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Effects of the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) on biomedical outcomes, observed cardiovascular events and cardiovascular risks in primary care: a longitudinal comparative study.

ABSTRACT: BACKGROUND: To assess whether the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) led to improvements in biomedical outcomes, observed cardiovascular events and predicted cardiovascular risks after 12-month intervention in the primary care setting. METHODS: A random sample of 1,248 people with diabetes enrolled to RAMP-DM for at least 12 months was selected and 1,248 people with diabetes under the usual primary care were matched by age, sex, and HbA1c level at baseline as the usual care group. Biomedical and cardiovascular outcomes were measured at baseline and at 12-month after the enrollment. Difference-in-differences approach was employed to measure the effect of RAMP-DM on the changes in biomedical outcomes, proportion of subjects reaching treatment targets, observed and predicted cardiovascular risks. RESULTS: Compared to the usual care group, RAMP-DM group had lower cardiovascular events incidence (1.21% vs 2.89%, P?=?0.003), and net decrease in HbA1c (-0.20%, P?

SUBMITTER: Jiao FF

PROVIDER: S-EPMC4145236 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Effects of the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) on biomedical outcomes, observed cardiovascular events and cardiovascular risks in primary care: a longitudinal comparative study.

Jiao Fang Fang FF Fung Colman Siu Cheung CS Wong Carlos King Ho CK Wan Yuk Fai YF Dai Daisy D Kwok Ruby R Lam Cindy Lo Kuen CL

Cardiovascular diabetology 20140821

<h4>Background</h4>To assess whether the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) led to improvements in biomedical outcomes, observed cardiovascular events and predicted cardiovascular risks after 12-month intervention in the primary care setting.<h4>Methods</h4>A random sample of 1,248 people with diabetes enrolled to RAMP-DM for at least 12 months was selected and 1,248 people with diabetes under the usual primary care were matched ...[more]

PMID: 25142791

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Project description:BackgroundStudies on the long-term effectiveness of multidisciplinary risk-stratification based management in Chinese population were rare. This study aimed to evaluate the effectiveness of a multidisciplinary risk assessment and management program for patients with diabetes mellitus (RAMP-DM) in reducing the risks of cardiovascular complications and all-cause mortality.MethodsA prospective cohort study was conducted in 18,188 propensity score matched RAMP-DM participants and subjects with diabetes under usual primary care (9,094 subjects in each group). The study endpoints were the first occurrence of coronary heart disease (CHD), stroke, heart failure (HF), total cardiovascular disease (CVD) and all-cause mortality. We constructed multivariable Cox proportional hazard regressions to estimate the association between the RAMP-DM intervention and the first occurrence of study endpoints.ResultsThe median follow-up period was 36 months. Three hundred and ninety-nine CVD events occurred in the RAMP-DM group, as compared with 608 in the control group [adjusted hazard ratio, 0.629; 95% confidence interval (CI) 0.554-0.715; P < 0.001]. The total number of all-cause deaths in RAMP-DM group was less than half that of control group (202 vs 552, adjusted hazard ratio, 0.363; 95% CI, 0.308-0.428; P < 0.001). The adjusted hazard ratios of the RAMP-DM group for CHD, stroke, and HF were 0.570 (95% CI, 0.470-0.691; P < 0.001), 0.652 (95% CI, 0.546-0.780; P < 0.001), and 0.598 (95%CI, 0.446-0.802; P = 0.001), respectively.ConclusionsThe RAMP-DM intervention was associated with lower incidences of individual and total cardiovascular complications, as well as all-cause mortality over 3 years follow-up. The encouraging results provided evidence to support that the structured risk-stratification management leading by a multidisciplinary clinical team was an effective approach to reduce future cardiovascular complications in people with diabetes.Clinical trial registryNCT02034695, http://www.ClinicalTrials.gov.

