PMID- 36068684
OWN - NLM
STAT- MEDLINE
DCOM- 20221110
LR  - 20221115
IS  - 1365-2710 (Electronic)
IS  - 0269-4727 (Linking)
VI  - 47
IP  - 11
DP  - 2022 Nov
TI  - Impact of breakthrough trials on prescription trends of sodium-glucose 
      cotransporter-2 inhibitors in Japan: An interrupted time-series analysis.
PG  - 1796-1804
LID - 10.1111/jcpt.13768 [doi]
AB  - WHAT IS KNOWN AND OBJECTIVE: Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) 
      have been increasingly prescribed for the treatment of type 2 diabetes mellitus 
      (T2DM). We aimed to investigate the impact of clinical trials presenting 
      remarkable results on the prescription of SGLT-2is and the relationship between 
      the impact and generalisability of the breakthrough trials on SGLT-2is. METHODS: 
      This retrospective cohort study involved 32,949 patients with T2DM who were 
      prescribed at least one antidiabetic agent in the Japan Medical Data Center 
      health insurance database. Prescription rates of SGLT-2is were calculated monthly 
      from April 2014 to March 2020. We evaluated the impact of the EMPA-REG OUTCOME 
      study for an Asian subgroup on the prescription rate of empagliflozin and the 
      impact of the CANVAS/CANVAS-R study on the prescription rate of canagliflozin. 
      Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were estimated 
      using the quasi-Poisson regression model in the overall population, subgroup with 
      a history of cardiovascular disease (high-risk group), and subgroup without a 
      history and risk factors of cardiovascular disease (low-risk group). RESULTS AND 
      DISCUSSION: The EMPA-REG OUTCOME study for the Asian subgroup led to increased 
      prescription rates of empagliflozin 3 months after its publication in the overall 
      population and high-risk group but not in low-risk group (IRR [95% CI]: 1.40 
      [1.17-1.66], 1.39 [1.05-1.84], and 1.00 [0.79-1.27], respectively). The increase 
      in high-risk group may be appropriate because this study included patients with a 
      history of cardiovascular disease only. The CANVAS/CANVAS-R study led to 
      increased prescription rates of canagliflozin 3 months after its publication in 
      the overall population, high-risk group, and low-risk group (IRR [95% CI]: 1.52 
      [1.06-2.19], 1.39 [1.06-1.83], and 1.81 [1.20-2.75], respectively). The increase 
      in low-risk group may not be appropriate because this study did not include 
      patients without a history or risk factors of cardiovascular disease. WHAT IS NEW 
      AND CONCLUSION: The breakthrough trials increased prescription rates not only for 
      patients to whom the trial results could be extrapolated but also for those in 
      whom trial benefits were not certain. Our findings suggest that information about 
      breakthrough trials may need to be provided along with data on trial result 
      generalisability.
CI  - (c) 2022 John Wiley & Sons Ltd.
FAU - Iketani, Ryo
AU  - Iketani R
AUID- ORCID: 0000-0001-9740-4295
AD  - Center for Outcomes Research and Economic Evaluation for Health, National 
      Institute of Public Health, Wako, Saitama, Japan.
FAU - Imai, Shinobu
AU  - Imai S
AD  - Department of Drug Safety and Risk Management, School of Pharmacy, Tokyo 
      University of Pharmacy and Life Sciences, Tokyo, Japan.
LA  - eng
GR  - JP20K16102/Japan Society for the Promotion of Science/
PT  - Journal Article
DEP - 20220906
PL  - England
TA  - J Clin Pharm Ther
JT  - Journal of clinical pharmacy and therapeutics
JID - 8704308
RN  - 0SAC974Z85 (Canagliflozin)
RN  - HDC1R2M35U (empagliflozin)
RN  - 0 (Sodium-Glucose Transporter 2 Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - IY9XDZ35W2 (Glucose)
RN  - 9NEZ333N27 (Sodium)
SB  - IM
MH  - Humans
MH  - Canagliflozin/therapeutic use
MH  - *Diabetes Mellitus, Type 2/drug therapy/complications
MH  - *Sodium-Glucose Transporter 2 Inhibitors/therapeutic use
MH  - *Cardiovascular Diseases/etiology
MH  - Retrospective Studies
MH  - Japan
MH  - Hypoglycemic Agents/therapeutic use
MH  - Prescriptions
MH  - Glucose/therapeutic use
MH  - Sodium
OTO - NOTNLM
OT  - administrative claims data
OT  - clinical trial
OT  - diabetes mellitus
OT  - sodium-glucose cotranspoter-2 inhibitors
OT  - time-series analysis
EDAT- 2022/09/08 06:00
MHDA- 2022/11/11 06:00
CRDT- 2022/09/07 00:52
PHST- 2022/08/20 00:00 [revised]
PHST- 2022/06/15 00:00 [received]
PHST- 2022/08/24 00:00 [accepted]
PHST- 2022/09/08 06:00 [pubmed]
PHST- 2022/11/11 06:00 [medline]
PHST- 2022/09/07 00:52 [entrez]
AID - 10.1111/jcpt.13768 [doi]
PST - ppublish
SO  - J Clin Pharm Ther. 2022 Nov;47(11):1796-1804. doi: 10.1111/jcpt.13768. Epub 2022 
      Sep 6.