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Analgesia Dose Prescribing and Estimated Glomerular filtration Rate Decline: a General Practice Database Linkage Cohort Study

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Analgesia Dose Prescribing and Estimated Glomerular filtration Rate Decline: a General Practice Database Linkage Cohort Study Open Access Research BMJ Open: first published as 10.1136/bmjopen-2014-005581 on 19 August 2014. Downloaded from Analgesia dose prescribing and estimated glomerular filtration rate decline: a general practice database linkage cohort study Paul Nderitu,1 Lucy Doos,2 Vicky Y Strauss,3 Mark Lambie,1 Simon J Davies,1 Umesh T Kadam1 To cite: Nderitu P, Doos L, ABSTRACT et al Strengths and limitations of this study Strauss VY, . Analgesia Objective: We aimed to quantify the short-term effect dose prescribing and of non-steroidal anti-inflammatory drugs (NSAIDs), ▪ estimated glomerular filtration General practice patients with a wide spectrum aspirin and paracetamol analgesia dose prescribing on rate decline: a general of chronic kidney disease (CKD) and non-CKD practice database linkage estimated glomerular filtration rate (eGFR) decline in were included in this study. cohort study. BMJ Open the general practice population. ▪ Analgesia dose prescribing was standardised 2014;4:e005581. Design: A population-based longitudinal clinical data using the WHO defined daily dose method. doi:10.1136/bmjopen-2014- linkage cohort study. ▪ The outcome of estimated glomerular filtration 005581 Setting: Two large general practices in North rate decline is based on current clinical guide- Staffordshire, UK. lines and changes to renal function were corre- ▸ Prepublication history for Participants: Patients aged 40 years and over with ≥2 lated against analgesia use. this paper is available online. eGFR measurements spaced ≥90 days apart between 1 ▪ Data on over-the-counter use was not available To view these files please January 2009 and 31 December 2010 were selected. in this study. visit the journal online Exposure: Using WHO Defined Daily Dose standardised ▪ There were a limited number of patients with (http://dx.doi.org/10.1136/ cumulative analgesia prescribing, patients were stage 3–5 CKD with high-dose analgesia use. bmjopen-2014-005581). categorised into non-user, normal and high-dose groups. Received 28 April 2014 Outcome measure: The primary outcome was defined Revised 29 July 2014 as a >5 mL/min/1.73 m2/year eGFR decrease between the requiring risk factors of CKD progression to http://bmjopen.bmj.com/ fi 2 Accepted 30 July 2014 first and last eGFR. Logistic regression analyses were be identi ed and minimised. Comorbidities used to estimate risk, adjusting for sociodemographics, such as diabetes mellitus (DM), cardiovascu- comorbidity, baseline chronic kidney disease (CKD) lar disease (CVD) and hypertension are well- status, renin-angiotensin-system inhibitors and other known risk factors for CKD progression.1 analgesia prescribing. The National Institute for Health and Results: There were 4145 patients (mean age 66 years, Clinical Excellence (NICE) UK guidelines 55% female) with an analgesia prescribing prevalence of (2008) identified non-steroidal anti- 17.2% for NSAIDs, 39% for aspirin and 22% for inflammatory drugs (NSAIDs) as one pos- on September 28, 2021 by guest. Protected copyright. 1 – Health Services Research paracetamol and stage 3 5 CKD prevalence was 16.1% sible risk factor for CKD progression and Unit, Institute of Science and (n=667). Normal or high-dose NSAID and paracetamol Technology in Medicine, advised that their use be restricted in CKD prescribing was not significantly associated with eGFR 2 Keele University, Keele, UK patients. Although the acute effects of 2 decline. High-dose aspirin prescribing was associated Public Health, Epidemiology with a reduced risk of eGFR decline in patients with a NSAID use on renal function are well recog- and Biostatistics, NIHR 3 baseline (first) eGFR ≥60 mL/min/1.73 m2;OR=0.52 nised, the chronic effects are unclear with Horizon Scanning Centre, conflicting findings in the literature. Few School of Health and (95% CI 0.35 to 0.77). Population Sciences, Conclusions: NSAID, aspirin and paracetamol studies have used standardised drug doses to University of Birmingham, prescribing over 2 years did not significantly affect eGFR quantify the unsafe levels of use with invalid Birmingham, UK decline with a reduced risk of eGFR decline in high-dose or arbitrary definitions of maintenance or 3 Nuffield Department of aspirin users with well-preserved renal function. high levels of analgesic use.4 Orthopaedics, Rheumatology However, the long-term effects of analgesia use on NSAIDs and aspirin in comorbid cardio- and Musculoskeletal eGFR decline remain to be determined. Sciences, Centre for Statistics metabolic diseases are used widely in the in Medicine, Botnar Research CKD and general population with prescrip- Centre, University of Oxford, tions making up a significant proportion of Oxford, UK use.5 Low-dose aspirin is indicated for use as BACKGROUND a thromboprophylactic agent while NSAIDs Correspondence to 6 Dr Paul Nderitu; Chronic kidney disease (CKD) is a major are indicated for use as simple analgesics by [email protected] cause of morbidity and mortality