The primary objective of DAPA-CKD is to assess whether dapagliflozin compared with placebo reduces the composite endpoint of worsening of renal function (defined as a composite endpoint of an eGFR decline >50%, ESRD or renal death) or cardiovascular death in patients with CKD. In addition, the trial will examine the effects of dapagliflozin, compared with placebo, on the composite endpoint of worsening of renal function, the composite endpoint of hospitalization for heart failure or cardiovascular death and all-cause mortality. Additional exploratory endpoints include changes in eGFR and urinary albumin: creatinine ratio (UACR) as well as health-related quality of life. The trial is registered with www.clinicaltrials.gov (NCT03036150).
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Dapagliflozin
Dapagliflozin
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used to improve glycemic control in adults with type 2 diabetes.
It works by reducing reabsorption of filtered glucose in the kidneys, leading to increased urinary glucose excretion.
Dapagliflozin has been shown to reduce HbA1c, body weight, and blood pressure in clinical trials.
Reserach into its effeects and optimal use is ongoing.
PubCompare.ai can help locate the best protocols and products to enhance your Dapagliflozin reasearch, improving reproducibility and accuracy.
It works by reducing reabsorption of filtered glucose in the kidneys, leading to increased urinary glucose excretion.
Dapagliflozin has been shown to reduce HbA1c, body weight, and blood pressure in clinical trials.
Reserach into its effeects and optimal use is ongoing.
PubCompare.ai can help locate the best protocols and products to enhance your Dapagliflozin reasearch, improving reproducibility and accuracy.
Most cited protocols related to «Dapagliflozin»
Albumins
Cardiovascular System
Congestive Heart Failure
Creatinine
dapagliflozin
EGFR protein, human
Hospitalization
Kidney
Kidney Failure
Patients
Placebos
Urine
The study enrolled 340 outpatients with type 2 diabetes managed at any of the 51 participating clinics in Japan. The full list of study investigators is provided in Additional file 1 . Enrollment began in July 2017 and ended in June 2018. The inclusion criteria were as follows: (1) patients with type 2 diabetes who had not used any glucose-lowering agents within 8 weeks before consenting, or those who had used only metformin; (2) those with HbA1c (NGSP values) levels of ≥ 7.1% (54 mmol/mol) but not > 10.0% (86 mmol/mol); (3) those aged between 20 and 80 years; (4) those with body mass index (BMI) of ≥ 23 kg/m2; (5) those who could be monitored closely for medication compliance; and (6) those who provided written consent to participate in the study. The following exclusion criteria were used: (1) patients with type 1 diabetes or secondary diabetes; (2) those with a medical history of diabetic ketoacidosis; (3) those with a medical history of myocardial infarction, cerebral infarction, or stroke within 12 weeks before consenting to the study; (4) those with severe liver disease having more than fivefold higher than normal levels of AST and ALT; (5) those with renal disease [serum creatinine ≥ 1.3 mg/dL, or estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2]; (6) those with unstable hypertension or dyslipidemia within 12 weeks before consent to the study; (7) those who were pregnant or breastfeeding or were planning to become pregnant during the study; and (8) dehydrated patients [test results showed abnormalities in hematocrit or blood urea nitrogen (BUN) or patient complaints of dehydration].
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Cerebral Infarction
Cerebrovascular Accident
Congenital Abnormality
Creatinine
Dehydration
Diabetes Mellitus
Diabetes Mellitus, Insulin-Dependent
Diabetes Mellitus, Non-Insulin-Dependent
Diabetic Ketoacidosis
Dyslipidemias
Glomerular Filtration Rate
Glucose
High Blood Pressures
Index, Body Mass
Kidney Diseases
Liver Diseases
Metformin
Myocardial Infarction
Outpatients
Patients
Serum
Urea Nitrogen, Blood
Volumes, Packed Erythrocyte
DAPA‐HF is an international, multicentre, parallel group, event‐driven, randomized, double‐blind, trial in patients with chronic HFrEF, evaluating the effect of dapagliflozin 10 mg, compared with placebo, given once daily, in addition to standard of care, on the risk of worsening heart failure and cardiovascular death. The trial is registered as ClinicalTrials.gov Identifier: NCT03036124.
