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RESEARCH CASES

RWD 기반의 연구사례를 확인해보세요.

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#1. Empagliflozin vs. DPP-4i in Heart failure

​연구개요

Empagliflozin (SGLT-2i) 투약군과 DPP-4i 투약군의 Heart failure risk 비교

​참고논문

Patorno, Elisabetta, et al. "The EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) study programme: Design and exposure accrual for an evaluation of empagliflozin in routine clinical care." Endocrinology, Diabetes & Metabolism 3.1 (2020): e00103.

​참고논문 결과

· 3개 claims data sets 사용

· 3개 claims data sets에서 PS 매칭에 의해서 코호트 추출 후 Characteristics까지 분석

분석방법

· Incidence rate (Time at risk = start +1 day ~ end +548 days)

분석결과

DPP-4i 투약군의 Heart failure 발생율이 Empagliflozin 투약군 보다 높음.

DB

Empagliflozin 투약군의 Heart failure 발생
Proportion
(per 1k persons)

DPP-4i 투약군의 Heart failure 발생
Proportion
(per 1k persons)

CDM_HIRA_2016

5.63

39.03

CDM_HIRA_2017

17.60

31.52

#2. Desmopressin vs. Anticholinergics in Hyponatremia

​연구개요

Desmopressin 투약군과 Anticholinergics 투약군의 Hyponatremia 비교

​참고논문

Fralick, Michael, et al. "Desmopressin and the risk of hyponatremia: A population-based cohort study." PLoS medicine 16.10 (2019).

​참고논문 결과

Desmopressin vs. Oxybutynin → HR 13.19 (6.69 – 26.01, p < 0.01)

분석방법

· Washout period: 30 days

· Incidence rate (TAR = start +1day ~ start +365 days)

· Cox proportional hazard

· PS Matching 1:4

분석결과

· Desmopressin 투약군의 저나트륨혈증이 유의하게 risk 더 높음 (HIRA 2016, 2017).
· Cox proportional hazard results

DB

Estimate (Hazard ratio)

P-value

CDM_HIRA_2016

2.86

0.03

CDM_HIRA_2017

2.50

0.01

#3. Pioglitazone vs. Non-user in Bladder cancer

​연구개요

Thiazolidinedione 계열의 당뇨 치료제인 Pioglitazone 투약군과 Non-user의 Bladder cancer 비교

​참고논문

Garry, Elizabeth M., et al. "Study design choices for evaluating the comparative safety of diabetes medications:

An evaluation of pioglitazone use and risk of bladder cancer in older US adults with type‐2 diabetes." Diabetes, Obesity and

Metabolism 21.9 (2019): 2096-2106.

​참고논문 결과

HR 1.10 (1.01-1.20)

분석방법

· Incidence rate (Time at risk = start +1 day ~ start +365 days)
· Cox proportional hazards
· PS Matching 1:4

분석결과

Pioglitazone 투약군과 투약하지 않은 2형 당뇨 환자군간의 방광암 risk는 유의한 차이를 보이지 않음.

DB

Estimate (Hazard ratio)

P-value

CDM_HIRA_2012

1.50

0.51

CDM_HIRA_2013

1.78

0.22

CDM_HIRA_2014

0.73

0.52

CDM_HIRA_2015

1.47

0.28

CDM_HIRA_2016

0.88

0.73

CDM_HIRA_2017

1.10

0.85

#4. SGLT-2i vs. DPP-4i in Diabetic Ketoacidosis

​연구개요

SGLT-2i 투약군과 DPP-4i 투약군의 Diabetic Ketoacidosis 비교

​참고논문

Fralick, Michael, Sebastian Schneeweiss, and Elisabetta Patorno. "Risk of diabetic ketoacidosis after initiation of an SGLT2 inhibitor."

New England Journal of Medicine 376.23 (2017): 2300-2302.

​참고논문 결과

HR 2.2 (1.4 - 3.6)

분석방법

· Incidence rate (Time at risk = start +1 day ~ start +365 days)
· Cox proportional hazards
· PS Matching 1:4

분석결과

SGLT-2i 투약군의 당뇨케토산증 risk가 더 높은 결과를 보이나 이는 유의하지 않음.

DB

Estimate (Hazard ratio)

P-value

CDM_HIRA_2016

1.25

0.71

CDM_HIRA_2017

2.32

0.11

#5. Biologic medications vs. Non-biologic medication in Serious infection

​연구개요

Biologic medications 투약군과 Non-biologic medications 투약군의 Serious infection risk 비교

​참고논문

Dommasch, Erica D., et al. "Risk of serious infection in patients receiving systemic medications for the treatment of psoriasis."

JAMA dermatology 155.10 (2019): 1142-1152.

