PMID- 26530268
OWN - NLM
STAT- MEDLINE
DCOM- 20160712
LR  - 20231111
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 32
IP  - 11
DP  - 2015 Nov
TI  - Effects of Baseline Blood Pressure and Low-Density Lipoprotein Cholesterol on 
      Safety and Efficacy of Canagliflozin in Japanese Patients with Type 2 Diabetes 
      Mellitus.
PG  - 1085-103
LID - 10.1007/s12325-015-0255-8 [doi]
AB  - INTRODUCTION: Sodium glucose co-transporter 2 inhibitors decrease hemoglobin A1c 
      (HbA1c) and blood pressure (BP) and slightly increase low-density lipoprotein 
      cholesterol (LDL-C) in patients with type 2 diabetes mellitus (T2DM). The effects 
      of baseline BP and LDL-C on the safety and efficacy of canagliflozin in patients 
      were analyzed post hoc in a phase III study. METHODS: Japanese patients with T2DM 
      were classified by baseline systolic BP (SBP) of <130 or >/=130 mmHg, diastolic BP 
      (DBP) of <80 or >/=80 mmHg, and LDL-C of <120 or >/=120 mg/dL. Canagliflozin was 
      administered daily to patients for 52 weeks at doses of either 100 mg (n = 584) 
      or 200 mg (n = 715). The effects of canagliflozin on the incidence of adverse 
      events (AEs), BP, and LDL-C were evaluated. RESULTS: No clear differences were 
      observed in overall safety among the subgroups classified by baseline SBP, DBP, 
      or LDL-C, except for a slight imbalance in AEs associated with volume depletion 
      with 200 mg of canagliflozin. The decrease in mean SBP and DBP was evident in 
      subgroups with baseline SBP >/=130 mmHg and DBP >/=80 mmHg. Mean LDL-C was decreased 
      in subgroups with baseline LDL-C >/=120 mg/dL at both canagliflozin doses, and they 
      were slightly increased, but did not exceed 120 mg/dL in subgroups with baseline 
      LDL-C <120 mg/dL. The changes in HbA1c and body weight from those observed at 
      baseline were not different between subgroups classified by SBP, DBP, and LDL-C 
      at either dose. CONCLUSION: The present post hoc analysis indicates that 
      canagliflozin is well tolerated irrespective of baseline BP and LDL-C in patients 
      with T2DM. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01387737. 
      FUNDING: Mitsubishi Tanabe Pharma Corporation.
FAU - Inagaki, Nobuya
AU  - Inagaki N
AD  - Department of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate 
      School of Medicine, Kyoto, Japan.
FAU - Goda, Maki
AU  - Goda M
AD  - Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. 
      gouda.maki@mm.mt-pharma.co.jp.
FAU - Yokota, Shoko
AU  - Yokota S
AD  - Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
FAU - Maruyama, Nobuko
AU  - Maruyama N
AD  - Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
FAU - Iijima, Hiroaki
AU  - Iijima H
AD  - Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01387737
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20151103
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Sodium-Glucose Transporter 2)
RN  - 0SAC974Z85 (Canagliflozin)
MH  - Aged
MH  - Asian People
MH  - *Blood Pressure
MH  - Body Weight
MH  - Canagliflozin/administration & dosage/adverse effects/*therapeutic use
MH  - Cholesterol, LDL/*blood
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Glycated Hemoglobin
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Incidence
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Sodium-Glucose Transporter 2
PMC - PMC4662712
OTO - NOTNLM
OT  - Blood pressure
OT  - Canagliflozin
OT  - Low-density lipoprotein cholesterol (LDL-C)
OT  - Sodium glucose co-transporter 2 (SGLT2) inhibitor
OT  - Type 2 diabetes mellitus
OT  - Volume depletion
EDAT- 2015/11/05 06:00
MHDA- 2016/07/13 06:00
PMCR- 2015/11/03
CRDT- 2015/11/05 06:00
PHST- 2015/09/14 00:00 [received]
PHST- 2015/11/05 06:00 [entrez]
PHST- 2015/11/05 06:00 [pubmed]
PHST- 2016/07/13 06:00 [medline]
PHST- 2015/11/03 00:00 [pmc-release]
AID - 10.1007/s12325-015-0255-8 [pii]
AID - 255 [pii]
AID - 10.1007/s12325-015-0255-8 [doi]
PST - ppublish
SO  - Adv Ther. 2015 Nov;32(11):1085-103. doi: 10.1007/s12325-015-0255-8. Epub 2015 Nov 
      3.