title: Steroid withdrawal during 5 years following heart transplantation, and the relationship between steroid dosage at 1-year follow-up and complications during the next 2 years: results from the RESTCO study.
abstract: BACKGROUND
  Little information is available regarding the controversial issue of steroid withdrawal following heart transplantation (HT), or instead in the incidence of adverse steroid effects at dosages typically employed in Spain.
  
  
  METHODS
  We analyzed the 5-year follow-up records of 1209 patients (82.5% men, aged ≥ 18 years) who underwent HT between 2000 and 2005 and survived at least 1 month in 13 Spanish centers. The incidences of first steroid withdrawal before 1, 3, and 5 years post-HT were expressed as Kaplan-Meier probability estimates. Three patient groups defined in accordance with steroid dosage at 1-year follow-up (0, ≤ 5, and >5 mg/d; groups A, B, and C, respectively) were compared with regard to the incidence of de novo hypertension, diabetes, and bone fractures over the following 2 years.
  
  
  RESULTS
  The 5-year incidence of withdrawal was 28%, 21% of whom required reintroduction of steroids. Kaplan-Meier probabilities of withdrawal before 1, 3, and 5 years post-HT were 8.8% (95% confidence interval ([CI] 7.3%-10.7%), 27.8% (CI 25.2%-30.6%), and 30.2% (CI 27.5%-33.2%), respectively. At 1-year follow-up, 9.9% of patients were steroid-free, 28.9% were taking ≤ 5 mg/d, and 61.3% >5 mg/d. The 2-year incidence of de novo hypertension increased significantly (P = .012) from 13.5% to 29.6% to 35.3% in groups A, B, and C respectively. These groups did not differ significantly in regard to the 2-year incidence of diabetes or bone fractures.
  
  
  CONCLUSIONS
  Reintroduction of steroids was required by 21% of the 28% of Spanish HT patients who has been weaned from steroids within 5 years of HT. The incidence of de novo hypertension between 1 and 3 years post-HT increased with steroid dosage at 1-year follow-up. De novo diabetes and bone fractures showed no similar significant association.
authors.affiliation: Complejo Hospitalario, Universitario de A Coruña, A Coruña, Spain. marisa.crespo.leiro@sergas.es
authors.forename: M G
authors.initials: MG
authors.lastname: Crespo Leiro
authors.forename: L A
authors.initials: LA
authors.lastname: Bonet
authors.forename: M J
authors.initials: MJ
authors.lastname: Paniagua Martín
authors.forename: M
authors.initials: M
authors.lastname: Gómez Bueno
authors.forename: P
authors.initials: P
authors.lastname: Escribano
authors.forename: F
authors.initials: F
authors.lastname: González Vilchez
authors.forename: J L
authors.initials: JL
authors.lastname: Rodríguez Lambert
authors.forename: V
authors.initials: V
authors.lastname: Brossa Loidi
authors.forename: E
authors.initials: E
authors.lastname: Lage Gallé
authors.forename: J
authors.initials: J
authors.lastname: Delgado Jiménez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D003920:Diabetes Mellitus / Q000139:chemically induced / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D050723:Fractures, Bone / Q000139:chemically induced / Q000453:epidemiology; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control*; D006085:Graft Survival / Q000187:drug effects*; D016027:Heart Transplantation / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D006973:Hypertension / Q000139:chemically induced / Q000453:epidemiology; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D013030:Spain / Q000453:epidemiology; D013256:Steroids / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D013256:Steroids