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

J Drugs Dermatol. 2010 Aug;9(8):969-74.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Aged
  • Betamethasone / administration & dosage
  • Betamethasone / adverse effects
  • Betamethasone / analogs & derivatives*
  • Betamethasone / therapeutic use
  • Calcitriol / administration & dosage
  • Calcitriol / adverse effects
  • Calcitriol / analogs & derivatives*
  • Calcitriol / therapeutic use
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects*
  • Dermatologic Agents / 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
  • Psoriasis / physiopathology
  • Time Factors
  • Young Adult

Substances

  • Dermatologic Agents
  • Drug Combinations
  • Ointments
  • betamethasone dipropionate, calcipotriol drug combination
  • Betamethasone
  • Calcitriol