3.3.4. Adverse events
Serious adverse events were reported in both randomised trials. The
trial by Kasper et al reported 48/308 (15.6%) SAEs in the pregabalin
groups and 22/153 (14.4%) in the active control (lorazepam) (32). The
Kasper et al study also reported one death within the intervention
group, and it was not considered related to the study drug. (32) The
trial by McDonald et al reported SAEs resulting across all medicine
groups deprescribed and gabapentinoid specific SAEs are unclear. (31)
Serious adverse events were not reported from the observational studies.
(27, 28)
Adverse events were reported in both randomised trials. The Kasper et al
trial reported 242/308 (78.6%) AEs in the pregabalin groups and 115/153
(75.2%) in the active control (lorazepam) (29). The most common adverse
events being headache, dizziness and insomnia. (32) The other trial
reported the most common adverse events for the entire study cohort, and
did not specify gabapentinoid-specific adverse events. (31) Adverse
events were not reported in the observational studies. (27, 28)
Only one study reported adverse events that resulted in participant
withdrawal from the trial. (32) There were 50 adverse drug events that
resulted in withdrawal from the study. (32) Information regarding the
number and types of adverse events for the non-randomised controlled
trials was not reported. Adverse Drug Withdrawal Events were reported in
the study by McDonald, but gabapentinoid-related events are unclear.
Only one study reported details of rescue medicine use to manage
symptoms. (32) Rescue medicine was permitted in one study of a gradual
‘rescue taper’ (i.e. extending the two-week tapering period of the
participant’s allocated drug to four weeks) if participants experienced
severe discontinuation symptoms during tapering periods and up to seven
days afterwards. (32) A total of 39 (out of 615 randomised) participants
required the extended rescue taper (10 participants in the high-dose
(450 – 600 mg/d) pregabalin arm, 17 participants in the low-dose (150
– 300 mg/d) pregabalin arm, and 12 participants in the lorazepam
control arm). (32)