Download Where does my current medication come from? The story of enzymes

Where does my current medication come from?
The story of enzymes
Many people with Cystic Fibrosis (CF) have a
reduction in function of their pancreas,
which is an organ next to the liver that
produces enzymes that digest food.
How was it tested?
Pancreatic enzymes, like a number of other
older medicines, were made before it was
required to test medicines in clinical trials.
In more then 85% of people with CF the
sticky mucus blocks pancreatic enzymes
from reaching food in the small intestine.
This can lead to poor digestion and
absorption of food as well as difficulty
gaining and maintaining a healthy weight.
Therefore replacement enzymes have to be
taken by mouth with every meal and snack.
In April 2004, a new rule was issued by the
authorities. To receive approval for use, the
enzymes had to be tested in clinical trials in
people with pancreatic diseases, which
include CF.
What kind of drug are enzymes?
It is a capsule that contains three categories
of enzymes: lipase, amylase and protease.
A number of trials were carried out. For
example, 32 people with CF tested Creon
24000 (pancreatine) over 5 weeks. Half of
them received ‘placebo’ (dummy drugs); the
other half received the Creon 24000. After 5
weeks the groups changed medication, those
who took Creon 24000 got placebo and vice
versa.
This study, and others, showed that
pancreatic enzymes are effective and safe*.
How is it made?
It all started in 1900 with a powder
consisting of pancreatine. These days coated
microspheres are the latest development
with the potential to optimise treatment of
pancreatic exocrine insufficiency.
Were clinical trials of pancreatic enzymes
necessary?
Yes, because there were reports of health
problems in people with CF when an enzyme
product was used which did not work as it
should.
By requiring enzymes to be consistent
in their formulation and to work
properly, people with CF can be assured
that they are getting the right amount
of enzymes for their digestive and
nutritional needs.
Taking enzymes practically
•Enzymes should be taken just before
eating, or as guided by your CF
dietitian.
•Avoid “skipping” enzymes.
•Keep a supply of enzymes with you if
meals and snacks may be eaten away
from home.
•If the enzyme capsules are opened,
don’t crush or chew the enzyme
beads. They won’t work so well.
•Keep enzymes at room temperature.
* For complete product information please read patient
information leaflet of this medicine