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Observational study of upper gastrointestinal tract bleeding events in patients taking duloxetine and nonsteroidal anti-inflammatory drugs: a case-control analysis.

Li H, Cheng Y, Ahl J, Skljarevski V - Drug Healthc Patient Saf (2014)

Bottom Line: To determine whether the concomitant use of duloxetine with prescription nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin was associated with an increased risk for upper gastrointestinal (UGI) bleeding compared with taking these analgesics alone.Comparing exposure group 2 and group 4, the adjusted odds ratio was 1.03 (95% confidence interval [CI], 0.94, 1.12), and the adjusted relative excess risk due to interaction was 0.352 (95% CI: -0.18, 0.72) for risk of UGI bleeding, neither of which support an increased risk or an interaction between duloxetine and prescription NSAID or aspirin for these events.In addition, there was no evidence of an interaction between duloxetine and prescription NSAIDs or aspirin for an increased risk of these events.

View Article: PubMed Central - PubMed

Affiliation: Neurosciences, Eli Lilly and Company, Indianapolis, IN, USA.

ABSTRACT

Purpose: To determine whether the concomitant use of duloxetine with prescription nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin was associated with an increased risk for upper gastrointestinal (UGI) bleeding compared with taking these analgesics alone.

Methods: Truven Health Analytics MarketScan Research Databases were examined for hospital admissions of adult patients indexed from January 1, 2007-December 31, 2011. Cases were patients with UGI hemorrhage or peptic ulcer disease. Controls were randomly selected from the remaining admissions to match 10:1 with cases based on age, sex, and admission date. Prescription medication exposure groups of interest were: 1) no exposure to duloxetine, NSAIDs or aspirin; 2) duloxetine only; 3) NSAIDs or aspirin only; 4) duloxetine plus NSAIDs or aspirin. Logistic regression and relative excess risk due to interaction was utilized to estimate any increased risk of UGI bleeding for patients prescribed these medications across these groups.

Results: There were 33,571 cases and 335,710 controls identified. Comparing exposure group 2 and group 4, the adjusted odds ratio was 1.03 (95% confidence interval [CI], 0.94, 1.12), and the adjusted relative excess risk due to interaction was 0.352 (95% CI: -0.18, 0.72) for risk of UGI bleeding, neither of which support an increased risk or an interaction between duloxetine and prescription NSAID or aspirin for these events.

Conclusion: There was no evidence of an increased risk for UGI bleeding when duloxetine was taken with prescription NSAIDs or aspirin. In addition, there was no evidence of an interaction between duloxetine and prescription NSAIDs or aspirin for an increased risk of these events.

No MeSH data available.


Related in: MedlinePlus

Selection of study population.Abbreviations: NSAIDs, nonsteroidal anti-inflammatory drugs; SNRI, serotonin norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; THAM, Truven Health Analytics MarketScan; UGI, upper gastrointestinal.
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f1-dhps-6-167: Selection of study population.Abbreviations: NSAIDs, nonsteroidal anti-inflammatory drugs; SNRI, serotonin norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; THAM, Truven Health Analytics MarketScan; UGI, upper gastrointestinal.

Mentions: The selection of the study population is summarized in Figure 1. The study cohort included all adult patients listed in the THAM database from January 1, 2007–December 31, 2011. Encounters up to 12 months prior to each index admission were searched to identify comorbid conditions, and a 3-month window following the index date captured the inpatient length of stay and any acute postindex events. Therefore, the index of hospital admissions of the study population was between January 1, 2008–September 30, 2011. Patients were excluded if they had: esophageal varices, Mallory–Weiss syndrome, alcoholism, chronic liver disease, coagulopathies, and malignant neoplasms; were pregnant; or had a major organ transplant. Approximately 2,272 cases were estimated to provide 80% power to detect a combined additive effect of exposure to duloxetine and concomitant NSAIDs or aspirin for UGI bleeding events.


