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

Atorvastatin is being tested as a possible treatment of Raynaud’s phenomenon and digital ulcer in scleroderma patients.

How Lipitor works

Scleroderma is an autoimmune disease and, as such, caused by an overactive immune system that mistakenly attacks the body’s own tissues. Excessive inflammation leads to scarring and thickening of the connective tissue of multiple organs, including blood vessels. Complications associated with blood vessel scarring include Raynaud’s phenomenon, digital ulcers, and pulmonary hypertension.

Lipitor belongs to a group of medicines called statins that lower blood cholesterol levels by reducing its production by the liver. Statins also have immunomodulatory and anti-inflammatory properties that may help to protect the vascular system, delaying blood vessel changes that occur in scleroderma and reducing scarring or fibrosis.

Studies for Raynaud’s phenomenon

A “case series” in six patients with scleroderma showed that atorvastatin could be beneficial in treating scleroderma-associated Raynaud’s phenomenon and digital ulcers. Patients in it were treated with atorvastatin and prednisolone, an anti-inflammatory medication and common scleroderma therapy, for three months.

Results from that study in Iran were published in the Journal of Case Reports in Practice in 2016. Its authors concluded that statins like “atorvastatin are useful for reducing RP  [Raynaud’s phenomenon] and DU [digital ulcers] in SSc patients. This study proved that a dose of 40 mg atorvastatin can improve the quality of the patients.” 

An investigator-initiated Phase 2 study (NCT02370784) is currently evaluating the therapy in patients with early diffuse systemic scleroderma at the University of Pittsburgh. The study aims to determine atorvastatin’s effects on blood vessel function and Raynaud’s symptoms in about 30 patients. This trial, which is still enrolling eligible patients, is due to concluded in December 2019.

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