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    Home > Active Ingredient News > Digestive System Information > Vonolasheng is approved for maintenance treatment of reflux esophagitis, which significantly reduces the risk of recurrence!

    Vonolasheng is approved for maintenance treatment of reflux esophagitis, which significantly reduces the risk of recurrence!

    • Last Update: 2021-11-04
    • Source: Internet
    • Author: User
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    Only for medical professionals to read for reference.
    Recently, a new acid inhibitory drug potassium ion competitive acid blocker (P-CAB) voronola fumarate green tablets (hereinafter referred to as voronolasheng) has been approved for reflux esophagitis (RE) After the initial treatment, it was again approved by the National Medical Products Administration (NMPA) of China for the maintenance treatment of patients with recurrent RE
    .

    RE, as a more serious type of gastroesophageal reflux disease (GERD), usually manifests as a damaged mucosa of the distal esophagus under endoscopy, that is, esophageal erosion and/or esophageal ulcer
    .

    The latest meta-analysis showed that [1], GERD significantly increased the risk of esophageal adenocarcinoma, pharynx, and larynx malignancies by 357%, 276%, and 137%, respectively
    .

    RE sustained or untreated can lead to a variety of esophageal complications such as esophageal ulcers, esophageal stricture, esophageal bleeding, Barrett esophagus and esophageal adenocarcinoma
    .

    Studies have shown [2] that if there is no maintenance treatment after the initial treatment of RE patients, the mucosal recurrence rate is 70% at 6 months, and the mucosal recurrence rate is as high as 90% after 1 year, suggesting that RE is a chronic progressive disease and requires "initial The whole course of management of "treatment + maintenance treatment" can continue to relieve symptoms, maintain mucosal healing, and reduce the rate of disease recurrence
    .

    The incidence of RE is on the rise and is prone to chronic progress.
    Long-term harm RE can occur in people of any age, and the age of 40 to 60 is the age at which the disease occurs
    .

    Smoking, obesity, age, drinking, application of non-steroidal anti-inflammatory drugs (NSAID), psychosocial factors and genetic factors can all lead to the occurrence of RE [3]
    .

    Although the prevalence of RE in China is lower than that in Western countries, in recent years, with changes in life>
    .

    In view of the huge population base, the burden of diseases facing China is still heavy, RE has gradually become a common chronic disease of the digestive system and an important problem faced by clinicians
    .

    RE recurrence rate is high, and the concept of maintenance treatment needs to be strengthened.
    RE emphasizes comprehensive treatment methods.
    In addition to life>
    .

    At present, both P-CAB and proton pump inhibitor (PPI) are the treatments of choice for RE
    .

    However, more and more studies have found that [5-7], PPIs treatment of RE has a low mucosal healing rate and a limited symptom relief rate
    .

    Studies have shown that [5,8-9] RE patients have a mucosal healing rate of 73.
    3%~87.
    0% when receiving PPIs for 8 weeks, and the symptom relief rate of 4 weeks or 8 weeks of treatment is only 51.
    0%~76.
    0%
    .

    In addition, a Chinese real-world study [10] showed that the mucosal healing rate of patients after PPIs treatment was only 40.
    4%
    .

    Studies on the efficacy and compliance of PPIs in the treatment of RE have found that [10], on the one hand, the standard dose of PPIs is not effective, and RE patients often need to receive increased doses and times; on the other hand, in clinical practice, more than half Of patients are unable to take the medication on time.
    When the condition improves slightly, the patient’s compliance is often reduced, and there are phenomena such as missed, forgotten, or even self-discontinuation of the medication, which makes the treatment effect unable to be maintained and consolidated, resulting in poor disease Control and cure [11-12]
    .

    More importantly, it was found in the follow-up study of RE [13] that if there is no maintenance treatment after the initial treatment of PPIs, the recurrence rate of symptoms in RE patients is as high as 90% within 6 months of stopping the drug
    .

    Even for patients with mucosal healing after initial treatment, if maintenance treatment is not performed, the recurrence rate of mucosal injury in patients at 6 months is still as high as 71% [14]
    .

    At present, how to improve the diagnosis and treatment of RE, reduce the mucosal recurrence rate and relieve symptoms has become a hot spot for clinicians and patients
    .

    Prescribe "prescriptions" for the optimization of RE 1.
    Strengthen patient education and pay attention to life>
    .

    Studies have found [16-17] that weight loss (BMI decreased by more than 3.
    5 kg/m2) and smoking cessation can reduce the risk of symptoms of RE patients by 40% and 5%, respectively
    .

    The symptom relief rate of patients after correcting the bad diet was significantly higher than that of uncorrected patients (98.
    3% vs.
    85.
    9%, P <0.
    001) [18]
    .

    Patient education is an important part of disease management.
    It is also very important to strengthen patients' awareness of self-management to improve their life>
    .

    2.
    Standardized disease diagnosis and treatment, and full management is "essential".
    In a multi-center, randomized, double-blind, parallel, placebo-controlled study [19], 173 patients with RE who had mucosal healing after 8 weeks of acid suppression treatment were enrolled It was found that only 9% of patients receiving full-course management had disease recurrence during the one-year observation period, while 75% of patients who received only initial treatment had ≥1 recurrence, suggesting that maintenance treatment after initial treatment can be Reduce disease recurrence rate
    .

    Compared with RE patients who only receive initial treatment, full-course management can bring longer-lasting symptom relief and mucosal healing
    .

