Ventus Medical has announced that clinical data from three poster presentations presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies further confirm PROVENT Sleep Apnea Therapy's clinical utility in treating mild, moderate and severe obstructive sleep apnea (OSA).
An estimated 50 million people in the US suffer from obstructive sleep apnea, yet there are few treatment options that meet all patients’ needs. PROVENT Therapy offers a new alternative that is discreet, easy to use, disposable and comfortable to use throughout the night, regardless of a patient’s sleep position, explained Philip Westbrook, MD, Emeritus Professor of Medicine at UCLA and Ventus Medical’s Chief Medical Officer. These new data offer additional evidence that PROVENT Therapy is clinically-proven and truly designed with the patient’s needs in mind.
We welcome innovation and additional treatment options for our patients with sleep breathing disorders, said Meir Kryger, MD, Director of Sleep Medicine Research and Education at Gaylord Hospital in Wallingford, CT. These results are very promising, and Ventus is clearly taking the appropriate steps to establish this treatment through rigorous clinical testing.
Three Poster Presentations:
1. Mechanism of Action Study
A physiologic mechanism of action study (abstract 0591), by Dennis Hwang, MD, and colleagues, including David Rapoport, MD, Associate Professor of Medicine, New York University School of Medicine, found that PROVENT Therapy produced marked improvement in sleep-disordered breathing in 8 of 11 treated patients with some residual sleep-disordered breathing during REM sleep. Of the 8 patients, 5 demonstrated a complete response and 3 a partial response.
These positive efficacy findings were associated with positive and prolonged intranasal pressure when the patient exhales, said Dr. Rapoport. We believe it is this pressure, known as autoPEEP (positive end-expiratory pressure), that keeps the airway open until the patient inhales, may increase the end-expiratory lung volume, and thus creates a pull on the trachea and upper airway. This is how PROVENT Therapy prevents apneic episodes and helps patients with sleep-disordered breathing.
In the 8 responsive PROVENT Therapy patients, end-expiratory intranasal pressure increased to a range between 11and 26cmH2O during periods of complete success, whereas the non-responders’ intranasal pressure ranged from 3 to 10 cmH2O, with lowest pressures at the time of failure of treatment. This suggests that the increased pressure could have been the mechanism of action that keeps the airway open until the patient inhales.
2. Modeling the Effectiveness of PROVENT Therapy Compared to CPAP
A model (abstract 0599) comparing the efficacy and compliance of current PROVENT Therapy data to continuous positive airway pressure (CPAP) data from the literature suggests that PROVENT Therapy may prevent a similar or greater number of apnea/hypopnea events as compared to CPAP when the therapies’ respective adherence rates are taken into account.
This model analysis by Anne Abreu, Director of Reimbursement and Business Development at Ventus Medical, and colleagues, compared the effectiveness of PROVENT Therapy versus CPAP taking into consideration both apneas and hypopneas prevented during hours of use and those not prevented due to lack of use.
Results showed that PROVENT Therapy may prevent a similar or greater number of abnormal breathing events as compared to CPAP, based on the modeling scenarios. This model demonstrates the importance of factoring in compliance rates when choosing a therapy for treating obstructive sleep apnea, said Ms. Abreu.
3. PROVENT Therapy Pooled Data Analysis
A new analysis of pooled data from prior PROVENT Therapy studies (abstract 0570) by Philip Westbrook, MD, Emeritus Professor of Medicine at UCLA and Ventus Medical’s Chief Medical Officer, and colleagues, showed success rates and a significant change in Apnea-Hypopnea Index (AHI) in 58 patients that demonstrate the viability of PROVENT Therapy via expiratory resistive loading in the treatment of OSA.
These success rates are comparable to alternative therapies, such as mandibular advancement devices and surgical approaches, and PROVENT had fewer adverse events, explained Dr. Westbrook. Given PROVENT Therapy is much easier to try than these other therapies, it could be an early consideration for the treatment of OSA.
Results demonstrated that PROVENT Therapy reduced AHI from 26.6+/-24.8 to 13.7+/-20.1, a 49% reduction (p less than 0.001). During the treatment night, 72% of subjects met either the AHI less than 10 or AHI improved by at least 50% criteria; 36% met the success criteria of AHI less than 5; 59% met AHI less than 10; and 66% had an AHI less than 50% of their baseline value. Further, 50% of subjects met both the AHI less than 10 and AHI improved by at least 50% criteria.