Implementation of pre-seasonal sublingual immunotherapy with a five-grass pollen tablet during optimal dosage assessment.

BACKGROUND: The optimal dose (300IR) of a five-grass pollen sublingual immunotherapy tablet in terms of efficacy was previously demonstrated from the first pollen season. OBJECTIVE: Here, we aim to confirm whether this dose remained optimal during the peak of the pollen season by assessing the efficacy and quality of life data. METHODS: A total of 628 subjects with grass pollen rhinoconjunctivitis were randomized in a double-blind, placebo-controlled, multi-centre, pan-European trial. Subjects received once-daily tablets (Stallergenes, Antony, France) of 100IR, 300IR, 500IR or placebo, starting 4 months before and throughout the 2005 grass pollen season. The pollen season was defined as the first day of 3 consecutive days with a grass pollen count above 30 grains/m(3) of air, recorded using Hirst-type volumetric pollen traps, to the last day before 3 consecutive days with a pollen count below 30 grains/m(3). RESULTS: The grass pollen season lasted an average of 30 days, with a peak of 12 days. The mean treatment duration before the grass pollen season was similar in the four treatment groups (121.4+/-31.1 to 128.6+/-15.4 days in the safety population). Both the 300IR and 500IR groups had highly significant improvements in Rhinoconjunctivitis Total Symptom Score (RTSS) vs. placebo at the peak pollen season (P=0.0005 and 0.0014, respectively), which agreed with improvements in RTSS in the primary evaluations. The average RTSS scores were slightly elevated during the peak pollen season in all treatment groups. The overall Rhinoconjunctivitis Quality of Life Questionnaire score confirmed the optimal dosage 300IR at peak (P<0.0001) and at the end (P< or =0.0031) of the pollen season. All doses were well tolerated. CONCLUSION: At the peak pollen season, the efficacy and quality of life data for both 300IR and 500IR groups was significantly improved vs. the placebo group. These results confirm the conclusions of the primary evaluations and validate the use of 300IR tablets for clinical practice.

Economic evaluation of Nootropil in the treatment of acute stroke in France.

The primary objective of this study was to investigate the economic impact of treatment of acute ischaemic stroke with piracetam vs placebo according to the societal perspective in France. Socio-demographic, clinical and resource utilisation data for piracetam and placebo patients during the acute phase following stroke was obtained from the Piracetam Acute Stroke Study (PASS) clinical trial database. The economic analysis was based on the population defined as being treated within 6 h 59 min following stroke and presenting an initial Orgogozo score of less than 55. Resource utilisation data concerning the rehabilitation phase, outpatient follow-up and institutionalisation was obtained from decision tree analysis. There was a higher percentage of autonomous patients in the piracetam group (27.8%) compared to placebo (22.9%). The mean duration of hospitalisation (autonomous 21.8 days; non-autonomous 30.3 days) and the cost of an autonomous patient was lower than a non-autonomous patient. The total cost per stroke patient receiving piracetam was estimated at 103 KF during the 6-month period, compared to 106 KF per placebo patient. The major cost driver was hospitalisation during the acute phase, representing approximately 50% of the total cost per patient. In patients with moderate to severe stroke treated within 6.59 h, piracetam was cost-effective compared to placebo over the 6-month study period.