<p>Bempedoic acid inhibits renal tubular OAT2 and may increase blood uric acid levels. In clinical trials, 26% of Bempedoic acid-treated patients with normal baseline uric acid values (versus 9.5% placebo) experienced hyperuricemia one or more times, and 3.5% of patients experienced clinically significant hyperuricemia reported as an adverse reaction (versus 1.1% placebo). Increases in uric acid levels usually occurred within the first 4 weeks of treatment initiation and persisted throughout treatment. After 12 weeks of treatment, the mean placebo-adjusted increase in uric acid compared to baseline was 0.8 mg/dL for patients treated with Bempedoic acid.<br />
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Elevated blood uric acid may lead to the development of gout. Gout was reported in 1.5% of patients treated with Bempedoic acid and 0.4% of patients treated with placebo. The risk for gout events was higher in patients with a prior history of gout (11.2% Bempedoic acid versus 1.7% placebo), although gout also occurred more frequently than placebo in patients treated with Bempedoic acid who had no prior gout history (1.0% Bempedoic acid versus 0.3% placebo). Advise patients to contact their healthcare provider if symptoms of hyperuricemia occur. Assess serum uric acid when clinically indicated. Monitor patients for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.<br />
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Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. In clinical trials, tendon rupture occurred in 0.5% of patients treated with Bempedoic acid versus 0% of placebo-treated patients and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to months of starting Bempedoic acid. Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders.<br />
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Discontinue Bempedoic acid immediately if the patient experiences rupture of a tendon. Consider discontinuing Bempedoic acid if the patient experiences joint pain, swelling, or inflammation. Advise patients to rest at the first sign of tendinitis or tendon rupture and to contact their healthcare provider if tendinitis or tendon rupture symptoms occur. Consider alternative therapy in patients with a history of tendon disorders or tendon rupture.</p>