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Short- and long-term safety assessment of a two-compound ointment containing calcipotriene/betamethasone dipropionate (Taclonex/Daivobet/Dovobet ointment): hypothalamic-pituitary-adrenal axis function in patients with psoriasis vulgaris.

Abstract
The two-compound ointment (Taclonex/Daivobet/Dovobet ointment) combining calcipotriene 50 microg/g and betamethasone 0.5 mg/g (as dipropionate) is very effective in the treatment of psoriasis vulgaris. There is a possibility that hypothalamo-pituitary-axis (HPA) suppression may occur if the potent corticosteroid component is absorbed to a sufficient extent. The effect of the two-compound ointment on HPA axis function was assessed in two studies. Study 1 was a four-week, double-blind study which compared the effects of the two-compound ointment with betamethasone 0.5 mg/g (as dipropionate; Diprosone) ointment in 24 patients with extensive psoriasis (involving 15-30% of the body surface area). No patients receiving the two-compound ointment had HPA axis suppression. Study 2 assessed HPA axis function after four and 52 weeks in a subset of patients (n = 19) participating in a long-term safety study. Patients were treated with the two-compound ointment for the first four weeks followed by 48 weeks of treatment as needed with either 1) two-compound ointment; 2) two-compound ointment alternating with calcipotriene four-weekly or 3) calcipotriene. No patients using the two-compound ointment for all 52 weeks or alternating four-weekly with calcipotriene had HPA axis suppression.
AuthorsColin Fleming, Cecilia Ganslandt, Graham P Leese
JournalJournal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 9 Issue 8 Pg. 969-74 (Aug 2010) ISSN: 1545-9616 [Print] United States
PMID20684147 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Dermatologic Agents
  • Drug Combinations
  • Ointments
  • betamethasone dipropionate, calcipotriol drug combination
  • Betamethasone
  • Calcitriol
Topics
  • Administration, Cutaneous
  • Adult
  • Aged
  • Betamethasone (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Calcitriol (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Dermatologic Agents (administration & dosage, adverse effects, therapeutic use)
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Hypothalamo-Hypophyseal System (drug effects)
  • Male
  • Middle Aged
  • Ointments
  • Pituitary-Adrenal System (drug effects)
  • Prospective Studies
  • Psoriasis (drug therapy, physiopathology)
  • Time Factors
  • Young Adult

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