCUSSION: Because the cases were sometimes atypical
we propose the use of the term 'ALS-like syndrome' and speculate
whether this is part of a spectrum of rare neuromuscular damage. The
diagnosis of ALS is often problematic, and the insidiousness and
chronicity of the disease make causality with a drug difficult to
assess.
The disproportionally high reporting makes this an important signal
nevertheless, since ALS is serious clinically and statins are so
widely used. Wide use of the statins also makes a chance finding more
probable, but is unlikely to cause disproportional reporting when
there are no obvious biases identified.
CONCLUSION: We emphasise the rarity of this possible association, and
also the need for further study to establish whether a causal
relationship exists. We do advocate that trial discontinuation of a
statin should be considered in patients with serious neuromuscular
disease such as the ALS-like syndrome, given the poor prognosis and a
possibility that progression of the disease may be halted or even
reversed.
PMID: 17536877 [PubMed - in process
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