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[e-drug] Antidiabetic drugs (cont)

  • Subject: [e-drug] Antidiabetic drugs (cont)
  • From: "Perla Mordujovich" <pmordujo@netverk.com.ar>
  • 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
      WHO EDL.
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:

    1.1-Insulin 40U/100U
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.

    1.2- Glibenclamide
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" <pmordujo@netverk.com.ar>
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