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RESEARCH CASES

Take a glimpse at RWD research cases.

(Details will be available through EVIX-INSIGHT PRO™.)

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

Overview

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

Reference

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.

Result of Ref.

· 3개 claims data sets 사용

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

Analysis Methods

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

Result

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

Overview

Desmopressin 투약군과 Anticholinergics 투약군의 Hyponatremia 비교

Reference

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

Result of Ref.

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

Analysis Methods

· Washout period: 30 days

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

· Cox proportional hazard

· PS Matching 1:4

Result

· 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

Overview

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

Reference

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.

Result of Ref.

HR 1.10 (1.01-1.20)

Analysis Methods

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

Result

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

Overview

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

Reference

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.

Result of Ref.

HR 2.2 (1.4 - 3.6)

Analysis Methods

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

Result

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

Overview

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

Reference

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.

Result of Ref.

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

Analysis Methods

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

Result

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

Overview

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

Psychotic disorder risk 비교 연구

Reference

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

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

Result of Ref.

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

Analysis Methods

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

Result

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

Overview

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

Reference

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

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

Result of Ref.

HR 1.0 (0.9-1.1)

Analysis Methods

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

Result

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

Overview

Rivaroxaban 투약군과 warfarin 투약군의 CV risks 비교

Reference

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.

Result of Ref.

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

Analysis Methods

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

Result

· 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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