PMID- 30393961 OWN - NLM STAT- MEDLINE DCOM- 20200203 LR - 20231013 IS - 1463-1326 (Electronic) IS - 1462-8902 (Print) IS - 1462-8902 (Linking) VI - 21 IP - 3 DP - 2019 Mar TI - CANadian CAnagliflozin REgistry: Effectiveness and safety of canagliflozin in the treatment of type 2 diabetes mellitus in Canadian clinical practice. PG - 691-699 LID - 10.1111/dom.13573 [doi] AB - AIM: There is limited information concerning the effects of canagliflozin (CANA), a sodium-glucose co-transporter 2 inhibitor (SGLT2i) in a real-world clinical setting in Canada. CanCARE is a 12-month, prospective, observational analysis to demonstrate the effectiveness and safety of CANA in usual clinical practice in Canada. MATERIALS AND METHODS: SGLT2i-naive adult patients with type 2 diabetes mellitus (T2DM) (n = 527) on a stable antihyperglycemic agent (AHA) regimen with glycated hemoglobin (A1C) >/= 7%, an estimated glomerular filtration rate (eGFR) >/= 60 mL/min/1.73m(2) , were initiated on CANA as part of their usual treatment approach, and were followed for a period of 12 months. The primary effectiveness objective was the mean change in HbA1c from baseline to 6 and 12 months. RESULTS: Significant improvement from baseline in mean HbA1c levels were observed at 6 months (-0.90%; 95% CI, -1.02, -0.78) and at 12 months (-1.04%; 95% CI, -1.15, -0.92), regardless of duration of diabetes or background AHA treatment regimen. Similarly, significant decreases in systolic blood pressure (-4.65 mm Hg); body weight (-3.24 kg), waist circumference (-2.91 cm) and body mass index (-1.15 kg/m(2) ) were observed at 12 months. Additionally, 40.5% of patients achieved the double endpoint (>/=0.5% HbA1c reduction and >/= 3% weight loss), while 24.3% of patients achieved the triple composite endpoint (>/=0.5% HbA1c reduction, >/=3% weight loss and >/= 4 mm Hg systolic blood pressure reduction). No unexpected adverse events were reported. CONCLUSION: CANA provided sustained clinically meaningful improvements in cardiometabolic parameters in this study in a real-world setting, confirming findings from randomized controlled trials. CI - (c) 2018 John Wiley & Sons Ltd. FAU - Woo, Vincent AU - Woo V AD - University of Manitoba, Winnipeg, Manitoba, Canada. FAU - Bell, Alan AU - Bell A AD - University of Toronto, Toronto, Ontario, Canada. FAU - Clement, Maureen AU - Clement M AD - University of British Columbia, Vancouver, British Columbia, Canada. FAU - Noronha, Luis AU - Noronha L AD - Diabetes Heart Research Center, Toronto, Ontario, Canada. FAU - Tsoukas, Michael A AU - Tsoukas MA AD - McGill University Health Center, Montreal, Quebec, Canada. FAU - Camacho, Fernando AU - Camacho F AD - University of Waterloo, Waterloo, Ontario, Canada. FAU - Traina, Shana AU - Traina S AD - Janssen Global Services, LLC, Raritan, New Jersey. FAU - Georgijev, Natasha AU - Georgijev N AD - Janssen Inc., Toronto, Ontario, Canada. FAU - Culham, Matthew D AU - Culham MD AD - Janssen Inc., Toronto, Ontario, Canada. FAU - Rose, Jennifer B AU - Rose JB AD - Janssen Inc., Toronto, Ontario, Canada. FAU - Rapattoni, Wally AU - Rapattoni W AUID- ORCID: 0000-0001-6400-982X AD - Janssen Inc., Toronto, Ontario, Canada. FAU - Bajaj, Harpreet S AU - Bajaj HS AUID- ORCID: 0000-0002-1461-1465 AD - LMC Diabetes and Endocrinology, Brampton, Ontario, Canada. AD - Division of Endocrinology, Mt. Sinai Hospital, Toronto, Ontario, Canada. