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A 52‐week randomized safety study of a calcipotriol/betamethasone dipropionate two‐compound product (Dovobet ® /Daivobet ® /Taclonex ® ) in the treatment of psoriasis vulgaris
Author(s) -
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.
Publication year - 2006
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/j.1365-2133.2006.07236.x
Subject(s) - calcipotriol , medicine , betamethasone dipropionate , dermatology , psoriasis , betamethasone , adverse effect , randomized controlled trial , corticosteroid , odds ratio , confidence interval
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.