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Background The THEMIS study (NCT01991795; in analysis phase; n=19,349) compares the effect of dual antiplatelet therapy (DAPT) vs ASA alone for the prevention of major cardiovascular (CV) events in type 2 diabetes (T2D) patients with coronary artery disease (CAD) at high CV risk, but without prior myocardial infarction (MI) or stroke. However, there is a lack of real-life data on CV risk in a THEMIS-like population compared to MI patients, where treatment with DAPT is guideline standard. The aim of this study was to investigate the CV risk in a THEMIS-like population vs an MI population Methods Patients invasively managed in Sweden (2006–2014) were identified using the SWEDEHEART registry and the National Patient Registry. Two populations were studied: a THEMIS-like population including patients with CAD and T2D, ≥1 vessel disease or elective percutaneous coronary intervention [PCI], and no prior stroke or MI), and a MI patient population alive at discharge. The cumulative incidence of the primary composite outcome (CV death (CVD)/MI/stroke) was estimated 3 years after index using the Kaplan-Meier method, and with probability plots adjusted for age, sex, atrial fibrillation, and heart failure. A 30 days blanking period for outcome was added to ensure capture of new events (index THEMIS-pop.: after angiography; index MI-pop.: after discharge). Results Overall, 6,534 THEMIS-like patients and 96,638 MI patients were included. At index, the THEMIS-like patients (CAD and T2D without previous MI/stroke) were aged 67.1 years (mean), 26.6% women, 9.2% AF, and 4.7% HF, while the MI patients were aged 67.3 years (mean), 30.7% women, 15.5% T2D, 17.9% previous MI, 5.2% stroke, 6.4% AF, and 4.8% HF. Three-year cumulative incidence for the composite outcome CVD/MI/stroke was 0.149 (95% CI 0.140, 0.158) for THEMIS-like patients, and 0.148 (95% CI 0.145, 0,15) for MI patients (p=0.88 log rank test) (Figure). Corresponding adjusted probably plots: 0.135 (95% CI 0.127, 0.143) and 0.131 (95% CI 0.128, 0.133). MI was the main risk driver with greatest cumulative incidence in both populations (0.091 vs 0.087) (Figure). Figure 1 Conclusions In this Swedish real-life setting, THEMIS-like patients, followed from 30 days after invasive intervention, had a similar long-term risk for CV events compared with MI patients surviving 30 days after discharge, with MI as the main risk driver, despite having no previous ischemic events. The present data indicate that long-term ischemic risk prevention should be a key strategy in coronary artery disease patients with diabetes requiring elective invasive intervention. Acknowledgement/Funding AstraZeneca

Background: Pharmacological treatment of asthma includes bronchodilators and ICS used in a stepwise approach to achieve asthma control. Still, many patients have inadequately controlled asthma, which may relate to reliance on SABA and underuse of ICS. In a nationwide Swedish asthma population, we examined the use of ICS in SABA-reliant patients. Methods: Data for asthma patients aged 12–45 years were linked from mandatory health registers. Asthma was defined as at least 2 collections of drugs for obstructive lung disease (ATC R03) at pharmacy in any 12-month period 2006–2014 (inclusion date: 2nd collection). In the one-year period following inclusion, patients were stratified by number of collected SABA canisters (reliance defined as >2 SABA canisters) and by daily ICS use (low-dose: ≤400µg, medium-dose: 401–800µg, high-dose: >800µg [BDP equivalent]). Results: A total of 365,324 asthma patients of all GINA severity steps were included (mean age 27.6 years; 55% women). In total 30% (n=110,824, mean age 27.5 years, 53% women) were SABA-reliant, and of these patients 29% had no collection of ICS, 39% were on low-dose, 28% medium-dose, and 5% high-dose ICS. SABA-reliant patients without ICS were slightly older (28.3 vs 27.2 years, p Conclusion: In this nationwide Swedish population, almost one third of asthma patients were SABA-reliant, of which more than 25% had no collection of ICS. These contemporary findings reveal that a large proportion of asthma patients are not adequately treated according to guidelines, which calls for attention to treatment and follow-up of this patient population.

