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Overview

In controlled clinical studies, 40/214 (19%) of patients randomized to ADVICOR discontinued therapy prior to study completion. Of the 214 patients enrolled 18 (8%) discontinued due to flushing. In the same controlled studies, 9/94 (10%) of patients randomized to lovastatin and 19/92 (21%) of patients randomized to NIASPAN also discontinued treatment prior to study completion secondary to adverse events. Flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse events, and occurred in 53% to 83% of patients treated with ADVICOR. Spontaneous reports with NIASPAN and clinical studies with ADVICOR suggest that flushing may also be accompanied by symptoms of dizziness or syncope, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema.

Adverse Reactions Information

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. The adverse reaction information from clinical studies does, however provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described in this section reflect the exposure to ADVICOR in two double-blind, controlled clinical studies of 400 patients. The population was 28 to 86 years-of-age, 54% male, 85% Caucasian, 9% Black, and 7% Other, and had mixed dyslipidemia.

In addition to flushing, other adverse events occurring in 5% or greater of patients treated with ADVICOR are shown in Table 10 below.

Table 10: Treatment-Emergent Adverse Events in ≥ 5% of Patients (Events Irrespective of Causality; Data from Controlled, Double-Blind Studies)

Adverse Event ADVICOR NIASPAN Lovastatin
Total Number of Patients 214 92 94
Cardiovascular 163 (76%) 66 (72%) 24 (26%)
Flushing 152 (71%) 60 (65%) 17 (18%)
Body as a Whole 104 (49%) 50 (54%) 42 (45%)
Asthenia 10 ( 5%) 6 ( 7%) 5 ( 5%)
Flu Syndrome 12 ( 6%) 7 ( 8%) 4 ( 4%)
Headache 20 ( 9%) 12 (13%) 5 ( 5%)
Infection 43 (20%) 14 (15%) 19 (20%)
Pain 18 ( 8%) 3 ( 3%) 9 (10%)
Pain, Abdominal 9 ( 4%) 1 ( 1%) 6 ( 6%)
Pain, Back 10 ( 5%) 5 ( 5%) 5 ( 5%)
Digestive System 51 (24%) 26 (28%) 16 (17%)
Diarrhea 13 ( 6%) 8 ( 9%) 2 ( 2%)
Dyspepsia 6 ( 3%) 5 ( 5%) 4 ( 4%)
Nausea 14 ( 7%) 11 (12%) 2 ( 2%)
Vomiting 7 ( 3%) 5 ( 5%) 0
Metabolic and Nutrit. System 37 (17%) 18 (20%) 13 (14%)
Hyperglycemia 8 ( 4%) 6 ( 7%) 6 ( 6%)
Musculoskeletal System 19 ( 9%) 9 (10%) 17 (18%)
Myalgia 6 ( 3%) 5 ( 5%) 8 ( 9%)
Skin and Appendages 38 (18%) 19 (21%) 11 (12%)
Pruritus 14 ( 7%) 7 ( 8%) 3 ( 3%)
Rash 11 ( 5%) 11 (12%) 3 ( 3%)

Note: Percentages are calculated from the total number of patients in each column.

See also the full prescribing information for niacin extended release (Niaspan) and lovastatin products.

The following adverse events have also been reported with niacin, lovastatin, and/or other HMG-CoA reductase inhibitors, but not necessarily with ADVICOR, either during clinical studies or in routine patient management.

Body as a Whole: chest pain; abdominal pain; edema; chills; malaise
Cardiovascular: atrial fibrillation; tachycardia; palpitations, and other cardiac arrhythmias; postural hypotension, orthostasis; hypotension; syncope
Eye: toxic amblyopia; cystoid macular edema; ophthalmoplegia; eye irritation, blurred vision, progression of cataracts
Gastrointestinal: activation of peptic ulcers and peptic ulceration; dyspepsia; vomiting; anorexia; constipation; flatulence, pancreatitis; hepatitis; fatty change in liver; jaundice; and rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma, eructation, fatal and non-fatal hepatic failure
Metabolic: gout, decreased glucose tolerance
Musculoskeletal: muscle cramps; myopathy; rhabdomyolysis; arthralgia, myalgia
Nervous: dizziness; insomnia; dry mouth; paresthesia; anxiety; tremor; vertigo; peripheral neuropathy; psychic disturbances; dysfunction of certain cranial nerves, nervousness, burning sensation/skin burning sensation, peripheral nerve palsy
Psychiatric depression
Skin: hyper-pigmentation; acanthosis nigricans; urticaria; alopecia; dry

There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).

Clinical Laboratory Abnormalities

Chemistry

Elevations in serum transaminases (see WARNINGS - Liver Dysfunction), CPK and fasting glucose, and reductions in phosphorus. Niacin extended-release tablets have been associated with slight elevations in LDH, uric acid, total bilirubin, amylase and creatine kinase. Lovastatin and/or HMG-CoA reductase inhibitors have been associated with elevations in alkaline phosphatase, γ-glutamyl transpeptidase and bilirubin, and thyroid function abnormalities.

Hematology

Niacin extended-release tablets have been associated with slight reductions in platelet counts and prolongation in PT (see WARNINGS).

Drug Abuse And Dependence

Neither niacin nor lovastatin is a narcotic drug. ADVICOR has no known addiction potential in humans.