FLUCORTAC (fludrocortisone), corticosteroid
CARDIOVASCULAR - New indication
Opinions on drugs -
Posted on
Jul 18 2018
Reason for request
Extension of indication
Low clinical benefit for the treatment of neurogenic orthostatic hypotension, with no proven clinical added value for the treatment of this disease.
FLUCORTAC has been granted a marketing authorisation for the treatment of neurogenic orthostatic hypotension in the event of failure of and to supplement non-medicinal measures.
The data available, which have a low level of evidence, suggest a modest improvement in blood pressure on standing.
No comparative data are available to date documenting the efficacy and safety of fludrocortisone compared to midodrine.
The use of fludrocortisone is well-established in cases of failure of non-medicinal measures.
Clinical Benefit
Low |
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Clinical Added Value
no clinical added value |
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