Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs

Abstract

Objective To compare rates of upper gastrointestinal haemorrhage among elderly patients given selective cyclo-oxygenase-2 (COX 2) inhibitors and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). Design Observational cohort study. Setting Administrative data from Ontario,

Individual NSAIDs and Upper Gastrointestinal Complications

“…Selected characteristics of the 28 studies included in the meta-analysis are summarized in table I; 3 studies were cohort studies,[20,24,26] 10 were nested case-control studies,[7,11,17–19,23,25,33,35,67] and 15 were case-control studies. [12–16,21,22,27–32,34,68] Twelve studies, all case-control studies, were field studies collecting individual information by standardized questionnaires.…”

“…Six studies conducted in healthcare databases did not conduct any validation of the cases identified. [14,17–20,68] Sixteen studies reported aggregate results for patients with and without a history of UGIC,[7,12–14,16,20–23,28,31–34,67,68] and 12 provided results for patients without a history of UGIC;[11,15,17–19,24–27,29,30,35] the remaining study was a case-crossover study. [14] Most studies excluded subjects with a history of a known cause of UGIC, including the use of gastrotoxic medications and life-threatening diseases (table II).…”

“…Four studies did not have any exclusion criteria. [20,22,28,34] Among the 14 case-control studies, seven included hospital controls;[12,13,16,21,29–31] five included both hospital and community controls;[22,27,28,32,34] one included community controls;[15] and two were case-crossover studies. [14,68] All case-control studies were matched on age, sex (except one study[16]), hospital or geographic area, and index date.…”

“…Three of the case-control studies with hospital and community controls estimated separate results for each set of controls;[22,28,34] as results between the two sets were similar, we included in the meta-analysis results reported using hospital controls. In cohort studies, current use of NSAIDs was defined as the time covered by each prescription,[20,24] and one study extended the coverage by 15 days. [26] Most case-control studies defined current use of NSAIDs as any use ending at the index date or within 7 days before the index date.…”

“…A few case-control studies considered current use as that ending up to 30 days[11,13,17,19,28,35] or 90 days[18] before the index date. Two cohort studies focused on new users of NSAIDs,[20,26] and one nested case-control study provided results for both new users and all users (incident and prevalent) of NSAIDs. [17] In addition to age and sex, the most frequent confounders considered were a history of peptic ulcer (21 studies),[7,11,15–31,35,67] smoking (13 studies),[7,11,15,18,20,21,23,27–32] alcohol use (9 studies),[7,15,19,21,27,28,30–32] use of proton-pump inhibitors and anti-ulcer medications (11 studies),[16–23,30,67,68] and concurrent use of medications increasing the risk of UGIC (16 studies).…”