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[e-drug] Antidiabetic drugs (cont)
- Subject: [e-drug] Antidiabetic drugs (cont)
- From: "Perla Mordujovich" <firstname.lastname@example.org>
- Date: Mon, 23 Sep 2002 18:26:37 -0400 (EDT)
E-drug: Antidiabetic drugs (cont)
Dear Valeria and Leo Offerhaus:
I'd like to make some commentaries related with hypoglycaemic drugs..
1) Valeria's suggestions about 3 hypoglycaemic drugs on the current
2) Leo Offerhaus' commentary about front boxes in the EDL.
1) I have participated in some of the WHO Essential Committees and I can
exchange with both of you my opinion:
This issue has been discussed in several meetings and the reason for
keeping the 40U is that in several nondeveloping countries is the only
one they have. Any way, it was highlighted the intention of some of these
countries representatives to promote changes in their own countries. There
is a general agreement about the need of its deletion from the EDL.
If we look at the evidences of efficacy of glucose lowering drugs , not only
to normalize glyceaemia but, more important, to prevent or delay diabetic
complications, the only sulfonylurea which has already demonstrated
efficacy to prevent or delay microangiopathic complications is glibenclamide.
In the UKPDS trial only "strict control" by glibenclamide had a
significantly favourable effect on the incidence of the "first clinical
complication of diabetes". Insulin and chlorpropamide had no such effect..
The UKPDS trial followed for 10 years more than 4200 diabetics. (They had
only 2% lost to follow-up). It has been argued that this trial had many
methodological strengths : independent team, largely public funding, a
protocol published in advance, relevant end points, and is pragmatic (the
study population and the treatments corresponded to routine clinical
practice). But also has some flaws: it was unblinded, few patients stayed on
the initially allocated single-drug-glucose lowering regimen throughout the
But UKPDS is the best published trial to assess the benefit of therapies for
patients under 65 with recent onset type 2 diabetes (patients who failed
to be controlled only with non pharmacological treatment)
We don't have yet trial's results like these with gliclazide.
Up to that time, we should choose glibenclamide for the treatment of non
overweighted type 2 diabetes patients. In terms of safety, hypoglycaemia
could be avoided selecting the exact dosage each patient need ,
taking into account adequate diets and programme of physical
In terms of cost , glibenclamide is the cheapest one. An analysis of the
comparative mean cost of treatments/month with oral hypoglycaemic drugs
made for us last year in Argentina showed these value for both drugs:
glibenclamide 13,50 US$/month
gliclazide 26,40 US$/month
So , if we take into account the best available evidence of the
Benefit/risk/cost analysis for the
treatment of non obese type 2 diabetes patients, we must choose
glibenclamide. Considering its convenience, we remember the possibility of
hypoglycaemia , so we have to add the precautions needed in choosing its
1-UKPDS . Group " Intensive blood-glucose control with sulphonylureas or
insulin compared with conventional treatment and risk of complications in
patients with type 2 diabetes" UKPDS 33 Lancet
2-Management of type 2 diabetes Rev. Prescrire; 1999;19(196):448-456.
2). In relation to the square box in front of glibenclamide in the EDL , we
must add that there is an ongoing discussion in the WHO EDL
Committees, on the
issue of square boxes.
Not all drugs can be replaced by others of the same group.
A paradigmatic example on this issue are NSAIDS. If we keep a square
box in front of ibuprofen., we could choose naproxen or diclofenac
instead (they belong also to the NSAIDS group) but, all three
medicines expose patients to
different risks of GI adverse effects. We can conclude that they are not
exchangeable in terms of their GI safety.
With best regards
Dr Perla M Buschiazzo
Professor of Pharmacology
School of Medicine
National University of La Plata
"Perla Mordujovich" <email@example.com>
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