Table 1

Monitoring recommendations

Increased risk in RCTsDifficulties in interpreting results from RCTsIncreased risk in prospective cohort studiesStatus and relevance of AEFeasible method for monitoring purpose availableMonitoring advised
Adverse eventN/A, data not availablec, conflicting data; s, small numbers; e, endpoint inaccurately definedN/A, data not availablec (LE), clinical endpoint (life expectancy); c (QoL), clinical endpoint (quality of life); s, surrogate endpoint; b, biomarker–, not indicated; c, in clinical trials; d, in daily practice
 Electrolyte disturbancesN/ANobYesc
 EdemaNos ec (QoL)Yesc d
 Renal dysfunction (creatinine clearance)N/AN/AbYes
 Heart failureNos ec (LE, QoL)No
 HypertensionNoesYesc d (standard care)
 Ischemic CVD / atherosclerosisNosc (LE, QoL)Noc d (standard care)
 InfectionsPossiblyc ec (LE, QoL)Noc
 Peptic ulcer diseasePossiblyc sc (LE, QoL)Yesc d (standard care)
 PancreatitisN/AN/Ac (LE)Yes
 Mood disturbancesPossiblyc s ec (QoL)Noc
 PsychosisN/AYes*c (QoL)Noc
Endocrine & metabolic
 Diabetes / glucose intolerancePossiblyc esYesc d
 Body weight and fat redistributionPossiblycc (QoL)Yesc d (standard care)
 Interference with hormone secretionYess ebNoc
 Skin atrophyN/AN/Ac (QoL)Noc
 Acne, hirsutism, alopecia, bruisabilityNos ec (QoL)Yesc
Musculo skeletal
 Osteoporosis (BMD)Possiblyc esYesc d
 OsteonecrosisN/AYes*c (QoL)Noc
 MyopathyN/AYes*c (QoL)Noc
 CataractNos ec (QoL)Yesc
 Glaucoma (intra-ocular pressure)Yess esYesc d
  • * Data indicating that risk may be increased with high-dose glucocorticoid therapy.

  • The ‘increased risk’ columns describe the risk of occurrence for all adverse events (AEs). Preferably, data from randomised controlled trials (RCTs) were used. If lacking, data from prospective cohort studies were included. Difficulties in interpreting results from RCTs are mentioned. ‘Endpoint inaccurately defined’ means there are problems with the definition of an AE (eg, What is ‘diabetes’? Cut off values?). In case of ‘small numbers’ only a few studies (or: limited number of patients included) report an AE and therefore drawing firm conclusions is impossible. ‘Conflicting data’ mean that different studies show opposite outcomes on occurrence of an AE. The relevance of AEs is split in three different levels. A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes or pharmacologic responses to a therapeutic intervention. A surrogate endpoint is a biomarker intended to substitute for a clinical endpoint, that is, a biomarker that is expected to predict presence or lack of clinical benefit or harm. A clinical endpoint is a characteristic or variable that reflects how a patient feels or functions (QoL, quality of life), or how long a patient survives (LE, life expectancy).

  • AE, adverse event; BMD, bone mineral density; CVD, cardiovascular disease; RCT, randomised clinical trial.