Abstracts

Rationale: Levetiracetam (LEV) has been formulated as an oral solution. The SOLUTION Study (N01242) was designed to determine the degree of patient acceptability of LEV oral solution, to evaluate the relationship between its acceptability and treatment compliance, to determine patient preference over any previous antiepileptic drug (AED) and to assess its tolerability.Methods: Transversal study in patients (age ≥16 yrs) with partial seizures (with/without secondary generalisation). For inclusion, patients must have been prescribed LEV oral solution according to usual practice and received it for ≥28 days; they also had to understand/complete the study questionnaire. Patients with altered taste/smell perception were excluded. Study consisted of a questionnaire assessing overall acceptability of LEV oral solution and specific items relating to organoleptic characteristics (evaluation of taste, intensity of taste, aftertaste) and aspects of use (ease of use, convenience). Acceptability was correlated with each of these 5 items and also with treatment compliance; patient preference for LEV oral solution over any previous AED was investigated. Tolerability was assessed by evaluating adverse events (AEs). Results: 389 patients were included (51%F/49%M; mean±SD age 47.5±19.0 [range 13-83] yrs); 92.8% (361/389) were evaluable for acceptability and 100% (389/389) for tolerability. Mean±SD LEV oral solution dose was 1235.4±625.3 (range 100-3000) mg/day; mean±SD treatment duration was 2.10±2.42 (range 0.03-24) months. Overall, 65.3% patients rated LEV oral solution as “very acceptable” or “acceptable”; 23.3% were “indifferent”; 11.3% rated it as “unacceptable” or “very unacceptable”. There were no acceptability differences based on sex, age, epilepsy onset, or treatment duration. For taste evaluation, 41.5% patients responded “very pleasant” or “pleasant” and 39.9% “neither pleasant nor unpleasant”. For taste intensity, 54.3% patients responded “neither strong nor mild” and 20.8% “mild” or “very mild”. 54.3% patients indicated that LEV oral solution left an aftertaste, of these, 70.5% stated it “did not bother them”. 75.4% rated it as “very easy” or “easy” to use. 61.7% rated it as “very convenient” or “convenient” to use and 17.7% as “neither convenient nor inconvenient”. Degree of acceptability was significantly correlated with each of the 5 items studied (Chi-square test: p<0.0001). 52.7% patients “strongly agreed” or “agreed” that LEV oral solution helped them comply with treatment; 32.7% were “undecided” and 14.6% “disagreed” or “strongly disagreed”. Of the patients who received another AED before LEV oral solution and specified a preference (n=176), 72.2% preferred LEV oral solution. LEV oral solution was well tolerated. 10% (39/389) patients reported a total of 53 treatment-related AEs; the most frequently reported were drowsiness, nausea and dizziness.Conclusions: LEV oral solution demonstrated a high degree of patient acceptability, which in the majority of patients resulted in greater treatment and patient compliance over any previous AED. LEV oral solution was well tolerated. UCB Funded.