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Suboptimal Prescribing of Proton-Pump Inhibitors in Low-Dose Aspirin Users: a Cohort Study in Primary Care

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Suboptimal Prescribing of Proton-Pump Inhibitors in Low-Dose Aspirin Users: a Cohort Study in Primary Care Open Access Research BMJ Open: first published as 10.1136/bmjopen-2013-003044 on 24 July 2013. Downloaded from Suboptimal prescribing of proton-pump inhibitors in low-dose aspirin users: a cohort study in primary care Hilda J I de Jong,1 Joke C Korevaar,1 Liset van Dijk,1 Eef Voogd,1 Christel E van Dijk,1 Martijn G H van Oijen2,3 To cite: de Jong HJI, ABSTRACT et al ARTICLE SUMMARY Korevaar JC, van Dijk L, . Objective: Determine the adherence to Suboptimal prescribing of recommendations of concomitant proton-pump proton-pump inhibitors in Article focus inhibitor (PPI) treatment in regular low-dose of aspirin low-dose aspirin users: ▪ Low-dose of aspirin (LDASA) use is associated a cohort study in primary (LDASA) users, taking factors associated with the with a wide variety of gastrointestinal (GI) side care. BMJ Open 2013;3: probability of receiving a PPI into account. effects. e003044. doi:10.1136/ Design: Cohort study. ▪ Concomitant use of proton-pump inhibitor bmjopen-2013-003044 Setting: Data were obtained from 120 Dutch primary (PPIs) for patients who are at increased risk for care centres participating in the Netherlands GI complications is advised. ▸ Prepublication history and Information Network of Primary Care (LINH). ▪ Adherence and persistence of PPI use in primary additional material for this Participants: Patients 18 years and older who care of patients using LDASA frequently is still paper is available online. To were regularly prescribed LDASA (30–325 mg) in indefinite. view these files please visit 2008–2010 were included. Key messages the journal online Main outcome measures: Regular medication (http://dx.doi.org/10.1136/ ▪ Primary care physicians do not fully adhere to the use was defined as receiving each consecutive bmjopen-2013-003044). current recommendations to prescribe PPIs regu- prescription within 6 months after the previous one. larly to LDASA users with an increased GI risk. Based on national guidelines, we categorised LDASA Received 12 April 2013 ▪ Concomitant regular use of PPI with LDASA in users into low and high gastrointestinal (GI) risk. A Revised 11 June 2013 patients with an increased GI risk was 46% in Accepted 25 June 2013 multilevel multivariable logistic regression analysis primary care. was applied to identify patient characteristics that http://bmjopen.bmj.com/ ▪ Thirty-six per cent of the LDASA users with an influenced on the probability of regular PPI increased GI risk and treated in primary care, prescriptions. obtained no PPI prescriptions, and 18% obtained Results: We identified 12 343 patients who started prescriptions irregular. LDASA treatment, of whom 3213 (26%) were at increased risk of GI complications. In this group, Strengths and limitations of this study concomitant regular use of PPI was 46%, 36% did not ▪ Large representative sample of patients moni- receive PPI prescriptions and 18% obtained tored in daily practice in primary care. prescriptions irregularly (p<0.0001). The chance to ▪ No information was available why patients with on October 1, 2021 by guest. Protected copyright. obtain regularly PPI prescriptions versus no PPI was an increased GI risk did not obtain PPI prescrip- significantly influenced by, among others, previous GI tions, or why they became an irregular PPI user. complications (OR 13.9 (95% CI 11.8 to 16.4)), use of non-steroidal anti-inflammatory drugs (OR 5.2 (4.3 to 1 6.3)), glucocorticosteroids (6.1 (4.6 to 8.0)), selective NIVEL, Netherlands Institute INTRODUCTION for Health Services Research, serotonin reuptake inhibitors (9.1 (6.7 to 12.2)), drugs Utrecht, The Netherlands for functional GI disorders (2.4 (1.9 to 3.0)) and Worldwide, the number of deaths from car- 2Division of Digestive increased age. diovascular disease was estimated at 17.3 Diseases, David Geffen Conclusions: Primary care physicians do not fully million in 2008, and it is expected to increase School of Medicine, UCLA, adhere to the current recommendations to prescribe to approximately 23.6 million by 2030.1 Los Angeles, California, USA PPIs regularly to LDASA users with an increased GI 3 Treatment with low-dose of aspirin (LDASA) Department of Medicine, risk. More than 50% of the patients with an increased UCLA/VA Center for is recommended for the prevention of cardio- GI risk are not treated sufficiently with a concomitant Outcomes Research and vascular events in patients with a history of PPI, increasing the risk of GI side effects. This finding Education (CORE), Los myocardial infarction, stroke, transient ischae- underlines the necessity to consider merging – Angeles, California, USA mic attack or (in)stable angina.2 4 While recommendations into one common, standard and LDASA use is associated with a decreased risk Correspondence to frequently used recommendation by primary care 5 Joke C Korevaar; physicians. of cardiovascular events, its use is also asso- [email protected] ciated with a wide variety of gastrointestinal