​참고논문 결과

Optum DB à HR 1.33 (0.78–2.27), p = 0.29 / Truven DB 결과 à HR 1.02 (0.76–1.38), p = 0.55

분석방법

· Incidence rate (Time at risk = start +1 day ~ end +120 days)
· Cox proportional hazards
· PS Matching 1:1

분석결과

HIRA 2016 DB에서는 건선 환자 중 Acitretin 투약군의 감염 질환 risk가 더 높은 결과를 보임. 하지만 다른 DB에서는

다른 결과들을 보이지만 모두 유의하지 않음.

DB

Estimate (Hazard ratio)

P-value

CDM_HIRA_2012

0.45

0.15

CDM_HIRA_2013

0.70

0.48

CDM_HIRA_2014

0.92

0.84

CDM_HIRA_2015

1.13

0.81

CDM_HIRA_2016

2.60

0.08

CDM_HIRA_2017

0.45

0.15

#6. Methylphenidate vs. Atomoxetine in Psychotic disorder risks

​연구개요

25세 이하 ADHD 환자 중 두 약물 Methylphenidate (MPH, 중추신경자극제)과 Atomoxetine (비중추신경자극제)의

Psychotic disorder risk 비교 연구

​참고논문

Moran, Lauren V., et al. "Psychosis with Methylphenidate or Amphetamine in Patients with ADHD."

New England Journal of Medicine 380.12 (2019): 1128-1138.

​참고논문 결과

Methylphenidate vs. Amphetamine (국내 미승인 약물) à HR 1.65 (1.31-2.09)

분석방법

· Incidence rate (Time at risk = start +7 day ~ start +365 days)
· Cox proportional hazards
· PS Matching 1:1

분석결과

N수가 작아 모든 DB에서 통계적 검정력은 낮음. HIRA 2017 DB에서는 중추신경자극제인 Methylphenidate의

Psychotic disorder risk가 더 높은 결과를 보이나 유의하지 않음

DB

Estimate (Hazard ratio)

P-value

CDM_HIRA_2012

2.00

0.62

CDM_HIRA_2015

0.50

0.62

CDM_HIRA_2017

3.00

0.11

#7. Telmisartan vs. Ramipril in CV risks

​연구개요

Telmisartan (ARB) 투약군과 Ramipril (ACEi) 투약군의 CV risks 비교 연구

​참고논문

Fralick, Michael, et al. "Use of health care databases to support supplemental indications of approved medications."

JAMA internal medicine 178.1 (2018): 55-63.

​참고논문 결과

HR 1.0 (0.9-1.1)

분석방법

· Incidence rate (Time at risk = start +1 day ~ start +365 days)
· Cox proportional hazards
· PS Matching 1:1

분석결과

HIRA 2012년 DB에서만 Ramipril 투약군의 Outcome risk가 유의하게 높고 다른 DB에서는 risk의 차이 없음.

DB

Estimate (Hazard ratio)

P-value

CDM_HIRA_2012

0.66

0.04

CDM_HIRA_2013

1.10

0.66

CDM_HIRA_2014

1.07

0.75

CDM_HIRA_2015

0.92

0.72

CDM_HIRA_2016

0.96

0.84

CDM_HIRA_2017

1.00

1.00

#8. Rivaroxaban vs. warfarin in CV risks

​연구개요

Rivaroxaban 투약군과 warfarin 투약군의 CV risks 비교

​참고논문

Coleman, Craig I., et al. "Real-world evidence of stroke prevention in patients with nonvalvular atrial fibrillation

in the United States: the REVISIT-US study." Current medical research and opinion 32.12 (2016): 2047-2053.

​참고논문 결과

Combined CV risks HR =0.61 (0.45-0.82)  /  Intracranial hemorrhage (ICH) HR = 0.53 (0.35-0.79)

분석방법

· Incidence rate (Time at risk = start +1 day ~ end +0 day)
· Cox proportional hazards
· Stratification : 5 strata

분석결과

· 참고 논문 결과와 다른 결과 도출됨.

· 1번 Outcome: Combined CV risks → Rivaroxaban 투약군과 warfarin 투약군 간의 CV risk의 유의한 차이 없음.

DB

Estimate (Hazard ratio)

P-value

CDM_HIRA_2015

1.12

0.75

CDM_HIRA_2016

1.11

0.57

CDM_HIRA_2017

0.96

0.85

· 2번 Outcome: Intracranial hemorrhage → Rivaroxaban 투약군이 ICH risk가 더 높음 (HIRA 2016, 2017).

DB

Estimate (Hazard ratio)

P-value

CDM_HIRA_2015

0.99

0.99

CDM_HIRA_2016

2.31

0.12

CDM_HIRA_2017

1.83

0.39

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