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Table 3 Summary of gastroprotection in clinical practice

From: Nonsteroidal anti-inflammatory drugs (NSAIDs), cyxlooxygenase-2 selective inhibitors (coxibs) and gastrointestinal harm: review of clinical trials and clinical practice

Reference Study design Population Main outcomes Main results
Adherence and appropriateness of gastroprotection prescribing
Sturkenboom et al. Aliment Pharm Ther 2003 18: 1137–1147 Holland [36] Retrospective cohort study using primary care database between 1997 and 2003 Patients aged ≥18 years with 12 months data in database (382,000 patients; 80,000 users of NSAIDs) Adherence to gastroprotective agents Of 65,190 patients taking NSAIDs, 784 had PPI or H2A, in about equal numbers. Patients prescribed gastroprotection were significantly older, had more risk factors, and had more cardiovascular disease
85% of H2A prescriptions were below recommended dose
31% of patients receiving PPI were non-adherent intially, but only about 40% took PPI long term
Appropriateness of gastroprotection prescribing
Smalley et al. Arthritis Rheum 2002 46: 2195–2200 USA [37] Retrospective cohort study using Medicaid database during 1999–2000 Patients aged ≥ 50 years, with 12 months data, filled one NSAID prescription (319,000, of whom 107,000 received at least one NSAID prescription) Frequency of use of gastroprotective measures according to NSAID use and risk factors Recommended gastroprotection in 9% of patients with one risk factor, 11% of those with two risk factors. Most patients had no gastroprotection, whilst about 25% had inadequate gastroprotection.
No information about adherence
Pilotto et al. Drugs Aging 2003 20:701–710 Italy [38] Prospective study of drug use by patients aged ≥ 65 years. 3,200 patients of 63 randomly chosen general practitioners, in 1999 Patients aged ≥ 65 years Of 3,200 patients, 800 prescribed NSAID Use of prescribed medicines NSAID and high-dose aspirin prescribed for 25% of patients
Use of GI protective drugs was 24% of NSAID users with at least one risk factor by virtue of age, slightly higher than for non users of NSAIDs
No information about adherence
Sturkenboom et al. Rheumatology 2003 42 (Suppl 3):iii23–iii31 Holland [39] Retrospective cohort study using primary care database between 1997 and 2002 Patients aged ≥18 years with 12 months data in database (382,000 patients; 80,000 users of NSAIDs) Prevalence of prophylactic gastro-protective strategies, and association with risk factors In patients with at least one risk factor, 87% had no gastroprotective strategy
Proportion with no gastroprotection reduced over time
No information about adherence
Hartnell et al, Am J Geriatr Pharmacother 2004 2: 171–180 Canada [40] Retrospective cross-sectional study of pharmacy database for older people, 2001–2002 Patients aged ≥ 65 years with 12 months data who filled prescription for NSAID, coxib, or high-dose aspirin (14,600 older patients using NSAID or coxib) Use of gastroprotective strategies Of 11,000 NSAID users, 14% received gastroprotection Of 3,600 coxib users, 5% received gastroprotection Gastroprotection not used in 65%
NSAID alone used in 67% of patients with only age as a risk factor, falling to 63% with one additional, and 52% with two additional risk factors
No information about adherence
Dominick et al. Ann Pharmacother 2004 38: 1159–1164 USA [41] Retrospective cohort study of sample of 4,338 veterans with GI bleeding in 1999 Patients had ICD code for GI ulceration or bleeding. Veterans were predominantly male, 50% aged 65 years or older Use of gastroprotective strategies and prescribing NSAIDs in six months following event 1% prescribed coxib
20% prescribed NSAID; of these 75% prescribed gastroprotection, 25% no gastroprotection
No information about adherence
Herings & Goettsch. Ann Pharmacother 2004 38: 760–763 Holland [42] Nested case control analysis of database (1 million people; 10,000 patients included), 2000 to 2001 Patients had to have at least two prescriptions for NSAID, with total duration > 100 days Adequate gastroprotection (> 400 μg misoprostol; ≥ 2 times recommended dose of H2A; ≥ 1 times recommended dose of PPI) One or more gastroprotective strategies used in 43% of NSAID users.