Cardiovascular System
Congestive Heart Failure
dapagliflozin
Patients
Placebos
The following pre‐specified sub‐groups of interest will be assessed for the dual primary endpoints: age at vs. below, vs. above, the median; sex; race; geographic region; NYHA class (II vs. III/IV) at enrolment; LVEF category at enrolment (41–49% vs. 50–59%, and ≥60%); NT‐proBNP at enrolment (at or below, vs. above the median); randomization in hospital or within 30 days of discharge vs. others; eGFR at enrolment (<60 vs. ≥60 mL/min/1.73 m2); body mass index at enrolment (<30 vs. ≥30 kg/m2); diabetes status at enrolment; systolic blood pressure at randomization (at or below vs. above the median); atrial fibrillation or flutter vs. other rhythms at enrolment. The effect of treatment will also be assessed as a function of LVEF and glycated haemoglobin examined as continuous variables.
In addition to the within trial analyses, we have pre‐specified prior to the unblinding of DAPA‐HF that data from both dapagliflozin heart failure trials, DAPA‐HF and DELIVER, will be pooled and assessed in a patient‐level meta‐analysis to assess the effect of dapagliflozin across the full spectrum of heart failure.
In addition to the within trial analyses, we have pre‐specified prior to the unblinding of DAPA‐HF that data from both dapagliflozin heart failure trials, DAPA‐HF and DELIVER, will be pooled and assessed in a patient‐level meta‐analysis to assess the effect of dapagliflozin across the full spectrum of heart failure.
Amino-terminal pro-brain natriuretic peptide
Atrial Fibrillation
Congestive Heart Failure
dapagliflozin
Diabetes Mellitus
EGFR protein, human
Hemoglobin, Glycosylated
Index, Body Mass
Interest Groups
Patient Discharge
Patients
Systolic Pressure
Most recents protocols related to «Dapagliflozin»
Dapagliflozin was prescribed for children aged < 19 years with kidney disease and proteinuria despite taking an angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), with an eGFR of ≥ 20 ml/min/1.73 m 2 at baseline between July 2022 and December 2023. Clinicians adjusted the dose based on body weight and eGFR, but there was no standardized protocol. All eligible patients who consented received dapagliflozin during this period. Children treated with dapagliflozin for > 3 months were reviewed in this study. None of the children had any of the following pre-existing conditions: polycystic kidney disease, type 1 diabetes, uncontrolled urinary tract infections, kidney transplantation, current cancer diagnosis, and evidence of liver disease. Proteinuria was defined as a spot urine protein/creatinine ratio (uPCR) of ≥ 0.2 mg/mg. The term "eGFR dipping" refers to the immediate reduction in eGFR instantly after starting the dapagliflozin treatment. Decreased proteinuria was defined as a uPCR lower than the initial treatment level at the last visit, and glycosuria as the presence of glucose 4 + in a patient's spot urine stick test at the 1-month visit. This retrospective study was approved by the Seoul National University Hospital institutional review board (IRB no. 2304-049-1421).
RASi persistence was assessed during the 12 months after index in patients with and without T2D in the preapproval cohort and in patients without T2D in the postapproval cohort. RASis were represented by several different types (11 ACE is and six angiotensin receptor blockers). Using the highest dose (HD) available in each country according to registered drug prescription doses, each RASi was categorized into three dose levels: low (<50% of the HD available), intermediate (50%–99% of the HD available), and high (100% of the HD available). This was performed separately within each country because the HD available for each RASi type varied across countries (Supplemental Table 5 ).
Dapagliflozin persistence was assessed during the 12 months after index in patients without T2D during the period after its approval for CKD in each country (postapproval cohort). Dapagliflozin persistence was assessed in patients without T2D to ensure that patients received dapagliflozin for the treatment of CKD and not for the T2D indication. Dapagliflozin treatment initiation was defined as the first-recorded dapagliflozin 10-mg prescription. Unlike RASis, which do not have a target dose for the treatment of CKD, dapagliflozin has a guideline-recommended target dose of 10 mg across all countries.15 (link) It may also be used at a dose of 5 mg. Hence, dapagliflozin was categorized into two dose levels: target dose (10 mg; the approved dose for CKD treatment) and intermediate dose (5 mg).
For both RASis and dapagliflozin, the duration of each filled prescription was calculated based on the number of days covered by the number of pills contained in the box and the prescribed dose.14 (link),16 (link)–18 (link, link) Once a patient had used all the pills from a given prescription, the patient was considered to have discontinued treatment until a new prescription was filled.14 (link),18 (link) Hence, persistence is based on the proportion of patients on treatment at a given time point and is affected by both poor adherence and deliberate discontinuation.
