Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
Ключови думи
Резюме
Описание
Atorvastin (Lipitor) is a commonly used drug approved by the FDA for treatment of dyslipidemias. It is a relatively safe drug to use with periodic monitoring.
Eligibility critera:
- age 18-60, females, as a marjority of lupus patients are female
- at least 4 ACR (American College of Rheumatology) criteria of SLE(Systemic Lupus Erythematosus)
- Moderate to Severe disease activity using approved SLEDAI(Systemic Lupus Erythematosus Disease Activity Index)
- LDL cholesterol 100-190mg/dl
Exclusion criteria:
- Pregnancy, and or lactating or wants to get pregnant
- Unable to take atorvastatin due to allergy, liver disease, elevated liver functions, myositis, or elvated CPK(creatine phosphakinase)
- already on lipid lowering therapy
- already on amiodarone, clarithromycin, cyclosporin, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin,k cholestyramine, colestipol
- has a dianosis of Myositis. Our goal is to colledt preliminary data to see if there is a trend for the efficacy of atorvastatin in ameliorating SLE disease activity and to evaluate TLRs(Toll-like receptor) in SLE patients. A p value of <0.05 will be considered statistically significant. Our baseline and at subsequent visits, we will have 80% power to detect a minimum of 34%-39% difference for most of the continous variables measured at different intervals.
Дати
Последна проверка: | 08/31/2009 |
Първо изпратено: | 08/19/2007 |
Очаквано записване подадено: | 08/20/2007 |
Първо публикувано: | 08/21/2007 |
Изпратена последна актуализация: | 03/22/2010 |
Последна актуализация публикувана: | 03/23/2010 |
Действителна начална дата на проучването: | 08/31/2007 |
Приблизителна дата на първично завършване: | 09/30/2008 |
Очаквана дата на завършване на проучването: | 11/30/2008 |
Състояние или заболяване
Интервенция / лечение
Drug: atorvastatin
Фаза
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | Female |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - Age 18-60, female - have at least four ACR criteria for SLE - SLEDAI score > 4 - LDL cholesterol level from 100-190mg/dl Exclusion Criteria: - Pregnant, lactating, or wanting to become pregnant - unable to take atorvastatin due to allergy, liver disease, elevated lever function test, myositis, or eleveated CPK - already on lipid lowering therapy - participating in another lupus study - on drugs such as: amiodarone, clarithromycin, clclosporine, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin, cholestryrmine, colestipol - has a diagnosis of myositis |
Резултат
Първични изходни мерки
1. decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9. [3 months]
Вторични изходни мерки
1. lower lipid levels in female lupus patients [3 months]