Details

Autor(en) / Beteiligte

• Kragballe, K.
• Austad, J.
• Barnes, L.
• Bibby, A.
• De La Brassinne, M.
• Cambazard, F.
• Fleming, C.
• Heikkilä, H.
• Jolliffe, D.
• Peyri, J.
• Svensson, Å.
• Toole, J.
• Wozel, G.

Titel

A 52-week randomized safety study of a calcipotriol/betamethasone dipropionate two-compound product (Dovobet®/Daivobet®/Taclonex®) in the treatment of psoriasis vulgaris

Ist Teil von

• British journal of dermatology (1951), 2006-06, Vol.154 (6), p.1155-1160

Ort / Verlag

Oxford, UK: Blackwell Publishing Ltd

Erscheinungsjahr

2006

Quelle

Wiley Blackwell Single Titles

Beschreibungen/Notizen

• Summary Background  The calcipotriol/betamethasone dipropionate two‐compound product Dovobet®/Daivobet®/Taclonex®(LEO Pharma A/S, Ballerup, Denmark) has been shown to be safe and effective in the treatment of psoriasis for up to 8 weeks. As psoriasis is a chronic disease, long‐term treatment may be required, so there is a need to investigate the safety of its use over a longer period of time. Objectives  To investigate the safety of two treatment regimens involving use of the two‐compound product over 52 weeks in the treatment of patients with psoriasis. Methods  Patients (n = 634) were randomized double‐blind to treatment with: (i) 52 weeks of the two‐compound product (two‐compound group); (ii) 52 weeks of alternating 4‐week periods of the two‐compound product and calcipotriol (alternating group); or (iii) 4 weeks of the two‐compound product followed by 48 weeks of calcipotriol (calcipotriol group). Treatments in all groups were used once daily when required. Results  Adverse drug reactions (ADRs) occurred in 45 (21·7%) patients in the two‐compound group, 63 (29·6%) in the alternating group and 78 (37·9%) in the calcipotriol group. The odds ratio for an ADR in the two‐compound group relative to the calcipotriol group was 0·46 (95% confidence interval 0·30–0·70; P < 0·001). ADRs of concern associated with long‐term topical corticosteroid use occurred in 10 (4·8%) patients in the two‐compound group, six (2·8%) in the alternating group and six (2·9%) in the calcipotriol group; those with the highest incidence were skin atrophy, occurring in four (1·9%), one (0·5%) and two (1·0%) patients, respectively, and folliculitis, in three (1·4%), one (0·5%) and no patients, respectively. Conclusions  Treatment with the two‐compound product for up to 52 weeks appears to be safe and well tolerated whether used on its own or alternating every 4 weeks with calcipotriol treatment.