Assessment of tolerability in elderly patients: changing to lamotrigine therapy.
BACKGROUND
Of all age groups, adults older than 75 years have the highest risk of seizures, especially partial seizures. In the past, physicians commonly used phenytoin, carbamazepine, and valproic acid as antiepileptic drugs (AEDs) in the elderly. However, these AEDs have potential adverse effects and drug interactions that may make them less desirable than newer AEDs for this age group.


OBJECTIVE
The primary objective of this study was to assess the effects of changing the AED regimen to lamotrigine (LTG) in elderly patients (aged >or=60 years) who were initially unsatisfied with their drug regimen because of adverse effects or continuing seizures. These patients comprised a subgroup from a multicenter, open-label trial of partial-seizure patients who switched to LTG. Other objectives included assessing the change in quality of life in patients taking LTG as adjunctive therapy and as monotherapy, and evaluating the efficacy of LTG for seizures when used as adjunctive treatment and as monotherapy.


METHODS
The study involved 2 phases: LTG was first added to the regimen, and then patients could change to LTG monotherapy. Tolerability, the primary end point, was assessed using the Liverpool Adverse Experience Profile (AEP). Secondary end points included quality of life, as measured with the Quality of Life in Epilepsy-31 inventory, investigator global assessment, patient's self-rated satisfaction with treatment, and Profile of Mood States. The proportion of patients who completed each phase with at least a 50% reduction in seizures from baseline and the proportion of patients remaining seizure free throughout each phase were also determined.


RESULTS
Sixty-two patients aged >or=60 years (mean [SD]age, 71.3 [7.6] years; 31 men, 31 women) were enrolled. After adding LTG, older patients reported fewer adverse effects, improved mood, better quality of life, and fewer seizures. Changing to LTG as monotherapy produced further improvement in all measurements. For the primary end point, mean improvement in AEP scores from baseline was 2.3 at the end of the adjunctive therapy phase (P = 0.027) and 5.7 by the end of the monotherapy phase (P < 0.005). In addition, there was a mean improvement of 2.0 in the AEP score from the adjunctive therapy to the monotherapy phase.


CONCLUSIONS
For older patients with seizures who were unhappy with their AED regimen because of adverse effects, continuing seizures, or both, adding LTG to the drug regimen was associated with improved tolerability and effectiveness, and switching to LTG monotherapy was associated with further improvement.
Evans
Bradley K
BK
Northern Michigan Neurology, Traverse City, Michigan 49684-2340, USA. bradevans@charter.net
Kustra
Robert P
RP
Hammer
Anne E
AE
D000339:Affect / Q000187:drug effects; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004827:Epilepsy / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D000077213:Lamotrigine; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D014227:Triazines / Q000009:adverse effects* / Q000627:therapeutic use*
D000927:Anticonvulsants; D014227:Triazines; D000077213:Lamotrigine