A Phase 3, Open-Label, Multisite, Randomized, Parallel Group Study of the Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin Administered Once Daily (QD) Compared to Simvastatin for 6 Weeks in Subjects With Hypercholesterolemia (A5091030)

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of cholesterol medications to see how the different treatments compare to one another.

Start Date01 Jan 2006

Sponsor / Collaborator

Pfizer Inc.

NCT00267267

/ TerminatedPhase 3

Phase 3, Open-Label, Multi-Center, Double-Blind, Randomized, Parallel Group Study Efficacy and Safety of Fixed Combination Torcetrapib/Atorvastatin, Administered Once Daily (QD) Compared to Fixed Combination Ezetimibe/Simvastatin for 6 Weeks in Subjects With Dyslipidemia.

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
Cholesterol levels will be measured over six weeks in subjects being treated with two different kinds of combination cholesterol medications to see how the different treatments compare to one another.

Start Date01 Jan 2006

Sponsor / Collaborator

Pfizer Inc.

NCT00267280

/ TerminatedPhase 3

Start Date01 Jan 2006

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with HDL-cholesterol

100 Translational Medicine associated with HDL-cholesterol

0 Patents (Medical) associated with HDL-cholesterol

7,683

Literatures (Medical) associated with HDL-cholesterol

01 Dec 2025·Current Atherosclerosis Reports

Quo Vadis after AEGIS: New Opportunities for Therapies Targeted at Reverse Cholesterol Transport?

Review

Author: Watts, Gerald F ; Lan, Nick S R

AbstractPurpose of ReviewHigh-density lipoprotein (HDL) is integral to reverse cholesterol transport (RCT), a process considered to protect against atherosclerotic cardiovascular disease (ASCVD). We summarise findings from the recent AEGIS-II trial and discuss new opportunities for HDL therapeutics targeted at RCT.Recent FindingsMendelian randomisation studies have suggested a causal association between the functional properties of HDL and ASCVD. However, the AEGIS-II trial of CSL112, an apolipoprotein A-I therapy that enhances cholesterol efflux, did not meet its primary endpoint. Exploratory analyses demonstrated that CSL112 significantly reduced ASCVD events among participants with a baseline low-density lipoprotein (LDL)-cholesterol ≥ 100 mg/dL, suggesting that RCT may depend on LDL-cholesterol levels.SummaryThe role of HDL therapeutics in patients with familial hypercholesterolaemia, inherited low HDL-cholesterol and impaired HDL function, especially with inadequately controlled LDL-cholesterol, merits further investigation. The treatment of patients with monogenic defects in HDL metabolism remains a significant gap in care that needs further research.

01 Jun 2025·American Journal of Medicine Open

Prevalence of Meeting Daily Step Count Recommendations in Cardiovascular Patients With and Without Metabolic Syndrome

Article

Author: Pomilla, William A ; Wang, Ming ; Gardner, Andrew W ; Zhang, Shangming ; Liang, Menglu ; Cherin, Neyha ; Montgomery, Polly S

PurposeWe compared the prevalence of older cardiovascular patients with and without metabolic syndrome (MetS) who met the recommendations of walking more than 7000 and 10,000 steps/d, and we determined whether MetS status was significantly associated with meeting the daily step count recommendations before and after adjusting for demographic variables, comorbid conditions, and cardiovascular risk factors.MethodsOlder cardiovascular participants with MetS (n = 489) and without MetS (n = 154) were assessed on their walking for seven consecutive days with a StepWatch activity monitor.ResultsThe MetS group took significantly fewer steps/d than the non-MetS control group (7307 ± 3625 vs. 8933 ± 4487 steps/d; P < .001). Only 47 % and 21 % of the MetS group walked ≥7000 and 10,000 steps/d, respectively, whereas 68 % and 34 % of the control group met these recommendations (P < .001 and p = .002, respectively). The odds of walking 7000 steps/d were 52 % lower in the MetS group (OR = 0.48, 95 %CI = 0.29-0.77, P = .003), and the odds of walking 10,000 steps/d were a 37 % lower trend (OR = 0.63, 95 %CI = 0.39-1.04, P = .069). Additionally, the odds of walking 7000 and 10,000 steps/d were lower in participants with reduced HDL-cholesterol (OR = 0.35, 95 %CI = 0.21-0.60, P < .001 and OR = 0.45, 95 %CI = 0.25-0.80, P = .007, respectively) and abdominal obesity (OR = 0.52, 95 %CI = 0.37-0.74, P < .001 and OR = 0.45, 95 %CI = 0.30-0.68, P < .001, respectively).ConclusionsOlder cardiovascular participants with MetS had an 18 % lower daily step count compared to those without MetS and were less likely to meet the 7000 and 10,000 steps/d recommendations. Additionally, older cardiovascular participants who were least likely to meet the daily step count recommendations included those who had reduced HDL-cholesterol and abdominal obesity.

01 Jun 2025·Clinical Nutrition ESPEN

Effects of defatted rice bran-fortified bread on gut microbiome, cardiovascular risk, gut discomfort, wellbeing and gut physiology in healthy adults with low dietary fibre intake

Article

Author: Maggo, Jasjot ; Günther, Catrin S ; Wall, Catherine L ; Mullaney, Jane A ; Fraser, Karl ; Cooney, Janine M ; McNabb, Warren C ; Ng, Hwei Min ; Foster, Meika ; Frampton, Chris ; Gearry, Richard B ; Bayer, Simone B ; Roy, Nicole C ; Cabrera, Diana

BACKGROUND & AIMSInadequate dietary fibre (DF) intake is associated with suboptimal gut function and increased risk of several human diseases. Bread is commonly consumed and is ideal to incorporate cereal bran to increase DF content. No human studies have investigated the effects of defatted rice bran (DRB) in bread, which has triple the DF of white bread, purported hypo-allergenicity and a unique nutrient profile, as a dietary intervention in healthy adults. This study aims to assess the relative abundances of a composite of key faecal microbial genera and species involved in DF fermentation and metabolism following the habitual intake of DRB-fortified bread and its influence on other biological markers of host and microbial interactions, cardiovascular risk profile, patient-reported outcomes, total DF intake, and gut physiology in healthy adults with low baseline DF intake.METHODSFifty-six healthy adults with low baseline DF intake (<18 g/day (females), <22 g/day (males)) completed a two-arm, placebo-controlled, double-blind, randomised, crossover study. Participants consumed three (females) or four (males) slices of DRB-fortified bread or control bread daily as part of their usual diet for four weeks, with the intervention periods separated by a two-week washout. Outcomes included faecal microbiota composite (primary outcome); relative abundances (taxa and gene); faecal moisture content and bile acid concentrations; plasma and faecal organic acid concentrations; cardiovascular risk profile; gut comfort, psychological wellbeing parameters; total DF intake; whole gut transit time, and were measured at baseline and following each intervention phase. Additionally, in a sub-study, 15 participants ingested gas-sensing capsules to assess whole and regional gut transit times, and total and regional colonic hydrogen and carbon dioxide concentrations at the same timepoints.RESULTSDRB-fortified bread consumption significantly increased total DF intake from 20.7 g/day to 43.4 g/day (p < 0.001). No significant differences were observed in the primary outcome, microbial taxa composite within and between groups (False Discovery Rate (FDR) correction, p > 0.10). As compared to control, the DRB group had increased relative abundances of Faecalibacterium prausnitzii (unadjusted p = 0.04), Bifidobacterium longum (unadjusted p = 0.12), and Bacteroides ovatus (unadjusted p = 0.10); lower relative abundances in Coprococcus genus (unadjusted p = 0.09), Roseburia faecis (unadjusted p = 0.02) and Prevotella copri species (unadjusted p = 0.05). However, no significant differences were observed in the relative abundances of these taxa within and between groups (FDR correction p > 0.10) and for most of the other outcomes between groups (p > 0.05). Only mean serum high-density lipoprotein (HDL) concentrations significantly increased (p = 0.006), and mean total cholesterol (TC) to HDL concentration ratio significantly lowered (p = 0.02) in the DRB group compared to the control group.CONCLUSIONThis is the first human study to show that a high-DF DRB-fortified bread improved DF intake, HDL cholesterol profiles, and may affect the gut microbiota composition in healthy adults with low DF intake. These findings support the substitution of white bread with DRB-fortified bread as an effective method to improve DF intake, which may have subsequent benefits on gut physiology and metabolic health.

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