“…Data were from an existing multi-database retrospective cohort study conducted by the Canadian Network for Observational Drug Effect Studies (CNODES) [ 12 ], a pan-Canadian network that examines questions of drug safety and effectiveness at the request of government stakeholders. This cohort study investigated the safety and effectiveness of sodium-glucose cotransporter-2 (SGLT2) inhibitors, a new class of antidiabetic medications, compared to dipeptidyl peptidase-4 (DPP-4) inhibitors [ 13 – 16 ]. Databases from five Canadian provinces (Alberta, British Columbia, Manitoba, Ontario, and Quebec) and the United Kingdom (UK) Clinical Practice Research Datalink (CPRD) were used.…”
Section: Methodsmentioning
confidence: 99%
“…The cohort has been described in detail elsewhere [ 13 – 16 ]. Briefly, the cohort for the initial multi-database study included patients who received a prescription for a SGLT2 inhibitor or a DPP-4 inhibitor.…”
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.
“…Data were from an existing multi-database retrospective cohort study conducted by the Canadian Network for Observational Drug Effect Studies (CNODES) [ 12 ], a pan-Canadian network that examines questions of drug safety and effectiveness at the request of government stakeholders. This cohort study investigated the safety and effectiveness of sodium-glucose cotransporter-2 (SGLT2) inhibitors, a new class of antidiabetic medications, compared to dipeptidyl peptidase-4 (DPP-4) inhibitors [ 13 – 16 ]. Databases from five Canadian provinces (Alberta, British Columbia, Manitoba, Ontario, and Quebec) and the United Kingdom (UK) Clinical Practice Research Datalink (CPRD) were used.…”
Section: Methodsmentioning
confidence: 99%
“…The cohort has been described in detail elsewhere [ 13 – 16 ]. Briefly, the cohort for the initial multi-database study included patients who received a prescription for a SGLT2 inhibitor or a DPP-4 inhibitor.…”
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.
“…In another real‐world comparative study, however, a propensity score‐matched cohort of 209 867 new users of a SGLT2i vs the same number of users of a DPP‐4i followed for a mean of 0.9 years had 5.1 vs 6.4 MI, 3.9 vs 7.7 CV deaths, and 2.6 vs 3.5 ischemic strokes, the composite of major adverse CV events occurring significantly less often at rates of 11.4 vs 16.5 per 1000 person‐years; furthermore, there were 3.1 vs 7.7 HF events per 1000 person‐years 9 . Using the same dataset to match 208 757 new users of SGLT2i with the same number of users of a DPP‐4i, ketoacidosis occurred at rates of 2.03 vs 0.75 per 1000 person‐years, with overlapping 95% confidence ranges for dapagliflozin, empagliflozin, and canagliflozin; persons treated with insulin had lower risk, suggesting that, although infrequent, ketoacidosis might be particularly likely to occur in persons requiring insulin but not begun on this treatment 10 …”
The outpouring of new and important information pertaining to diabetes and its treatment makes it both a challenge and a pleasure to endeavor to keep up. Some notes follow on an assortment of articles that attracted your editor's attention.
“…Eine Metaanalyse stellte für SGLT2i im Vergleich zu anderen Antidiabetika ein erhöhtes Risiko für Volumendepletion und genitale Mykosen Genitale Mykosen fest [ 29 ]. Die gleiche Analyse konnte keine eindeutige Evidenz für ein erhöhtes Risiko von diabetischer Ketoazidose (DKA) unter SGLT2i finden (moderate Evidenzstärke); mehrere retrospektive Kohortenstudien beschreiben jedoch eine Häufung von euglykämer DKA euglykämer DKA unter SGLT2i, v. a. in Kombination mit Insulintherapie [ 30 , 31 , 32 ]. Ein erhöhtes DKA-Risiko trat sowohl in CREDENCE (HR: 10,8, 95 %-KI: 1,39–83,6) als auch in SCORED (0,6 % in der Sotaglifozingruppe vs. 0,3 % in der Placebogruppe; p = 0,02) auf, jedoch mit jeweils nur geringen Fallzahlen.…”
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