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BARCELONA — Statin therapy may ameliorate the vascular dysfunction that can lead to Raynaud's phenomenon and digital ulcers in systemic sclerosis, Dr. Anna Abou-Raya said at the annual European Congress of Rheumatology.
Systemic sclerosis is characterized by widespread vascular pathology, with initial events involving endothelial cell damage, loss of normal vasodilatory mediators, and excessive vasoconstriction. Within 4 years of diagnosis, up to 65% of patients have digital ulcers, which are painful and disabling and can be associated with infection, gangrene, and amputation, Dr. Abou-Raya said. Effective treatment remains elusive for many patients.
Aside from their well-documented lipid-lowering properties, statins display pleiotropic effects including effects on endothelial function that may be of benefit in slowing or preventing vascular damage.
“The appearance of endothelial cell abnormalities can be considered the crucial, and maybe the initial event in the pathogenesis of systemic sclerosis,” Dr. Abou-Raya said.
“Furthermore, endothelial activation and damage are primary events not only at the initiation but throughout the course of disease,” she added.
To evaluate the potential for statin therapy to retard or prevent vascular damage in systemic sclerosis, Dr. Abou-Raya and associates undertook a controlled study that randomized 40 patients with persistent Raynaud's phenomenon to receive atorvastatin, 40 mg/day, or placebo for 4 months.
The mean age of the patients was 49.7 years, and the mean duration of Raynaud's phenomenon was 8 years. The mean number of digital ulcers existing at baseline was 3.3, and all of the patients fulfilled the American College of Rheumatology criteria for having systemic sclerosis with Raynaud's phenomenon, despite ongoing vasodilator therapy.
Exclusion criteria included diabetes; hypercholesterolemia; hypertension; and cardiac, hepatic, and renal disease.
A mean of 1.6 new ulcers developed in patients in the statin group, compared with a mean of 2.5 new ulcers in the placebo group, which was a statistically significant difference, said Dr. Abou-Raya of the department of rheumatology at the University of Alexandria, Egypt.
Patients were also evaluated for functional status, with statistically significant improvements being seen on the modified Scleroderma Health Assessment Questionnaire Disability Index and on visual analog scale scores for pain and for physician global assessment.
Moreover, biomarkers of endothelial damage, such as intercellular adhesion molecule 1 (ICAM-1) and sE-selectin, as well as acute phase reactants, also improved significantly among patients in the atorvastatin group, Dr. Abou-Raya reported.
The drug was well tolerated, and there were no study dropouts.
The results of this study suggest statins can be beneficial in alleviating vascular dysfunction and improving patient functioning in systemic sclerosis.
“These drugs are relatively inexpensive, even in developing countries, and with our very limited therapeutic arsenal, any drug that leads to any improvement is a welcome addition,” saidDr. Abou-Raya.
Larger studies will be needed to confirm these results, she added.
BARCELONA — Statin therapy may ameliorate the vascular dysfunction that can lead to Raynaud's phenomenon and digital ulcers in systemic sclerosis, Dr. Anna Abou-Raya said at the annual European Congress of Rheumatology.
Systemic sclerosis is characterized by widespread vascular pathology, with initial events involving endothelial cell damage, loss of normal vasodilatory mediators, and excessive vasoconstriction. Within 4 years of diagnosis, up to 65% of patients have digital ulcers, which are painful and disabling and can be associated with infection, gangrene, and amputation, Dr. Abou-Raya said. Effective treatment remains elusive for many patients.
Aside from their well-documented lipid-lowering properties, statins display pleiotropic effects including effects on endothelial function that may be of benefit in slowing or preventing vascular damage.
“The appearance of endothelial cell abnormalities can be considered the crucial, and maybe the initial event in the pathogenesis of systemic sclerosis,” Dr. Abou-Raya said.
“Furthermore, endothelial activation and damage are primary events not only at the initiation but throughout the course of disease,” she added.
To evaluate the potential for statin therapy to retard or prevent vascular damage in systemic sclerosis, Dr. Abou-Raya and associates undertook a controlled study that randomized 40 patients with persistent Raynaud's phenomenon to receive atorvastatin, 40 mg/day, or placebo for 4 months.
