scholarly journals Renal effectiveness and safety of the sodium-glucose cotransporter-2 inhibitors: a population-based cohort study

2021 ◽  
Vol 9 (2) ◽  
pp. e002496
Author(s):  
Wajd Alkabbani ◽  
Arsene Zongo ◽  
Jasjeet K Minhas-Sandhu ◽  
Dean T Eurich ◽  
Baiju R Shah ◽  
...  
Keyword(s):  
Cohort Study ◽  
Renal Disease ◽  
Disease Progression ◽  
Population Based ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Renal Disease Progression ◽  
Sodium Glucose Cotransporter ◽  
Increased Risk ◽  
Significant Difference

IntroductionTo assess the comparative effectiveness and safety of renal-related outcomes associated with sodium-glucose cotransporter-2 inhibitors (SGLT2-i) initiation among patients with type 2 diabetes using real-world data.Research design and methodsWe conducted a population‐based cohort study using administrative healthcare data from Alberta (AB), Canada and primary care data from the Clinical Practice Research Datalink (CPRD), UK. From a cohort of new metformin users, we identified initiators of a SGLT2-i or dipeptidyl peptidase-4 inhibitor (DPP4-i) between January 1, 2014 and March 30, 2018 (AB) or between January 1, 2013 and November 29, 2018 (CPRD). Initiators of an SGLT2-i or DPP4-i were followed until death, disenrolment, therapy discontinuation, or study end date. The effectiveness outcome was renal disease progression, defined as a composite of new-onset macroalbuminuria, serum creatinine doubling with estimated glomerular filtration rate of ≤45 mL/min/1.73 m2, renal replacement therapy, hospital admission or death from renal causes. The safety outcome was hospitalization due to acute kidney injury (AKI). We adjusted for confounding using high-dimensional propensity score matching and estimated HRs using Cox proportional hazards regression. Aggregate data from each database were combined by random-effects meta‐analysis.ResultsAmong the 29 465 included patients (20 564 AB, 8901 CPRD), 37.5% were new SGLT2-i users in AB and 21.3% in CPRD. Compared with DPP4 initiators, SGLT2-i initiators were associated with a reduced risk of renal disease progression (pooled HR 0.79, 95% CI 0.62 to 1.00); however, there was no significant difference in the risk of AKI (pooled HR 0.89, 95% CI 0.58 to 1.36). These findings were consistent with other exposure definitions and antidiabetic comparators.ConclusionsOur findings support a renoprotective effect of SGLT2-i without an increased risk of AKI, compared with clinically relevant active comparators.

Abstract P135: Varenicline and the Risk of Adverse Cardiovascular Events: A Population-Based Cohort Study

Circulation ◽  
2014 ◽  
Vol 129 (suppl_1) ◽  
Author(s):  
Kristian B Filion ◽  
Sophie Dell'Aniello ◽  
Maria Eberg ◽  
Christel Renoux ◽  
Stella S Daskalopoulou ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Cohort Study ◽  
Cardiovascular Events ◽  
Proportional Hazards Model ◽  
Population Based ◽  
Cox Proportional Hazards Model ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Increased Risk ◽  
The Mean

Background: Clinical trial results suggest that varenicline is the most efficacious smoking cessation therapy. However, its cardiovascular safety is controversial, with recent meta-analyses providing conflicting results. Our objective was to compare the effect of varenicline to that of bupropion on the risk of cardiovascular events. Methods: We conducted a population-based cohort study of new users of varenicline or bupropion using data extracted from the UK’s Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics. Our primary endpoint was a composite of myocardial infarction, coronary revascularization, stroke, and all-cause mortality. An ‘as-treated’ analysis with a Cox proportional hazards model was used, with patients censored 7 days after the end of their last prescription or upon switching smoking cessation drugs. In secondary analyses, we compared varenicline and bupropion to nicotine replacement therapy (NRT) in pairwise comparisons. All analyses used high-dimensional propensity scores to adjust for potential confounding. Results: Our primary cohort included 90,522 varenicline users and 12,640 bupropion users. The mean age was 44 years, and 48% were men. The mean treatment duration was 45 days. A total of 128 events occurred among varenicline users, and 15 occurred among bupropion users. Although estimates suggest that varenicline may modestly increase the risk of cardiovascular events compared to bupropion, they were accompanied by wide 95% CIs (Table). Both varenicline and bupropion users had significantly lower risks of cardiovascular events than NRT users (Table). Conclusions: While we cannot exclude a modestly increased risk of cardiovascular events with varenicline relative to bupropion, such events remain rare, and both varenicline and bupropion are associated with a decreased risk of cardiovascular events compared with NRT. The long-term benefits obtained due to the increased smoking abstinence with varenicline likely outweigh any increased cardiovascular risk.

