Jang (2022)
Relapsed/refractory multiple myeloma
Oncology • Other Data • South Korea
Study Metrics
Quality Indicators
Study Information
| First Author: | Jang |
| Publication Year: | 2022 |
| DOI: | https://doi.org/10.3390/ijerph192013560 |
| Preprint: | No preprint |
Institution & Funding
| Institution Type: | Academic |
| Institutions: | College of Pharmacy and Research Institute of Pharmaceutical Sciences at Seoul National University, and Department of Internal Medicine at Seoul National University Hospital |
| Funding: | Declared: Public |
| Funding Institutions: | This research was supported by a grant (2020MFDS171) from the Ministry of Food and Drug Safety in 2020. |
Study Context
| Disease: | Relapsed/refractory multiple myeloma |
| Disease Category: | Oncology |
| Data Type: | Other |
| Number of Data Sources: | 2 |
| Geography: | South Korea |
| Eligible Sample: | 263.0 |
| Number of Treatments: | 2 |
Analytical Methods
| Matching Method: | PS Matching, 1:1 matching |
| Analysis Method: | Cox PH |
| Estimand: | Not defined |
Quality Methods
Target Trial Information
| Target Trial Name: | ASPIRE |
| Registration Number: | NCT01080391 |
| Target Trial DOI: | https://doi.org/10.1056/nejmoa1411321 |
TTE vs RCT Comparisons
Detailed comparison between Target Trial Emulation results and corresponding Randomized Controlled Trial outcomes.
Acute kidney injury
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Acute kidney injury
RCT Result
0.78
95% CI: [0.63, 0.96]
vs
TTE Result
0.70
95% CI: [0.59, 0.82]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Acute renal failure
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Acute renal failure
RCT Result
1.19
95% CI: [0.70, 2.00]
vs
TTE Result
1.30
95% CI: [0.53, 3.16]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
All cause death
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
All cause death
RCT Result
0.68
95% CI: [0.57, 0.82]
vs
TTE Result
0.78
95% CI: [0.67, 0.91]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Coronary revascularization
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Coronary revascularization
RCT Result
0.86
95% CI: [0.72, 1.04]
vs
TTE Result
0.94
95% CI: [0.87, 1.02]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Cough
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Cough
RCT Result
1.94
95% CI: [1.37, 2.72]
vs
TTE Result
1.04
95% CI: [0.45, 2.45]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Diabetic ketoacidosis
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Diabetic ketoacidosis
RCT Result
1.99
95% CI: [0.20, 17.80]
vs
TTE Result
1.09
95% CI: [0.72, 1.64]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Diarrhea
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Diarrhea
RCT Result
1.44
95% CI: [1.08, 1.92]
vs
TTE Result
1.03
95% CI: [0.52, 1.99]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Dyspenia
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Dyspenia
RCT Result
1.38
95% CI: [0.94, 2.00]
vs
TTE Result
2.27
95% CI: [1.24, 4.16]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Fracture
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Fracture
RCT Result
0.98
95% CI: [0.76, 1.27]
vs
TTE Result
0.94
95% CI: [0.87, 1.03]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Genital infection
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Genital infection
RCT Result
3.74
95% CI: [2.70, 5.19]
vs
TTE Result
1.49
95% CI: [1.35, 1.65]
Concordance Assessment
CIs do not overlap
Both point to similar conclusion
Heart failure
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Heart failure
RCT Result
1.59
95% CI: [0.83, 3.02]
vs
TTE Result
1.45
95% CI: [0.61, 3.48]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
hospitalization for heart failure
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
hospitalization for heart failure
RCT Result
0.65
95% CI: [0.50, 0.85]
vs
TTE Result
0.85
95% CI: [0.75, 0.95]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Hospitalization for unstable angine
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Hospitalization for unstable angine
RCT Result
0.99
95% CI: [0.74, 1.34]
vs
TTE Result
