Monitoring recommendations
| Increased risk in RCTs | Difficulties in interpreting results from RCTs | Increased risk in prospective cohort studies | Status and relevance of AE | Feasible method for monitoring purpose available | Monitoring advised | |
|---|---|---|---|---|---|---|
| Adverse event | N/A, data not available | c, conflicting data; s, small numbers; e, endpoint inaccurately defined | N/A, data not available | c (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 | |
| Cardiovascular | ||||||
| Dyslipidemia | No | e | – | s | Yes | c |
| Electrolyte disturbances | N/A | – | No | b | Yes | c |
| Edema | No | s e | – | c (QoL) | Yes | c d |
| Renal dysfunction (creatinine clearance) | N/A | – | N/A | b | Yes | – |
| Heart failure | No | s e | – | c (LE, QoL) | No | – |
| Hypertension | No | e | – | s | Yes | c d (standard care) |
| Ischemic CVD / atherosclerosis | No | s | – | c (LE, QoL) | No | c d (standard care) |
| Infectious | ||||||
| Infections | Possibly | c e | – | c (LE, QoL) | No | c |
| Gastro-intestinal | ||||||
| Peptic ulcer disease | Possibly | c s | – | c (LE, QoL) | Yes | c d (standard care) |
| Pancreatitis | N/A | – | N/A | c (LE) | Yes | – |
| Psychological | ||||||
| Mood disturbances | Possibly | c s e | – | c (QoL) | No | c |
| Psychosis | N/A | – | Yes* | c (QoL) | No | c |
| Endocrine & metabolic | ||||||
| Diabetes / glucose intolerance | Possibly | c e | – | s | Yes | c d |
| Body weight and fat redistribution | Possibly | c | – | c (QoL) | Yes | c d (standard care) |
| Interference with hormone secretion | Yes | s e | – | b | No | c |
| Dermatological | ||||||
| Skin atrophy | N/A | – | N/A | c (QoL) | No | c |
| Acne, hirsutism, alopecia, bruisability | No | s e | – | c (QoL) | Yes | c |
| Musculo skeletal | ||||||
| Osteoporosis (BMD) | Possibly | c e | – | s | Yes | c d |
| Osteonecrosis | N/A | – | Yes* | c (QoL) | No | c |
| Myopathy | N/A | – | Yes* | c (QoL) | No | c |
| Ophthalmological | ||||||
| Cataract | No | s e | – | c (QoL) | Yes | c |
| Glaucoma (intra-ocular pressure) | Yes | s e | – | s | Yes | c 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.