The mean age of the patients was 49.7 years, and the mean duration of Raynaud's phenomenon was 8 years. The mean number of digital ulcers existing at baseline was 3.3, and all of the patients fulfilled the American College of Rheumatology criteria for having systemic sclerosis with Raynaud's phenomenon, despite ongoing vasodilator therapy.
Exclusion criteria included diabetes; hypercholesterolemia; hypertension; and cardiac, hepatic, and renal disease.
A mean of 1.6 new ulcers developed in patients in the statin group, compared with a mean of 2.5 new ulcers in the placebo group, which was a statistically significant difference, said Dr. Abou-Raya of the department of rheumatology at the University of Alexandria, Egypt.
Patients were also evaluated for functional status, with statistically significant improvements being seen on the modified Scleroderma Health Assessment Questionnaire Disability Index and on visual analog scale scores for pain and for physician global assessment.
Moreover, biomarkers of endothelial damage, such as intercellular adhesion molecule 1 (ICAM-1) and sE-selectin, as well as acute phase reactants, also improved significantly among patients in the atorvastatin group, Dr. Abou-Raya reported.
The drug was well tolerated, and there were no study dropouts.
The results of this study suggest statins can be beneficial in alleviating vascular dysfunction and improving patient functioning in systemic sclerosis.
“These drugs are relatively inexpensive, even in developing countries, and with our very limited therapeutic arsenal, any drug that leads to any improvement is a welcome addition,” saidDr. Abou-Raya.
Larger studies will be needed to confirm these results, she added.
BARCELONA — Statin therapy may ameliorate the vascular dysfunction that can lead to Raynaud's phenomenon and digital ulcers in systemic sclerosis, Dr. Anna Abou-Raya said at the annual European Congress of Rheumatology.
Systemic sclerosis is characterized by widespread vascular pathology, with initial events involving endothelial cell damage, loss of normal vasodilatory mediators, and excessive vasoconstriction. Within 4 years of diagnosis, up to 65% of patients have digital ulcers, which are painful and disabling and can be associated with infection, gangrene, and amputation, Dr. Abou-Raya said. Effective treatment remains elusive for many patients.
Aside from their well-documented lipid-lowering properties, statins display pleiotropic effects including effects on endothelial function that may be of benefit in slowing or preventing vascular damage.
“The appearance of endothelial cell abnormalities can be considered the crucial, and maybe the initial event in the pathogenesis of systemic sclerosis,” Dr. Abou-Raya said.
“Furthermore, endothelial activation and damage are primary events not only at the initiation but throughout the course of disease,” she added.
To evaluate the potential for statin therapy to retard or prevent vascular damage in systemic sclerosis, Dr. Abou-Raya and associates undertook a controlled study that randomized 40 patients with persistent Raynaud's phenomenon to receive atorvastatin, 40 mg/day, or placebo for 4 months.
The mean age of the patients was 49.7 years, and the mean duration of Raynaud's phenomenon was 8 years. The mean number of digital ulcers existing at baseline was 3.3, and all of the patients fulfilled the American College of Rheumatology criteria for having systemic sclerosis with Raynaud's phenomenon, despite ongoing vasodilator therapy.
Exclusion criteria included diabetes; hypercholesterolemia; hypertension; and cardiac, hepatic, and renal disease.
A mean of 1.6 new ulcers developed in patients in the statin group, compared with a mean of 2.5 new ulcers in the placebo group, which was a statistically significant difference, said Dr. Abou-Raya of the department of rheumatology at the University of Alexandria, Egypt.
Patients were also evaluated for functional status, with statistically significant improvements being seen on the modified Scleroderma Health Assessment Questionnaire Disability Index and on visual analog scale scores for pain and for physician global assessment.
Moreover, biomarkers of endothelial damage, such as intercellular adhesion molecule 1 (ICAM-1) and sE-selectin, as well as acute phase reactants, also improved significantly among patients in the atorvastatin group, Dr. Abou-Raya reported.
The drug was well tolerated, and there were no study dropouts.
The results of this study suggest statins can be beneficial in alleviating vascular dysfunction and improving patient functioning in systemic sclerosis.
“These drugs are relatively inexpensive, even in developing countries, and with our very limited therapeutic arsenal, any drug that leads to any improvement is a welcome addition,” saidDr. Abou-Raya.
Larger studies will be needed to confirm these results, she added.