scholarly journals Paediatric rotavirus vaccination, coeliac disease and type 1 diabetes in children: a population-based cohort study

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Thomas Inns ◽  
Kate M. Fleming ◽  
Miren Iturriza-Gomara ◽  
Daniel Hungerford
Keyword(s):  
Type 1 Diabetes ◽  
Cohort Study ◽  
Coeliac Disease ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Rotavirus Vaccine ◽  
Rotavirus Vaccination ◽  
Increased Risk ◽  
The Uk

Abstract Background Rotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The UK introduced infant rotavirus vaccination in 2013. We have previously shown that rotavirus vaccination can have beneficial off-target effects on syndromes, such as hospitalised seizures. We therefore investigated whether rotavirus vaccination prevents CD and T1D in the UK. Methods A cohort study of children born between 2010 and 2015 was conducted using primary care records from the Clinical Practice Research Datalink. Children were followed up from 6 months to 7 years old, with censoring for outcome, death or leaving the practice. CD was defined as diagnosis of CD or the prescription of gluten-free goods. T1D was defined as a T1D diagnosis. The exposure was rotavirus vaccination, defined as one or more doses. Mixed-effects Cox regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CIs). Models were adjusted for potential confounders and included random intercepts for general practices. Results There were 880,629 children in the cohort (48.8% female). A total of 343,113 (39.0%) participants received rotavirus vaccine; among those born after the introduction of rotavirus vaccination, 93.4% were vaccinated. Study participants contributed 4,388,355 person-years, with median follow-up 5.66 person-years. There were 1657 CD cases, an incidence of 38.0 cases per 100,000 person-years. Compared with unvaccinated children, the adjusted HR for a CD was 1.05 (95% CI 0.86–1.28) for vaccinated children. Females had a 40% higher hazard than males. T1D was recorded for 733 participants, an incidence of 17.1 cases per 100,000 person-years. In adjusted analysis, rotavirus vaccination was not associated with risk of T1D (HR = 0.89, 95% CI 0.68–1.19). Conclusions Rotavirus vaccination has reduced diarrhoeal disease morbidity and mortality substantial since licencing in 2006. Our finding from this large cohort study did not provide evidence that rotavirus vaccination prevents CD or T1D, nor is it associated with increased risk, delivering further evidence of rotavirus vaccine safety.

scholarly journals Validity of an algorithm to identify cardiovascular deaths from administrative health records: a multi-database population-based cohort study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lisa M. Lix ◽  
Shamsia Sobhan ◽  
Audray St-Jean ◽  
Jean-Marc Daigle ◽  
Anat Fisher ◽  
...  
Keyword(s):  
Cohort Study ◽  
Cardiovascular Mortality ◽  
Population Based ◽  
Vital Statistics ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Health Records ◽  
Predictive Values ◽  
Site Specific ◽  
Hospital Deaths

Abstract Background Cardiovascular death is a common outcome in population-based studies about new healthcare interventions or treatments, such as new prescription medications. Vital statistics registration systems are often the preferred source of information about cause-specific mortality because they capture verified information about the deceased, but they may not always be accessible for linkage with other sources of population-based data. We assessed the validity of an algorithm applied to administrative health records for identifying cardiovascular deaths in population-based data. Methods Administrative health records were from an existing multi-database cohort study about sodium-glucose cotransporter-2 (SGLT2) inhibitors, a new class of antidiabetic medications. Data were from 2013 to 2018 for five Canadian provinces (Alberta, British Columbia, Manitoba, Ontario, Quebec) and the United Kingdom (UK) Clinical Practice Research Datalink (CPRD). The cardiovascular mortality algorithm was based on in-hospital cardiovascular deaths identified from diagnosis codes and select out-of-hospital deaths. Sensitivity, specificity, and positive and negative predictive values (PPV, NPV) were calculated for the cardiovascular mortality algorithm using vital statistics registrations as the reference standard. Overall and stratified estimates and 95% confidence intervals (CIs) were computed; the latter were produced by site, location of death, sex, and age. Results The cohort included 20,607 individuals (58.3% male; 77.2% ≥70 years). When compared to vital statistics registrations, the cardiovascular mortality algorithm had overall sensitivity of 64.8% (95% CI 63.6, 66.0); site-specific estimates ranged from 54.8 to 87.3%. Overall specificity was 74.9% (95% CI 74.1, 75.6) and overall PPV was 54.5% (95% CI 53.7, 55.3), while site-specific PPV ranged from 33.9 to 72.8%. The cardiovascular mortality algorithm had sensitivity of 57.1% (95% CI 55.4, 58.8) for in-hospital deaths and 72.3% (95% CI 70.8, 73.9) for out-of-hospital deaths; specificity was 88.8% (95% CI 88.1, 89.5) for in-hospital deaths and 58.5% (95% CI 57.3, 59.7) for out-of-hospital deaths. Conclusions A cardiovascular mortality algorithm applied to administrative health records had moderate validity when compared to vital statistics data. Substantial variation existed across study sites representing different geographic locations and two healthcare systems. These variations may reflect different diagnostic coding practices and healthcare utilization patterns.

