Introduction
Approximately 40% of adults use Proton Pump Inhibitors (PPIs) for treating acid-related disorders, although a potentially inappropriate indication has been observed in 30%-80% of cases. Moreover, PPIs have been associated with adverse events. Therefore, PPI discontinuation should be encouraged, particularly when their use is inappropriate or in case of lack of benefit. However, past studies failed to provide sustainable ways for reducing inappropriate PPI administration and novel models of deprescribing have been developed
Aims & Methods
We aimed to evaluate whether the use of alginate during mandatory PPI washout prior to reflux testing in patients with reflux-like symptoms is helpful in sustaining PPI deprescription. In this retrospective study, consecutive patients with typical (i.e. heartburn and/or regurgitation) or atypical (i.e. chronic cough, asthma) symptoms potentially related to GERD, on long-term PPI therapy (>3months), referred to our outpatient clinic for reflux testing because of PPI refractoriness or to confirm long-term PPI administration were included. Demographic and clinical (endoscopy, esophagogram, symptoms) data were recorded before PPI withdrawal and after (within 6 months) functional testing. Patients were asked to stop PPIs at least 2 weeks prior to testing, while they were allowed to take alginate (Gaviscon Advance, Reckitt Benckiser, United Kingdom) or other rescue medications during PPI withdrawal, on as needed basis or as standardised treatment (after each meal and before night) according to disease severity. Symptoms were collected by means of the validated GerdQ questionnaire (positive for GERD when >8), in case of typical symptoms, and Reflux Symptom Index (RSI positive for laryngopharyngeal reflux disease when >13), in case of atypical symptoms. Moreover, data regarding Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) and the results of high-resolution manometry with impedance-pH monitoring were recorded
Results
Three-hundred and eighty patients with typical symptoms [222 male, mean age 59] and 240 patients with atypical symptoms [143 male, mean age 63] were recruited. According to GerdQ before testing, 243 patients (64%) reporting typical symptoms had GERD, while based on RSI, 173 patients (72%) reporting atypical symptoms had laryngopharyngeal reflux disease. Mean time of PPI withdrawal before testing was 18 days (range 13-21) and most patients (80%) took alginate as rescue therapy. At the follow-up visit after testing, 280 patients (74%) with typical symptoms (median follow-up time of 2 months) and 130 patients (54%) with atypical symptoms (median follow-up time of 3 months) did not resume PPIs. According to GerdQ after testing, 182 patients (48%) reporting typical symptoms had GERD compared to 64% before testing (p=0.0001), while based on RSI, 146 patients (61%) reporting atypical symptoms had laryngopharyngeal reflux disease compared to 72% before testing (p=0.0118). Moreover, patients taking alginate on standardised treatment were able to stop PPI more frequently than patients taking alginate on as needed basis (76% vs. 48%, p<0.05). Finally, GERD-HRQL improved in patients with both typical and atypical symptoms after testing (p<0.05).
Conclusion
Alginate administration favored PPI deprescribing by improving symptom burden and quality of life. Our findings highlight the potential use of alginate for reducing the impact of PPIs on the costs of health care system and their pharmacological misuse
Disclosure
Edoardo Vincenzo Savarino has served as speaker for Abbvie, Agave, AGPharma, Alfasigma, Aurora Pharma, CaDiGroup, Celltrion, Dr Falk, EG Stada Group, Fenix Pharma, Fresenius Kabi, Galapagos, Janssen, JB Pharmaceuticals, Innovamedica/Adacyte, Malesci, Mayoly Biohealth, Omega Pharma, Pfizer, Reckitt Benckiser, Sandoz, SILA, Sofar, Takeda, Tillots, Unifarco; has served as consultant for Abbvie, Agave, Alfasigma, Biogen, Bristol-Myers Squibb, Celltrion, Diadema Farmaceutici, Dr. Falk, Fenix Pharma, Fresenius Kabi, Janssen, JB Pharmaceuticals, Merck & Co, Nestlè, Reckitt Benckiser, Regeneron, Sanofi, SILA, Sofar, Synformulas GmbH, Takeda, Unifarco; he received research support from Pfizer, Reckitt Benckiser, SILA, Sofar, Unifarco, Zeta Farmaceutici