de Jong HJI, Korevaar JC, van Dijk L, et al. BMJ Open 2013;3:e003044. doi:10.1136/bmjopen-2013-003044 1 Suboptimal prescribing of PPIs in LDASA users in primary care BMJ Open: first published as 10.1136/bmjopen-2013-003044 on 24 July 2013. Downloaded from (GI) side effects, such as dyspepsia, peptic ulcers and and registration is still on-going.22 In the Netherlands, upper and lower GI bleedings.67 all citizens are registered with a primary care physician GI complications associated with LDASA use are more who act as a gatekeeper for access to specialised care.23 frequently present in patients who are older than Prescription data were classified according to the 70 years, have a history of peptic ulcer, have had an Anatomical Therapeutic and Chemical (ATC) classifica- infection with Helicobacter pylori and/or used concomi- tion,24 and morbidity was coded by using the International tant drug therapies with non-steroidal anti-inflammatory Classification of Primary Care (ICPC) scheme.25 The drugs (NSAIDs), including cyclooxygenase-2 (COX-2) privacy regulation of LINH was approved by the Dutch inhibitors, other antiplatelet agents or anticoagulants, Data Protection Authority. According to Dutch legislation, glucocorticosteroids and/or selective serotonin reuptake neither obtaining informed consent nor approval by a inhibitors (SSRIs).67Concomitant proton-pump inhibi- medical ethics committee is obligatory for database tor (PPI) therapy is associated with a reduction of the studies. – risk of GI complications.8 11 In this longitudinal, observational study, all patients Therefore, concomitant use of PPIs for patients who aged 18 years and older who started with regular use of use regular LDASA and are at increased risk for GI com- LDASA (30–325 mg) treatment between 1 January 2008 plications has been described in guidelines from and 31 December 2010 were included under the condi- medical societies and scientific associations from both tion that their history was available at least 1 year before the USA and Europe.12 13 In the Netherlands—the the date of the first prescription of LDASA. This time setting of our study—an expert group with a focus on period was chosen to confirm that no LDASA prescrip- optimising extramural medication safety published spe- tions were given in the year prior to inclusion. Regular cific recommendations for adequate GI protection, that use of LDASA was defined as receiving each consecutive is, prescribing PPIs in regular LDASA users with an prescription within 6 months after the previous one. A increased risk of GI complications in 2008, which was gap of maximal 6 months was chosen because in daily finalised in 2009.14 These recommendations are in line practice patients rarely collect a subsequent prescription with the USA, National Institute for Health and Clinical exactly on the day their supply of their previous prescrip- Excellence (NICE) and European Society of Cardiology tion has ended, normally 90 days, but rather earlier (ESC) guidelines,12 13 15 and describe that PPIs are the (overlap of two prescriptions) or later (gap between two preferred agents for the therapy and prophylaxis of prescriptions). In order not to bias our results towards aspirin-associated GI injury.12 Risk reduction due to PPI irregular user categorisation, we used a maximum treatment observed in case–control and cohort studies period of 6 months. Irregular LDASA users, according ranged in most cases from 40% to 80%.16 to our definition, were excluded from the analyses as Several observational studies described the use of con- well as users with just one LDASA prescription. Aspirin http://bmjopen.bmj.com/ comitant PPI in patients receiving NSAID including therapy was identified by a prescription of acetylsalicylic aspirin, and showed that 67–90% of the users with at acid (ATC-codes B01AC06, N02BA01 and N02BA51), least one risk factor did not receive gastroprotective carbasalate calcium (B01AC08, N02BA15 and N02BA65) – therapy as recommended.17 19 Two studies focused on or acetylsalicylic acid in combination with other drugs LDASA patients; in one study the definition of increased (B01AC30). GI risk was limited, namely a positive H pylori status, the Based upon the HARM-WRESTLING recommenda- other study had a small sample size of LDASA tions,14 we categorised new LDASA users into low or 20 21 patients. Although evidence regarding the adher- increased risk of GI complications. Patients with an on October 1, 2021 by guest. Protected copyright. ence to concomitant PPI use in patients with an increased risk of GI complications were identified by the increased risk for GI complications is increasing, the following selection rules applied in consecutive order: adherence and persistence of PPI use is still indefinite. (1) 80 years or older; (2) 70 years or older with simul- The objective of this study is to determine the adher- taneous use of NSAIDs, oral anticoagulants, platelet ence to recommendations of concomitant PPI treatment aggregation inhibitors, glucocorticosteroids, SSRIs in regular LDASA users, taking factors associated with and/or spironolacton or (3) 60 years or older with a the probability of receiving a PPI into account.
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