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Prednisolon – systemiskt

Klassificering: A

Preparat: Pediapred, Precortalon® aquosum, Prednisolon Actavis, Prednisolon Alternova, Prednisolon APL, Prednisolon Ebb, Prednisolon EQL Pharma, Prednisolon JENAPHARM, Prednisolon Pfizer, Prednisolon Pilum, Prednisolone Sodium Phosphate, Solu-Decortin

ATC kod: H02AB06

Sammanfattning

En liten studie på infantil spasm visade något bättre effekt hos pojkar. I en studie på idiopatiskt nefrotiskt syndrom hade pojkar över 4 år bättre effekt av högre initialdos prednisolon.

Vår bedömning är att de beskrivna skillnaderna i nuläget inte motiverar olika dosering eller behandling beroende på kön.

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 effects

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 the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Försäljning på recept

Fler kvinnor än män hämtade ut läkemedel innehållande prednisolon (ATC-kod H02AB06) på recept i Sverige år 2015, totalt 140 121 kvinnor och 103 238 män. Det motsvarar 29 respektive 21 personer per tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. I åldersgruppen 0-9 år var läkemedel innehållande prednisolon i genomsnitt 1,3 gånger vanligare hos pojkar och i åldersgruppen 10 år och äldre i genomsnitt 1,3 gånger vanligare hos flickor/kvinnor [12].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2017-01-17

Referenser

  1. van Staa TP, Leufkens HG, Cooper C. The epidemiology of corticosteroid-induced osteoporosis: a meta-analysis. Osteoporos Int. 2002;13:777-87. PubMed
  2. Donnan PT, Libby G, Boyter AC, Thompson P. The population risk of fractures attributable to oral corticosteroids. Pharmacoepidemiol Drug Saf. 2005;14:177-86. PubMed
  3. Hansen KE, Kleker B, Safdar N, Bartels CM. A systematic review and meta-analysis of glucocorticoid-induced osteoporosis in children. Semin Arthritis Rheum. 2014;44:47-54. PubMed
  4. Magee MH, Blum RA, Lates CD, Jusko WJ. Prednisolone pharmacokinetics and pharmacodynamics in relation to sex and race. J Clin Pharmacol. 2001;41:1180-94. PubMed
  5. Meffin PJ, Brooks PM, Sallustio BC. Alterations in prednisolone disposition as a result of time of administration, gender and dose. Br J Clin Pharmacol. 1984;17:395-404. PubMed
  6. Noureen N, Rana MT. Clinical profile and response to oral prednisolone in infantile spasm. J Coll Physicians Surg Pak. 2010;20:186-9. PubMed
  7. Hiraoka M, Tsukahara H, Haruki S, Hayashi S, Takeda N, Miyagawa K et al. Older boys benefit from higher initial prednisolone therapy for nephrotic syndrome The West Japan Cooperative Study of Kidney Disease in Children. Kidney Int. 2000;58:1247-52. PubMed
  8. Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA. Prednisolone response in patients with chronic obstructive pulmonary disease: results from the ISOLDE study. Thorax. 2003;58:654-8. PubMed
  9. Greene AK, Couto RA. Oral prednisolone for infantile hemangioma: efficacy and safety using a standardized treatment protocol. Plast Reconstr Surg. 2011;128:743-52. PubMed
  10. Morin C, Fardet L. Systemic glucocorticoid therapy: risk factors for reported adverse events and beliefs about the drug A cross-sectional online survey of 820 patients. Clin Rheumatol. 2015;34:2119-26. PubMed
  11. Kahaly GJ, Pitz S, Hommel G, Dittmar M. Randomized, single blind trial of intravenous versus oral steroid monotherapy in Graves' orbitopathy. J Clin Endocrinol Metab. 2005;90:5234-40. PubMed
  12. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2017-01-26.] länk

Författare: Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler

Godkänt av: Karin Schenck-Gustafsson