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20181205 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0SAC974Z85 (Canagliflozin) SB - IM MH - Adult MH - Aged MH - Canada MH - Canagliflozin/adverse effects/*therapeutic use MH - Diabetes Mellitus, Type 2/*drug therapy/epidemiology MH - Drug-Related Side Effects and Adverse Reactions/epidemiology MH - Electronic Health Records/statistics & numerical data MH - Female MH - General Practice/statistics & numerical data MH - Humans MH - Male MH - Middle Aged MH - Registries MH - Treatment Outcome PMC - PMC6667918 OTO - NOTNLM OT - Canadian OT - SGLT2 inhibitor OT - canagliflozin OT - effectiveness OT - prospective OT - real-world COIS- V. W. served as an investigator and received grant support from Janssen Inc. (Canada) during the conduct of the study; is involved in clinical trials for Eli Lilly, Locemia, BMS, Astra Zeneca, Janssen, Merck, Novo Nordisk and Sanofi; and serves on advisory boards for Eli Lilly, Merck, Astra Zeneca, Novo Nordisk, Janssen and Sanofi. A. B. served as an investigator and received grant support from Janssen Inc. (Canada) during the conduct of the study; has received personal fees for speaking and for CME development as well as grants for clinical trials, and serves on advisory boards for AstraZeneca, Bristol-Myers Squibb Company, Novartis AG, Pfizer Inc, Bayer AG, Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals Inc., Sanofi and Valeant Pharmaceuticals International Inc. M. C. served as an investigator and received grant support from Janssen Inc., Canada during the conduct of the study; has received personal fees for speaking and for CME development from Novo Nordisk; and has received personal fees from Eli Lilly, Sanofi, AstraZeneca, Boehringer Ingelheim and Abbott. L. N. served as an investigator and received grant support from Janssen Inc. (Canada) during the conduct of the study; has received research fees from NovoNordisk and Sanofi; and has received consulting and/or speaking fees from Janssen, Abbott, AstraZeneca, Bristol-Myers Squibb Company, Novartis AG, Pfizer Inc, Bayer AG, Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals Inc., Sanofi, Valeant Pharmaceuticals International Inc. and Merck. M. T. served as an investigator and received grant support from Janssen Inc. (Canada) during the conduct of the study; and is involved in clinical trials for Eli Lilly, Astra Zeneca, Novo Nordisk and Sanofi. F. C. received grants from Janssen Inc., Canada, during the conduct of the study; and has received grants from Janssen Pharmaceuticals Inc. S. T. is a current employee of Janssen Global Services LLC. N. G., M. D. C., W. R. and J. B. R. are current employees of Janssen Inc. (Canada). H. S. B. served as an investigator and received grant support from Janssen Inc. (Canada) during the conduct of the study; and has received research support or personal fees from Abbott, Astra Zeneca, Bayer, Boehringer Ingelheim Inc., Eli Lilly, Janssen, Merck, Novo Nordisk, Sanofi, Pfizer, Takeda and Valeant Pharmaceuticals International Inc. AUTHOR CONTRIBUTIONS: A. B., M. C., H. S. B., V. W., N. G., S. T., J. B. R. were involved with study concept, design and protocol, with statistical analysis and plan development, and with review. F. C. was involved with statistical analysis and plan development, and with review. A B., M. C., H. S. B., V. W., N. G., S. T., F. C., M. T., L. N., J. B. R. and W. R. were involved in interpreting data as well as drafting the manuscript. All authors were involved in reviewing the manuscript and approved the final draft of the manuscript for submission. EDAT- 2018/11/06 06:00 MHDA- 2020/02/06 06:00 PMCR- 2019/07/31 CRDT- 2018/11/06 06:00 PHST- 2018/08/24 00:00 [received] PHST- 2018/10/26 00:00 [revised] PHST- 2018/11/01 00:00 [accepted] PHST- 2018/11/06 06:00 [pubmed] PHST- 2020/02/06 06:00 [medline] PHST- 2018/11/06 06:00 [entrez] PHST- 2019/07/31 00:00 [pmc-release] AID - DOM13573 [pii] AID - 10.1111/dom.13573 [doi] PST - ppublish SO - Diabetes Obes Metab. 2019 Mar;21(3):691-699. doi: 10.1111/dom.13573. Epub 2018 Dec 5.