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Dr. Olschewski, you have extensive experience treating
patients with PAH. Do the ACCP guidelines apply in general
to your practice in Germany? How do you decide which drug
to use?
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 Horst
Olschewski, MD
Lecturer, Division of Pulmonary and Critical
Care Medicine
Justus-Liebig Universität
Giessen, Germany
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The ACCP recommendations are only partly applicable
to our clinical practice in Germany. The development of
PAH treatment in Germany has been different from that
in the United States and the approval situation is also
different. For example,
intravenous epoprostenol was never used in considerable
numbers of patients in Germany and has never been approved
in our country. Instead, inhaled iloprost or intravenous
iloprost was the drug of first choice until bosentan became
available. The recommendation of bosentan (grade A) is
applicable in our country and fits our practice. In contrast,
intravenous epoprostenol is not approved, is extremely
expensive, and having a practical alternative, is hardly
used in German patients. While intravenous iloprost is
more widely used, it is approved only for peripheral artery
occlusive disease. It is not mentioned in the ACCP Clinical
Practice Guidelines as it was not tested in randomized
controlled studies. Subcutaneous treprostinil is not approved
and does not play a major role in Germany.
In contrast, inhaled iloprost plays a considerable role
as the only approved alternative to bosentan and as a
suitable combination partner to any other PAH therapy.
In Germany, there has been extensive experience with the
use of inhaled
iloprost since 1994 and the benefit is considered substantial
by most experts, including for patients who are severely
ill. The ACCP recommendation (intermediate benefit) does
not reflect the result of the double-blind, controlled
Aerosolized Iloprost Randomized (AIR) study, which showed
an improvement in 6-minute walk test results similar to
that seen with intravenous epoprostenol and bosentan (PPH
+59 m).1 Beraprost was used off-label
with enthusiasm by some
German centers since 1997 but it turned out that the longterm
results were disappointing, particularly in severe disease
states. As it is not approved, it plays no major role
in clinical practice. In contrast, sildenafil plays a
role although it has not been approved for PAH. It is
mostly used in combination with approved drugs where these
are not sufficient.
There are ongoing clinical trials in the United
States with iloprost, and completed trials in Europe.
Do you feel that this drug will be used increasingly?
Inhaled iloprost has a place in the management
of PAH in Germany. Since bosentan was introduced, it is
no longer the drug of first choice because of the practical
difficulties (six to nine inhalations per day) and a high-tech
nebulizing device necessitating training of the patient
and personnel. I am sure there will be increasing use
of inhaled iloprost as an alternative to intravenous prostanoid
therapy when bosentan is not effective or stopped because
of side effects. The advantages compared to epoprostenol
and subcutaneous treprostinil are substantial with regard
to systemic side effects and the risk of catheter-related
complications. I am quite sure the drug will be increasingly
used.
Reference
1.Olschewski H, Simonneau G, Galie N,
Higenbottam T, Naeije R, Rubin LJ, et al. Inhaled iloprost
for severe pulmonary hypertension. N Engl J Med. 2002;347(5):322-9.
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