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HAS THE CURTAIN FINALLY FALLEN ? |
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William
Withering introduced the foxglove decoction to
medicine in the treatment of dropsy more than 200 years
ago, thereby ushering in a new era in the therapy of
heart failure. In the last two hundred years this drug
must have been given to millions of people. Many small
studies in the past looked at various aspects of this
drug and never before has any other drug been subjected
to more audit than digoxin. I reviewed the state of the
art of digoxin use way back in 1988.(1) Since then many
new studies did come to fruitition and I think it is time
to review the subject again. Finally the much awaited
extensive, placebo-controlled study of digoxin’s
usefulness in heart failure, Digoxin Investigation Group
(DIG) has been published (2).
Heart failure is still an enigma and it is very difficult
to say how many people die of heart failure and
how many die with it. So most of the statistics on
death in patients with heart failure have to be taken
with a pinch of salt. One has to take into account the
accompanying factors before deciding on the management of
heart failure. Now that ACE inhibitors
(angiotensin-converting-enzyme-inhibitors ) have been
shown to reduce death in heart failure patients (3) the
need for digoxin is not that urgent as in the past
without any specific treatment available.
Positive ionotrophic drugs like digoxin did not find
favour in the long run. The drug in question is
milrinone, which did more harm than good.(4) Almost
similar was the story of vasodilators which came with a
bang in the seventies but very soon faded away because of
the tachyphylaxis. (5) Earlier studies by Katz and his
group did show extra fibrosis in the heart muscle in
those patients who died of heart failure treated with
digoxin.(6) Tired and ischaemic myocardium finds it
difficult to respond to positive ionotrophic drugs.
Search for newer ways of treating heart failure brought
the new ACE inhibitors into the picture. There have been
renewed interest in betablockers in the treatment of
heart failure not only of the predominantly diastolic
pump dysfunction, but also the global dysfunction
variety. CIBIS, using the new betablocker bisaprolol, is
one such study.(7)
DIG study referred to above did throw light on some of
the important aspects of heart failure management. There
were two wings to the trial. The main part of the study
looked at patients with severe failure ( left ventricular
ejection fractions less than 45% ) and there were 3397
patients in the digoxin group as against 3403 patients in
the placebo group. In addition all these patients did
receive diuretics, ACE inhibitors and other measures as
and when needed. In an anciliary trial there were
patients with ejection fractions above 45% ( 492 in the
digoxin group and 496 in the placebo group ): in both the
groups the patients were randomly allocated to the
treatment groups. This was a double blind, placebo
controlled, randomised trial in the true sense.
The salient features of the results are as follows:
- Digoxin had no
effect on the overall mortality when it was
added to diuretics and ACE inhibitors.
- There were fewer
deaths due to worsening of the heart failure in
the digoxin group.
- Digoxin, unlike other
positive ionotrophic agents like
dobutamine,beta-agonists, milrinone, enoximone,
did not show increased mortality in heart
failure.
- Digoxin, however, did
show some reduction in the hospitalisation rates
in patients with heart failure.
There were more number of
people with suspected digoxin toxicity in the group
taking the drug but none of them needed hospitalisation
because of that and most of their serum digoxin levels
were within normal limits on review.
[index]
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