NIASPAN Safety & Tolerability

Demonstrated safety in clinical trials

In three safety and efficacy trials of NIASPAN® (niacin extended-release tablets) in combination with lovastatin,* there were no greater increases of serum transaminase elevations compared to NIASPAN monotherapy:1

  • 1% incidence of reversible serum transaminase >3 times ULN during treatment (n=10 of 1028)
  • 3 of 10 elevations occurred at doses outside the recommended dose limit of 2000 mg/40 mg
  • Low incidence of myopathy (0.09%; n=1079)†‡
  • No reports of rhabdomyolysis (0.00%; n=1079)‡
  • NIASPAN/lovastatin doses up to 2000 mg/40 mg

Rare cases of rhabdomyolysis have been associated with concomitant administration of lipid- altering doses (> or= 1 g/day) of niacin and HMG-CoA reductase inhibitors. Patients on combined therapy with HMG-CoA reductase inhibitors and NIASPAN should be monitored carefully for any signs and symptoms of muscle pain, tenderness, or weakness particularly during the initial months of therapy and during any periods of upward dosage titration of either drug.

* Niacin in combination with bile acid binding resins promotes the regression of atherosclerosis in patients with established coronary artery disease and hypercholesterolemia.
† One suspected case of myopathy reported in a long-term, open-label study.
‡ Includes additional patients from an open-label study.

The most common drug side effect of niacin, the active ingredient in NIASPAN, is flushing. This effect decreases over time as patients develop a tolerance.2 Other common adverse events (>5% of patients) in clinical trials include headache, pain, diarrhea, dyspepsia, nausea, vomiting, abdominal pain, rhinitis, itching, and rash.1

NIASPAN should not be substituted for equivalent doses of immediate-release (crystalline) niacin. When switching patients to NIASPAN from immediate-release niacin, initiate with low doses (500 mg daily) and then titrate to desired therapeutic response.

The American Heart Association states that "dietary supplement niacin should not be used as a substitute for prescription niacin."3 Learn more

Flushing is a common, yet manageable drug effect of niacin.
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NIASPAN is a prescription niacin agent indicated to RAISE HDL-C, REGRESS atherosclerosis, and REDUCE recurrent non-fatal MI.*

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References

1. NIASPAN® prescribing information. North Chicago, IL; Abbott Laboratories.

2. Capuzzi DM, Guyton JR, Morgan JM, et al. Efficacy and safety of an extended-release niacin (NIASPAN): a long-term study. Am J Cardiol. 1998;82:74U-81U.

3. American Heart Association. Cholesterol-lowering drugs. Dallas: TX. Available online at: http://www.americanheart.org/presenter.jhtml?identifier=163