L2. Obtain Baseline Serum Transaminase (ALT/AST) Prior to Starting Lipid Lowering Therapy

objective

Establish baseline transaminase monitoring parameters prior to initiating lipid lowering therapy.

background

Asymptomatic increases in transaminases to greater than three times the upper limits of normal (ULN) on two consecutive lab tests is estimated to occur 0.1 - 2 percent in patients receiving lipid-lowering drug treatment (incidence is similar to patients treated with placebo).  In case of statins, elevations are usually transient and may normalize even with continued therapy or may not reoccur even with reintroduction of the same statin dose.  Nonetheless, patients should be monitored until the transaminase has normalized.

recommendations

1. Baseline serum transaminase (ALT/AST) should be obtained prior to starting lipid-lowering therapy.  [I]
2. Levels of serum transaminase (ALT/AST) should be obtained in patients on statin, 6-12 weeks after starting statin therapy, and/or change in dose or combination therapy, then annually or more frequently, if indicated.  [I]
3. Levels of serum transaminase (ALT/AST) should be obtained in patients on niacin, 6-12 weeks after reaching a daily dose of 1,500 mg and 6-12 weeks after reaching the maximum daily dose, then annually or more frequently, if indicated.  [I]
   

discussion

Statins are tolerated well by most persons.  It is reported that elevated hepatic transaminases generally occur in 0.5 percent to 2 percent of cases and are dose dependent (Hsu et al., 1995, Bradford et al., 1991).  It has not been determined whether transaminase elevation with statin therapy constitutes true toxicity.  Reversal of transaminase elevation is frequently noted with a reduction in dose, and elevations do not often recur with re-challenge or selection of another statin. No specific evidence exists showing exacerbation of liver disease by statins; however, statin use is contraindicated in patients with cholestasis and active liver disease (Cressman et al., 1988; Hunninghake, 1990).