Objective: To evaluate the efficacy and safety of nicergoline in the treatment of balance disorders of central origin in adult and elderly patients. Design and setting: Prospective, double-blind, placebo-controlled, parallel-group, randomised trial of nicergoline 30mg twice daily and placebo administered for 3 months. After baseline evaluation, patients were assessed monthly for efficacy and safety. The study was carried out in outpatients in five centres in Italy. Patients: Eighty-nine adult and elderly outpatients (mean age 67.1 years) with balance disorders of central origin. Interventions: At baseline, a complete clinical and instrumental otoneurological examination was carried out and the Vertigo-Dizziness Differential Diagnosis Score was calculated. Efficacy was assessed by the Dizziness Assessment Rating Scale (DARS), Dizziness Handicap Inventory (DHI) and static posturography. The safety evaluation included monitoring of adverse events, vital signs, haematology and blood chemistry. Main outcome measures and results: The DARS total score was significantly reduced by both treatments; however, score change from baseline was significantly greater in the nicergoline group compared with the placebo group from the first month of treatment (p = 0.002). The between-treatment difference further increased (p < 0.001) in the following 2 months of treatment up to the end of the study. The DHI score change from baseline was also significantly greater in the nicergoline group compared with placebo (p < 0.001) at all timepoints, both for the total score and for all domains (functional, emotional and physical). A strong correlation was observed between DARS and DHI total score change from baseline. Static posturography measurements indicated an improvement for almost all considered variables in the nicergoline group, although no statistically significant difference was observed compared with placebo; however, significant changes from baseline were observed only in the nicergoline group. Adverse events were observed in 4.5% of the nicergoline and 4.4% of the placebo patients. Conclusions: Nicergoline is an effective and well tolerated treatment for the clinical symptoms related to central vertigo and improves the quality of life of patients with dizziness.

Nicergoline in balance alterations in adult and elderly patients - A double-blind, placebo-controlled study / G. Felisati, A. Battaglia, M. Papini, B. Rossini, O. Pignataro. - In: CLINICAL DRUG INVESTIGATION. - ISSN 1173-2563. - 22:11(2002), pp. 731-740.

Nicergoline in balance alterations in adult and elderly patients - A double-blind, placebo-controlled study

G. Felisati
Primo
;
O. Pignataro
Ultimo
2002

Abstract

Objective: To evaluate the efficacy and safety of nicergoline in the treatment of balance disorders of central origin in adult and elderly patients. Design and setting: Prospective, double-blind, placebo-controlled, parallel-group, randomised trial of nicergoline 30mg twice daily and placebo administered for 3 months. After baseline evaluation, patients were assessed monthly for efficacy and safety. The study was carried out in outpatients in five centres in Italy. Patients: Eighty-nine adult and elderly outpatients (mean age 67.1 years) with balance disorders of central origin. Interventions: At baseline, a complete clinical and instrumental otoneurological examination was carried out and the Vertigo-Dizziness Differential Diagnosis Score was calculated. Efficacy was assessed by the Dizziness Assessment Rating Scale (DARS), Dizziness Handicap Inventory (DHI) and static posturography. The safety evaluation included monitoring of adverse events, vital signs, haematology and blood chemistry. Main outcome measures and results: The DARS total score was significantly reduced by both treatments; however, score change from baseline was significantly greater in the nicergoline group compared with the placebo group from the first month of treatment (p = 0.002). The between-treatment difference further increased (p < 0.001) in the following 2 months of treatment up to the end of the study. The DHI score change from baseline was also significantly greater in the nicergoline group compared with placebo (p < 0.001) at all timepoints, both for the total score and for all domains (functional, emotional and physical). A strong correlation was observed between DARS and DHI total score change from baseline. Static posturography measurements indicated an improvement for almost all considered variables in the nicergoline group, although no statistically significant difference was observed compared with placebo; however, significant changes from baseline were observed only in the nicergoline group. Adverse events were observed in 4.5% of the nicergoline and 4.4% of the placebo patients. Conclusions: Nicergoline is an effective and well tolerated treatment for the clinical symptoms related to central vertigo and improves the quality of life of patients with dizziness.
Settore MED/31 - Otorinolaringoiatria
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/190928
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