This trial is evaluating whether Sildenafil will improve 1 primary outcome and 9 secondary outcomes in patients with Scleroderma, Systemic. Measurement will happen over the course of Baseline and 4 months.
This trial requires 30 total participants across 2 different treatment groups
This trial involves 2 different treatments. Sildenafil is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
In people with SSc-associated vascular disease, sildenafil therapy may reduce the extent of pulmonary arterial disease and RV failure, in part through a VEGF-independent mechanism.
This article documents the use of available medications in the clinic, and presents a review of the evidence for these treatments in the literature of scleroderma. These data may provide some guidance to the practitioner's decision-making.
Sildenafil does demonstrate an improvement in exercise capacity in patients with scleroderma and an improvement in quality of life in patients not using concomitant medications. These benefits are seen in both treatment groups in a clinically meaningful manner.
This pilot study suggests that sildenafil significantly improves quality of life for those with systemic scleroderma, without any significant adverse effects. Sildenafil may prove to be beneficial, particularly in those with concomitant pulmonary hypertension.
The exact figure of scleroderma, systemic a year could not be given due to low incidence. However, SSc seems to be more common in Caucasians than Hispanics and African Americans.
Patients with SSc may experience a number of symptoms such as Raynaud's phenomenon, nail involvement, cutaneous vascular abnormalities, joint involvement and arthritis. These symptoms may mimic those of other systemic connective tissue diseases such as SLE. Patients should be aware that the symptoms and the clinical manifestations of these diseases may be similar.
There is a clear overlap between systemic sclerosis and the other scleroderma syndromes, particularly polymyositis. Even before scleroderma is diagnosed, nearly half of patients will have polymyositis.
This article is a systematic review, that looks at the known effects on one of the most common autoimmune disorders, diffuse cutaneous systemic sclerosis. It looks at the main manifestations of scleroderma, including skin involvement, autoimmunity, renal crises and aortic involvement. It also describes therapies that are being investigated to treat the autoimmune symptoms and complications of systemic scleroderma.
Oral steroids, oral methotrexate or oral cyclophosphamide can alleviate many of the symptoms of systemic sclerosis, and the clinical course of the disease is less severe compared with those who are not treated. Therefore, such treatments should be applied strictly in an effort to promote a better prognosis when necessary.
Trials involving sildenafil that have not been mentioned in the literature suggest that sildenafil does have good therapeutic effects in patients with pulmonary hypertension. One study suggests sildenafil may also benefit SSc patients by improving endothelial function. Whether these findings replicate those from studies investigating the use of sildenafil in vascular disease is not clear. At present the precise impact sildenafil, or similar agents, may have on SSc patients can only be ascertained by clinical trials.
The majority of persons (69.1%) with scleroderma, systemic were women. The average age the disease was diagnosed for women was 47.2 years. The average age the disease was diagnosed for men was 50.5 years. There was a significant difference between the average age of diagnosis of scleroderma, systemic in men in comparison to women.
Sildenafil might be one of the first line drugs used to treat SSc, particularly in patients with pulmonary or cardiovascular disease. This retrospective study suggests that sildenafil has pleiotropic properties: anti-inflammatory, vasorelaxant and anticancer activities; a unique combination of properties with anti-inflammatory and vasodilatory effects. Results from a recent paper might pave the way for a prospective drug trial to test the hypothesis that sildenafil could be used as a therapeutic agent in SSc patients.