Search

Mirtazapine is an established antidepressant with well-documented efficacy demonstrated in controlled clinical trials. However, the gap between the results obtained in controlled clinical trials and everyday clinical practice exists. Therefore, the importance of naturalistic studies in psychiatry is becoming recognized. The aim of present naturalistic study was to acquire data on efficacy, safety, and preference of mirtazapine orally disintegrating tablets during a 17-week treatment of depression. This prospective, open-label, multicenter study in patients with mild to severe depression was conducted at 47 mental health centers of Lithuania by 78 psychiatrists. Patients were initially given 15 mg or 30 mg of mirtazapine orally disintegrating tablets; the maximum allowed dose was 45 mg per day. The primary efficacy measure was the total score on the Hamilton Depression Rating Scale-17 (HAMD-17), the Clinical Global Impression-Severity (CGI-S), and Clinical Global Impression-Improvement (CGI-I) scales. Tolerability was primarily measured by assessing the incidence of treatment-emergent adverse events. Patients were evaluated at baseline, at weeks 1, 5, 9, 13, and 17. A total of 779 patients (595 women [76.4%] with a mean [SD] age of 50.2 [13.65] and 184 men [23.6%] with a mean [SD] age of 52.4 [14.6] years) were enrolled into the study; 687 (88.2%) patients completed the study. The mean (SD) daily dose of mirtazapine orally disintegrating tablets was 29.0 (3.8) mg. The mean total (SD) HAMD-17 score improved significantly from 25.7 (4.6) to 7.3 (4.3) (P<0.005). At each visit, the mean HAMD-17 score was significantly lower than that at the preceding visit. At week 17, remission (HAMD-17 score < or =7) was observed in 436 (56%) patients. The mean (SD) CGI-S score improved significantly from 4.9 (1.0) at baseline to 1.5 (0.6) at endpoint (P<0.001). According to the CGI-I assessments, 621 patients (89.4%) improved and improved very much. The vast majority of patients (80%) preferred the new formulation of mirtazapine - mirtazapine orally disintegrating tablet. Treatment-emergent adverse events occurred in 106 patients (13.6%). The most frequent adverse events were weight gain, sedation, dizziness, and dry mouth. In this study conducted in Lithuania with depressed patients, a significant improvement was shown in all efficacy measures. In addition, mirtazapine orally disintegrating tablet was a well-tolerated and preferable formulation for the treatment of depressed patients.

As many as 60% of the patients do not follow the therapy recommended by their physicians. An important factor that can influence patient's compliance is the physician's opinion about the tolerability and safety of prescribed medication. However, the efforts of both parties, not only physician but also patient, have benefits on the outcome of treatment. Patient's opinion on choosing the form of medication is appropriate way ensuring better compliance. The aim of the survey was to ascertain the opinion of depressed patients towards a new formulation of antidepressant drug, mirtazapine - orally disintegrating tablet Remeron SolTab. The study was approved by Lithuanian State Medicines Control Agency and local Ethics Committee. A total of 453 depressed patients were included in the survey. Most of the patients used a 30-mg dose of Remeron SolTab (n=344, 75.88%). Most of the patients (n=189, 41.81%) had a positive opinion about the taste of medication ("very pleasant"). According to the results of the survey, 281 (61.95%) used Remeron SolTab regularly. However, 129 (28.54%) patients noted that the new drug formulation had no influence on the regularity of use. Statistically significantly more patients (81.86%) noted that they would choose Remeron SolTab compared to the patients who would prefer conventional form of the medication (2.21%). In 184 (40.71%) patients, a significant mood improvement was noted. Most of the patients (n=246, 54.20%) indicated that mood improved. Based on the results of the survey it can be concluded that patient will prefer the drug (or its new formulation) he/she liked and thus will follow physician's instructions and cooperate with physician more closely. A limitation of this study relates to the study design and questionnaire itself, since it was not validated in appropriate way. However, the results of the survey are in line with the results of the similar surveys from other countries and reflect the general tendencies towards antidepressant use.