|
|
| Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Ezetimibe]] |
| {{Ezetimibe}}
| |
| {{CMG}}; {{AE}} {{SS}}
| |
| | |
| ==Adverse Reactions==
| |
| | |
| The following serious adverse reactions are discussed in greater detail in other sections of the label:
| |
| | |
| *Liver enzyme abnormalities [see Warnings and Precautions (5.2)]
| |
| *[[Rhabdomyolysis]]]] and [[myopathy]] [see Warnings and Precautions (5.3)]
| |
| | |
| '''Monotherapy Studies''': In the ZETIA controlled clinical trials database (placebo-controlled) of 2396 patients with a median treatment duration of 12 weeks (range 0 to 39 weeks), 3.3% of patients on ZETIA and 2.9% of patients on placebo discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with ZETIA that led to treatment discontinuation and occurred at a rate greater than placebo were:
| |
| | |
| *[[Arthralgia]] (0.3%)
| |
| *[[Dizziness]] (0.2%)
| |
| *[[Gamma-glutamyltransferase]] increased (0.2%)
| |
| | |
| The most commonly reported adverse reactions (incidence ≥2% and greater than placebo) in the ZETIA monotherapy controlled clinical trial database of 2396 patients were: [[upper respiratory tract infection]] (4.3%), [[diarrhea ]](4.1%), [[arthralgia]] (3.0%), [[sinusitis]] (2.8%), and pain in extremity (2.7%).
| |
| | |
| '''[[statin]] Coadministration Studies''': In the ZETIA + [[statin]] controlled clinical trials database of 11,308 patients with a median treatment duration of 8 weeks (range 0 to 112 weeks), 4.0% of patients on ZETIA + [[statin]] and 3.3% of patients on [[statin]] alone discontinued due to adverse reactions. The most common adverse reactions in the group of patients treated with ZETIA + [[statin]] that led to treatment discontinuation and occurred at a rate greater than [[statin]] alone were:
| |
| | |
| *Alanine aminotransferase increased (0.6%)
| |
| *[[Myalgia]] (0.5%)
| |
| *[[Fatigue]], [[aspartate aminotransferase ]]increased, [[headache]], and pain in extremity (each at 0.2%)
| |
| | |
| The most commonly reported adverse reactions (incidence ≥2% and greater than [[statin]] alone) in the ZETIA + [[statin]] controlled clinical trial database of 11,308 patients were: [[nasopharyngitis]] (3.7%), [[myalgia]] (3.2%), [[upper respiratory tract infection]] (2.9%), [[arthralgia ]](2.6%) and [[diarrhea]] (2.5%).
| |
| | |
| ===Clinical Trials Experience===
| |
| | |
| Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the 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.
| |
| | |
| ====Monotherapy====
| |
| | |
| In 10 double-blind, placebo-controlled clinical trials, 2396 patients with primary hyperlipidemia (age range 9–86 years, 50% women, 90% Caucasians, 5% Blacks, 3% Hispanics, 2% Asians) and elevated LDL-C were treated with ZETIA 10 mg/day for a median treatment duration of 12 weeks (range 0 to 39 weeks).
| |
| | |
| Adverse reactions reported in ≥2% of patients treated with ZETIA and at an incidence greater than placebo in placebo-controlled studies of ZETIA, regardless of causality assessment, are shown in Table 1.
| |
| | |
| {|
| |
| |-
| |
| |[[File:zetia01.jpg|thumb|800px]]
| |
| |-
| |
| |}
| |
| | |
| ====Combination with a [[statin]]====
| |
| | |
| In 28 double-blind, controlled (placebo or active-controlled) clinical trials, 11,308 patients with primary [[hyperlipidemia]] (age range 10–93 years, 48% women, 85% Caucasians, 7% Blacks, 4% Hispanics, 3% Asians) and elevated LDL-C were treated with ZETIA 10 mg/day concurrently with or added to on-going [[statin]] therapy for a median treatment duration of 8 weeks (range 0 to 112 weeks).
| |
| | |
| The incidence of consecutive increased transaminases (≥3 × ULN) was higher in patients receiving ZETIA administered with [[statin]]s (1.3%) than in patients treated with [[statin]]s alone (0.4%). [See Warnings and Precautions (5.2).]
| |
| | |
| Clinical adverse reactions reported in ≥2% of patients treated with ZETIA + [[statin]] and at an incidence greater than [[statin]], regardless of causality assessment, are shown inTable 2.
| |
| | |
| {|
| |
| |-
| |
| |[[File:zetia02.jpg|thumb|800px]]
| |
| |-
| |
| |}
| |
| | |
| ====Combination with Fenofibrate====
| |
| | |
| This clinical study involving 625 patients with mixed dyslipidemia (age range 20–76 years, 44% women, 79% Caucasians, 0.1% Blacks, 11% Hispanics, 5% Asians) treated for up to 12 weeks and 576 patients treated for up to an additional 48 weeks evaluated coadministration of ZETIA and [[Fenofibrate]]. This study was not designed to compare treatment groups for infrequent events. Incidence rates (95% CI) for clinically important elevations (≥3 × ULN, consecutive) in hepatic transaminase levels were 4.5% (1.9, 8.8) and 2.7% (1.2, 5.4) for [[Fenofibrate]] monotherapy (n=188) and ZETIA coadministered with [[Fenofibrate]] (n=183), respectively, adjusted for treatment exposure. Corresponding incidence rates for cholecystectomy were 0.6% (95% CI: 0.0%, 3.1%) and 1.7% (95% CI: 0.6%, 4.0%) for [[Fenofibrate]] monotherapy and ZETIA coadministered with [[Fenofibrate]], respectively [see Drug Interactions (7.3)]. The numbers of patients exposed to coadministration therapy as well as [[Fenofibrate]] and ezetimibe monotherapy were inadequate to assess gallbladder disease risk. There were no CPK elevations >10 × ULN in any of the treatment groups.
| |
| | |
| ===Post-Marketing Experience===
| |
| | |
| Because the reactions below are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
| |
| | |
| The following additional adverse reactions have been identified during post-approval use of ZETIA:
| |
| | |
| [[Hypersensitivity]] reactions, including [[anaphylaxis]], [[angioedema]], [[rash]], and [[urticaria]]; [[erythema multiforme]]; [[arthralgia]]; [[myalgia]]; elevated creatine phosphokinase; [[myopathy]]/[[Rhabdomyolysis]]]] [see Warnings and Precautions (5.3)]; elevations in liver transaminases; [[hepatitis]]; abdominal pain; [[thrombocytopenia]]; [[pancreatitis]]; [[nausea]]; [[dizziness]]; [[paresthesia]]; [[depression]]; [[headache]]; [[cholelithiasis]]; [[cholecystitis]].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ZETIA (EZETIMIBE) TABLET [MERCK SHARP & DOHME CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a773b0b2-d31c-4ff4-b9e8-1eb2d3a4d62a | publisher = | date = | accessdate = 11 February 2014 }}</ref>
| |
| | |
| | |
| ==References==
| |
| | |
| {{Reflist|2}}
| |
| | |
| [[Category:Hypolipidemic agents]]
| |
| [[Category:Lactams]]
| |
| [[Category:Merck]]
| |
| [[Category:Schering-Plough]]
| |
| [[Category:Azetidines]]
| |
| [[Category:Organofluorides]]
| |
| [[Category:Phenols]]
| |
| [[Category:Cardiovasuclar Drugs]]
| |
| [[Category:Drugs]]
| |