Correspondence
In Reply
Since 2007 studies have been conducted in several European countries (Norway, the UK, Germany) of the quality of life in AI patients compared with the age-matched and sex-matched normal population. All studies showed in the statistical comparison that the quality of life of AI patients was notably lower than in the normal population. The clinical relevance seems to manifest itself in the fact that, correspondingly, a higher proportion of patients are able to work only within restricted limitations or are unfit for work. However, variability between individuals is high, and, similarly, there are patients whose quality of life is relatively high. The causes of the impairments are not known. After excluding comorbidities, the clinical picture is comparable for primary and secondary AI, and the assumption is that the non-physiological cortisol profile that is achieved by modern replacement therapy is relevantly associated with this. Data from relevant interventional studies are scarce, but support this hypothesis. All the authors’ competing interests were reported in the study. None of us has equity interests. We mentioned the preparation in addition to others (prednisolone, prednisone [Lodotra], hydrocortisone [Chronocort]) and cited results from the registration trial. The authors did not provide a rating of “beneficial effect.”
We would very much welcome a study comparing prednisolone and Viropharma’s hydrocortisone preparation. At first glance, prednisolone seems sensible and has been tried and tested in clinical practice. But it has a much longer and possible very different effect on the glucocorticoid receptor. Female patients with primary AI who took 5 mg prednisolone had a notably lower bone density after several years’ replacement therapy than female patients taking 20 mg hydrocortisone (1).
The registration trial for Viropharma’s hydrocortisone preparation was conducted in Sweden, where the current average daily substitution dosage is 30 mg hydrocortisone. We agree with our correspondents that this dosage is too high. In Germany, as mentioned in our article, substitution treatment is given at a dosage of 15–25 mg hydrocortisone/day.
DOI: 10.3238/arztebl.2014.0224b
On behalf of the authors
Prof. Dr. med. Marcus Quinkler
Klinik für Innere Medizin mit Schwerpunkt Endokrinologie,
Diabetologie und Stoffwechsel, Charité Campus Mitte
Charité Universitätsmedizin Berlin
marcus.quinkler@charite.de
Conflict of interest statement
Prof. Quinkler works as a consultant for Viropharma Inc. He received reimbursement of conference participation fees, travel and accommodation costs, as well as fees for the preparation of scientific continuing education events from Viropharma.
| 1. | Koetz KR, Ventz M, Diederich S, Quinkler M: Bone mineral density is not significantly reduced in adult patients on low-dose glucocorticoid replacement therapy. J Clin Endocrinol Metab 2012; 97: 85–92. CrossRef MEDLINE |
| 2. | Quinkler M, Beuschlein F, Hahner S, Meyer G, Schöfl C, Stalla GK: Adrenal cortical insufficiency—a life threatening illness with multiple etiologies. Dtsch Arztebl Int 2013; 110(51–52): 882–8. VOLLTEXT |
