The
Pharmaceutical Journal Vol 266 No 7129 p5-6 Study suggests link between antiepileptics
and learning difficulties
Lung cancer awareness month
Infection risk with infliximab
Meningitis C cases drop but vigilance still required,
CMO says
Benefits of dual blockade of the renin-angiotensin system
Obesity drug useful for maintaining weight loss, say researchers
Risk of cardiac disorders with Orlaam
Children born to women who take antiepileptic drugs during pregnancy may be
more likely to have additional educational needs, results of a study have revealed.
Researchers from the Walton Centre for Neurology, Liverpool, conducted a retrospective
survey of 721 women with epilepsy aged between 16 and 40 years to determine
the level of exposure to antiepileptic drugs during pregnancy and the effects,
if any, on the resulting children.
Dr Naghme Adab and colleagues found that of the 400 children born to the women,
who were of school age at the time of the survey, 150 had been exposed to monotherapy
in utero, 74 had been exposed to polytherapy and 176 had had no exposure.
Of the 400 children, 33 (8.25 per cent) had received a local authority statement
for additional educational needs - 5.7 per cent of those who had not been exposed
to antiepileptic drugs and 10.3 per cent of those who had. This compared with
the local average for the area of 3.1 per cent.
Thirty per cent of children exposed to sodium valproate alone in utero
had additional educational needs compared with 3.2 per cent and 6.5 per cent
of those exposed to carbamazepine and other monotherapy, respectively. “This
generates a hypothesis that valproate as an individual drug carries particular
risks to learning and development of children,” they say.
Dr Adab and colleagues comment that the retrospective nature of the results
means that they should be interpreted with caution and that over 90 per cent
of pregnancies in women with epilepsy proceed without problem. They call for
adequately sized, prospective studies to be undertaken to quantify the risk
associated with commonly used antiepileptics and say that women should be advised
about the risks of new antiepileptic drugs as quickly as possible.
The authors say that about one-third of people receiving antiepileptic drugs
are women of reproductive age and that one in 250 pregnancies may be exposed
to antiepileptic drugs (Journal of Neurology, Neurosurgery and Psychiatry
2001;70:15).
Commenting on the study, Professor Martin Kendall (chairman, joint formulary
committee, British National Formulary) said: “The BNF advises that women with
epilepsy who wish to become pregnant should be referred to a specialist for
advice. It further recommends that women who become pregnant should be counselled
and offered antenatal screening to detect possible problems in the foetus.”
Sanofi-Synthélabo, the United Kingdom manufacturer of Epilim (sodium valproate),
commented on January 2 that the study had raised interesting issues that warranted
further investigation. However, it added that even the authors had stated that
the findings should be treated with caution.
The company recommended that, while further studies were ongoing, it would be
prudent to counsel women with epilepsy who were considering becoming pregnant
about the potential risks associated with all antiepileptic drugs and the benefit
of having their epilepsy well controlled.
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The Cancer Research Campaign has named January “Lung cancer awareness month”.
The charity says that lung cancer has a low public profile despite the fact
that it kills 33,370 people every year in Britain compared with 16,260 who die
from large bowel cancer and 12,680 from breast cancer. In addition, survival
rates for the most common cancers, except for lung cancer, have gone up since
the 1980s. The CRC says that there has been a wall of silence surrounding lung
cancer, which it calls the “invisible cancer”, and that public perception is
that lung cancer is a self-inflicted disease of smokers. The charity hopes that
its awareness campaign will help to increase lung cancer’s profile on the national
agenda.
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Patients receiving infliximab (Remicade) have been advised to be aware of
the risk of developing tuberculosis (TB) while taking the drug.
In a statement released at the end of December, the European Agency for the
Evaluation of Medicinal Products (EMEA) says that patients should be instructed
to seek medical advice if signs and/or symptoms suggestive of TB (eg, persistent
cough, weight loss, low-grade fever) appear. If active TB is suspected, treatment
should be stopped until the diagnosis is ruled out or the infection has been
treated. The EMEA adds that before starting treatment with infliximab, patients
should be evaluated for both active and latent (inactive) TB. If latent TB is
diagnosed, measures to prevent activation of the infection should be taken before
starting therapy and the risk/benefit ratio of treatment considered.
The recommendations have been made following 28 reported cases of TB in patients
treated with infliximab. Many of the reported cases of TB originated in countries
with a high incidence of the infection and the majority of patients had a prior
history of treatment with immunosuppressants and corticosteroids. In a significant
proportion of the cases, the onset of active TB occurred after three or fewer
infusions of infliximab, supporting a possible relationship with the initiation
of infliximab treatment, the EMEA says. As clinical experience with infliximab
is still limited, the onset or re-activation of TB after a longer period of
treatment cannot be ruled out. An estimated 100,000 patients have been treated
with infliximab worldwide since it was launched in the United States in 1998.
