Symptom severity, social supports, coping styles, and quality of life among individuals’ diagnosed with Ménierè’s disease

Porter, Megan; Boothroyd, Roger A.

doi:10.1177/1742395314567926

Cited by 21 publications

(22 citation statements)

References 39 publications

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“…These results are consistent with the previously reported Phase 1b study with OTO-104 (12), and provide further evidence that intratympanic steroids can provide reductions in vertigo (8–10,22,23). The observation that statistically significant improvement in SF-36 subscales following OTO-104 dosing is notable given the quality of life challenges experienced by patients with Ménière's disease (5,6). …”

Section: Discussionmentioning

confidence: 99%

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Intratympanic Sustained-Exposure Dexamethasone Thermosensitive Gel for Symptoms of Ménière's Disease

Lambert

Carey

Mikulec

et al. 2016

Otology &Amp; Neurotology

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Objective:To evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Ménière's disease.Study Design:Randomized, double-blind, placebo-controlled, Phase 2b study over 5 months.Setting:Fifty-two academic and community otolaryngology centers.Patients:One hundred fifty four patients (77 per group) aged 18 to 85 years inclusive.Intervention:Single intratympanic injection of OTO-104 (12 mg dexamethasone) or placebo.Main Outcome Measures:Efficacy (vertigo) and safety (adverse events, otoscopy, audiometry, tympanometry).Results:Primary endpoint (change from baseline in vertigo rate at Month 3) was not statistically significant (placebo [−43%], OTO-104 [−61%], P = 0.067). Improvements with OTO-104 were observed in prospectively defined secondary endpoints number of days with definitive vertigo, (Month 2 [P = 0.035], Month 3 [P = 0.030]), vertigo severity (Months 2–3, P = 0.046) and daily vertigo counts (Month 2, P = 0.042), and in some Short Form-36 (SF-36) subscales (Month 2 bodily pain P = 0.039, vitality P = 0.045, social functioning P = 0.025). No difference in tinnitus loudness or tinnitus handicap inventory (THI-25) was observed. OTO-104 was well tolerated; no negative impact on safety compared with placebo. Persistent tympanic membrane perforation was observed in two OTO-104 treated patients at study end.Conclusion:OTO-104 was well-tolerated, did not significantly affect change from baseline in vertigo rate, but did reduce number definitive vertigo days, vertigo severity, and average daily vertigo count compared with placebo during Month 3. Results provide insight into analyzing for a vertigo treatment effect and support advancing OTO-104 into Phase 3 clinical trials for the treatment of Ménière's disease symptoms.

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Section: Discussionmentioning

confidence: 99%

“…The disease may eventually result in irreversible sensorineural hearing loss at all frequencies in the affected ear and seriously impair a patient's quality of life (5,6). Treatments for the disease tend to focus on relieving vertigo, the most debilitating symptom associated with the disease.…”

mentioning

confidence: 99%

Intratympanic Sustained-Exposure Dexamethasone Thermosensitive Gel for Symptoms of Ménière's Disease

Lambert

Carey

Mikulec

et al. 2016

Otology &Amp; Neurotology

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“…American Academy of Otolaryngology–Committee on Hearing and Equilibrium (AAO–CHE) guidelines necessitate 24 month follow‐up to evaluate treatment response in MD . In the clinical setting, the fluctuating symptoms and prolonged timeframe over which response is evaluated can be a source of frustration for patients who often have reduced functional capacities due to this disease . As a result of these factors, clinicians often alter treatment plans, and clinical studies do not adhere to this 24‐month guideline in reporting outcomes for MD .…”

Section: Introductionmentioning

confidence: 99%

“…1 In the clinical setting, the fluctuating symptoms and prolonged timeframe over which response is evaluated can be a source of frustration for patients who often have reduced functional capacities due to this disease. 2 As a result of these factors, clinicians often alter treatment plans, and clinical studies do not adhere to this 24-month guideline in reporting outcomes for MD. 3 Early and frequent alterations in treatment algorithms for MD suggests that definitive control of vertigo early in the disease course is important to patients, and therapies aimed at achieving this outcome should be a goal of therapy.…”

Section: Introductionmentioning

confidence: 99%

Intratympanic Therapies in Ménière Disease: Evaluation of Outcomes and Early Vertigo Control

et al. 2018

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Objective To evaluate outcomes of intratympanic (IT) dexamethasone and gentamicin in Ménière Disease (MD). Methods Charts of adult patients with unilateral definite MD receiving IT gentamicin or dexamethasone from 2005 to 2017 were retrospectively reviewed. All patients had at least 6 months follow‐up. Failure in each group was defined as the need for more aggressive therapy. Prior to 2011, all patient received IT gentamicin, administered as primary therapy after failure of conservative treatment measures. Gentamicin was administered every 2 weeks, up to three injections, until vertigo control was achieved. Beginning in 2011, the treatment protocol shifted to IT dexamethasone as initial treatment, with gentamicin used for dexamethasone failures. Dexamethasone was administered weekly for up to three injections. Treatments could be repeated if symptoms recurred. Results Thirty‐three patients received IT dexamethasone, and 70 patients received IT gentamicin. Dexamethasone patients received a mean of 3.3 injections compared to 2.7 in the gentamicin group (P = 0.011). There were 12 (38%) failures in the dexamethasone group and only seven (10%) gentamicin failures (P = 0.025). No patients failed both treatments. The mean time to failure in the dexamethasone group was 5 months, whereas in the gentamicin group it was 27 months. Change in pure tone audiometry from baseline was not different between treatment groups (P = 0.30). Conclusion Subjects receiving IT gentamicin required fewer injections and had a significantly longer time to failure than IT dexamethasone. Audiometric outcomes were similar between the groups. The use of IT gentamicin as initial therapy for early and long‐term control of MD is safe and effective. Level of Evidence 3 Laryngoscope, 129:216–221, 2019

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“…Vertigo can last hours or even days, during which time the patient is often bedridden. The disease can have a significant effect on quality of life, including a not insignificant risk of workplace injury …”

Section: Introductionmentioning

confidence: 99%

Meniett device in meniere disease: Randomized, double‐blind, placebo‐controlled multicenter trial

et al. 2016

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Symptom severity, social supports, coping styles, and quality of life among individuals’ diagnosed with Ménierè’s disease

Cited by 21 publications

References 39 publications

Intratympanic Sustained-Exposure Dexamethasone Thermosensitive Gel for Symptoms of Ménière's Disease

Intratympanic Sustained-Exposure Dexamethasone Thermosensitive Gel for Symptoms of Ménière's Disease

Intratympanic Therapies in Ménière Disease: Evaluation of Outcomes and Early Vertigo Control

Meniett device in meniere disease: Randomized, double‐blind, placebo‐controlled multicenter trial

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