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A randomized, controlled study comparing the effects of vestipitant or vestipitant and paroxetine combination in subjects with tinnitus.
Otol Neurotol. 2011 Jul; 32(5):721-7.ON

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.

Authors+Show Affiliations

Clinical Pharmacology Science and Study Operations, Neuroscience Centre of Excellence in Drug Discovery GlaxoSmithKline, Harlow, UK. Claire.roberts67@gmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21646935

Citation

Roberts, Claire, et al. "A Randomized, Controlled Study Comparing the Effects of Vestipitant or Vestipitant and Paroxetine Combination in Subjects With Tinnitus." Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, vol. 32, no. 5, 2011, pp. 721-7.
Roberts C, Inamdar A, Koch A, et al. A randomized, controlled study comparing the effects of vestipitant or vestipitant and paroxetine combination in subjects with tinnitus. Otol Neurotol. 2011;32(5):721-7.
Roberts, C., Inamdar, A., Koch, A., Kitchiner, P., Dewit, O., Merlo-Pich, E., Fina, P., McFerran, D. J., & Baguley, D. M. (2011). A randomized, controlled study comparing the effects of vestipitant or vestipitant and paroxetine combination in subjects with tinnitus. Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 32(5), 721-7. https://doi.org/10.1097/MAO.0b013e318218a086
Roberts C, et al. A Randomized, Controlled Study Comparing the Effects of Vestipitant or Vestipitant and Paroxetine Combination in Subjects With Tinnitus. Otol Neurotol. 2011;32(5):721-7. PubMed PMID: 21646935.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, controlled study comparing the effects of vestipitant or vestipitant and paroxetine combination in subjects with tinnitus. AU - Roberts,Claire, AU - Inamdar,Amir, AU - Koch,Annelize, AU - Kitchiner,Pauline, AU - Dewit,Odile, AU - Merlo-Pich,Emilio, AU - Fina,Paolo, AU - McFerran,Don J, AU - Baguley,David M, PY - 2011/6/8/entrez PY - 2011/6/8/pubmed PY - 2011/12/16/medline SP - 721 EP - 7 JF - Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology JO - Otol Neurotol VL - 32 IS - 5 N2 - 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. SN - 1537-4505 UR - https://www.unboundmedicine.com/medline/citation/21646935/A_randomized_controlled_study_comparing_the_effects_of_vestipitant_or_vestipitant_and_paroxetine_combination_in_subjects_with_tinnitus_ L2 - https://doi.org/10.1097/MAO.0b013e318218a086 DB - PRIME DP - Unbound Medicine ER -