Project description:BACKGROUND:Individuals with diabetes often have high levels of atherogenic lipoproteins and cholesterol reflected by elevated low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and LDL particle number (LDL-PN). The presence of atherosclerotic cardiovascular disease (ASCVD) increases the risk of future cardiovascular events. We evaluated the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, alirocumab, among individuals with type 2 diabetes (T2DM), high LDL-C or non-HDL-C, and established ASCVD receiving maximally tolerated statin in ODYSSEY DM-DYSLIPIDEMIA (NCT02642159) and DM-INSULIN (NCT02585778). METHODS:In DM-DYSLIPIDEMIA, individuals with T2DM and mixed dyslipidemia (non-HDL-C???100 mg/dL; n?=?413) were randomized to open-label alirocumab 75 mg every 2 weeks (Q2W) or usual care (UC) for 24 weeks, with UC options selected before stratified randomization. In DM-INSULIN, insulin-treated individuals with T2DM (LDL-C???70 mg/dL; n?=?441) were randomized in a double-blind fashion to alirocumab 75 mg Q2W or placebo for 24 weeks. Study participants also had a glycated hemoglobin?<?9% (DM-DYSLIPIDEMIA) or?<?10% (DM-INSULIN). Alirocumab dose was increased to 150 mg Q2W at week 12 if week 8 LDL-C was???70 mg/dL (DM-INSULIN) or non-HDL-C was???100 mg/dL (DM-DYSLIPIDEMIA). Lipid reductions and safety were assessed in patients with ASCVD from these studies. RESULTS:This analysis included 142 DM-DYSLIPIDEMIA and 177 DM-INSULIN participants with ASCVD, including 95.1% and 86.4% with coronary heart disease, and 32.4% and 49.7% with microvascular diabetes complications, respectively. At week 24, alirocumab significantly reduced LDL-C, non-HDL-C, ApoB, and LDL-PN from baseline versus control. This translated into a greater proportion of individuals achieving non-HDL-C?<?100 mg/dL (64.6% alirocumab/23.8% UC [DM-DYSLIPIDEMIA]; 65.4% alirocumab/14.9% placebo [DM-INSULIN]) and ApoB?<?80 mg/dL (75.1% alirocumab/35.4% UC and 76.8% alirocumab/24.8% placebo, respectively) versus control at week 24 (all P?<?0.0001). In pooling these studies, 66.4% (alirocumab) and 67.0% (control) of individuals reported treatment-emergent adverse events. The adverse event pattern was similar with alirocumab versus controls. CONCLUSIONS:Among individuals with T2DM and ASCVD who had high non-HDL-C/LDL-C levels despite maximally tolerated statin, alirocumab significantly reduced atherogenic cholesterol and LDL-PN versus control. Alirocumab was generally well tolerated. Trial registration Clinicaltrials.gov. NCT02642159. Registered 30 December 2015 and Clinicaltrials.gov. NCT02585778. Registered 23 October 2015.

Project description:IntroductionThis study assessed baseline cardiovascular (CV) risk factors, concomitant CV medication use, risk of major adverse cardiac events-plus (MACE-plus), and bleeding adverse events (AEs) in patients with idiopathic pulmonary fibrosis (IPF) in three randomized, placebo-controlled phase III trials of pirfenidone.MethodsPatients in the pirfenidone phase III trials were included. Patients with unstable or deteriorating cardiac disease within 6 months before enrollment were ineligible. Medical history at baseline and concomitant CV medication use during treatment were reported. A retrospective, blinded review of AE preferred terms was conducted to identify MACE-plus and bleeding events. Subgroup analyses examined the impact of concomitant CV medication use on how pirfenidone treatment affected clinical outcomes.ResultsIn total, 1247 patients were included [n = 623 pirfenidone (2403 mg/day) and n = 624 placebo]. The median age was 68 years, 74% were male, and 65% were current/former smokers. Commonly reported CV risk factors included hypertension (52%), obesity (44%), hypercholesterolemia (23%), and hyperlipidemia (23%). Pre-existing cardiac disorders included coronary artery disease (16%), myocardial infarction (5%), and atrial fibrillation (5%). Lipid-modifying agents (60%), antithrombotic agents (54%), and renin-angiotensin inhibitors (39%) were commonly used concomitant CV medications. The incidences of MACE-plus and bleeding events were similar between the pirfenidone and placebo groups (1.8% and 2.9% for MACE-plus events and 3.7% and 4.3% for bleeding events, respectively). Except for patients receiving heparin, pirfenidone had a beneficial effect compared with placebo on efficacy outcomes regardless of concomitant CV medications.ConclusionsCV risk factors and comorbidities and use of concomitant CV medications are common in patients with IPF. Pirfenidone did not appear to increase the risk of CV or bleeding events. Use of several concomitant CV medications, including warfarin, did not appear to adversely impact pirfenidone's beneficial effect on efficacy outcomes.Trial registrationNCT00287716, NCT00287729, and NCT01366209.FundingF. Hoffmann-La Roche Ltd. and Genentech, Inc.

Dataset Information

Effects of the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) on biomedical outcomes, observed cardiovascular events and cardiovascular risks in primary care: a longitudinal comparative study.

Publications

Effects of the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) on biomedical outcomes, observed cardiovascular events and cardiovascular risks in primary care: a longitudinal comparative study.

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