Family Medicine Board Review

Family Medicine Board Review

Trust Your Gut Feeling!

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Issue No. 1 May 2011

Statins and Liver Injury:

Progression to liver failure due to statins is exceedingly rare. ( one case in/ 1.14 million patient-treatment years)

Rises in ALT is dose- dependant ( Except for Rosuvastatin)

Until there is a change in the FDA prescribing information, Transaminase levels should be checked before Statin therapy, 6-12 weeks after initiation of statins, after a dose increase, and every 6-12 months thereafter. (Routine monitoring of liver function test in asymptomatic patients is not supported by the available evidence and is in process for FDA review. Until then, above FDA recommendation is in place – mild increase of ALT is believed to be due to oozing of liver enzyme form cells rather than an actual liver damage- see below)

If pre-treatment transaminase level is high, further investigations should be done to determine the etiology of abnormal ALT before initiating the statins. If the increased ALT is due to Fatty liver, Statins should be started and in most cases will lead to a normal ALT after few weeks/months.

Reporting jaundice, malaise, fatigue, lethargy by patients plus having hepatomegaly, increased bilirubin & PTT in patients who are taking statins could be evidence of potential hepatotoxicity and statins should be discontinued. (In the absence of biliary obstruction, the preferred test to ascertain significant liver injury is fractionated bilirubin rather than isolated ALT elevation).

Isolated asymptomatic elevation of ALT level 1-3 ULN: does not need discontinuation of Statin. Periodic measurement of liver function test is recommended. (ULN= upper limit of normal)

Isolated asymptomatic elevation of ALT > 3 ULN: test should be repeated, consider to continue statins with close observation, or reduce the dose, or discontinue the med – also other etiologies should be ruled out. The same or a different statins (with the same or a lower dose) may be restarted when ALT is back to normal or if the Statin is not the etiology( Elevation don’t often occur with either same of another Statin)

According to NLA Expert Liver Panel, patients with chronic liver disease, nonalcoholic fatty liver disease, or nonalcoholic steatohepatitis may safely receive statins therapy. ( in case per case bases with observation, etc).

Does Statin Cause Diabetes?

Recently published data from the JUPITER study showing an increased incidence of diabetes with rosuvastatin (Crestor) therapy and a large meta-analysis (n=91,000) in the Lancet (DOI:10.1016/S0140-6736(09)61965-6) which concluded statin therapy was associated with a 9% increased risk for incident diabetes (odds ratio [OR] 1•09; 95% CI 1•02–1•17). This was recently in media.

The same researchers wrote:

"Statin therapy is associated with a slightly increased risk of development of diabetes, but the risk is low both in absolute terms and when compared with the reduction in coronary events. Clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change."

Another recent article about atorvastatin showed a similar finding. The problem that people forget is that statins save lives and the incidence of possible adverse effects and complication is very very low.