Trial reportClinical drug investigation2008
Evaluation of a new formulation of fenofibric acid, ABT-335, co-administered with statins : study design and rationale of a phase III clinical programme.
Trial report in Clinical drug investigation, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Safety Profile of Atorvastatin 80 mg: A Meta-Analysis of 17 Randomized Controlled Trials in 21,910 Participants.Drug safety · 2016Pooled it
- Lipid-lowering efficacy of rosuvastatin.The Cochrane database of systematic reviews · 2014 · on this mapPooled it
- Rare LPL gene variants attenuate triglyceride reduction and HDL cholesterol increase in response to fenofibric acid therapy in individuals with mixed dyslipidemia.Atherosclerosis · 2014Trial
- Interaction between SNPs in the RXRA and near ANGPTL3 gene region inhibits apoB reduction after statin-fenofibric acid therapy in individuals with mixed dyslipidemia.Journal of lipid research · 2012Trial
- LPL gene variants affect apoC-III response to combination therapy of statins and fenofibric acid in a randomized clinical trial of individuals with mixed dyslipidemia.Journal of lipid research · 2012Trial
- Variants in the APOA5 gene region and the response to combination therapy with statins and fenofibric acid in a randomized clinical trial of individuals with mixed dyslipidemia.Atherosclerosis · 2011Trial
- Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus.Cardiovascular drugs and therapy · 2011Trial
- Combination rosuvastatin plus fenofibric acid in a cohort of patients 65 years or older with mixed dyslipidemia: subanalysis of two randomized, controlled studies.Clinical cardiology · 2010Trial
- The effects of fenofibric acid alone and with statins on the prevalence of metabolic syndrome and its diagnostic components in patients with mixed dyslipidemia.Diabetes care · 2010Trial
- Year two assessment of fenofibric acid and moderate-dose statin combination: a phase 3, open-label, extension study.Clinical drug investigation · 2010Trial
- Fibrate pharmacogenomics: expanding past the genome.Pharmacogenomics · 2020Article
- Bioactivity guided fractionation and hypolipidemic property of a novel HMG-CoA reductase inhibitor from Ficus virens Ait.Lipids in health and disease · 2015Article
- Rare APOA5 promoter variants associated with paradoxical HDL cholesterol decrease in response to fenofibric acid therapy.Journal of lipid research · 2013Article
- A review of time courses and predictors of lipid changes with fenofibric acid-statin combination.Cardiovascular drugs and therapy · 2012 · on this mapReview
- Management of dyslipidemias with fibrates, alone and in combination with statins: role of delayed-release fenofibric acid.Vascular health and risk management · 2010Review
- Fenofibrate and metabolic syndrome.Endocrine, metabolic & immune disorders drug targets · 2010Review
- Fenofibric acid: a new fibrate approved for use in combination with statin for the treatment of mixed dyslipidemia.Vascular health and risk management · 2010Review
- A review on the rationale and clinical use of concomitant rosuvastatin and fenofibrate/fenofibric acid therapy.Clinical pharmacology : advances and applications · 2010Article
- Pitavastatin: evidence for its place in treatment of hypercholesterolemia.Core evidence · 2010Article
- Latest drug developments in the field of cardiovascular disease.The International journal of angiology : official publication of the International College of Angiology, Inc · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveAtherogenic lipid parameters in patients with mixed dyslipidaemia have been demonstrated to increase atherosclerotic coronary heart disease (CHD) risk. Clinical studies have shown that HMG-CoA reductase inhibitor (statin) and fibric acid derivative (fibrate) combination therapy is effective at improving multiple lipid abnormalities in different patient populations at increased risk of CHD. However, inconsistencies with respect to trial designs and safety issues have limited the clinical use of this combination therapy. A comprehensive, controlled clinical trial programme was thus designed to evaluate three separate statins in combination with ABT-335, a new formulation of fenofibric acid.
methodsThree separate 22-week, phase III, double-blind, active-controlled trials will evaluate combination therapy with ABT-335 135 mg/day and either rosuvastatin (10 mg/day and 20 mg/day), atorvastatin (20 mg/day and 40 mg/day) or simvastatin (20 mg/day and 40 mg/day) in comparison to either ABT-335 or the corresponding statin monotherapy. An approximate total of 2400 patients with elevated triglycerides (TG) [> or =150 mg/dL], reduced high-density lipoprotein cholesterol (HDL-C) [<40 mg/dL for men and <50 mg/dL for women], and elevated low-density lipoprotein cholesterol (LDL-C) [> or =130 mg/dL] will be randomized to one of six intervention arms per trial (two combination therapy and four monotherapy groups). The pre-specified primary efficacy endpoint is a composite of the mean percent changes in HDL-C and TG (comparing each combination therapy with the corresponding statin monotherapy dose) and LDL-C (comparing each combination therapy with ABT-335 monotherapy). Secondary endpoints include mean percent changes in non-HDL-C, very LDL-C, total cholesterol, apolipoprotein B and high sensitivity C-reactive protein levels. At study end, patients may enroll in a 12-month open-label extension study that will evaluate the long-term efficacy and safety of combination therapy.
conclusionThis is the largest phase III randomized, controlled clinical programme to date evaluating the efficacy and safety of the combined use of a new formulation of fenofibric acid (ABT-335) with three commonly prescribed statins in patients with mixed dyslipidaemia.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.