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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

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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.
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Keywords: betamethasone dipropionate; calcipotriol; psoriasis; randomized controlled trial; safety; two-compound product

Document Type: Research Article

Affiliations: 1: Hudlegekontoret, Sandvika, Norway 2: St James's Hospital, Dublin, Ireland 3: LEO Pharma, Princes Risborough HP27 9RR, U.K. 4: Université de Liège, Liège, Belgium 5: Hôpital Nord, Saint-Etienne, France 6: Perth Royal Infirmary, Perth, U.K. 7: Helsinki University Central Hospital, Helsinki, Finland 8: Hospital de Bellvitge, l'Hospitalet de Llobregat, Spain 9: University Hospital of Malmö, Malmö, Sweden 10: Dermadvances Research, Winnipeg, Canada 11: University Hospital Carl-Gustav-Carus, Dresden, Germany

Publication date: 01 June 2006

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