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1. Safety and efficacy of combined high-dose treatment with calcipotriol ointment and solution in patients with psoriasis

Author

Peter E. Hutchinson, D.M. Tillman, F.G. Larsen, C. Green, K.J. Hamberg, C.S. Munro, P. Kidson, Knud Kragballe, P.C.M. van de Kerkhof, and J.K. Jensen

Subjects
Adult, Male, medicine.medical_specialty, Calcitriol, medicine.medical_treatment, Administration, Topical, Dermatology, Severity of Illness Index, law.invention, Ointments, chemistry.chemical_compound, Pharmacotherapy, Randomized controlled trial, law, Psoriasis, Medicine, Humans, Calcipotriol, Aged, Probability, Chemotherapy, Analysis of Variance, Dose-Response Relationship, Drug, business.industry, Epidermal differentiation and cutaneous inflammation, Anthralin, Middle Aged, medicine.disease, Surgery, Clinical trial, Solutions, medicine.anatomical_structure, Treatment Outcome, chemistry, Scalp, Epidermale differentiatie en cutane ontstekingsprocessen, Drug Therapy, Combination, Female, business, medicine.drug, Follow-Up Studies
Abstract

Background: In the vast majority of psoriatic patients, psoriatic lesions are localised on the body as well as on the scalp. Therefore, safety data on the combined use of calcipotriol in lotion and calcipotriol in ointment are needed. Objective: This study investigated the effect of high-dose treatment with a combination of calcipotriol ointment and scalp solution on calcium metabolism, indices of bone turnover and PASI in patients with extensive psoriasis. Methods: Following a 2-week wash-out period, 88 patients were randomised to 4 weeks of treatment with either calcipotriol ointment/scalp solution (80–100 g/week and 30–50 ml/week, respectively; n = 41) or with a dithranol/tar regimen (n = 47). Patients were seen at weeks 1, 2 and 4 during treatment and 1 week following cessation of treatment. Results: No significant differences at the end of treatment were found between the 2 groups with respect to 24-hour urinary excretion of calcium (expressed as calcium/creatinine ratio), phosphate or pyridinoline, serum concentrations of calcium (albumin corrected), creatinine, phosphate, parathyroid hormone, 25-hydroxyvitamin D3, 1,25-dihydroxyvitamin D3, osteocalcin, alkaline phosphatase (total and bone-specific iso-enzymes) or 1-collagen telopeptide. At the end of treatment, the psoriasis area and severity index had decreased by 57.4% in the calcipotriol group and by 36.1% in the dithranol/tar group (p = 0.004). Investigators’ and patients’ assessments of overall efficacy also favoured treatment with calcipotriol (p < 0.001). Conclusion: The combined use of calcipotriol ointment/scalp solution did not affect the indices of calcium metabolism or bone turnover and was significantly more effective than dithranol/tar in reducing disease severity and extent in patients with extensive psoriasis.

Published
2002

2. Effects of Seocalcitol (EB1089) on Nitrosomethyl Urea-Induced Rat Mammary Tumors.

Author

K.W. Colston, G. Pirianov, E. Bramm, K.J. Hamberg, and L. Binderup

Abstract

Although 1,25-dihydroxyvitamin D3 is a potent cell-differentiating agent, its use in cancer prevention or therapy is precluded because it induces hypercalcemia. Synthetic analogs have been developed which inhibit tumor progression in animal models of breast cancer. One analog, Seocalcitol (EB1089) has been shown to be effective in causing regression of N-methyl-nitrosourea-induced rat mammary tumors. However, at the most effective oral dose, a significant increase in serum and urinary calcium levels were observed. In order to compare the efficacy of different dosing schedules of Seocalcitol, rats were treated either 6 times weekly (1 µg/kg) or by intermittent dosing to achieve the same total weekly dose. All dosing schedules of Seocalcitol were effective in inhibiting tumor progression. Once daily dosing was significantly more effective than intermittent dosing but was associated with a greater rise in serum calcium concentration. In order to evaluate alternative treatment strategies to limit calcemic effects, we assessed the efficacy of limiting vitamin D-induced hypercalcemia using bisphosphonates. Seocalcitol (2.5 µg/kg daily p.o. for 4 weeks) alone and in combination with pamidronate (APD 0.4 mg/kg per day s.c.) or the same dose of the bisphosphonate EB1053 caused substantial tumor regression. No statistically significant difference was seen between combination treatment and Seocalcitol treatment alone. Co-treatment with APD or EB1053 did not limit the rise in serum calcium induced by Seocalcitol alone. Cessation of treatment or administration of a lower dose (1 µg/kg twice weekly) reversed hypercalcemia, hypercalciuria and weight loss induced by high dose Seocalcitol. However, reduction in tumor volume was maintained in the majority of animals. [ABSTRACT FROM AUTHOR]

Published
2003

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