Lipitor (atorvastatin) is a statin, or cholesterol-lowering therapy, manufactured by Pfizer. It is approved by the U.S. Food and Drug Administration to prevent cardiovascular disease and to treat dyslipidemia, or abnormal levels of lipids in the blood.

Lipitor is now being tested as a possible treatment for Raynaud’s phenomenon and digital ulcers in scleroderma patients.

How Lipitor works

Scleroderma is an autoimmune disease caused by the immune system mistakenly attacking the body’s own tissues and leading to scarring and thickening of the connective tissue in multiple organs, including the blood vessels. This can cause blood vessels to narrow and restrict the blood flow. Complications associated with this include Raynaud’s phenomenon, digital ulcers, and pulmonary hypertension.

As a statin, Lipitor helps lower cholesterol levels by reducing cholesterol production by the liver. Statins are also thought to play a role in the vascular system, stimulating blood vessels to relax and widen.

They also have immunomodulatory and anti-inflammatory propertiesas a result, Lipitor should improve blood flow and may help protect the vascular system by delaying blood vessel changes that occur in scleroderma and reducing scarring or fibrosis.

Lipitor in clinical trials for scleroderma

The effect of Lipitor in scleroderma, especially in relation to Raynaud’s phenomenon and digital ulcers, has been investigated in several case studies and clinical trials. Studies suggest that the therapy may be effective, but more trials are needed to confirm these findings.

Results of a randomized study comparing Lipitor to a placebo in 84 patients with systemic scleroderma was published in the Journal of Rheumatology in 2008.

The effect of Lipitor was assessed for four months and the treatment was shown to be well-tolerated. Patients taking Lipitor showed a significant decrease in the number of digital ulcers, and had a mean 1.6 new ulcers develop compared to 2.5 in the placebo group.

Patients also had improved quality of life and function, as they experienced less pain and fewer symptoms of Raynaud’s phenomenon when given Lipitor compared to placebo. Furthermore, certain markers in the blood suggested that Lipitor could be slowing damage to the blood vessels.

A case study in six patients with scleroderma, published in the Journal of Case Reports in Practice, also suggested that Lipitor could be beneficial in treating scleroderma-associated Raynaud’s phenomenon and digital ulcers.

Patients were treated daily with Lipitor and prednisolone, an anti-inflammatory medication and common scleroderma therapy, for three months. After treatment, patients had fewer digital ulcers and reduced symptoms of Raynaud’s phenomenon.

The authors of the study concluded that statins like Lipitor may improve quality of life in patients with scleroderma.

A Phase 2 study (NCT02370784) called TAMER aims to evaluate the effect of Lipitor in patients with early diffuse systemic scleroderma at the University of Pittsburgh, in collaboration with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

The clinical trial will assess Lipitor’s effect on blood vessel function and in reducing Raynaud’s symptoms in about 30 participants. This trial, which is still enrolling eligible patients, is due to conclude in December 2019.

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