ABSTRACT
AIM: To prove the equivalent efficacy of teberif (BCD-033, interferon beta-1) and rebif (interferon beta-1a) in patients with remitting multiple sclerosis (RMS). MATERIAL AND METHODS: A multicenter double blind placebo-controlled comparative randomized III phase study included 163 patients with RMS. Patients were randomized into three equal groups (teberif, rebif or placebo). RESULTS AND CONCLUSION: After 52 weeks, the equivalent efficacy of teberif and the brand drug rebif was shown. The result of assessment of the primary endpoint, which was combined unique active (CUA) lesion (the total of MRI T1-weighted lesions and new or newly enlarging T2-weighted lesions, without double counting of lesions with both activities), showed no significant differences (0.727±1.042 and 0.652±1.059 (p=0.7354, t-Student test) in the teberif and rebif groups, respectively. No between-group differences were found for other MRI indices and clinical parameters related with relapses. Teberif was shown to have a favorable safety and tolerability profile comparable to that of rebif. The results suggest the therapeutic equivalency of the drugs and form the basis for using the bioanalogue of interferon-beta 1 in patients with RMS.
Subject(s)
Multiple Sclerosis, Relapsing-Remitting , Adjuvants, Immunologic , Double-Blind Method , Humans , Injections, Subcutaneous , Interferon beta-1a/administration & dosage , Magnetic Resonance Imaging , Multiple Sclerosis, Relapsing-Remitting/drug therapySubject(s)
Acetamides/therapeutic use , Depressive Disorder/complications , Depressive Disorder/drug therapy , Headache Disorders/drug therapy , Headache Disorders/etiology , Adult , Headache Disorders/physiopathology , Humans , Male , Middle Aged , Receptor, Melatonin, MT1/antagonists & inhibitors , Receptor, Melatonin, MT2/antagonists & inhibitors , Young AdultABSTRACT
Psychosomatic presentations of generalized anxiety disorder (GAD) and an estimation of efficacy of adaptol in the treatment of patients with this pathology have been studied. The results of clinical examination of 67 patients with GAD , aged from 18 to 45 years, are presented. Adaptol was administered in dose 1500 mg daily during 60 days in 35 patients. The improvement was noted in 68,6% of cases. The high clinical efficacy of adaptol and the absence of side-effects are reported.
