ATC code: H02AB04
Large controlled studies on sex differences in the mineral corticoid effect of methylprednisolone are lacking.
A large meta-analysis have shown that high daily doses of oral glucocorticoids increase the risk of bone fractures to a similar degree in men and women, regardless of age and underlying disease. However, another large population-based study found a higher risk of fracture in women than men exposed to oral corticosteroids.
In our opinion, the described differences do not motivate differentiated dosing or treatment in men and women.
Pharmacokinetics of methylprednisolone was studied in healthy adults (6 men, 6 women) receiving a dose of 0.6 mg/kg ideal body weight. Clearance was 55% higher in women when corrected for body weight. Women received methylprednisolone during the luteal phase of the menstrual cycle [1]. A study in 13 premenopausal women undergoing renal transplantation observed no sex difference in clearance normalized for body weight when comparing the data to data of their men (18 men) [4].
Women had lower inhibitory concentration (IC50), meaning women needed less concentration of methylprednisolone than men to produce 50% suppression of cortisol secretion [5].
In patients with septic shock (125 men, 75 women), the effect of hydrocortisone was compared to methylprednisolone. Patients received either hydrocortisone i.v. 50 mg every 6 h or methylprednisolone 20 mg every 12 h, for 7 days. The two treatment groups were similar in terms of survival rates and time to reverse. There were no differences between men or women [6].
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].In a study of individuals with chronic low back pain (14 men, 14 women), receiving cumulative methylprednisolone doses of at least 3 g, did not find a relationship between dose and BMD outcome in men or women [7].
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Updated: 2020-08-28
Date of litterature search: 2017-02-02
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson