scholarly journals Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58

2021 ◽  
Author(s):  
Avivit Cahn ◽  
Itamar Raz ◽  
Lawrence A. Leiter ◽  
Ofri Mosenzon ◽  
Sabina A. Murphy ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Cardiovascular Prevention ◽  
Cardiovascular Death ◽  
Metabolic Effects ◽  
Atherosclerotic Cardiovascular Disease ◽  
Renal Outcomes ◽  
Metabolic Outcomes ◽  
Specific Outcome ◽  
Risk Patients ◽  
Treatment Interaction

<b>Aims: </b>International guidelines propose prescribing SGLT-2 inhibitors to patients with type-2 diabetes (T2D) as secondary prevention in patients with established atherosclerotic cardiovascular disease (ASCVD) or for primary prevention of cardiovascular events in high-risk patients with multiple risk factors (MRF) for ASCVD. The current analyses expand on the cardiovascular renal and metabolic effects of SGLT-2 inhibitors in MRF patients. <p><b>Methods: </b>The DECLARE-TIMI 58 trial randomized 17,160 patients with T2D and MRF (59.4%) or established ASCVD (40.6%) to dapagliflozin vs. placebo, followed for a median 4.2 years. The cardiovascular and renal outcomes in the MRF cohort were studied across clinically relevant subgroups for treatment effect and subgroup-based treatment interaction. </p> <p><b>Results:</b> Among patients with MRF, the reduction with dapagliflozin in risk of cardiovascular death or hospitalization for heart failure (CVD/HHF; HR 0.84, 95%CI 0.67-1.04) and the renal-specific outcome (HR 0.51, 95%CI 0.37-0.69) did not differ from patients with ASCVD (P<sub>interaction</sub> 0.99 and 0.72 respectively). The effect on CVD/HHF was entirely driven by a reduction in HHF (HR 0.64, 95%CI 0.46-0.88). The benefits of dapagliflozin on HHF and on the renal-specific outcome, among the subset with MRF, were directionally consistent across clinically relevant subgroups. At 48 months, HbA1c, weight, systolic blood-pressure and urinary albumin:creatinine ratio were lower with dapagliflozin vs. placebo and eGFR was higher (p<0.001). </p> <p><b>Conclusion: </b>In patients with T2D and MRF, dapagliflozin reduced the risk of HHF and adverse renal outcomes regardless of baseline characteristics. These analyses support the benefit of dapagliflozin on important outcomes in a broad primary prevention population.</p>

scholarly journals Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58

2021 ◽  
Author(s):  
Avivit Cahn ◽  
Itamar Raz ◽  
Lawrence A. Leiter ◽  
Ofri Mosenzon ◽  
Sabina A. Murphy ◽  
...  
Keyword(s):  
Primary Prevention ◽  
Cardiovascular Prevention ◽  
Cardiovascular Death ◽  
Metabolic Effects ◽  
Atherosclerotic Cardiovascular Disease ◽  
Renal Outcomes ◽  
Metabolic Outcomes ◽  
Specific Outcome ◽  
Risk Patients ◽  
Treatment Interaction

<b>Aims: </b>International guidelines propose prescribing SGLT-2 inhibitors to patients with type-2 diabetes (T2D) as secondary prevention in patients with established atherosclerotic cardiovascular disease (ASCVD) or for primary prevention of cardiovascular events in high-risk patients with multiple risk factors (MRF) for ASCVD. The current analyses expand on the cardiovascular renal and metabolic effects of SGLT-2 inhibitors in MRF patients. <p><b>Methods: </b>The DECLARE-TIMI 58 trial randomized 17,160 patients with T2D and MRF (59.4%) or established ASCVD (40.6%) to dapagliflozin vs. placebo, followed for a median 4.2 years. The cardiovascular and renal outcomes in the MRF cohort were studied across clinically relevant subgroups for treatment effect and subgroup-based treatment interaction. </p> <p><b>Results:</b> Among patients with MRF, the reduction with dapagliflozin in risk of cardiovascular death or hospitalization for heart failure (CVD/HHF; HR 0.84, 95%CI 0.67-1.04) and the renal-specific outcome (HR 0.51, 95%CI 0.37-0.69) did not differ from patients with ASCVD (P<sub>interaction</sub> 0.99 and 0.72 respectively). The effect on CVD/HHF was entirely driven by a reduction in HHF (HR 0.64, 95%CI 0.46-0.88). The benefits of dapagliflozin on HHF and on the renal-specific outcome, among the subset with MRF, were directionally consistent across clinically relevant subgroups. At 48 months, HbA1c, weight, systolic blood-pressure and urinary albumin:creatinine ratio were lower with dapagliflozin vs. placebo and eGFR was higher (p<0.001). </p> <p><b>Conclusion: </b>In patients with T2D and MRF, dapagliflozin reduced the risk of HHF and adverse renal outcomes regardless of baseline characteristics. These analyses support the benefit of dapagliflozin on important outcomes in a broad primary prevention population.</p>

scholarly journals Molecular Immune-Inflammatory Connections between Dietary Fats and Atherosclerotic Cardiovascular Disease: Which Translation into Clinics?

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 3768
Author(s):  
Elisa Mattavelli ◽  
Alberico Luigi Catapano ◽  
Andrea Baragetti
Keyword(s):  
Daily Intake ◽  
Cardiovascular Prevention ◽  
Small Sample ◽  
Dietary Lipids ◽  
Dietary Fats ◽  
Metabolic Effects ◽  
Atherosclerotic Cardiovascular Disease ◽  
Dietary Intakes ◽  
Attrition Rates ◽  
Anti Inflammatory

Current guidelines recommend reducing the daily intake of dietary fats for the prevention of ischemic cardiovascular diseases (CVDs). Avoiding saturated fats while increasing the intake of mono- or polyunsaturated fatty acids has been for long time the cornerstone of dietary approaches in cardiovascular prevention, mainly due to the metabolic effects of these molecules. However, recently, this approach has been critically revised. The experimental evidence, in fact, supports the concept that the pro- or anti-inflammatory potential of different dietary fats contributes to atherogenic or anti-atherogenic cellular and molecular processes beyond (or in addition to) their metabolic effects. All these aspects are hardly translatable into clinics when trying to find connections between the pro-/anti-inflammatory potential of dietary lipids and their effects on CVD outcomes. Interventional trials, although providing stronger potential for causal inference, are typically small sample-sized, and they have short follow-up, noncompliance, and high attrition rates. Besides, observational studies are confounded by a number of variables and the quantification of dietary intakes is far from optimal. A better understanding of the anatomic and physiological barriers for the absorption and the players involved in the metabolism of dietary lipids (e.g., gut microbiota) might be an alternative strategy in the attempt to provide a first step towards a personalized dietary approach in CVD prevention.

scholarly journals Association of Baseline HbA1c With Cardiovascular and Renal Outcomes: Analyses From DECLARE-TIMI 58

Diabetes Care ◽  
2022 ◽  
Author(s):  
Avivit Cahn ◽  
Stephen D. Wiviott ◽  
Ofri Mosenzon ◽  
Erica L. Goodrich ◽  
Sabina A. Murphy ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Cardiovascular Events ◽  
Cox Regression ◽  
Cardiovascular Death ◽  
Atherosclerotic Cardiovascular Disease ◽  
Baseline Hba1c ◽  
Renal Outcomes ◽  
Increased Risk ◽  
Hba1c Levels

OBJECTIVE Current guidelines recommend prescribing SGLT2 inhibitors to patients with type 2 diabetes and established or at high risk for atherosclerotic cardiovascular disease (ASCVD), irrespective of HbA1c levels. We studied the association of HbA1c with cardiovascular and renal outcomes and whether the benefit of dapagliflozin varies by baseline HbA1c. RESEARCH DESIGN AND METHODS In the Dapagliflozin Effect on Cardiovascular Events trial (DECLARE-TIMI 58), 17,160 patients with type 2 diabetes were randomly assigned to dapagliflozin or placebo for a median follow-up of 4.2 years. Cardiovascular and renal outcomes by baseline HbA1c in the overall population and with dapagliflozin versus placebo in HbA1c subgroups were studied by Cox regression models. RESULTS In the overall population, higher baseline HbA1c was associated with a higher risk of cardiovascular death or hospitalization for heart failure (HHF); major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and ischemic stroke; and cardiorenal outcomes (adjusted hazard ratios 1.12 [95% CI 1.06–1.19], 1.08 [1.04–1.13], and 1.17 [1.11–1.24] per 1% higher level, respectively). Elevated HbA1c was associated with a greater increased risk for MACE and cardiorenal outcomes in patients with multiple risk factors (MRF) than in established ASCVD (P-interaction = 0.0064 and 0.0093, respectively). Compared with placebo, dapagliflozin decreased the risk of cardiovascular death/HHF, HHF, and cardiorenal outcomes, with no heterogeneity by baseline HbA1c (P-interaction &gt; 0.05). CONCLUSIONS Higher HbA1c levels were associated with greater cardiovascular and renal risk, particularly in the MRF population, yet the benefits of dapagliflozin were observed in all subgroups irrespective of baseline HbA1c, including patients with HbA1c &lt;7%.

scholarly journals The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58

2021 ◽  
Author(s):  
Ofri Mosenzon ◽  
Stephen D Wiviott ◽  
Hiddo H J Heerspink ◽  
Jamie P Dwyer ◽  
Avivit Cahn ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Cardiovascular Death ◽  
Continuous Variable ◽  
Renal Outcome ◽  
Favourable Effect ◽  
Atherosclerotic Cardiovascular Disease ◽  
Cardiovascular Outcome Trial ◽  
Specific Outcome ◽  
Outcome Trial ◽  
End Stage

<b>Objective: </b>Sodium glucose co-transporter 2 inhibitors (SGLT2i) improve albuminuria in patients with high cardiorenal risk. We report albuminuria change in the DECLARE-TIMI 58 cardiovascular outcome trial, which included populations with lower cardiorenal risk. <p><b>Methods:</b> DECLARE-TIMI 58 randomized 17,160 patients with type-2 diabetes, Creatinine Clearance>60 ml/min, and either atherosclerotic cardiovascular disease (CVD); (40.6%) or risk-factors for CVD (59.4%) to dapagliflozin or placebo. Urinary albumin-creatinine ratio (UACR) was tested at baseline, 6-months, 12-months and yearly thereafter. Change in UACR over time was measured as a continuous and categorical variable (≤15; >15 to<30; ≥30-≤300; >300 mg/g), by treatment arm. Composite cardiorenal outcome was ≥40% sustained-decline in eGFR to <60 mL/min/1.73m², end-stage kidney disease, cardiovascular- or renal-death; specific renal outcome included all except cardiovascular-death.</p> <p><b>Results:</b> Baseline UACR was available for 16,843 (98.15%) participants; 9,067 (53.83%) with ≤15 mg/g; 2,577 (15.30%) with <15->30 mg/g; 4,030 (23.93%) with 30-300 mg/g; and 1,169 (6.94%) with >300 mg/g. Measured as continuous variable, UACR improved from baseline to 4.0 years with dapagliflozin, compared to placebo, across all UACR and eGFR categories (all p<0.0001). Sustained-confirmed ≥1 category improvement in UACR was more common in dapagliflozin vs. placebo [HR=1.45 (95%CI 1.35-1.56 p<0.0001)]. Cardiorenal outcome was reduced with dapagliflozin for subgroups of UACR ≥30 mg/g (p<0.0125, P<sub>int</sub>=0.033); renal-specific outcome was reduced for all UACR subgroups (p<0.05, P<sub>int</sub>=0.480).</p> <p><b>Conclusion: </b>In DECLARE-TIMI 58, dapagliflozin demonstrated a favourable effect on UACR and renal specific outcome across baseline UACR categories, including patients with normal albumin excretion. The results suggest a role for SGLT2i also in the primary prevention of diabetic kidney disease. </p>

scholarly journals The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58

2021 ◽  
Author(s):  
Ofri Mosenzon ◽  
Stephen D Wiviott ◽  
Hiddo H J Heerspink ◽  
Jamie P Dwyer ◽  
Avivit Cahn ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Cardiovascular Death ◽  
Continuous Variable ◽  
Renal Outcome ◽  
Favourable Effect ◽  
Atherosclerotic Cardiovascular Disease ◽  
Cardiovascular Outcome Trial ◽  
Specific Outcome ◽  
Outcome Trial ◽  
End Stage

<b>Objective: </b>Sodium glucose co-transporter 2 inhibitors (SGLT2i) improve albuminuria in patients with high cardiorenal risk. We report albuminuria change in the DECLARE-TIMI 58 cardiovascular outcome trial, which included populations with lower cardiorenal risk. <p><b>Methods:</b> DECLARE-TIMI 58 randomized 17,160 patients with type-2 diabetes, Creatinine Clearance>60 ml/min, and either atherosclerotic cardiovascular disease (CVD); (40.6%) or risk-factors for CVD (59.4%) to dapagliflozin or placebo. Urinary albumin-creatinine ratio (UACR) was tested at baseline, 6-months, 12-months and yearly thereafter. Change in UACR over time was measured as a continuous and categorical variable (≤15; >15 to<30; ≥30-≤300; >300 mg/g), by treatment arm. Composite cardiorenal outcome was ≥40% sustained-decline in eGFR to <60 mL/min/1.73m², end-stage kidney disease, cardiovascular- or renal-death; specific renal outcome included all except cardiovascular-death.</p> <p><b>Results:</b> Baseline UACR was available for 16,843 (98.15%) participants; 9,067 (53.83%) with ≤15 mg/g; 2,577 (15.30%) with <15->30 mg/g; 4,030 (23.93%) with 30-300 mg/g; and 1,169 (6.94%) with >300 mg/g. Measured as continuous variable, UACR improved from baseline to 4.0 years with dapagliflozin, compared to placebo, across all UACR and eGFR categories (all p<0.0001). Sustained-confirmed ≥1 category improvement in UACR was more common in dapagliflozin vs. placebo [HR=1.45 (95%CI 1.35-1.56 p<0.0001)]. Cardiorenal outcome was reduced with dapagliflozin for subgroups of UACR ≥30 mg/g (p<0.0125, P<sub>int</sub>=0.033); renal-specific outcome was reduced for all UACR subgroups (p<0.05, P<sub>int</sub>=0.480).</p> <p><b>Conclusion: </b>In DECLARE-TIMI 58, dapagliflozin demonstrated a favourable effect on UACR and renal specific outcome across baseline UACR categories, including patients with normal albumin excretion. The results suggest a role for SGLT2i also in the primary prevention of diabetic kidney disease. </p>

scholarly journals The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58

2021 ◽  
Author(s):  
Ofri Mosenzon ◽  
Stephen D Wiviott ◽  
Hiddo H J Heerspink ◽  
Jamie P Dwyer ◽  
Avivit Cahn ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Cardiovascular Death ◽  
Continuous Variable ◽  
Renal Outcome ◽  
Favourable Effect ◽  
Atherosclerotic Cardiovascular Disease ◽  
Cardiovascular Outcome Trial ◽  
Specific Outcome ◽  
Outcome Trial ◽  
End Stage

<b>Objective: </b>Sodium glucose co-transporter 2 inhibitors (SGLT2i) improve albuminuria in patients with high cardiorenal risk. We report albuminuria change in the DECLARE-TIMI 58 cardiovascular outcome trial, which included populations with lower cardiorenal risk. <p><b>Methods:</b> DECLARE-TIMI 58 randomized 17,160 patients with type-2 diabetes, Creatinine Clearance>60 ml/min, and either atherosclerotic cardiovascular disease (CVD); (40.6%) or risk-factors for CVD (59.4%) to dapagliflozin or placebo. Urinary albumin-creatinine ratio (UACR) was tested at baseline, 6-months, 12-months and yearly thereafter. Change in UACR over time was measured as a continuous and categorical variable (≤15; >15 to<30; ≥30-≤300; >300 mg/g), by treatment arm. Composite cardiorenal outcome was ≥40% sustained-decline in eGFR to <60 mL/min/1.73m², end-stage kidney disease, cardiovascular- or renal-death; specific renal outcome included all except cardiovascular-death.</p> <p><b>Results:</b> Baseline UACR was available for 16,843 (98.15%) participants; 9,067 (53.83%) with ≤15 mg/g; 2,577 (15.30%) with <15->30 mg/g; 4,030 (23.93%) with 30-300 mg/g; and 1,169 (6.94%) with >300 mg/g. Measured as continuous variable, UACR improved from baseline to 4.0 years with dapagliflozin, compared to placebo, across all UACR and eGFR categories (all p<0.0001). Sustained-confirmed ≥1 category improvement in UACR was more common in dapagliflozin vs. placebo [HR=1.45 (95%CI 1.35-1.56 p<0.0001)]. Cardiorenal outcome was reduced with dapagliflozin for subgroups of UACR ≥30 mg/g (p<0.0125, P<sub>int</sub>=0.033); renal-specific outcome was reduced for all UACR subgroups (p<0.05, P<sub>int</sub>=0.480).</p> <p><b>Conclusion: </b>In DECLARE-TIMI 58, dapagliflozin demonstrated a favourable effect on UACR and renal specific outcome across baseline UACR categories, including patients with normal albumin excretion. The results suggest a role for SGLT2i also in the primary prevention of diabetic kidney disease. </p>

scholarly journals Modern principles of cardiovascular disease prevention

2021 ◽  
Vol 13 (2) ◽  
pp. 15-26
Author(s):  
Leonid L. Bershtein
Keyword(s):  
Cardiovascular Disease ◽  
Risk Assessment ◽  
Primary Prevention ◽  
Disease Prevention ◽  
Russian Federation ◽  
Cardiovascular Prevention ◽  
Atherosclerotic Cardiovascular Disease ◽  
Middle Income ◽  
Middle Income Countries ◽  
The World

Atherosclerotic cardiovascular disease is the leading cause of death in the world, primarily in low-and middle-income countries, including Russian Federation. According to WHO experts, the global atherosclerotic cardiovascular disease epidemic can be brought under control mainly by improving the cardiovascular prevention. This paper describes the modern principles of risk assessment in people without manifested atherosclerotic cardiovascular disease, as well as considers drug and non-drug methods of primary prevention.

scholarly journals The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58

2021 ◽  
Author(s):  
Ofri Mosenzon ◽  
Stephen D Wiviott ◽  
Hiddo H J Heerspink ◽  
Jamie P Dwyer ◽  
Avivit Cahn ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Cardiovascular Death ◽  
Continuous Variable ◽  
Renal Outcome ◽  
Favourable Effect ◽  
Atherosclerotic Cardiovascular Disease ◽  
Cardiovascular Outcome Trial ◽  
Specific Outcome ◽  
Outcome Trial ◽  
End Stage

<b>Objective: </b>Sodium glucose co-transporter 2 inhibitors (SGLT2i) improve albuminuria in patients with high cardiorenal risk. We report albuminuria change in the DECLARE-TIMI 58 cardiovascular outcome trial, which included populations with lower cardiorenal risk. <p><b>Methods:</b> DECLARE-TIMI 58 randomized 17,160 patients with type-2 diabetes, Creatinine Clearance>60 ml/min, and either atherosclerotic cardiovascular disease (CVD); (40.6%) or risk-factors for CVD (59.4%) to dapagliflozin or placebo. Urinary albumin-creatinine ratio (UACR) was tested at baseline, 6-months, 12-months and yearly thereafter. Change in UACR over time was measured as a continuous and categorical variable (≤15; >15 to<30; ≥30-≤300; >300 mg/g), by treatment arm. Composite cardiorenal outcome was ≥40% sustained-decline in eGFR to <60 mL/min/1.73m², end-stage kidney disease, cardiovascular- or renal-death; specific renal outcome included all except cardiovascular-death.</p> <p><b>Results:</b> Baseline UACR was available for 16,843 (98.15%) participants; 9,067 (53.83%) with ≤15 mg/g; 2,577 (15.30%) with <15->30 mg/g; 4,030 (23.93%) with 30-300 mg/g; and 1,169 (6.94%) with >300 mg/g. Measured as continuous variable, UACR improved from baseline to 4.0 years with dapagliflozin, compared to placebo, across all UACR and eGFR categories (all p<0.0001). Sustained-confirmed ≥1 category improvement in UACR was more common in dapagliflozin vs. placebo [HR=1.45 (95%CI 1.35-1.56 p<0.0001)]. Cardiorenal outcome was reduced with dapagliflozin for subgroups of UACR ≥30 mg/g (p<0.0125, P<sub>int</sub>=0.033); renal-specific outcome was reduced for all UACR subgroups (p<0.05, P<sub>int</sub>=0.480).</p> <p><b>Conclusion: </b>In DECLARE-TIMI 58, dapagliflozin demonstrated a favourable effect on UACR and renal specific outcome across baseline UACR categories, including patients with normal albumin excretion. The results suggest a role for SGLT2i also in the primary prevention of diabetic kidney disease. </p>

LDL-cholesterol lowering efficacy of atorvastatin® in primary prevention. Real-world experience in a developing country; a program based on evidence, personalization, and empowerment

2021 ◽  
Vol 9 (11) ◽  
Author(s):  
Enrique Morales-Villegas ◽  
Abigail Vega-Velasco ◽  
Gualberto Moreno-Virgen
Keyword(s):  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Cardiovascular Prevention ◽  
Scientific Quality ◽  
Atherosclerotic Cardiovascular Disease ◽  
Net Benefit ◽  
Therapeutic Class ◽  
Risk Patients

Despite the iconoclasts of the LDL-centric principle and the net benefit of statins, the plurality, quantity, and especially the scientific quality of the evidence that supports the causal role of low-density lipoprotein cholesterol (LDL-C) in atherosclerosis, as well as the net benefit of statins in its prevention, make these two concepts, universal principles accepted by all guidelines worldwide. The efficacy, safety, and cost-effectiveness of statins have been confirmed in multiple randomized and controlled clinical trials. However, paradoxically, and especially in developing countries like Mexico, the use of this therapeutic class is suboptimal. The reasons to explain this paradox are multiple and are analyzed in this article, which has the purpose of confirming the efficacy, safety, and significant potential impact of statins in the "real developing world." To fulfill this purpose, this article presents our center experience using statins, especially atorvastatin®, in patients without atherosclerotic cardiovascular disease (ASCVD). Founded on an evidence-based, personalization, and empowerment program, our results in almost four hundred patients in primary cardiovascular prevention are as follows. In intermediate-risk patients, atorvastatin® 10 mg/day with a baseline LDL-C of 111.6 mg/dL (±25.1), reduced LDL-C by 38.0% (±13.9); atorvastatin® 20 mg/day with a baseline LDL-C of 124.4 mg/dL (±25.3), reduced LDL-C by 44.9% (±15.0) (p <0.005 for both). In the atorvastatin® 10/20 mg/day cohort (a total of 294 patients), 87.7% (258 patients) achieved a ≥30% LDL-C reduction, and 36.7% (108 patients) a ≥50% reduction. In the atorvastatin 10/20 mg/day cohort, with an average baseline LDL-C of 122.6 mg/dL (±25.6), 92.5 and 55.7% achieved LDL-C of ≤100 and ≤70 mg/dL, respectively. In high-risk patients, atorvastatin® 40 mg/day with a baseline LDL-C of 151.7 mg/dL (±31.6), there was an LDL-C average reduction of 54.7% (±12.2). Atorvastatin 80mg/day with a baseline LDL-C of 160.2 mg/dL (±41.5) produced an LDL-C average reduction of 62.5% (±10.8) (P <0.005 for both). In the atorvastatin® 40/80 mg/day cohort (89 patients), 98.8% (88 patients) achieved a ≥30% LDL-C reduction, and 76.4% (68 patients) achieved a ≥50% reduction. In the atorvastatin 40/80 mg/day cohort, with an average baseline LDL-C of 153.0 mg/dL (±33.2), 95.8 and 62.9% achieved LDL-C of ≤100 and ≤70 mg/dL, respectively.

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