Within the database, a separate cohort was created for each pairwise comparison of SGLT2i versus an alternative non-gliflozin class. Cohort membership required patients to be new users of the study medications of interest (defined as no use of the medications in the 365-day washout period preceding medication initiation), be older than 65 years of age at cohort entry and have no evidence of gestational or type 1 diabetes (T1D), cancer, end-stage renal disease, or human immunodeficiency virus infection. With the sole exception of heart failure phenotype (see below), all baseline covariates including eligibility criteria and patient characteristics were assessed in the 365 days prior to the date of medication initiation.
The study cohort was further restricted to patients with the presence of HHF with ICD codes corresponding to HFrEF (ICD-9: 428.2× or ICD-10: I50.2×) or HFpEF (ICD-9: 428.3 × or ICD-10: I50.3×) in either the first or second position of the inpatient discharge diagnosis using all available lookback. The positive predictive value for this approach for identifying patients with HFrEF is 72% and 90% using ejection fraction [EF] thresholds of ≤ 40% and ≤ 50%, respectively, and 92% for HFpEF for an EF threshold of > 50% [19 ]. Patients with evidence of both or neither HF subtypes were excluded from analyses.
The study was comprised of four pairwise comparison cohorts, which included patients with: (1a) HFrEF initiating SGLT2i versus DPP4i; (1b) HFrEF initiating SGLT2i versus GLP-1RA; (2a) HFpEF initiating SGLT2i or DPP4i; and (2b) HFpEF initiating SGLT2i or GLP-1RA. For SGLT2i versus DPP4i comparisons, patients using combination empagliflozin–linagliptin therapy were excluded from analysis. Further, individuals initiating SGLT2i and the comparator on the same day were also excluded from analyses. Patients meeting the inclusion and exclusion criteria could contribute to each cohort only once, but the same patient could be included in more than one cohort.
The study cohort was further restricted to patients with the presence of HHF with ICD codes corresponding to HFrEF (ICD-9: 428.2× or ICD-10: I50.2×) or HFpEF (ICD-9: 428.3 × or ICD-10: I50.3×) in either the first or second position of the inpatient discharge diagnosis using all available lookback. The positive predictive value for this approach for identifying patients with HFrEF is 72% and 90% using ejection fraction [EF] thresholds of ≤ 40% and ≤ 50%, respectively, and 92% for HFpEF for an EF threshold of > 50% [19 ]. Patients with evidence of both or neither HF subtypes were excluded from analyses.
The study was comprised of four pairwise comparison cohorts, which included patients with: (1a) HFrEF initiating SGLT2i versus DPP4i; (1b) HFrEF initiating SGLT2i versus GLP-1RA; (2a) HFpEF initiating SGLT2i or DPP4i; and (2b) HFpEF initiating SGLT2i or GLP-1RA. For SGLT2i versus DPP4i comparisons, patients using combination empagliflozin–linagliptin therapy were excluded from analysis. Further, individuals initiating SGLT2i and the comparator on the same day were also excluded from analyses. Patients meeting the inclusion and exclusion criteria could contribute to each cohort only once, but the same patient could be included in more than one cohort.
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