Familial Atherosclerosis Treatment Study (FATS)
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]
Official Title
Familial Atherosclerosis Treatment Study
Objective
The objective of this study is to compare the effects of two intensive lipid altering therapies in men with familial combined hyperlipidemia as assessed by arteriography.
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Timeline
| Timeline | |
| Start Date | January 1984 |
| End Date | August 1989 |
| Status | Completed |
The previous information was derived from ClinicalTrials.gov on 08/18/2014 using the identification number NCT00000512.
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | |
| Allocation | Randomized |
| Endpoint | Efficacy Study |
| Interventional Model | Parallel Assignment |
| Masking | Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Study Details | |
| Primary Purpose | Treatment |
| Condition | Cardiovascular Diseases, coronary arteriosclerosis, coronary disease, heart diseases, myocardial ischemia |
| Intervention | Drug: lovastatin Drug: colestipol Drug: niacin |
| Study Arms | Experimental: Niacin—Colestipol Group Experimental: Lovastatin—Colestipol Group Placebo Comparator: Conventional-Therapy Group |
| Population Size | 146 |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT00000512.
Eligibility Criteria
Inclusion Criteria
- Men
- Age 62 or younger
- Elevated apolipoprotein B levels
- Coronary atherosclerosis
- Family history of coronary heart disease
Exclusion Criteria
Outcomes
Primary Outcomes
Change in the mean severity of proximal stenosis
Publications
Conclusion
Both the intensive lipid lowering therapies were equally effective. Both reduced the frequency of progression of coronary lesions (21% and 25% versus 46% in the control group), increased the frequency of regression (32% and 39% versus 11%), and reduced the incidence of cardiovascular events in men with coronary artery disease who were at high risk for cardiovascular events.[1][2][3][4][5][6][7]
References
- ↑ Brown G, Albers JJ, Fisher LD; et al. (1990). "Regression of coronary artery disease as a result of intensive lipid-lowering therapy in men with high levels of apolipoprotein B". N. Engl. J. Med. 323 (19): 1289–98. doi:10.1056/NEJM199011083231901. PMID 2215615. Unknown parameter
|month=ignored (help) - ↑ Zhao XQ, Brown BG, Hillger L; et al. (1993). "Effects of intensive lipid-lowering therapy on the coronary arteries of asymptomatic subjects with elevated apolipoprotein B". Circulation. 88 (6): 2744–53. PMID 8252687. Unknown parameter
|month=ignored (help) - ↑ Phan BA, Muñoz L, Shadzi P; et al. (2013). "Effects of niacin on glucose levels, coronary stenosis progression, and clinical events in subjects with normal baseline glucose levels (<100 mg/dl): a combined analysis of the Familial Atherosclerosis Treatment Study (FATS), HDL-Atherosclerosis Treatment Study (HATS), Armed Forces Regression Study (AFREGS), and Carotid Plaque Composition by MRI during lipid-lowering (CPC) study". Am. J. Cardiol. 111 (3): 352–5. doi:10.1016/j.amjcard.2012.09.034. PMID 23168285. Unknown parameter
|month=ignored (help) - ↑ Stewart BF, Brown BG, Zhao XQ; et al. (1994). "Benefits of lipid-lowering therapy in men with elevated apolipoprotein B are not confined to those with very high low density lipoprotein cholesterol". J. Am. Coll. Cardiol. 23 (4): 899–906. PMID 8106695. Unknown parameter
|month=ignored (help) - ↑ Brown BG, Hillger L, Zhao XQ, Poulin D, Albers JJ (1995). "Types of change in coronary stenosis severity and their relative importance in overall progression and regression of coronary disease. Observations from the FATS Trial. Familial Atherosclerosis Treatment Study". Ann. N. Y. Acad. Sci. 748: 407–17, discussion 417–8. PMID 7695184. Unknown parameter
|month=ignored (help) - ↑ Maher VM, Brown BG, Marcovina SM, Hillger LA, Zhao XQ, Albers JJ (1995). "Effects of lowering elevated LDL cholesterol on the cardiovascular risk of lipoprotein(a)". JAMA. 274 (22): 1771–4. PMID 7500507. Unknown parameter
|month=ignored (help) - ↑ Zambon A, Hokanson JE, Brown BG, Brunzell JD (1999). "Evidence for a new pathophysiological mechanism for coronary artery disease regression: hepatic lipase-mediated changes in LDL density". Circulation. 99 (15): 1959–64. PMID 10208998. Unknown parameter
|month=ignored (help)