Comparative Efficacy and Tolerability of Immediate-Release Clozapine (AZALEPTIN®) and Extended Release Clozapine (Azaleptin® Retard) in Patients with Schizophrenia Resistant to Antipsychotic Therapy
- A.E. Aliforenko
, - V.A. Khazanov,
- Valentin Vladimirovich Larchenko,
- V.V. Bykov,
- P.D. Yudina,
- A.A. Demyanova
Abstract
Background. Clozapine therapy is the only effective treatment for patients with schizophrenia resistant to other antipsychotics. This article presents the results of the clinical trial (phase III) of a new dosage form of clozapine (Azaleptin® retard).
Aim — to compare the efficacy and safety of therapy with Azaleptin® retard and AZALEPTIN® in patients with schizophrenia.
Materials and methods. A clinical study was conducted involving 261 patients with therapy-resistant schizophrenia aged 18 to 60 years (mean age 40.12 ± 9.44 years). The therapeutic dose of Azaleptin® retard was 200 mg once daily, the dose of AZALEPTIN® was 100 mg twice daily. The duration of the therapy course was 26 weeks. The efficacy of therapy was assessed by PANSS, CGI-S and CGI-I scales before the start of therapy and by the end of the 4th, 8th, 12th, 18th, 22nd and 26th weeks. The safety of therapy was assessed by registration of adverse events and serious adverse events.
Results. The compared drugs AZALEPTIN® and Azaleptin® retard have equal efficacy: they reduce the severity of general psychotic symptoms in patients with treatment-resistant schizophrenia to the same extent (95 % confidence intervals for the mean change in scores on the PANSS, CGI-S and CGI-I scales do not exceed the limits of “non-inferiority”). Different dosing regimens of clozapine drugs do not affect the safety of patient therapy.
Conclusion. The obtained data indicate the possibility of switching patients with schizophrenia from therapy with AZALEPTIN® to Azaleptin® retard, taking into account the advantage of a single controlled administration of the drug.
Keywords
treatment-resistant schizophrenia, atypical neuroleptics, clozapine, AZALEPTIN®, Azaleptin® retard
Author Biography
A.E. Aliforenko
Clinical Research Specialist, Medical Department, IPHAR LLC
V.A. Khazanov
MD, Professor, General Director, IPHAR LLC
Valentin Vladimirovich Larchenko
PhD, Deputy General Director for Clinical Work, Head of Medical Department, IPHAR LLC; Associate Professor of the Department of Propaedeutics of Internal Diseases with a Course of Therapy, Paediatric Faculty, Siberian State Medical University
V.V. Bykov
PhD, Head of Pharmaceutical Development Department, IPHAR LLC; Senior Lecturer, Department of Pharmacology, Siberian State Medical University
P.D. Yudina
Biostatistician of the Pharmacokinetic Research Group of the Medical Department, IPHAR LLC, Postgraduate Student of the Department of Pharmacology, Siberian State Medical University
A.A. Demyanova
Monitoring Specialist, Medical Department, IPHAR LLC
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