0.94
95% CI: [0.88, 1.01]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Hypertension
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Hypertension
RCT Result
2.23
95% CI: [1.38, 3.62]
vs
TTE Result
1.32
95% CI: [0.73, 2.40]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Hypoglycemic adverse event
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Hypoglycemic adverse event
RCT Result
1.00
95% CI: [0.89, 1.11]
vs
TTE Result
0.70
95% CI: [0.59, 0.84]
Concordance Assessment
CIs do not overlap
Different conclusions
Hypokalemia
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Hypokalemia
RCT Result
2.46
95% CI: [1.69, 3.57]
vs
TTE Result
1.91
95% CI: [0.62, 5.87]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Ischemic heart disease
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Ischemic heart disease
RCT Result
1.28
95% CI: [0.68, 2.42]
vs
TTE Result
1.00
95% CI: [0.34, 2.92]
Concordance Assessment
CIs overlap, suggesting concordance
Different conclusions
MACE (major adverse cardiovascular events)
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
MACE (major adverse cardiovascular events)
RCT Result
0.86
95% CI: [0.74, 0.99]
vs
TTE Result
0.87
95% CI: [0.79, 0.96]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Muscle spasm
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Muscle spasm
RCT Result
1.36
95% CI: [0.97, 1.89]
vs
TTE Result
5.12
95% CI: [1.05, 15.00]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Myocardial infarction
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Myocardial infarction
RCT Result
0.87
95% CI: [0.70, 1.09]
vs
TTE Result
0.91
95% CI: [0.76, 1.08]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Pyrexia
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Pyrexia
RCT Result
1.52
95% CI: [1.08, 2.11]
vs
TTE Result
1.79
95% CI: [0.97, 3.24]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Stroke
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Stroke
RCT Result
1.18
95% CI: [0.89, 1.56]
vs
TTE Result
0.89
95% CI: [0.75, 1.05]
Concordance Assessment
CIs overlap, suggesting concordance
Different conclusions
Thrombocytopenia
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Thrombocytopenia
RCT Result
1.40
95% CI: [1.02, 1.94]
vs
TTE Result
1.84
95% CI: [1.10, 3.06]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Thromboembolic event
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Thromboembolic event
RCT Result
0.75
95% CI: [0.42, 1.31]
vs
TTE Result
0.92
95% CI: [0.80, 1.05]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Transient ischemic attack
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Transient ischemic attack
RCT Result
0.85
95% CI: [0.51, 1.42]
vs
TTE Result
0.88
95% CI: [0.74, 1.04]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Upper respiratory tract infection
ASPIREPopulation
Korean patients with relapsed/refractory multiple myeloma (RRMM) aged ≥18 years
Intervention
KRd (carfilzomib, lenalidomide, and dexamethasone)
Comparison
Rd (lenalidomide and dexamethasone)
Outcome
Upper respiratory tract infection
RCT Result
1.68
95% CI: [1.19, 2.33]
vs
TTE Result
1.43
95% CI: [0.59, 3.56]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Urinary tract infection
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Urinary tract infection
RCT Result
0.99
95% CI: [0.87, 1.13]
vs
TTE Result
0.87
95% CI: [0.81, 0.94]
Concordance Assessment
CIs overlap, suggesting concordance
Both point to similar conclusion
Volume depletion
EMPA-REG OUTCOMEPopulation
Adult patients (≥18 years) with type 2 diabetes mellitus and established cardiovascular disease in Korean population
Intervention
Empagliflozin
Comparison
Sitagliptin
Outcome
Volume depletion
RCT Result
1.04
95% CI: [0.82, 1.30]
vs
TTE Result
0.84
95% CI: [0.76, 0.94]
Concordance Assessment
CIs overlap, suggesting concordance
Different conclusions
Transparency Indicators
Overall Transparency Score:
Conflicts & Funding
| Conflicts of Interest: | Declared: None |
| Funding Source: | Declared: Public |
| Funding Institutions: | This research was supported by a grant (2020MFDS171) from the Ministry of Food and Drug Safety in 2020. |