Epidemiology of first and recurrent venous thromboembolism: A population-based cohort study in patients without active cancer

2014 ◽  
Vol 112 (08) ◽  
pp. 255-263 ◽  
Author(s):  
Alexander T. Cohen ◽  
Luke Bamber ◽  
Stephan Rietbrock ◽  
Carlos Martinez
Keyword(s):  
Cohort Study ◽  
Venous Thromboembolism ◽  
The Elderly ◽  
Population Based ◽  
Incidence Rates ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Recurrence Rates ◽  
Recurrent Vte ◽  
Active Cancer

SummaryContemporary data from population studies on the incidence and complications of venous thromboembolism (VTE) are limited. An observational cohort study was undertaken to estimate the incidence of first and recurrent VTE. The cohort was identified from all patients in the UK Clinical Practice Research Datalink (CPRD) with additional linked information on hospitalisation and cause of death. Between 2001 and 2011, patients with first VTE were identified and the subset without active cancer-related VTE observed for up to 10 years for recurrent VTE. The 10-year cumulative incidence rates (CIR) were derived with adjustment for mortality as a competing risk event. A total of 35,373 first VTE events (12,073 provoked, 16,708 unprovoked and 6592 active cancer-associated VTE) among 26.9 million person-years of observation were identified. The overall incidence rate (IR) of VTE was 131.5 (95% CI, 130.2–132.9) per 100,000 person-years and 107.0 (95% CI, 105.8–108.2) after excluding cancer-associated VTE. DVT was more common in the young and PE was more common in the elderly. VTE recurrence occurred in 3671 (CIR 25.2%). The IR for recurrence peaked in the first six months at around 11 per 100 person years. It levelled out after three years and then remained at around 2 per 100 person years from year 4–10 of follow-up. The IRs for recurrences were particularly high in young men. In conclusion, VTE is common and associated with high recurrence rates. Effort is required to prevent VTE and to reduce recurrences.

scholarly journals Primary Care Consultations after Hospitalisation for Pneumonia: A Large Population-based Cohort Study

2020 ◽  
pp. BJGP.2020.0890
Author(s):  
Vadsala Baskaran ◽  
Fiona Pearce ◽  
Rowan H Harwood ◽  
Tricia McKeever ◽  
Wei Shen Lim
Keyword(s):  
Primary Care ◽  
Cohort Study ◽  
Large Population ◽  
Significant Proportion ◽  
Antibiotic Use ◽  
Population Based ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Respiratory Disorder ◽  
The Impact

Background: Up to 70% of patients report ongoing symptoms four weeks after hospitalisation for pneumonia, and the impact on primary care is poorly understood. Aim: To investigate the frequency of primary care consultations after hospitalisation for pneumonia, and the reasons for consultation. Design: Population-based cohort study. Setting: UK primary care database of anonymised medical records (Clinical Practice Research Datalink, CPRD) linked to Hospital Episode Statistics (HES), England. Methods: Adults with the first ICD-10 code for pneumonia (J12-J18) recorded in HES between July 2002-June 2017 were included. Primary care consultation within 30 days of discharge was identified as the recording of any medical Read code (excluding administration-related codes) in CPRD. Competing-risks regression analyses were conducted to determine the predictors of consultation and antibiotic use at consultation; death and readmission were competing events. Reasons for consultation were examined. Results: Of 56,396 adults, 55.9% (n=31,542) consulted primary care within 30 days of discharge. The rate of consultation was highest within 7 days (4.7 per 100 person-days). The strongest predictor for consultation was a higher number of primary care consultations in the year prior to index admission (adjusted sHR 8.98, 95% CI 6.42-12.55). The commonest reason for consultation was for a respiratory disorder (40.7%, n=12,840), 12% for pneumonia specifically. At consultation, 31.1% (n=9,823) received further antibiotics. Penicillins (41.6%, n=5,753) and macrolides (21.9%, n=3,029) were the commonest antibiotics prescribed. Conclusion: Following hospitalisation for pneumonia, a significant proportion of patients consulted primary care within 30 days, highlighting the morbidity experienced by patients during recovery from pneumonia.

