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.
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.
Fleming
Colin
C
Ninewells Hospital and Medical School, Dundee, United Kingdom.
Ganslandt
Cecilia
C
Leese
Graham P
GP
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D001623:Betamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009824:Ointments; D010913:Pituitary-Adrenal System / Q000187:drug effects*; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy / Q000503:physiopathology; D013997:Time Factors; D055815:Young Adult
D003879:Dermatologic Agents; D004338:Drug Combinations; D009824:Ointments; C517164:betamethasone dipropionate, calcipotriol drug combination; D001623:Betamethasone; D002117:Calcitriol