Use of Proton Pump Inhibitors After Antireflux Surgery
Objective Antireflux surgery (ARS) has been suggested as an alternative to lifelong use of proton pump inhibitors (PPI) in reflux disease. Data from clinical trials on PPI use after ARS have been conflicting. We investigated PPI use after ARS in the general Danish population using nationwide healthcare registries.
Design A nationwide retrospective follow-up study of all patients aged ≥18 and undergoing first-time ARS in Denmark during 1996–2010. Two outcome measures were used: redemption of first PPI prescription after ARS (index prescription) and a marker of long-term use, defined by an average PPI use of ≥180 defined daily doses (DDDs) per year. Kaplan–Meier curves and Cox proportional hazards model were used for statistics.
Results 3465 patients entered the analysis. 12.7% used no PPI in the year before surgery, while 14.2%, 13.4% and 59.7% used 1–89 DDD, 90–179 DDD and ≥180 DDD, respectively. Five-, 10- and 15-year risks of redeeming index PPI prescription were 57.5%, 72.4% and 82.6%, respectively. Similarly, 5-, 10- and 15-year risks of taking up long-term PPI use were 29.4%, 41.1% and 56.6%. Female gender, high age, ARS performed in most recent years, previous use of PPI and use of nonsteroidal anti-inflammatory drugs or antiplatelet therapy significantly increased the risk of PPI use.
Conclusions Risk of PPI use after ARS was higher than previously reported, and more than 50% of patients became long-term PPI users 10–15 years postsurgery. Patients should be made aware that long-term PPI therapy is often necessary after ARS.
Antireflux surgery (ARS) is an established alternative to medical treatment for severe GORD. Reduction in the use of acid-suppressive medicine, notably proton pump inhibitors (PPI), is an important reason why ARS is recommended for some GORD patients. Surgery is recommended to avoid the drawbacks of polypharmacy and the reduction in quality of life that many patients associate with having to use medication. Another aspect is the continuing increase in long-term use of PPI and the possible adverse effects this may lead to, such as enteric infections, fractures and nutritional deficiencies. Finally, ARS has been reported to be more cost-effective compared with long-term PPI therapy.
In clinical trials, the risk of PPI use after ARS has varied between 12% and 44% with follow-up periods from 1 to 12 years, with a tendency towards increased risk of PPI use with longer follow-up. However, PPI use has rarely been accounted for in detail and, to our knowledge, no studies have validated the rate of PPI use seen in the trials by cross-checking with prescription databases. More importantly, use of PPI after ARS in routine care, outside the rigorous conditions of randomised trials, has not been investigated.
Denmark has a tax-supported healthcare system enabling national health-related registers to present validated data of a geographically well-defined area and not just from single hospital centres. Using these registers, we sought to describe the use of PPI after ARS in the Danish general population in the period 1996–2010. The primary aim of the study was to estimate the proportion of ARS patients who redeemed prescriptions of PPI or who took up long-term PPI use after ARS. The secondary aim was to investigate factors that might predict the use of PPI after ARS.
Abstract and Introduction
Abstract
Objective Antireflux surgery (ARS) has been suggested as an alternative to lifelong use of proton pump inhibitors (PPI) in reflux disease. Data from clinical trials on PPI use after ARS have been conflicting. We investigated PPI use after ARS in the general Danish population using nationwide healthcare registries.
Design A nationwide retrospective follow-up study of all patients aged ≥18 and undergoing first-time ARS in Denmark during 1996–2010. Two outcome measures were used: redemption of first PPI prescription after ARS (index prescription) and a marker of long-term use, defined by an average PPI use of ≥180 defined daily doses (DDDs) per year. Kaplan–Meier curves and Cox proportional hazards model were used for statistics.
Results 3465 patients entered the analysis. 12.7% used no PPI in the year before surgery, while 14.2%, 13.4% and 59.7% used 1–89 DDD, 90–179 DDD and ≥180 DDD, respectively. Five-, 10- and 15-year risks of redeeming index PPI prescription were 57.5%, 72.4% and 82.6%, respectively. Similarly, 5-, 10- and 15-year risks of taking up long-term PPI use were 29.4%, 41.1% and 56.6%. Female gender, high age, ARS performed in most recent years, previous use of PPI and use of nonsteroidal anti-inflammatory drugs or antiplatelet therapy significantly increased the risk of PPI use.
Conclusions Risk of PPI use after ARS was higher than previously reported, and more than 50% of patients became long-term PPI users 10–15 years postsurgery. Patients should be made aware that long-term PPI therapy is often necessary after ARS.
Introduction
Antireflux surgery (ARS) is an established alternative to medical treatment for severe GORD. Reduction in the use of acid-suppressive medicine, notably proton pump inhibitors (PPI), is an important reason why ARS is recommended for some GORD patients. Surgery is recommended to avoid the drawbacks of polypharmacy and the reduction in quality of life that many patients associate with having to use medication. Another aspect is the continuing increase in long-term use of PPI and the possible adverse effects this may lead to, such as enteric infections, fractures and nutritional deficiencies. Finally, ARS has been reported to be more cost-effective compared with long-term PPI therapy.
In clinical trials, the risk of PPI use after ARS has varied between 12% and 44% with follow-up periods from 1 to 12 years, with a tendency towards increased risk of PPI use with longer follow-up. However, PPI use has rarely been accounted for in detail and, to our knowledge, no studies have validated the rate of PPI use seen in the trials by cross-checking with prescription databases. More importantly, use of PPI after ARS in routine care, outside the rigorous conditions of randomised trials, has not been investigated.
Denmark has a tax-supported healthcare system enabling national health-related registers to present validated data of a geographically well-defined area and not just from single hospital centres. Using these registers, we sought to describe the use of PPI after ARS in the Danish general population in the period 1996–2010. The primary aim of the study was to estimate the proportion of ARS patients who redeemed prescriptions of PPI or who took up long-term PPI use after ARS. The secondary aim was to investigate factors that might predict the use of PPI after ARS.
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