A Randomized, Controlled Study Comparing the Effects of... : Otology & Neurotology (original) (raw)

Audiology

A Randomized, Controlled Study Comparing the Effects of Vestipitant or Vestipitant and Paroxetine Combination in Subjects With Tinnitus

Roberts, Claire*; Inamdar, Amir†; Koch, Annelize‡; Kitchiner, Pauline‡; Dewit, Odile‡; Merlo-Pich, Emilio§; Fina, Paolo∥; McFerran, Don J.¶; Baguley, David M.#

*Clinical Pharmacology Science and Study Operations, †Discovery Medicine, Neuroscience Centre of Excellence in Drug Discovery GlaxoSmithKline, Harlow; ‡Addenbrooke's Centre for Clinical Investigation, Addenbrooke's Hospital, Cambridge, U.K.; §Neuroscience Centre of Excellence in Drug Discovery, ∥Neurosciences Discovery Biometrics, GlaxoSmithKline, Verona, Italy; ¶Department of Otolaryngology, Essex County Hospital, Colchester; and #Department of Audiology, Addenbrooke's Hospital, Cambridge, U.K.

Address correspondence and reprint requests to Claire Roberts, Ph.D., Novartis Pharma AG, Forum 1, Novartis Campus, CH-4056 Basel, Switzerland; E-mail: [email protected]

This research was funded by GlaxoSmithKline.

Abstract

Objective:

Tinnitus is a common symptom that demonstrates a significant comorbidity with anxiety and depression. The novel neurokinin-1 receptor antagonist, vestipitant, has anxiolytic properties and a good safety profile. Vestipitant was investigated for potential effect against chronic tinnitus as a stand-alone treatment and in conjunction with a selective serotonin reuptake inhibitor, paroxetine.

Study Design:

Randomized, double-blind, crossover study.

Setting:

Tertiary neurotologic and audiologic center with additional referrals from a secondary university hospital center.

Patients:

Twenty-four adult patients with tinnitus were randomized into the study.

Main Outcome Measures:

Visual analogue scale (VAS) measurements of tinnitus loudness (intensity), pitch and distress, VAS measurements of arousal/anxiety, Tinnitus Handicap Inventory, Quick Inventory of Depressive Symptomatology, and plasma concentrations of trial drugs.

Results:

No statistically significant treatment benefit effect was detected for tinnitus (intensity, pitch, and distress) VAS scores, arousal-anxiety VAS scores, Tinnitus Handicap Inventory, or tinnitus aggravation scores assessed on Days 1 and 14. However, a statistically significant worsening of tinnitus intensity and distress scores was observed after vestipitant compared with placebo for the mean data collected over the treatment period. No relevant differences in vestipitant plasma concentrations were observed between the subjects given the combination with paroxetine and those receiving vestipitant alone. No specific relationships were observed between tinnitus intensity and vestipitant plasma concentrations.

Conclusion:

Although well-tolerated vestipitant, alone or in combination with paroxetine, was not effective in ameliorating tinnitus in this patient group.