    A meta-analysis of 51 randomized controlled studies [20] also found that maintenance treatment for patients with GERD [including non-erosive reflux disease (NERD) and RE] can reduce the risk of symptom recurrence by 46%, esophagitis The risk of recurrence is reduced by 54%
    .

    The above studies confirmed that RE requires not only initial treatment, but also maintenance therapy to achieve full-course management of the disease.
    Symptom relief, mucosal healing, and recurrence prevention are the three important goals of RE full-course management, and are also important for evaluating the efficacy of RE acid-suppressing drugs.
    Direction
    .

    3.
    Optimize acid suppression treatment and solve clinical "pain points" Vonolasen is the first P-CAB to serve Chinese patients.
    It overcomes many limitations of PPIs and brings better acid suppression effects for RE patients
    .

    The half-life of PPIs is short (0.
    5-2 h), and the half-life of Vonolasheng is about 9 hours
    .

    Therefore, the duration of acid suppression, Vonolasheng>PPIs, can well control the patient's nocturnal reflux symptoms
    .

    The mechanism of action of PPIs determines that the maximum acid suppression effect can be obtained only when the gastric parietal cells are stimulated after eating.
    Therefore, PPIs should be taken 30-60 minutes before meals.
    If the use of PPIs is not regulated, the drug The antisecretory effect will be impaired, leading to poor disease control [21]
    .

    In comparison, Vonolasan is a direct active drug, no need to take it before meals, and the taking time is more flexible
    .

    In the convenience and convenience of taking, Vonolasan is better than PPIs
    .

    In terms of clinical efficacy, a phase III non-inferiority, open-label, double-blind, parallel group, multi-center study for Asian non-Japanese populations showed that [22], voronolax was administered once a day after 24 weeks of maintenance treatment The recurrence rates of the 10 mg group and 20 mg group were 13.
    3% and 12.
    3%, respectively, and the lansoprazole 15 mg group was 25.
    5% (Figure 1)
    .

    Figure 1 In the phase III maintenance treatment of Asian non-Japanese population, the efficacy of Vonolasen was significantly better than that of PPI Lansoprazole.
    In the data of the Chinese subgroup (n=491) of the study, Vonolasen 10 mg, 1 time per day The recurrence rates of the 20 mg and lansoprazole 15 mg groups were 13.
    8%, 14.
    0%, and 25.
    0%, respectively, and the long-term treatment safety was good (Figure 2)
    .

    Figure 2 Chinese patients with phase III maintenance treatment.
    Vonolasen has a significantly better efficacy than PPI lansoprazole.
    In terms of economy, after voronolasen is officially included in medical insurance at the end of 2020, the average daily and course of treatment costs have been significantly reduced, and at the same time it is compared with PPIs Compared with long-term cost-effectiveness advantages [23]
    .

    In short, the entire management of RE needs to run through the treatment, including "initial treatment + maintenance treatment".
    At present, PPIs treatment cannot meet the treatment needs.
    Vonolasen is improving medication compliance, promoting mucosal healing, symptom control, and preventing recurrence.
    It has significant clinical advantages, as well as good safety and pharmacoeconomics characteristics
    .

    It is hoped that the approval of its new indications will once again inject "new opportunities" into the standardized management of RE in China
    .

    [14]Johnson DA,et al.
    Am J Gastroenterol.
    2001 Jan;96(1):27-34.
    [15]Philip O,et al.
    Am J Gastroenterol,2013;108:308-328.
    [16]Jacobson BC,Somers SC,Fuchs CS,et al.
    New England Journal of Medicine,2006,354(22):2340-2348.
    [17]Ness-Jensen E,Lindam A,et al.
    Am J Gastroenterol.
    2014 Feb;109 (2):171-7.
    [18]Yuan LZ,Yi P,Wang GS,et al.
    Therap Adv Gastroenterol.
    2019 Sep 25;12:1756284819877788.
    [19]Robinson M,et al.
    Ann Intern Med.
    1996 May 15;124(10):859-867.
    [20]Donnellan C,et al.
    Cochrane Database Syst Rev.
    2005 Apr 18;(2):CD003245.
    [21]Otake K,Sakurai Y,Nishida H,et al.
    [J].
    Advances in therapy,2016,33(7):1140-1157.
    [22]Yinglian Xiao,et al.
    Data on file.
    [23]Zhenhua Wang,et al.
    Data on file.
    Previous recommendations: ▎ Regarding the confusion about the diagnosis and treatment of GERD, the essence and key points of Professor Chen Shengliang will be finished in one go! ▎How to manage gastroesophageal reflux disease? Please keep this medical map ▎Refractory GERD, where is the "difficulty"? What's the solution? The ESNM/ANMS consensus article understands ▎The symptoms of reflux esophagitis are relieved and the treatment reaches the standard.
    How do you look at this indicator? One Picture Interpretation Approval Number: VV-MEDMAT-55253 Approval Date: October 20, 2021 Expiration Date: October 20, 2023 Statement: Only for medical and health professionals to understand information ▎About the confusion about the diagnosis and treatment of GERD, the essence and key points, Professor Chen Shengliang, finished it in one go! ▎How to manage gastroesophageal reflux disease? Please keep this medical map ▎Refractory GERD, where is the "difficulty"? What's the solution? The ESNM/ANMS consensus article understands ▎The symptoms of reflux esophagitis are relieved and the treatment reaches the standard.
    How do you look at this indicator? One Picture Interpretation Approval Number: VV-MEDMAT-55253 Approval Date: October 20, 2021 Expiration Date: October 20, 2023 Statement: Only for medical and health professionals to understand information
    .

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    .

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