worldwide1 patients with a range of musculoskeletal Nderitu P, et al. BMJ Open 2014;4:e005581. doi:10.1136/bmjopen-2014-005581 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005581 on 19 August 2014. Downloaded from pathology. Therefore, the complete avoidance of consultation (containing diagnostic data) and prescrip- NSAIDs or aspirin among CKD patients may impact on tion (containing prescribed analgesia and co-drug ther- quality of life by excluding a major group of drug treat- apies) data between 2009 and 2010, laboratory data ment for pain symptoms. NSAIDs have been associated (containing blood tests) for all included patients in the with gastrointestinal and vascular complications;7 there- two included general practices (n=23 028 in 2009) fore, where contraindicated, paracetamol is often the chosen were available at the time of the study.11 12 preferred simple analgesic. However, paracetamol (acet- Ethical approval for CiPCA was granted by the North aminophen) is a metabolite of the banned nephrotoxic Staffordshire Ethics Committee. NSAID phenacetin and has been associated with renal dysfunction89with limited evidence on its effect on esti- Cohort selection mated glomerular filtration rate (eGFR) decline.810Few Patients aged 40 years and over with at least one eGFR studies have examined the effect of NSAIDs, aspirin and measurement from 1 January 2009 to 31 December paracetamol prescribing on eGFR decline among the 2010 were identified (2-year study period). Of these, CKD population.4 patients with two or more eGFR measurements during Given the clinical importance of CKD, the widespread the 2-year study period were eligible for inclusion and use of NSAIDs, aspirin and paracetamol and the con- formed the study cohort (figure 1). Patients aged under flicting literature, further research is required into the 40 years on 1 January 2009 were excluded because stage effects of analgesia use on eGFR decline. This study 3–5 CKD prevalence is low in this age group.14 aimed to investigate the effect of normal and high dose Patients with less than two valid eGFR measurements analgesia prescribing on eGFR decline in the general were excluded as eGFR decline could not be calculated. practice population with the aim of aiding prescribing Patients with less than 90 days between the first and last decision-making among patients with CKD requiring the eGFR measurements were also excluded to minimise the aforementioned analgesics. impact of acute renal failure and to gain more accurate estimates of eGFR decline and minimise the effects of measurement variability. Therefore, patients had a METHODS maximum follow-up interval of up to 2 years between Study design and setting the first and last eGFR and a minimal follow-up of Patients were selected from two general practices, both 90 days. Only the first and last eGFR measurements of which contribute to the Consultations in Primary during the study period were used to calculate the eGFR Care Archive (CiPCA) and Prescriptions in Primary Care decline rate. Archive (PiPCA) interlinked databases. The anonymised databases contain routinely collected consultation and Measurement of renal function http://bmjopen.bmj.com/ prescription data recorded since 2000 from 13 general The eGFR was calculated using the simplified 4-variable practices in North Staffordshire, UK.11 12 Practices Modification of Diet in Renal Disease (MDRD) equa- undergo annual assessments, feedback and training on tion, which includes the variables for serum creatinine, the quality of morbidity recording.13 In addition to age, gender and available ethnicity data.1 As defined by Figure 1 Flow chart of the patient selection process. on September 28, 2021 by guest. Protected copyright. 2 Nderitu P, et al. BMJ Open 2014;4:e005581. doi:10.1136/bmjopen-2014-005581 Open Access BMJ Open: first published as 10.1136/bmjopen-2014-005581 on 19 August 2014. Downloaded from the National Kidney Foundation—Kidney Disease Outcomes Quality Initiatives (NKF-KDOQI) guidelines,1 CKD is categorised into five stages (table 1). Stage 3–5 CKD can be categorised from the eGFR alone1 but stage 1 and 2 CKD requires further evidence of renal path- ology,1 which was not available in our study. Therefore, an approach employed by de Lusignan et al14 was used instead of stage 1 and 2 CKD definitions whereby patients with baseline (first) eGFRs between 60 and 89 were categorised as ‘mildly impaired’ and those with baseline eGFRs ≥90 were categorised as ‘normal’.14 Cumulative exposure definition Prescribed analgesics were identified by means of the relevant British National Formulary chapters.6 Data on drug dose, frequency and quantity (tablets or millilitres) for each drug were sought. All prescriptions (both con- tinuously and non-continuously issued) for analgesics given to patients from 1 January 2009 to the last eGFR measurement date (exposure period) were included in the cumulative exposure. Cumulative exposure before the last eGFR measurement was calculated as follows: Cumulative exposure = Total tablets or millilitres (before the last eGFR measurement) Â drug strength per tablet or millilitre Cumulative drug exposure was standardised using the WHO anatomical therapeutic classification and defined daily dose (DDD) method.
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