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Questions and Answers
What statistical method was used to estimate hazard ratios in the study?
What statistical method was used to estimate hazard ratios in the study?
What was the incidence rate of diabetic ketoacidosis per 1,000 person-years for DPP-4 inhibitors in cohort 1?
What was the incidence rate of diabetic ketoacidosis per 1,000 person-years for DPP-4 inhibitors in cohort 1?
In cohort 2, which drug class had a higher incidence of diabetic ketoacidosis?
In cohort 2, which drug class had a higher incidence of diabetic ketoacidosis?
How many participants were included for SGLT2 inhibitors in cohort 1?
How many participants were included for SGLT2 inhibitors in cohort 1?
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What was the purpose of adjusting for calendar time in the analysis?
What was the purpose of adjusting for calendar time in the analysis?
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What was the main objective of the study comparing SGLT2 inhibitors, DPP-4 inhibitors, and sulfonylureas?
What was the main objective of the study comparing SGLT2 inhibitors, DPP-4 inhibitors, and sulfonylureas?
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Which two medication classes were SGLT2 inhibitors compared to in this study?
Which two medication classes were SGLT2 inhibitors compared to in this study?
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What research design was used for the study on diabetic ketoacidosis?
What research design was used for the study on diabetic ketoacidosis?
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How was the association between medications and the risk of diabetic ketoacidosis adjusted in the study?
How was the association between medications and the risk of diabetic ketoacidosis adjusted in the study?
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What was the main outcome measured upon hospital admission in the study?
What was the main outcome measured upon hospital admission in the study?
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What patient population was specifically targeted in the study?
What patient population was specifically targeted in the study?
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What is the significance of investigating the comparative safety of SGLT2 inhibitors?
What is the significance of investigating the comparative safety of SGLT2 inhibitors?
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What does DPP-4 stand for in the context of diabetes treatment?
What does DPP-4 stand for in the context of diabetes treatment?
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What was the percentage increase of diabetic ketoacidosis with dapagliflozin compared to placebo?
What was the percentage increase of diabetic ketoacidosis with dapagliflozin compared to placebo?
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What was excluded when determining the cohort for the study?
What was excluded when determining the cohort for the study?
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Which of the following confounders was NOT mentioned in the adjustment for the study?
Which of the following confounders was NOT mentioned in the adjustment for the study?
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What was one of the primary medications excluded to minimize the capture of prevalent events?
What was one of the primary medications excluded to minimize the capture of prevalent events?
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What condition was specifically noted regarding the absolute increase in the incidence rate of diabetic ketoacidosis?
What condition was specifically noted regarding the absolute increase in the incidence rate of diabetic ketoacidosis?
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What was one limitation mentioned regarding comparative safety studies?
What was one limitation mentioned regarding comparative safety studies?
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Which of these medications is classified as an SGLT2 inhibitor?
Which of these medications is classified as an SGLT2 inhibitor?
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What information did the observational studies fail to consider adequately?
What information did the observational studies fail to consider adequately?
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What statistical adjustment was used to account for multiple testing in the study?
What statistical adjustment was used to account for multiple testing in the study?
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When matching patients in the study, what ratio was used?
When matching patients in the study, what ratio was used?
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Which of the following characteristics was balanced between the treatment groups?
Which of the following characteristics was balanced between the treatment groups?
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What method was used to assess the potential of unmeasured confounders in the study?
What method was used to assess the potential of unmeasured confounders in the study?
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What was the median follow-up time for SGLT2 inhibitor users in the study?
What was the median follow-up time for SGLT2 inhibitor users in the study?
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For the groups to be considered balanced, what must the standardized mean differences meet?
For the groups to be considered balanced, what must the standardized mean differences meet?
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Which characteristic showed the same percentage for both groups in the study?
Which characteristic showed the same percentage for both groups in the study?
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What was the threshold for considering results statistically significant in the subgroup analyses?
What was the threshold for considering results statistically significant in the subgroup analyses?
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What serious condition can be caused by the use of SGLT2 inhibitors?
What serious condition can be caused by the use of SGLT2 inhibitors?
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Which of the following SGLT2 inhibitors was specifically mentioned as a concern for diabetic ketoacidosis?
Which of the following SGLT2 inhibitors was specifically mentioned as a concern for diabetic ketoacidosis?
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What is used to define the primary outcome measure of diabetic ketoacidosis in the study?
What is used to define the primary outcome measure of diabetic ketoacidosis in the study?
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What action did the FDA take regarding SGLT2 inhibitors in 2015?
What action did the FDA take regarding SGLT2 inhibitors in 2015?
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What type of data is used for the studies conducted at the University of Pennsylvania?
What type of data is used for the studies conducted at the University of Pennsylvania?
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What code is associated with diabetic ketoacidosis for hospital admissions in the study?
What code is associated with diabetic ketoacidosis for hospital admissions in the study?
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What was a noted consequence of initiating an SGLT2 inhibitor different from the one at enrollment?
What was a noted consequence of initiating an SGLT2 inhibitor different from the one at enrollment?
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In the context given, what does 'censoring' refer to?
In the context given, what does 'censoring' refer to?
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Study Notes
Study Overview
- Research evaluates the comparative safety of SGLT2 inhibitors against DPP-4 inhibitors and sulfonylureas regarding the risk of diabetic ketoacidosis (DKA) in type 2 diabetes patients.
- Primary outcome measured was incidence of DKA at hospital admission.
Methodology
- Conducted an active comparator cohort study with new users of SGLT2 inhibitors, DPP-4 inhibitors, and sulfonylureas.
- Propensity score matching was utilized to adjust for confounding variables.
- Cox proportional hazards regression estimated hazard ratios and 95% confidence intervals, adjusting for calendar time.
Results: Incidence of DKA
- In the first cohort (SGLT2 vs. DPP-4), DKA incidence rates (per 1,000 person-years) were 6.0 for SGLT2 inhibitors and 4.3 for DPP-4 inhibitors.
- In the second cohort (SGLT2 vs. sulfonylureas), incidence rates were 6.3 for SGLT2 inhibitors and 4.5 for sulfonylureas.
- Absolute increase in DKA incidence was small, with a crude rate difference of 1.2 per 1,000 person-years.
Safety Warnings
- In 2015, the FDA warned that SGLT2 inhibitors may lead to DKA, leading to hospitalization, prompting updates on medication labels for SGLT2 inhibitors.
Cohort Characteristics
- Cohort consisted of approximately 85,125 patients per comparison group for SGLT2 and DPP-4, and 72,436 patients for SGLT2 and sulfonylureas.
- Demographics and characteristics were balanced between groups: mean age around 60 years, similar education, race distribution, income levels, comorbid conditions (including heart failure, hypertension, chronic kidney disease).
Adjustments for Confounding
- Adjusted for various confounders, including demographics (age, sex, race, income), comorbidities (heart failure, stroke), medication use, and diabetes complications.
- Used Bonferroni adjustment for statistical significance due to multiple subgroup analyses.
Follow-Up Data
- Median follow-up time for SGLT2 users was 138 days and for other cohorts around 128 days, indicative of sufficient tracking duration for assessing outcomes.
Conclusion
- Findings suggest a higher incidence of DKA with SGLT2 inhibitors compared to DPP-4 inhibitors and sulfonylureas, yet absolute risk remains low, supporting the need for further comparative safety research to inform clinical decision-making.
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