Aims and Objectives: Increasing evidence relating short-acting beta agonists (SABA) overuse to adverse outcomes has been reported. We examined the association between SABA use and all-cause mortality risk in a general asthma population. Methods: Linkage of drug and patient registries identified 365,324 asthma patients, aged 12–45yrs with ≥2 collections of drugs for obstructive lung disease in any 12-month period during 2006-2014 (inclusion: date of 2nd collection; exclusion: diagnosis of COPD and OCS-treated comorbidity). SABA overuse was defined as >2 SABA canisters (defined as 150 doses) in a 365-day baseline period following inclusion, and patients were further grouped: 3-5, 6-10 and ≥11 canisters/yr. Cox regression was applied to estimate hazard ratios (HR) of death with 95% confidence intervals (CI) for different levels of SABA use. Results: Among included patients (mean age 27.6yrs, 55% women), SABA overuse was identified in 30% of patients, with 21% collecting 3-5, 7% 6-10, and 2% ≥11 canisters/yr. Patients overusing SABA had more exacerbations, but were similar regarding age, sex and co-morbidities vs patients using ≤2 canisters/yr. A total of 2564 patients died during follow-up. Number of collected SABA canisters/yr was associated with increased mortality risk: 3-5 (HR 1.26, 95% CI 1.14-1.39); 6-10 (1.67, 1.49-1.87); and ≥11 (2.35, 2.02-2.72) vs patients collecting ≤2 canisters (adjusted for age, sex, GINA step, and Charlson comorbidity index). Conclusion: Increasing number of annually collected SABA canisters was associated with a gradually increased all-cause mortality risk. A need for focused management and appropriate drug use is indicated to improve management and disease control in asthma.

Background: Inadequately controlled asthma and underuse of inhaled corticosteroids (ICS) may lead to SABA reliance. Association of SABA reliance and asthma exacerbation risk in a nationwide Swedish asthma population was examined. Methods: Linking drug- and patient-registries identified 365,324 asthma patients, defined as individuals aged 12–45 years prescribed 2 medications for obstructive lung disease in any 12-month period from 2006-2014 (inclusion: date of 2nd claim). Patients with COPD or an oral corticosteroid (OCS)-treated comorbidity were excluded. SABA reliance was defined as claims for >2 SABA canisters in a 365-day baseline period following inclusion. Cut-off between low and medium/high-dose ICS was 400µg (BDP eq.) daily. Asthma-related exacerbations (hospitalizations and/or OCS claims) were identified in the subsequent 365-day observation period. Multivariable logistic regression was used to examine association of SABA reliance and exacerbation risk. Results: Of the included patients (mean age 27.6 years, 55% women), 93,256 (26%) had no ICS claims, 105,560 (29%) low-dose ICS, and 166,508 (45%) medium/high-dose ICS. SABA reliance was identified for 30% of patients, irrespective of ICS use. Exacerbation rates were greater among SABA-reliant vs non-reliant patients (19.97/100 PY vs. 12.50/100 PY, RR 1.60, 95% CI 1.57-1.63, P Conclusion: Among asthma patients in Sweden, one-third were SABA-reliant. As the SABA-reliant patients showed significantly greater exacerbation risk than non-reliant patients, the present data indicates a need for improved management.

