Proton pump inhibitors (PPIs) irreversibly inhibit the H⁺/K⁺-ATPase of the gastric parietal cell, the final common pathway of acid secretion. Because acid output resumes only after new pumps are synthesised, a single daily dose produces profound and sustained acid suppression that outlasts the drug's short plasma half-life [1]. Since omeprazole entered clinical practice in the late 1980s, lansoprazole, pantoprazole, rabeprazole, esomeprazole and dexlansoprazole have followed. Together they have transformed the management of acid-related disease and largely replaced surgery for uncomplicated peptic ulcer [2].

The established indications for PPIs include gastroesophageal reflux disease (GERD), erosive esophagitis, peptic ulcer disease, Helicobacter pylori eradication, prevention of NSAID-associated gastroduodenal injury, upper gastrointestinal bleeding and hypersecretory states such as Zollinger–Ellison syndrome [1,3]. For most of these, treatment is time-limited. Current GERD guidance recommends attempting discontinuation after an initial course in patients without erosive esophagitis or Barrett's esophagus. When maintenance is needed, the lowest effective dose should be used [3]. Long-term therapy remains justified in a defined group: severe erosive esophagitis, Barrett's esophagus, peptic stricture, objectively proven GERD that relapses off treatment, hypersecretory disorders, and patients with persistently high bleeding risk [4].

In practice, PPI use extends well beyond these indications. Generic availability, low unit cost, over-the-counter access and a perception of safety have encouraged liberal prescribing. Forgacs and Loganayagam warned that a large share of PPI prescriptions lacked a clear indication [5]. Heidelbaugh et al. later described two routes to overutilisation: inappropriate initiation, often as stress-ulcer prophylaxis in hospital, and failure to stop treatment once the original indication has resolved [6]. Prescriptions started during an admission are frequently carried over at discharge and renewed in outpatient clinics without review.

There is no agreed definition of "long-term" PPI therapy. A scoping review by Haastrup et al. found thresholds ranging from weeks to years and proposed that treatment beyond 8 weeks for reflux symptoms is a reasonable point at which to reassess [7]. Prolonged exposure matters because observational studies have linked long-term PPI use with enteric infection, hypomagnesaemia, vitamin B12 deficiency, fractures and kidney disease. Most of these associations are prone to confounding and do not prove causation [8], but they strengthen the case for using PPIs only when there is a clear indication.

Indian tertiary care data show heavy use of a narrow range of agents and a substantial proportion of prescriptions outside guideline indications. Venkataraman et al. reported that pantoprazole made up about three-quarters of PPI prescriptions in a tertiary hospital [9]. Juneja et al. and Zabiuddin Ahad et al. reported similar dominance of pantoprazole among hospitalised patients in North and South India [10,11]. Most of these studies, however, were limited to inpatients or single-day snapshots. They did not separately describe patients already on prolonged therapy across both outpatient and inpatient settings.

Drug utilization studies show which agents are used, for what indications, at what dose and frequency, and for how long. These data are the starting point for medication review and PPI stewardship programmes, as recommended by the American Gastroenterological Association and by evidence-based deprescribing guidelines [12,13]. The present study therefore aimed to describe the prescribing pattern of PPIs among adult long-term users at a tertiary care teaching hospital. It covers the agent prescribed, duration of therapy, dosing frequency, documented indication and concurrent medicines that modify gastrointestinal bleeding risk

This was a hospital-based, observational, cross-sectional drug utilization study. It was conducted in the Department of Pharmacology together with the participating outpatient and inpatient clinical departments of Amaltas Institute of Medical Sciences, a tertiary care teaching hospital in India. The study ran for 12 months [insert exact dates] after approval from the Institutional Ethics Committee. Reporting follows the STROBE statement for cross-sectional studies [14].

Study population. Adults aged 18 years or older who were currently receiving any PPI and had received PPI therapy for more than 8 weeks were eligible. Patients also had to give written informed consent and have enough prescription or clinical information to establish the agent and duration of treatment. We excluded patients taking a PPI only as part of a defined short-course H. pylori eradication regimen. We also excluded those whose PPI exposure could not be verified after reasonable attempts, those unable or unwilling to consent, and those enrolled in another intervention that determined PPI prescribing. Patients whose indication was poorly documented were not excluded; documentation quality was itself recorded as an outcome.