Dapagliflozin persistence was assessed during the 12 months after index in patients without T2D during the period after its approval for CKD in each country (postapproval cohort). Dapagliflozin persistence was assessed in patients without T2D to ensure that patients received dapagliflozin for the treatment of CKD and not for the T2D indication. Dapagliflozin treatment initiation was defined as the first-recorded dapagliflozin 10-mg prescription. Unlike RASis, which do not have a target dose for the treatment of CKD, dapagliflozin has a guideline-recommended target dose of 10 mg across all countries.15 (link) It may also be used at a dose of 5 mg. Hence, dapagliflozin was categorized into two dose levels: target dose (10 mg; the approved dose for CKD treatment) and intermediate dose (5 mg).
For both RASis and dapagliflozin, the duration of each filled prescription was calculated based on the number of days covered by the number of pills contained in the box and the prescribed dose.14 (link),16 (link)–
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All adult patients in the Clinformatics Data Mart, RWD and MDV databases were included in the descriptive analysis if they initiated or were eligible for dapagliflozin 10 mg during the study period. A list of eligibility criteria for this descriptive analysis can be found in Table S1 .
Summary statistics were used to describe patient demographics, clinical characteristics, comorbidities, medications and laboratory tests during the baseline period or on the index date. The study index date was defined as the date of first dapagliflozin 10 mg prescription (in the case of dapagliflozin initiators) or the first date on which patients met all eligibility criteria during the study period (in the case of eligible but untreated patients). Missing data were not imputed but are reported as a separate category.
Summary statistics were used to describe patient demographics, clinical characteristics, comorbidities, medications and laboratory tests during the baseline period or on the index date. The study index date was defined as the date of first dapagliflozin 10 mg prescription (in the case of dapagliflozin initiators) or the first date on which patients met all eligibility criteria during the study period (in the case of eligible but untreated patients). Missing data were not imputed but are reported as a separate category.
The base cohort for this analysis included all patients who met the eligibility criteria (Table 1 ) on any day (possible index date) during the study period in the two databases that contained UACR records (Clinformatics Data Mart and RWD). To increase the number of patients in this effectiveness analysis, patients were also included if they had a urinary protein-to-creatinine ratio (UPCR) measurement that corresponded to the UACR thresholds used as inclusion and exclusion criteria for the study. UPCR values were converted using the crude model PCR equation for predicted UACR, as described by Sumida et al. [21 (link)]. To allow a pooled analysis of both countries and thereby increase the study sample size, this analysis applied the more conservative dapagliflozin 10 mg indication for CKD treatment from the USA. Therefore, all included patients were eligible for dapagliflozin 10 mg according to the approved CKD indication. All eligible patients were considered potential comparators until they initiated dapagliflozin 10 mg. Patients who subsequently initiated dapagliflozin 10 mg and met the indication for the treatment of CKD were then categorized as ‘dapagliflozin initiators’. Dapagliflozin initiators could therefore be a matched comparator in the period before initiation.
Effectiveness analysis: eligibility criteria to identify patients with a possible index date
| Age | ≥ 18 years on index date |
| Meets CKD definition on or within 2 years before index date | UACR ≥ 30 mg/ga UPCR ≥ 150 mg/g CKD diagnosis code Two eGFR measurements ≥ 90 days apart, both < 60 mL/min/1.73 m2 |
| Continuous enrolment before index date | < 730 days |
| eGFR below threshold (on or within 1 year before index date) | 25 mL/min/1.73 m2 |
| UACRa above threshold (on or within 1 year before index date) or UPCR equivalent | 200 mg/g |
| History of comorbidities on or before index date | Type 1 diabetes Gestational diabetes mellitus Diagnosis indicating dialysis Polycystic kidney disease End-stage kidney disease |
| History of procedures on or before index date | Dialysis Procedure indicating end-stage kidney disease |
| History of prescriptions | Dapagliflozin 10 mg any time before index date Any SGLT2i on or 1 year before index date Hydroxychloroquine on index date Immunotherapy on or 6 months before index date |
CKD chronic kidney disease, eGFR estimated glomerular filtration rate, SGLT2i sodium–glucose cotransporter 2 inhibitor, UACR urinary albumin-to-creatinine ratio, UPCR urinary protein-to-creatinine ratio
aAlso included quantitative UPCR converted to UACR
We conducted a retrospective study involving adult patients, both with or without T2DM, who received their first prescription for dapagliflozin during hospitalization. Patients who had not previously taken any SGLT2i, who had taken dapagliflozin for a minimum of 5 consecutive days, and for whom the bioanalytical parameters under study were available were included. Therefore, the inclusion criteria were as follows: (1) age ≥ 18 years; (2) patients (with T2DM or not) who had never taken an SGLT2i; (3) patients who took dapagliflozin for the first time for at least 5 consecutive days during the period of hospitalization; and (4) patients for whom the bioanalytical parameters under study (blood glucose, creatinine, sodium, and potassium levels) were available both before dapagliflozin prescription (baseline) and 5 to 8 days after prescription (endpoint). The exclusion criteria were as follows: (1) age < 18 years; (2) patients who were already taking an SGLT2i prior to hospitalization; (3) patients who took dapagliflozin during hospitalization for less than 5 days; and (4) patients who started taking dapagliflozin during hospitalization but for whom the bioanalytical values under study were not available. The study period encompassed 23 months, from 1 September 2021 to 31 July 2023, at the Local Health Unit of Guarda and 30 months, from 1 January 2021 to 30 June 2023, at the Local Health Unit of Cova da Beira. Ethics approval was obtained from the Ethics Committee of the Local Health Unit of Guarda (SFTSS-REQ-22021; approval date: 3 April 2023) and the Local Unit Health of Cova da Beira (35/2023; approval date: 29 May 2023).
