Meta‐analysis: incidence of endoscopic gastric and duodenal ulcers in placebo arms of randomized placebo‐controlled NSAID trials
Summary Background The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials. Aim To investigate the incidence of gastric and duodenal ulcers (GDU) in placebo arms in NSAID trials over the last three decades. Methods Randomized placebo‐controlled trials of oral NSAIDs...
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| Published in | Alimentary pharmacology & therapeutics Vol. 30; no. 3; pp. 197 - 209 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford, UK
Blackwell Publishing Ltd
01.08.2009
Blackwell |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0269-2813 1365-2036 1365-2036 |
| DOI | 10.1111/j.1365-2036.2009.04038.x |
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| Abstract | Summary
Background The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials.
Aim To investigate the incidence of gastric and duodenal ulcers (GDU) in placebo arms in NSAID trials over the last three decades.
Methods Randomized placebo‐controlled trials of oral NSAIDs from 1975 to 2006 were systematically reviewed. The pooled incidence of GDU in placebo arms was calculated and compared. Meta‐regression was used to identify risk factors related to the incidence of the placebo ulcer at the study level.
Results Thirty‐six studies met inclusion criteria (duration of 6.5 days to 24 weeks). In total, 3.29% GDUs were reported in 36 placebo arms. The incidence of GDU in placebo arms was 0, 4.20% and 3.03% in the studies from 1975–1989, 1990–1999 and 2000–2006 respectively (P > 0.05). Eligible subjects with previous GI events and eligible subjects on co‐therapy with low‐lose aspirin/corticosteroids were associated with the increase in placebo ulcer incidence after adjusting for other factors.
Conclusions The incidence of GDU in placebo arms has not changed significantly over the last three decades, although has decreased in the past 10 years. Studies show that previous GI events and co‐therapy with low‐dose aspirin/corticosteroids were associated with increasing GDU in placebo arms. |
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| AbstractList | The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials.
To investigate the incidence of gastric and duodenal ulcers (GDU) in placebo arms in NSAID trials over the last three decades.
Randomized placebo-controlled trials of oral NSAIDs from 1975 to 2006 were systematically reviewed. The pooled incidence of GDU in placebo arms was calculated and compared. Meta-regression was used to identify risk factors related to the incidence of the placebo ulcer at the study level.
Thirty-six studies met inclusion criteria (duration of 6.5 days to 24 weeks). In total, 3.29% GDUs were reported in 36 placebo arms. The incidence of GDU in placebo arms was 0, 4.20% and 3.03% in the studies from 1975-1989, 1990-1999 and 2000-2006 respectively (P > 0.05). Eligible subjects with previous GI events and eligible subjects on co-therapy with low-lose aspirin/corticosteroids were associated with the increase in placebo ulcer incidence after adjusting for other factors.
The incidence of GDU in placebo arms has not changed significantly over the last three decades, although has decreased in the past 10 years. Studies show that previous GI events and co-therapy with low-dose aspirin/corticosteroids were associated with increasing GDU in placebo arms. Summary Background The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials. Aim To investigate the incidence of gastric and duodenal ulcers (GDU) in placebo arms in NSAID trials over the last three decades. Methods Randomized placebo‐controlled trials of oral NSAIDs from 1975 to 2006 were systematically reviewed. The pooled incidence of GDU in placebo arms was calculated and compared. Meta‐regression was used to identify risk factors related to the incidence of the placebo ulcer at the study level. Results Thirty‐six studies met inclusion criteria (duration of 6.5 days to 24 weeks). In total, 3.29% GDUs were reported in 36 placebo arms. The incidence of GDU in placebo arms was 0, 4.20% and 3.03% in the studies from 1975–1989, 1990–1999 and 2000–2006 respectively (P > 0.05). Eligible subjects with previous GI events and eligible subjects on co‐therapy with low‐lose aspirin/corticosteroids were associated with the increase in placebo ulcer incidence after adjusting for other factors. Conclusions The incidence of GDU in placebo arms has not changed significantly over the last three decades, although has decreased in the past 10 years. Studies show that previous GI events and co‐therapy with low‐dose aspirin/corticosteroids were associated with increasing GDU in placebo arms. The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials.BACKGROUNDThe safety of NSAIDs is often evaluated by comparison with placebo in clinical trials.To investigate the incidence of gastric and duodenal ulcers (GDU) in placebo arms in NSAID trials over the last three decades.AIMTo investigate the incidence of gastric and duodenal ulcers (GDU) in placebo arms in NSAID trials over the last three decades.Randomized placebo-controlled trials of oral NSAIDs from 1975 to 2006 were systematically reviewed. The pooled incidence of GDU in placebo arms was calculated and compared. Meta-regression was used to identify risk factors related to the incidence of the placebo ulcer at the study level.METHODSRandomized placebo-controlled trials of oral NSAIDs from 