Prednisolone – systemic use

Additional information

Pharmacokinetics and dosing

Prednisolone pharmacokinetics was investigated in healthy white and black men and women (16 men, 16 women) receiving a single oral dose 0.27 mg/kg of prednisone (precursor to prednisolone). Clearance of free prednisolone normalized for bodyweight was higher in men than women, regardless of race [4]. Contrary to this, another smaller study (4 men, 4 women) observed a higher total and free clearance in women after receiving prednisolone 0.075-1.5 mg/kg [5].

Effects

The response to prednisolone in children with infantile spasms has been evaluated (34 boys, 16 girls). Treatment with prednisolone was initiated at 2 mg/kg/day at lasted for maximum 6 weeks. Male sex was the only factor associated with favorable response [6].

A randomized controlled trial compared the efficacy of two different long-course treatment doses of prednisolone in children with idiopathic nephrotic syndrome (42 boys, 26 girls; age 1.5-14.4 years). Boys receiving the higher dose had higher rates of sustained remission than boys receiving the lower dose, especially for boys 4 years or older. No difference between treatments was observed for girls. The authors suggest that older boys may have a greater benefit if receiving higher initial prednisolone dose [7].

Oral prednisolone (0.6 mg/kg) to patients with COPD for two weeks before randomized treatment with fluticasone or placebo (407 men, 117 women) increased FEV1 (forced expiratory volume in 1 second) to a similar extent in men and women [8].

The efficacy of oral prednisolone in children with infantile hemangioma given 3 mg/kg/day for 1 month was similar in both boys and girls (6 boys, 19 girls) [9].

Adverse events

A large meta-analysis of corticosteroid-induced osteoporosis in adults showed that oral corticosteroid treatment with doses above 5 mg/day (of prednisolone or equivalent) reduced bone mineral density and increased the risk of fracture during treatment, irrespective of age, sex, or underlying disease (66 studies with 2891 patients with BMD measures, 71.5% women and 23 studies with 558 with fractures in corticosteroid users, and 244 235 corticosteroid users with fractures in the General Practice Research Database) [1]. However, a study not included in the meta-analysis, retrospectively analyzed the population attributable risk of fracture in a cohort using oral corticosteroids (8192 men, 12034 women). Compared to the general population, corticosteroids users had a higher risk of fracture (RR 1.90), and women had a higher risk than men (RR 2.13) [2]. Another meta-analysis of glucocorticoid therapy in children (in total 287 patients with BMD measure, and 37 819 with fractures) showed corticosteroid use to be associated with reduced spine bone mineral density and no sex difference in the risk for fracture were seen [3]. Several studies have shown that women using glucocorticoids report adverse events more frequently than men. An online questionnaire about glucocorticoid-induced adverse events showed that women reported more adverse events (211 men, 609 women). Most patients were on treatment with prednisone (59%) or prednisolone (32%). Patients taking prednisolone reported less adverse events than those taking prednisone [10]. More adverse events were also reported by women treated with oral prednisolone for Graves’ Orbitopathy, in a randomized single-blind trial (21 men, 49 women) [11].

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).