scholarly journals Association of chronic kidney disease with mortality risk in patients with lung cancer: a nationwide Taiwan population-based cohort study

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019661 ◽  
Author(s):  
Yu-Feng Wei ◽  
Jung-Yueh Chen ◽  
Ho-Shen Lee ◽  
Jiun-Ting Wu ◽  
Chi-Kuei Hsu ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Chronic Kidney Disease ◽  
Cohort Study ◽  
Kidney Disease ◽  
Renal Disease ◽  
Mortality Risk ◽  
Population Based ◽  
Research Database ◽  
Cox Regression Analysis ◽  
Increased Risk

ObjectiveOur population-based research aimed to clarify the association between chronic kidney disease (CKD) and mortality risk in patients with lung cancer.DesignRetrospective cohort studySettingNational health insurance research database in TaiwanParticipantsAll (n=1 37 077) Taiwanese residents who were diagnosed with lung cancer between 1997 and 2012 were identified. Eligible patients with baseline CKD (n=2269) were matched with controls (1:4, n=9076) without renal disease according to age, sex and the index day of lung cancer diagnosis.MethodsThe cumulative incidence of death was calculated by the Kaplan-Meier method, and the risk determinants were explored by the Cox proportional hazards model.ResultsMortality occurred in 1866 (82.24%) and 7135 (78.61%) patients with and without CKD, respectively (P=0.0001). The cumulative incidences of mortality in patients with and without chronic renal disease were 72.8% vs 61.6% at 1 year, 82.0% vs 76.6% at 2 years and 88.9% vs 87.2% at 5 years, respectively. After adjusting for multiple confounding factors including age and comorbidities, Cox regression analysis revealed that CKD was associated with an increased risk of mortality (adjusted HR 1.38; 95% CI 1.29 to 1.47). Stratified analysis further showed that the association was consistent across patient subgroups.ConclusionComorbidity associated with CKD is a risk factor for mortality in patients with lung cancer.

scholarly journals Poisoning substances taken by young people: a population-based cohort study

2018 ◽  
Vol 68 (675) ◽  
pp. e703-e710 ◽  
Author(s):  
Edward G Tyrrell ◽  
Denise Kendrick ◽  
Kapil Sayal ◽  
Elizabeth Orton
Keyword(s):  
Cohort Study ◽  
Young People ◽  
Population Based ◽  
Incidence Rates ◽  
Practice Research ◽  
Mortality Data ◽  
Clinical Practice Research Datalink ◽  
Self Harm ◽  
Harm Prevention ◽  
Rate Ratios

BackgroundGlobally, poisonings account for most medically-attended self-harm. Recent data on poisoning substances are lacking, but are needed to inform self-harm prevention.AimTo assess poisoning substance patterns and trends among 10–24-year-olds across EnglandDesign and settingOpen cohort study of 1 736 527 young people, using linked Clinical Practice Research Datalink, Hospital Episode Statistics, and Office for National Statistics mortality data, from 1998 to 2014.MethodPoisoning substances were identified by ICD-10 or Read Codes. Incidence rates and adjusted incidence rate ratios (aIRR) were calculated for poisoning substances by age, sex, index of multiple deprivation, and calendar year.ResultsIn total, 40 333 poisoning episodes were identified, with 57.8% specifying the substances involved. The most common substances were paracetamol (39.8%), alcohol (32.7%), non-steroidal anti-inflammatory drugs (NSAIDs) (11.6%), antidepressants (10.2%), and opioids (7.6%). Poisoning rates were highest at ages 16–18 years for females and 19–24 years for males. Opioid poisonings increased fivefold from 1998–2014 (females: aIRR 5.30, 95% confidence interval (CI) = 4.08 to 6.89; males: aIRR 5.11, 95% CI = 3.37 to 7.76), antidepressant poisonings three-to fourfold (females: aIRR 3.91, 95% CI = 3.18 to 4.80, males: aIRR 2.70, 95% CI = 2.04 to 3.58), aspirin/NSAID poisonings threefold (females: aIRR 2.84, 95% CI = 2.40 to 3.36, males: aIRR 2.76, 95% CI = 2.05 to 3.72) and paracetamol poisonings threefold in females (aIRR 2.87, 95% CI = 2.58 to 3.20). Across all substances poisoning incidence was higher in more disadvantaged groups, with the strongest gradient for opioid poisonings among males (aIRR 3.46, 95% CI = 2.24 to 5.36).ConclusionIt is important that GPs raise awareness with families of the substances young people use to self-harm, especially the common use of over-the-counter medications. Quantities of medication prescribed to young people at risk of self-harm and their families should be limited, particularly analgesics and antidepressants.

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