s-1743 and Respiratory-Tract-Infections

Debate continues on whether a causal association exists between the use of proton pump inhibitors (PPIs) and the risk of respiratory tract infections, in particular pneumonia.. To investigate the occurrence of community-acquired respiratory tract infections, including pneumonia, in patients receiving esomeprazole.. A retrospective investigation of pooled data on adverse events related to respiratory tract infections, originally reported in 24 randomised, double-blind clinical studies, was conducted. The frequencies of respiratory tract infections and their relative risks were calculated retrospectively for the total patient population (9602 patients receiving esomeprazole and 5500 receiving placebo) and for sub-populations defined according to sex, age, esomeprazole dose, indication and geographical region. The cumulative frequency of first occurrence of events was calculated over 180 days.. Frequencies of respiratory tract infections were similar in patients receiving esomeprazole and in those receiving placebo (any respiratory tract infection or signs/symptoms potentially indicating an respiratory tract infection, 0.278 and 0.296 patients per patient-year; lower respiratory tract infections, 0.048 and 0.058 per patient-year; pneumonia, 0.006 and 0.009 per patient-year, respectively). The relative risk for any respiratory tract infection in patients receiving esomeprazole compared with placebo was 0.94 (95% CI, 0.86-1.04). For lower respiratory tract infections, the relative risk was 0.82 (95% CI, 0.65-1.03) and for pneumonia, 0.66 (95% CI, 0.36-1.22). Sub-analyses by demographics, dose and indication yielded similar results to the overall analysis. The occurrence of respiratory tract infections was evenly distributed over time and similar in the esomeprazole and placebo groups.. There is no causal association between treatment with esomeprazole and the occurrence of community-acquired respiratory tract infections, including pneumonia.

Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Child; Child, Preschool; Community-Acquired Infections; Dose-Response Relationship, Drug; Double-Blind Method; Esomeprazole; Female; Humans; Infant; Male; Middle Aged; Pneumonia; Proton Pump Inhibitors; Respiratory Tract Infections; Retrospective Studies; Sex Factors; Young Adult

A potential causal association between an increase in gastric pH and a risk of community-acquired respiratory tract infection (RTI), specifically pneumonia, has been debated in relation to the use of potent gastric acid-suppressive medication.. To investigate the occurrence of community-acquired RTI, including pneumonia, in patients receiving esomeprazole versus placebo and other acid-suppressive agents in randomized clinical trials.. The AstraZeneca ARIADNE safety database was searched for comparative, controlled phase II-IV randomized, blinded clinical studies with esomeprazole and standard reporting of all adverse events (AEs). Pooled AE data were presented according to treatment comparison (esomeprazole versus placebo, esomeprazole 40 mg versus 20 mg daily, esomeprazole versus omeprazole, lansoprazole and/or ranitidine, respectively). Frequency and relative risk (RR), with 99% confidence interval (CI) and adjustment for time on treatment, were calculated for the following four AE categories: all RTIs; signs and symptoms potentially indicating RTI; lower RTI; and pneumonia.. Thirty-one studies were identified, in which 16 583 patients received esomeprazole and 12 044 patients received either placebo or comparator acid-suppressive drugs. The occurrence of all four categories of AEs was similar between esomeprazole and placebo (all RTIs: 9.2% versus 8.5%; signs and symptoms of RTI: 1.8% versus 1.8%; lower RTI: 1.6% versus 1.5%; and pneumonia: 0.2% in both groups). The RR estimates were as follows: all RTIs, 0.93 (99% CI 0.78, 1.11); signs and symptoms of RTI, 0.85 (99% CI 0.57, 1.27); lower RTI, 0.92 (99% CI 0.59, 1.42); and pneumonia, 0.94 (99% CI 0.29, 3.07). The distribution of RTIs by patient sex and age showed a similar pattern in esomeprazole and placebo-treated patients. The comparisons of esomeprazole with the other comparator acid-suppressive drugs showed a similar pattern with only minor numerical differences in the occurrence of RTI between the drugs. There were no significant between-group differences with esomeprazole versus placebo for all four categories of AEs according to esomeprazole dosage, treatment indication and duration of treatment.. This pooled analysis found no causal association between acid-suppressive therapy with esomeprazole and increased risk of community-acquired RTI, including pneumonia, in patients receiving this agent for gastric acid-related disorders.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Community-Acquired Infections; Esomeprazole; Female; Humans; Male; Middle Aged; Omeprazole; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Retrospective Studies; Young Adult