Quantitative benefit-risk assessment of methylprednisolone in multiple sclerosis relapses

BMC Neurology

Table 4 Upper risk limits computed for the various combinations of serious adverse effects and outcomes

Adverse effect	Outcome	Upper risk limit (%)
		Low-dose methylprednisolone	High-dose methylprednisolone
Acute severe allergy	Lethal	0.24	0.00^a
Acute severe allergy	Life-threatening	2.65	1.18
Cardio-pulmonary distress	Lethal	0.33	0.79
	Persistent	0.02	0.39
	Life-threatening	0.86	1.71
Diabetes	Lethal	0.02	0.53
	Persistent	0.86	1.05
	Life-threatening	0.07	0.13
Gastrointestinal haemorrhage	Lethal	0.26	0.39
	Persistent	0.13	0.13
	Life-threatening	0.37	0.79
Hepatotoxicity	Lethal	0.11	0.13
	Persistent	0.11	0.53
	Life-threatening	0.29	0.66
Myopathy	Persistent	0.46	0.79
Myopathy	Life-threatening	0.07	0.13
Osteonecrosis^b	Persistent	0.57	1.58
Pancreatitis	Lethal	0.04	0.13
Psychosis	Persistent	0.04	0.13
Psychosis	Life-threatening	0.07	0.13
Seizure	Lethal	0.09	0.39
	Persistent	0.13	0.00^a
	Life-threatening	0.13	0.13
Ventricular arrhythmia/cardiac arrest	Lethal	0.55	1.05
	Persistent	0.09	0.13
	Life-threatening	0.86	1.18
Total^c	Lethal	1.65	3.42
	Persistent	2.43	4.73
	Life-threatening	5.36	6.04

^a This clearly is not an upper limit; therefore, in the analyses the corresponding limits for low-dose methylprednisolone are used
^b No requirement on the reported time to onset, due to the difficulties in diagnosing osteonecrosis
^c The grand total for all three outcomes is 9.44 and 14.19 % for low-dose and high-dose methylprednisolone, respectively, based on a plain summation conforming to the structure of the model, where the effects are considered to be mutually exclusive. If one instead assumes that they are independent, the total risks of experiencing any of the effects are 9.07 and 13.34 %, respectively

ISSN: 1471-2377