71% of the 378 physicians participating in the study were cardiologists.
Physicians enrolled and treated patients at their discretion using the statin of their choice.
86% of the 1,261 patients not at goal on the initial dose did not achieve goal after 6 months whether titrated or not.
Physicians were instructed to treat per guidelines, follow prescribing information, counsel on diet, and titrate according to their professional judgment to achieve goal of LDL-C <100 mg/dL.
Median time to titration was 106 days, or about 3.5 months.
Study Design
Type of study: Prospective, process-of-care study.
Duration: 6 months.
Purpose: To evaluate the frequency of statin titration and its effect on LDL-C goal attainment.
Treatment regimen and number of patients
- High-risk patients (N = 2,829) with CHD or diabetes, elevated LDL-C per guidelines or physician-selected goal, and HDL-C <45 mg/dL, who had not achieved LDL-C goal
<100 mg/dL on initial statin dose. - Recommended starting doses were based on statin prescribing information.
- Most patients were initiated at the recommended starting dose for the prescribed statin.
- Initial statin chosen was simvastatin for 55% of patients, atorvastatin for 29% of patients, pravastatin for 10% of patients, and other statins for the remaining 5% of patients.
- Physicians were instructed to treat per guidelines, follow prescribing information, counsel on diet, and titrate according to their professional judgment to achieve goal of LDL-C <100 mg/dL.
- No changes in statin or combination therapy were allowed.
Primary end point: Frequency with which high-risk patients with hyperlipidemia were evaluated and whether doses of statins were titrated during a 6-month period.
Important Information About ZETIA
The effect of ZETIA on cardiovascular morbidity and mortality has not been determined.
ZETIA, administered alone or in combination with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated TOTAL-C, LDL-C, and Apo B in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia when diet alone is not enough.
Contraindications: hypersensitivity to any component of this medication.
Statin contraindications apply when used with a statin: active liver disease; unexplained persistent elevations in hepatic transaminase levels. Statins are contraindicated in pregnant and nursing women. Refer to the statin label for details.
When using ZETIA with a statin, also follow the label recommendations for that specific statin.
Selected Cautionary Information: When ZETIA was coadministered with a statin, consecutive elevations in hepatic transaminase levels (>3 x ULN) were slightly higher (1.3%) than those of statins alone (0.4%). Liver function tests should be performed when ZETIA is added to statin therapy and according to statin recommendations. Should an increase in ALT or AST >3 x ULN persist, consider withdrawal of ZETIA and/or the statin.
Patients should be advised to promptly report muscle pain, tenderness, or weakness. Risk for skeletal muscle toxicity increases with higher statin doses, advanced age (>65), hypothyroidism, renal impairment, and depending on the statin used, concomitant use of other drugs. Discontinue drug if myopathy is diagnosed or suspected.
ZETIA is not recommended in patients with moderate to severe hepatic impairment.
The coadministration of ZETIA with fibrates other than fenofibrate is not recommended until use in patients is adequately studied.
Exercise caution when using ZETIA and cyclosporine concomitantly because exposure to both drugs is increased. Cyclosporine concentrations should be monitored in these patients.
ZETIA should be used in pregnant or nursing women only if the benefit outweighs the risk.
In clinical trials, regardless of causality assessment, the most frequent side effects for ZETIA coadministered with a statin vs statin alone included nasopharyngitis (3.7% vs 3.3%), myalgia (3.2% vs 2.7%), upper respiratory tract infection (2.9% vs 2.8%), arthralgia (2.6% vs 2.4%), and diarrhea (2.5% vs 2.2%); for ZETIA administered alone vs placebo: upper respiratory tract infection (4.3% vs 2.5%), diarrhea (4.1% vs 3.7%), arthralgia (3.0% vs 2.2%), sinusitis (2.8% vs 2.2%), and pain in extremity (2.7% vs 2.5%).
Before prescribing ZETIA, please read the Prescribing Information.
Reference: 1. Foley KA, Simpson RJ Jr, Crouse JR III, Weiss TW, Markson LE, Alexander CM. Effectiveness of statin titration on low-density lipoprotein cholesterol goal attainment in patients at high risk of atherogenic events. Am J Cardiol. 2003;92(1):79–81.
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