ObjectivesTo investigate healthcare costs associated with hyperkalaemia (HK) among patients with chronic kidney disease (CKD), heart failure (HF) or diabetes.DesignBefore–after cohort study of patients with HK and matched patients without HK.SettingPopulation-based databases covering primary and secondary care for the entire of Northern Denmark.ParticipantsPatients with a first incident record of CKD (n=78 372), HF (n=14 233) or diabetes (n=37 479) during 2005–2011. Among all patients experiencing a first HK event (potassium level >5.0 mmol/L), healthcare costs were compared during 6 months before and 6 months after the HK event. The same cost assessment was conducted 6 months before and after a matched index date in a comparison cohort of patients without HK.Primary and secondary outcome measuresMean costs of hospital care, general practice and dispensed drugs converted to 2018 Euros.ResultsOverall, 17 747 (23%) CKD patients, 5141 (36%) HF patients and 4183 (11%) diabetes patients with a first HK event were identified. More than 40% of all HK patients across the patient groups had subsequent HK events with successively shorter times between the events. In CKD patients, overall mean costs were €5518 higher 6 months after versus before first HK, while €441 higher in matched CKD patients without HK, yielding HK-associated costs of €5077. Corresponding costs associated with a HK event were €6018 in HF patients, and €4862 in diabetes patients.ConclusionsAmong CKD, HF and diabetes patients, an incident HK event was common, and a large proportion of the patients experienced recurrent HK events. Substantial increase in healthcare costs associated with a HK event was observed in the HK patients compared with non-HK patients. These results are important to better understand the potential economic impact of HK among high-risk comorbid patients in a real-wold setting and help inform decision-making for clinicians and healthcare providers.

ObjectivesTo compare short-term cardiovascular (CV) outcome in type 2 diabetes (T2D) patients without ischaemic heart disease (IHD), with IHD but no prior myocardial infarction (MI), and those with prior MI; and assess the impact on risk of age when initiating first-time glucose-lowering drug (GLD).DesignCohort study linking morbidity, mortality and medication data from Swedish national registries.ParticipantsFirst-time users of GLD during 2007–2016.OutcomesPredicted cumulative incidence for the CV outcome (MI, stroke and CV mortality) was estimated. A Cox model was developed where age at GLD start and CV risk was modelled.Results260 070 first-time GLD users were included, 221 226 (85%) had no IHD, 16 294 (6%) had stable IHD—prior MI and 22 550 (9%) had IHD+MI. T2D patients without IHD had a lower risk of CV outcome compared with the IHD populations (±prior MI), (3-year incidence 4.78% vs 5.85% and 8.04%). The difference in CV outcome was primarily driven by a relative greater MI risk among the IHD patients. For T2D patients without IHD, an almost linear association between age at start of GLD and relative risk was observed, whereas in IHD patients, the younger (ConclusionsT2D patients without IHD had a lower risk of the CV outcome compared with the T2D populations with IHD, primarily driven by a greater risk of MI. For T2D patients without IHD, an almost linear association between age at start of GLD and relative risk was observed, whereas in IHD patients, the younger patients had a relative greater risk compared with older patients. Our findings suggest that intense risk prevention should be the key strategy in the management of T2D patients, especially for younger patients.

Differences in clinical effectiveness between angiotensin-converting enzyme inhibitors (ACEis) and angiotensin receptor blockers (ARBs) in the primary treatment of hypertension are unknown. The aim of this retrospective cohort study was to assess the prevention of type 2 diabetes and cardiovascular disease (CVD) in patients treated with ARBs or ACEis. Patients initiated on enalapril or candesartan treatment in 71 Swedish primary care centers between 1999 and 2007 were included. Medical records data were extracted and linked with nationwide hospital discharge and cause of death registers. The 11 725 patients initiated on enalapril and 4265 on candesartan had similar baseline characteristics. During a mean follow-up of 1.84 years, 36 482 patient-years, the risk of new diabetes onset was lower in the candesartan group (hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.69-0.96, P = 0.01) compared with the enalapril group. No difference between the groups was observed in CVD risk (HR 0.99, 95% CI 0.87-1.13, P = 0.86). More patients discontinued treatment in the enalapril group (38.1%) vs the candesartan group (27.2%). In a clinical setting, patients initiated on candesartan treatment had a lower risk of new-onset type 2 diabetes and lower rates of drug discontinuation compared with patients initiated on enalapril. No differences in CVD risk were observed.

Effect of dual antiplatelet treatment in post-MI survivor patients with age ≥65 years, diabetes, history of >1 MI, or renal disease as risk factors is studied in the PEGASUS-TIMI 54 trial*. The impact of these risk factors in unselected post-MI survivors has not been studied. A cohort study