Of these 65% were adequate, and 35% inadequate Use of gastroprotection was linked to having 2 or more risk factors, history of ulcers, and older age
25% of NSAID users were also taking anticoagulants, corticosteroids, or low dose aspirin
No information about adherence
Sebaldt et al. Am J Manag Care 2004 10:742–750 Canada [43] Cross-sectional study of 5,459 patients of 119 physicians Primary care physicians with hgih volume NSAID prescribing practices. OA patients had to be prescribed an NSAID Adherence to appropriate prescribing of coxibs and NSAIDs, with or without gastroprotection In patients with no GI risk factors (39% of total), 33% of prescribing was appropriate
In patients with at least one GI risk factor (61% of total), 74% of prescribing was appropriate
More use of coxibs with prior bleed, more severe pain, or with concomitant warfarin
Abraham et al. Gastroenterol 2005 129: 1171–1178 USA [44] Cross-sectional study of database, linked to other files (707,000 NSAID users, 303,000 high risk patients), 2002 Various definitions of high gastrointestinal risk, including age ≥ 65 years Adherence to gastroprotection guidelines 43% of NSAID users were at high risk of GI complications
73% of these not prescribed gastroprotection
27% of these prescribed gastroprotection (18% NSAID plus PPI, 9% coxib)
Greater gastroprotection use with two or more risk factors
Predictors of gastroprotection were previous upper gastrointestinal event, anticoagulant use, aspirin use, rheumatological disease
Thompson et al. Rheumatology 2005 44:1308–1310 UK [45] Cross-sectional survey of primary care practice 7,598 patients in practice in total 267 patients receiving repeat prescriptions for coxib or NSAID 204 NSAID 63 coxib Prescribing according to NICE guidance 69% NSAID users had one or more GI risk factors; antacids prescribed in 24% of those with a risk factor 74% coxib users had one or more GI risk factors; antacids prescribed in 6% of those with a risk factor
Price-Forbes et al. Rheumatology 2005 44:921–924 UK [46] Questionnaire survey of all patients attending clinics in 18 rheumatology units over 2 weeks 2,846 patients, of whom 791 were taking NSAIDs and 373 coxibs. 65% of users had diagnosis of OA or RA Prescribing according to GI risk factors Of NSAID users, 92% had at least one GI risk factor (mostly prolonged use, and age ≥ 65 years); only 8% received appropriate treatment. Gastroprotective drug prescribed for 191 patients (24%), of which 56% were PPI
Of coxib users, 97% of prescribing was appropriate, with 77 (21%) taking gastroprotective drug
Pilotto et al. Aliment Pharmacol Ther 2005 22: 147–155 Italy [[47] Prospective study of drug use by patients aged ≥ 65 years. 5,500 patients of 133 general practitioners, in 2003 Patients aged ≥ 65 years Use of prescribed NSAIDs, and GI symptoms NSAID use in 6%
Coxib use in 3%
New prescriptions for drugs for acid-related disorders in 13% of NSAID users, 6% of coxib users
No information on adherence
General information about gastroprotection prescribing
Schnitzer et al. Clin Ther 2001 23: 1984–1998 USA [48] Retrospective analysis of prescription database for 1998. 3 million new users of NSAIDs At least one NSAID prescription during 1998, and no use in prior 120 days (< 30 days acute; > 30 days chronic); 34% of chronic users 60 years or older Use of gastroprotective medicines, by NSAID In 1.4 million chronic users, the mean prescription was for 67 days supply.
Gastroprotection was prescribed for 14%, covering 22% of NSAID days
No information about risk factors or adherence
Teeling et al. Br J Clin Pharmacol 2004 57: 337–343 Ireland [49] Retrospective analysis of prescription database, 2000–2001 (1.2 million people). About 25,000 NSAID/coxib users Patients aged 16 years or older prescribed an NSAID Use of gastroprotective medicines, by NSAID No gastroprotection in about 80%. PPI used in about 15%. Use of PPI higher with coxibs than with non-selective NSAIDs. Coxibs much more likely to be prescribed in over 65s. No information about risk factors or adherence
Pilotto et al. Aliment Pharmacol Ther 2005 22: 147–155 Italy [47] Prospective study of drug use by patients aged ≥ 65 years. 5,500 patients of 133 general practitioners, in 2003 Patients aged ≥ 65 years Use of prescribed NSAIDS, and GI symptoms Non-selective NSAID use in 6%
Coxibs use in 3%
New prescriptions of drugs for acid-related disorders in 13% of NSAID users, 6% of coxib users
No information about adherence