1975 to 2006 were systematically reviewed. The pooled incidence of GDU in placebo arms was calculated and compared. Meta-regression was used to identify risk factors related to the incidence of the placebo ulcer at the study level.Thirty-six studies met inclusion criteria (duration of 6.5 days to 24 weeks). In total, 3.29% GDUs were reported in 36 placebo arms. The incidence of GDU in placebo arms was 0, 4.20% and 3.03% in the studies from 1975-1989, 1990-1999 and 2000-2006 respectively (P > 0.05). Eligible subjects with previous GI events and eligible subjects on co-therapy with low-lose aspirin/corticosteroids were associated with the increase in placebo ulcer incidence after adjusting for other factors.RESULTSThirty-six studies met inclusion criteria (duration of 6.5 days to 24 weeks). In total, 3.29% GDUs were reported in 36 placebo arms. The incidence of GDU in placebo arms was 0, 4.20% and 3.03% in the studies from 1975-1989, 1990-1999 and 2000-2006 respectively (P > 0.05). Eligible subjects with previous GI events and eligible subjects on co-therapy with low-lose aspirin/corticosteroids were associated with the increase in placebo ulcer incidence after adjusting for other factors.The incidence of GDU in placebo arms has not changed significantly over the last three decades, although has decreased in the past 10 years. Studies show that previous GI events and co-therapy with low-dose aspirin/corticosteroids were associated with increasing GDU in placebo arms.CONCLUSIONSThe incidence of GDU in placebo arms has not changed significantly over the last three decades, although has decreased in the past 10 years. Studies show that previous GI events and co-therapy with low-dose aspirin/corticosteroids were associated with increasing GDU in placebo arms. Background The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials. Aim To investigate the incidence of gastric and duodenal ulcers (GDU) in placebo arms in NSAID trials over the last three decades. Methods Randomized placebo‐controlled trials of oral NSAIDs from 1975 to 2006 were systematically reviewed. The pooled incidence of GDU in placebo arms was calculated and compared. Meta‐regression was used to identify risk factors related to the incidence of the placebo ulcer at the study level. Results Thirty‐six studies met inclusion criteria (duration of 6.5 days to 24 weeks). In total, 3.29% GDUs were reported in 36 placebo arms. The incidence of GDU in placebo arms was 0, 4.20% and 3.03% in the studies from 1975–1989, 1990–1999 and 2000–2006 respectively ( P > 0.05). Eligible subjects with previous GI events and eligible subjects on co‐therapy with low‐lose aspirin/corticosteroids were associated with the increase in placebo ulcer incidence after adjusting for other factors. Conclusions The incidence of GDU in placebo arms has not changed significantly over the last three decades, although has decreased in the past 10 years. Studies show that previous GI events and co‐therapy with low‐dose aspirin/corticosteroids were associated with increasing GDU in placebo arms. |
| Author | WANG, C. HUNT, R. H. YUAN, Y.‐H. YUAN, Y. |
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| CitedBy_id | crossref_primary_10_1002_pds_1846 crossref_primary_10_1097_MOG_0b013e32833e91eb crossref_primary_10_1111_j_1365_2036_2009_04120_x crossref_primary_10_2147_JPR_S440802 crossref_primary_10_1186_ar4176 crossref_primary_10_1016_j_cgh_2011_12_036 crossref_primary_10_1038_nrgastro_2015_117 crossref_primary_10_1186_1471_230X_13_54 crossref_primary_10_1136_gutjnl_2013_304722 crossref_primary_10_1159_000365248 crossref_primary_10_3389_fpsyt_2020_00797 crossref_primary_10_1111_j_1365_2036_2009_04108_x crossref_primary_10_1111_j_1443_1661_2012_01334_x |
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| Keywords | Duodenal ulcer Gastric ulcer Epidemiology Incidence Metaanalysis Non steroidal antiinflammatory agent Randomization Placebo Digestive diseases Intestinal disease Clinical trial Endoscopy Arm |
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Background The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials.
Aim To investigate the incidence of gastric and... Background The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials. Aim To investigate the incidence of gastric and duodenal... The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials. To investigate the incidence of gastric and duodenal ulcers (GDU) in... The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials.BACKGROUNDThe safety of NSAIDs is often evaluated by comparison with... |
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| SubjectTerms | Adolescent Adult Aged Aged, 80 and over Anti-Inflammatory Agents, Non-Steroidal - adverse effects Anti-Ulcer Agents - adverse effects Biological and medical sciences Digestive system Double-Blind Method Duodenal Ulcer - chemically induced Duodenal Ulcer - epidemiology Endoscopy Female Gastroenterology. Liver. Pancreas. Abdomen Humans Incidence Male Medical sciences Middle Aged Other diseases. Semiology Pharmacology. Drug treatments Randomized Controlled Trials as Topic Risk Factors Stomach Ulcer - chemically induced Stomach Ulcer - epidemiology Stomach. Duodenum. Small intestine. Colon. Rectum. Anus Young Adult |
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| Title | Meta‐analysis: incidence of endoscopic gastric and duodenal ulcers in placebo arms of randomized placebo‐controlled NSAID trials |
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