Observational study of upper gastrointestinal tract bleeding events in patients taking duloxetine and nonsteroidal anti-inflammatory drugs: a case-control analysis.

Li H, Cheng Y, Ahl J, Skljarevski V - Drug Healthc Patient Saf (2014)

Selection of study population.Abbreviations: NSAIDs, nonsteroidal anti-inflammatory drugs; SNRI, serotonin norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; THAM, Truven Health Analytics MarketScan; UGI, upper gastrointestinal.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4222172&req=5

f1-dhps-6-167: Selection of study population.Abbreviations: NSAIDs, nonsteroidal anti-inflammatory drugs; SNRI, serotonin norepinephrine reuptake inhibitor; SSRI, selective serotonin reuptake inhibitor; THAM, Truven Health Analytics MarketScan; UGI, upper gastrointestinal.
Mentions: The selection of the study population is summarized in Figure 1. The study cohort included all adult patients listed in the THAM database from January 1, 2007–December 31, 2011. Encounters up to 12 months prior to each index admission were searched to identify comorbid conditions, and a 3-month window following the index date captured the inpatient length of stay and any acute postindex events. Therefore, the index of hospital admissions of the study population was between January 1, 2008–September 30, 2011. Patients were excluded if they had: esophageal varices, Mallory–Weiss syndrome, alcoholism, chronic liver disease, coagulopathies, and malignant neoplasms; were pregnant; or had a major organ transplant. Approximately 2,272 cases were estimated to provide 80% power to detect a combined additive effect of exposure to duloxetine and concomitant NSAIDs or aspirin for UGI bleeding events.

Bottom Line: To determine whether the concomitant use of duloxetine with prescription nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin was associated with an increased risk for upper gastrointestinal (UGI) bleeding compared with taking these analgesics alone.Comparing exposure group 2 and group 4, the adjusted odds ratio was 1.03 (95% confidence interval [CI], 0.94, 1.12), and the adjusted relative excess risk due to interaction was 0.352 (95% CI: -0.18, 0.72) for risk of UGI bleeding, neither of which support an increased risk or an interaction between duloxetine and prescription NSAID or aspirin for these events.In addition, there was no evidence of an interaction between duloxetine and prescription NSAIDs or aspirin for an increased risk of these events.

View Article: PubMed Central - PubMed

Affiliation: Neurosciences, Eli Lilly and Company, Indianapolis, IN, USA.

ABSTRACT

Purpose: To determine whether the concomitant use of duloxetine with prescription nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin was associated with an increased risk for upper gastrointestinal (UGI) bleeding compared with taking these analgesics alone.

Methods: Truven Health Analytics MarketScan Research Databases were examined for hospital admissions of adult patients indexed from January 1, 2007-December 31, 2011. Cases were patients with UGI hemorrhage or peptic ulcer disease. Controls were randomly selected from the remaining admissions to match 10:1 with cases based on age, sex, and admission date. Prescription medication exposure groups of interest were: 1) no exposure to duloxetine, NSAIDs or aspirin; 2) duloxetine only; 3) NSAIDs or aspirin only; 4) duloxetine plus NSAIDs or aspirin. Logistic regression and relative excess risk due to interaction was utilized to estimate any increased risk of UGI bleeding for patients prescribed these medications across these groups.

Results: There were 33,571 cases and 335,710 controls identified. Comparing exposure group 2 and group 4, the adjusted odds ratio was 1.03 (95% confidence interval [CI], 0.94, 1.12), and the adjusted relative excess risk due to interaction was 0.352 (95% CI: -0.18, 0.72) for risk of UGI bleeding, neither of which support an increased risk or an interaction between duloxetine and prescription NSAID or aspirin for these events.

Conclusion: There was no evidence of an increased risk for UGI bleeding when duloxetine was taken with prescription NSAIDs or aspirin. In addition, there was no evidence of an interaction between duloxetine and prescription NSAIDs or aspirin for an increased risk of these events.

No MeSH data available.


Related in: MedlinePlus