N-of-1 Trial of a Statin, Placebo, or No Treatment to Assess Side Effects

Statins are frequently discontinued due to perceived side effects, despite some blinded trials showing no excess of symptoms compared to placebo. This double-blind, three-group, n-of-1 trial investigated whether symptoms would be induced by a statin or placebo in patients who had previously discontinued statins due to side effects occurring within two weeks of initiation. Patients received four bottles each containing atorvastatin (20 mg), placebo, or nothing (empty bottles), to be used for a one-month period according to a random sequence. Participants used a smartphone application to report symptoms. The trial aimed to test the induction of symptoms by statin or placebo

Statins are frequently discontinued due to perceived side effects, despite some blinded trials showing no excess of symptoms compared to placebo. This double-blind, three-group, n-of-1 trial investigated whether symptoms would be induced by a statin or placebo in patients who had previously discontinued statins due to side effects occurring within two weeks of initiation. Patients received four bottles each containing atorvastatin (20 mg), placebo, or nothing (empty bottles), to be used for a one-month period according to a random sequence. Participants used a smartphone application to report symptoms. The trial aimed to test the induction of symptoms by statin or placebo