Operational definition. Long-term PPI use was defined as continuous or recurrent PPI treatment for more than 8 weeks, in line with the threshold proposed by Haastrup et al. [7]. Duration was further grouped as >8 weeks to 6 months, >6 to 12 months, >1 to 2 years and >2 years.

Sample size. The sample size was calculated with n = Z²pq/d². The anticipated prevalence (p) was set at 50% in the absence of reliable local data, with Z = 1.96 and an absolute precision (d) of 5%. This gave a minimum of 385 patients. Allowing about 10% for incomplete records or non-response, the final sample size was 425.

Data collection. Eligible patients were screened consecutively. Demographic details (age, sex), clinical setting (outpatient or inpatient) and clinical diagnoses were recorded on a pre-designed case record form. The medication history captured the PPI name, dose, frequency, route and duration; the initial and current indication; the prescribing department; and any previous attempt at discontinuation. Concurrent medicines relevant to gastrointestinal bleeding risk were recorded: NSAIDs, aspirin, other antiplatelet agents, anticoagulants and systemic corticosteroids. Case records were reviewed for GERD, erosive esophagitis, Barrett's esophagus, peptic ulcer disease, previous upper gastrointestinal bleeding, NSAID-associated risk, hypersecretory disorders and available endoscopy findings. Information was obtained from prescriptions, paper and electronic case records, and patient or caregiver interviews where needed. Each patient was assigned one primary documented indication. Dyspepsia without objective evidence of an indication needing long-term therapy was recorded as a separate category, as were patients for whom no indication could be found. Documentation was graded as complete, partial but sufficient, or insufficient.

Ethics. No PPI was started, changed or stopped for research purposes. All treatment decisions remained with the treating physician. Patient confidentiality was maintained by assigning study codes.

Statistical analysis. Data were entered into Microsoft Excel and analysed with SPSS. Categorical variables were expressed as frequencies and percentages. Concurrent medicine categories were not mutually exclusive, so percentages for those categories were calculated against the total sample and do not sum to 100%. Proportions for key outcomes are reported with 95% confidence intervals (CI) calculated by the Wald method.

A total of 425 long-term PPI users were included in the analysis.

Table 1. Demographic and clinical characteristics of study participants (N = 425)

The largest group was aged 40–59 years (41.2%), and more than one-third (37.6%) were aged 60 years or older. Men made up 54.1% of the sample. Most long-term users (61.2%) were identified in outpatient clinics, showing that prolonged PPI therapy is largely an ambulatory issue.

Table 2. Distribution of PPIs prescribed (N = 425)

Pantoprazole was the most frequently prescribed agent (44.7%; 95% CI 40.0–49.4), followed by omeprazole (24.7%) and rabeprazole (15.3%). Esomeprazole and lansoprazole together accounted for 15.3% of prescriptions. Dexlansoprazole was not prescribed.

Table 3. Duration of PPI therapy (N = 425)

Almost one-third of patients (30.6%) had been on a PPI for between 8 weeks and 6 months. However, 42.4% (95% CI 37.7–47.1) had continued beyond 1 year, and 18.8% had been treated for more than 2 years.

Table 4. Documented indications for PPI therapy (N = 425)

GERD was the commonest documented indication (29.4%), followed by NSAID-associated prophylaxis (16.5%) and peptic ulcer disease (12.9%). Conditions that usually justify long-term therapy (previous upper GI bleeding and Barrett's esophagus or erosive esophagitis) together made up 14.1%. In contrast, 115 patients (27.1%; 95% CI 22.8–31.3) were receiving a PPI for dyspepsia without an established long-term indication (15.3%) or had no indication recorded (11.8%).

Table 5. Concurrent medicines relevant to gastrointestinal bleeding risk (N = 425)

Categories are not mutually exclusive; percentages do not total 100%.