To estimate the prevalence of short-term renal dysfunction and electrolyte imbalance among the patients receiving dapagliflozin, with a 95% confidence level and 5% precision, and assuming an expected prevalence of 20% (derived from a pilot study conducted by the researchers and which included 124 patients), a sample size of 246 patients was determined to be necessary.
To estimate the prevalence of short-term renal dysfunction and electrolyte imbalance among the patients receiving dapagliflozin, with a 95% confidence level and 5% precision, and assuming an expected prevalence of 20% (derived from a pilot study conducted by the researchers and which included 124 patients), a sample size of 246 patients was determined to be necessary.
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Top products related to «Dapagliflozin»
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Dapagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor. It is a laboratory equipment product used for research and development purposes.
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Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a class of pharmaceutical compounds used to lower blood glucose levels in individuals with type 2 diabetes. It functions by reducing the reabsorption of glucose in the kidneys, leading to increased urinary glucose excretion.
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Prism 9 is a powerful data analysis and graphing software developed by GraphPad. It provides a suite of tools for organizing, analyzing, and visualizing scientific data. Prism 9 offers a range of analysis methods, including curve fitting, statistical tests, and data transformation, to help researchers and scientists interpret their data effectively.
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Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It is used to measure the inhibitory activity of SGLT2, a key regulator of glucose homeostasis.
More about "Dapagliflozin"
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a class of medications used to manage type 2 diabetes by reducing reabsorption of filtered glucose in the kidneys.
This leads to increased urinary glucose excretion, helping to improve glycemic control in adults with the condition.
Research has shown that dapagliflozin can effectively lower HbA1c levels, body weight, and blood pressure in clinical trials.
Scientists are continuously exploring its effects and optimal therapeutic applications.
To enhance the accuracy and reproducibility of your dapagliflozin research, consider leveraging the powerful AI-driven tools of PubCompare.ai.
This leading platform can help you identify the best protocols from literature, preprints, and patents, ensuring your experiments are built on solid foundations.
When designing your dapagliflozin studies, you may also consider incorporating other relevant techniques and reagents, such as fasting blood sugar (FBS) measurements, the TRIzol reagent for RNA extraction, and statistical analysis software like GraphPad Prism (versions 7, 8, or 9) or SAS (version 9.4).
These complementary approaches can provide valuable insights and strengthen the overall quality of your research.
By combining the latest advancements in dapagliflozin pharmacology with cutting-edge research tools and techniques, you can take your investigations to new heights and contribute to the ongoing progress in managing type 2 diabetes.
Experiance the difference PubCompare.ai can make in your dapagliflozin research journey.
This leads to increased urinary glucose excretion, helping to improve glycemic control in adults with the condition.
Research has shown that dapagliflozin can effectively lower HbA1c levels, body weight, and blood pressure in clinical trials.
Scientists are continuously exploring its effects and optimal therapeutic applications.
To enhance the accuracy and reproducibility of your dapagliflozin research, consider leveraging the powerful AI-driven tools of PubCompare.ai.
This leading platform can help you identify the best protocols from literature, preprints, and patents, ensuring your experiments are built on solid foundations.
When designing your dapagliflozin studies, you may also consider incorporating other relevant techniques and reagents, such as fasting blood sugar (FBS) measurements, the TRIzol reagent for RNA extraction, and statistical analysis software like GraphPad Prism (versions 7, 8, or 9) or SAS (version 9.4).
These complementary approaches can provide valuable insights and strengthen the overall quality of your research.
By combining the latest advancements in dapagliflozin pharmacology with cutting-edge research tools and techniques, you can take your investigations to new heights and contribute to the ongoing progress in managing type 2 diabetes.
Experiance the difference PubCompare.ai can make in your dapagliflozin research journey.