Real-world effectiveness of treatments for type 2 diabetes, hypercholesterolemia, and hypertension in Canadian routine care – Results from the CardioVascular and metabolic treatment in Canada: Assessment of REal-life therapeutic value (CV-CARE) registry, 12-months results. (December 2020)

• Record Type: Journal Article
• Authors: Goldenberg, Ronald; Bell, Alan; Cheng, Willoon; Fils-Aimé, Nadège; Burrows, Melonie; Blavignac, Jessica; Parron, Emilia; Barakat, Maxime
• Is Part Of: Diabetes research and clinical practice. Volume 170(2020)
• Publication Date: 2020-12
• Subjects: Cardiovascular disorders -- Metabolic disorders -- Hypercholesterolemia -- Hypertension -- Registry-based study -- Type 2 diabetes; ACEi angiotensin-converting enzyme inhibitors -- ACR albumin/creatinine ratio -- ACS acute coronary syndrome -- AE adverse event -- ApoB apolipoprotein B -- ARB angiotensin receptor blocker -- AV atrioventricular -- AZI azilsartan -- AZI/CHL azilsartan/chlorthalidone -- BMI body-mass index -- BP blood pressure -- C colesevelam -- CCB calcium channel blocker -- CCS Canadian Cardiovascular Society -- CHEP Canadian Hypertension Education Program -- CI confidence interval -- CKD chronic kidney disease -- CRF Case Report Form -- CV cardiovascular -- CVD cardiovascular disease -- DBP diastolic blood pressure -- DCCT Diabetes Control and Complications Trial -- def definition -- eGFR estimated glomerular filtration rate -- ESC European Society of Cardiology -- FPG fasting plasma glucose -- GI gastrointestinal -- HbA1c glycated hemoglobin -- HCh hypercholesterolemia -- HDL-C high-density lipoprotein-cholesterol -- HTN hypertension -- LDL-C low-density lipoprotein cholesterol -- MedDRA medical dictionary for regulatory activities -- MetER metformin hydrochloride extended release -- MetIR metformin immediate release -- mo months -- N/A not available -- PCSK9 proprotein convertase subtilisin kexin 9 -- RAASi renin-angiotensin aldosterone system inhibitors -- RCT Randomized controlled trials -- RWE real-world evidence -- SAE serious adverse event -- SBP systolic blood pressure -- SOC standard of care -- T2D type 2 diabetes -- TC total cholesterol -- TG triglycerides -- TXC diltiazem extended-release -- UKPDS United Kingdom Prospective Diabetes Study; Diabetes -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462
• DOI: 10.1016/j.diabres.2020.108416
• Languages: English
• ISSNs: 0168-8227

Abstract

Highlights: Achieving targets of cardiometabolic disease parameters crucial to delay complications. RWE of the safety and efficacy of CV and metabolic drugs in Canada is scarce. CV-CARE provides RWE in Canadian routine clinical care setting. Abstract: Aims: The CV-CARE registry provides RWE in Canadian routine clinical practice. Methods: CV-CARE is a multi-site, observational, prospective Canadian registry enrolling patients initiating treatment with metformin hydrochloride extended-release (MetER) for T2D; colesevelam (C) for HCh; and azilsartan (AZI), azilsartan/chlorthalidone (AZI/CHL) or diltiazem extended-release (TXC) for HTN. Patient characteristics/assessment were performed at baseline and 12 ± 6 months. Primary outcome was absolute change in HbA1c and FPG (MetER); % change in LDL-C (C); and absolute change in BP (AZI-AZI/CHL-TXC). Results: Of the 4194 patients in the primary analysis population, 24% were taking MetER, 39% were taking C, 33% were taking AZI, 12% were taking AZI/CHL, and 3% were taking TXC. At 12 months, MetER-treated patients had an absolute mean (95% CI) change in HbA1c of −0.3% [−0.4; −0.2] and in FPG of 0.7 mmol/L [−1.0; −0.4]. C-treated patients had a mean (95% CI) % change in LDL-C of −13.0% [−14.6; −11.4]. Absolute mean (95% CI) changes in SBP were −18.7 mmHg [−19.7; −17.7](AZI), −21.3 mmHg [−23.1; −19.5](AZI/CHL), and -12.3 mmHg [−15.1; −9.6](TXC). Conclusion: In a real-world Canadian setting, MetER, C, AZI, AZI/CHL, and TXC show improvement of the cardiometabolic profile of T2D, HCh, and HTN patients.