Overall, 300 patients (70.6%) were taking at least one of these medicines. NSAIDs (34.1%) and aspirin (25.9%) were the most common. Other antiplatelets, systemic corticosteroids and anticoagulants were taken by 16.5%, 15.3% and 10.6% respectively. Fewer than one-third (29.4%) had no such exposure.

Table 6. Dosing frequency of PPIs (N = 425)

Once-daily dosing was the most common regimen (68.2%). Nearly one-third of patients (31.8%; 95% CI 27.4–36.2) received twice-daily or more frequent dosing, a level of acid suppression that guidelines reserve for selected indications.

This study found that long-term PPI use at our centre is concentrated on pantoprazole, often lasts more than a year, and in more than a quarter of patients rests on a weak or unrecorded indication. Most long-term users were middle-aged or older and were identified in outpatient clinics. This matches the pattern described by Heidelbaugh et al., in which therapy started in hospital or for transient symptoms is renewed in ambulatory care without reassessment [6].

Pantoprazole accounted for 44.7% of prescriptions. This agrees with other Indian tertiary care studies, although its share here was lower. Venkataraman et al. reported pantoprazole in about 76% of prescriptions [9], Juneja et al. in about 58% [10], and Zabiuddin Ahad et al. in about 90% of inpatients across South Indian hospitals [11]. Those studies were largely inpatient-based, where intravenous pantoprazole is the usual parenteral choice. Our inclusion of outpatients, in whom oral agents such as omeprazole and rabeprazole are widely available, may explain the wider spread of agents. Because clinical efficacy is broadly comparable at equivalent doses [1,3], choice of agent matters less than the indication, dose and duration.

Duration was the most striking finding: 42.4% had used PPIs for more than a year and 18.8% for more than two years. The 8-week threshold we used is the reassessment point proposed by Haastrup et al. [7]. Beyond it, current guidance expects a documented reason to continue or a trial of step-down [3,12]. In a Danish primary care cohort, Reimer and Bytzer verified an indication in only 27% of long-term users [15]. This suggests that continuation by default is common across health systems, not only in our setting.

GERD was the leading indication (29.4%), as in most utilization studies. A GERD label alone does not justify indefinite therapy, however. The ACG guideline advises a trial of discontinuation in patients without erosive disease or Barrett's esophagus [3]. The 15.3% treated for dyspepsia and the 11.8% with no documented indication are the clearest targets for review. AGA guidance recommends that patients without a definite chronic indication be considered for deprescribing [12].

More than two-thirds of patients were taking an NSAID, antiplatelet, anticoagulant or corticosteroid. These exposures can justify gastroprotection, but only when combined with other risk factors such as older age, prior ulcer or dual antithrombotic therapy. In the COMPASS trial, routine pantoprazole did not significantly reduce clinically important upper gastrointestinal events in patients on rivaroxaban and/or aspirin who were not selected for high risk [16]. Concurrent medication exposure should therefore prompt formal risk assessment rather than automatic, indefinite PPI therapy.

Nearly one-third of patients (31.8%) were on twice-daily or more frequent dosing. This is much higher than the 11% twice-daily rate reported in a South Indian inpatient survey [11]. High-dose regimens are appropriate for severe erosive disease, refractory symptoms or hypersecretory states, but many patients on twice-daily dosing can be stepped down once symptoms are controlled [12,13].

The study has limitations. It was conducted at a single centre, and its cross-sectional design cannot show how prescriptions changed over time. Duration and indication relied partly on records and patient recall. In addition, over-the-counter PPI use may have been under-captured. Its strengths are the inclusion of both outpatients and inpatients, an a priori sample size, and the retention of poorly documented cases, so that documentation quality could be reported rather than hidden.

Long-term PPI therapy at this tertiary care hospital is dominated by pantoprazole, frequently continues beyond one year, and is commonly given at more than once-daily frequency. More than one in four long-term users were treated for dyspepsia without an established long-term indication or had no indication recorded. Most were also taking medicines that affect bleeding risk, which should prompt formal risk assessment rather than automatic continuation. Recording the indication, intended duration and review date on every PPI prescription, together with scheduled medication review, could reduce unnecessary long-term exposure. The appropriateness of these prescriptions against evidence-based criteria is examined in a companion analysis.

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