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There has been a 75 per cent drop overall in the number of cases of meningitis
C in target groups who have been vaccinated, the Department of Health has announced.
The reduction in the number of cases is as high as 90 per cent in the under
one-year and 15 to 17 year-old age groups, who were the first to be immunised,
it said in a press release on January 3.
Professor Liam Donaldson (chief medical officer) described the reduction in
cases as a “wonderful achievement” but warned that meningitis B was still common.
Parents and health care professionals should continue to be vigilant to the
symptoms of meningitis, he said.
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Benefits of dual blockade of the renin-angiotensin systemResearch suggests that blood pressure can be more effectively reduced
by dual blockade of the renin-angiotensin system compared with the reduction
attained with a single agent. It has also found that combination therapy
may be more effective at reducing microalbuminuria. |
Study provides evidence for combination therapy in hypertension |
Sibutramine is effective at maintaining weight loss, say researchers led by
Professor Philip James (Rowett Research institute, Aberdeen).
In a 24-month trial to assess the long-term weight-maintaining effects of the
drug, 499 patients were treated with 10mg sibutramine daily for six months,
in conjunction with an individualised calorie-controlled diet. Of these, 467
patients achieved more than 5 per cent weight loss and were randomised to receive
either sibutramine (352 patients) or placebo (115 patients) for a further 18
months. (The dose of sibutramine was increased up to a maximum of 20mg/day if
weight gain occurred.)
The patients who continued to receive sibutramine maintained their weight loss
for a further 12 months, with only a slight increase in weight thereafter, say
the researchers. Of the 204 sibutramine-treated patients who completed the trial,
89 (43 per cent) maintained 80 per cent or more of their original weight loss,
compared with nine (16 per cent) of the 57 patients remaining in the placebo
group.
The researchers comment: “The importance of sibutramine in maintaining a lower
weight was shown by the immediate and steady increase in bodyweight once the
placebo group stopped taking sibutramine.”
Throughout the study, fasting blood was taken to assess metabolic changes. Treatment
with sibutramine resulted in decreases in serum triglycerides, very low density
lipoprotein cholesterol, insulin C-peptide and uric acid but not in total or
low density lipoprotein cholesterol. High density lipoprotein cholesterol concentrations
increased following treatment with sibutramine. This increase continued throughout
the weight maintenance phase of the study in both the treatment and placebo
groups.
An increase in blood pressure affected more sibutramine-treated than placebo-treated
patients (8 per cent vs 3 per cent), say the researchers. Some patients were
withdrawn from the trial because of concerns over these blood pressure increases
and difficulties in controlling pre-existing hypertension. Other adverse events
that occurred more frequently in the sibutramine group than in the placebo group
included insomnia, nausea and dry mouth.
The researchers suggest that the risk of increased blood pressure due to sibutramine
treatment will be counteracted by the drug’s beneficial impact on lipid abnormalities
(Lancet 2000;356:2119).
A spokeswoman for Knoll told The Journal on January 2 that the company
hoped to launch sibutramine (Reductil) in the United Kingdom in the first half
of this year.
Sibutramine, a tertiary amine, was originally developed as an antidepressant
agent. Its weight-loss-inducing properties are mediated by inhibition of neuronal
reuptake of noradrenaline and serotonin at receptor sites that affect food intake,
and by the prevention of reductions in energy expenditure experienced during
weight loss.
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Prescribers have been advised not to start new patients on levacetylmethadol
(Orlaam) therapy. The advice was issued by the European Agency for the Evaluation
of Medicinal Products (EMEA) after it became aware of 10 cases of life-threatening
cardiac disorders associated with the drug that had been reported since July,
1997. The 10 cases included ventricular rhythm disorders such as torsade de
pointes.
Patients currently taking levacetylmethadol are advised by the EMEA not to stop
treatment suddenly without seeking medical advice and to contact their physician
for advice regarding their medication. The EMEA says that its scientific committee,
the Committee for Proprietary Medicinal Products, is to perform a full comparative
risk/benefit re-assessment of levacetylmethadol.
A spokesman for Britannia Pharmaceuticals, the UK distributor of Orlaam, told
The Journal on January 3 that the company had sent letters to all pharmacists
who had ordered Orlaam since its launch in February, 2000, drawing attention
to the EMEA’s advice.
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