The response to atorvastatin in 64 patients with isolated hypertriglyceridemia ( Fredrickson Type IV) treated across several clinical trials is shown in the table below (Table 9). For the atorvastatin-treated patients, median (min, max) baseline TG level was 565 (267 to 1,502).
|Placebo (N=12)||Atorvastatin 10 mg (N=37)||Atorvastatin 20 mg (N=13)||Atorvastatin 80 mg (N=14)|
|Triglycerides||-12.4 (-36.6, 82.7)||-41.0 (-76.2, 49.4)||-38.7 (-62.7, 29.5)||-51.8 (-82.8, 41.3)|
|Total-C||-2.3 (-15.5, 24.4)||-28.2 (-44.9, -6.8)||-34.9 (-49.6, -15.2)||-44.4 (-63.5, -3.8)|
|LDL-C||3.6 (-31.3, 31.6)||-26.5 (-57.7, 9.8)||-30.4 (-53.9, 0.3)||-40.5 (-60.6, -13.8)|
|HDL-C||3.8 (-18.6, 13.4)||13.8 (-9.7, 61.5)||11.0 (-3.2, 25.2)||7.5 (-10.8, 37.2)|
|VLDL-C||-1.0 (-31.9, 53.2)||-48.8 (-85.8, 57.3)||-44.6 (-62.2, -10.8)||-62.0 (-88.2, 37.6)|
|non-HDL-C||-2.8 (-17.6, 30.0)||-33.0 (-52.1, -13.3)||-42.7 (-53.7, -17.4)||-51.5 (-72.9, -4.3)|
The results of an open-label crossover study of 16 patients (genotypes: 14 apo E2/E2 and 2 apo E3/E2) with dysbetalipoproteinemia (Fredrickson Type III) are shown in the table below (Table 10).
|Median % Change (min, max)|
|Median (min, max) at Baseline (mg/dL)||Atorvastatin 10 mg||Atorvastatin 80 mg|
|Total-C||442 (225, 1,320)||-37 (-85, 17)||-58 (-90, -31)|
|Triglycerides||678 (273, 5,990)||-39 (-92, -8)||-53 (-95, -30)|
|IDL-C + VLDL-C||215 (111, 613)||-32 (-76, 9)||-63 (-90, -8)|
|non-HDL-C||411 (218, 1,272)||-43 (-87, -19)||-64 (-92, -36)|
In a study without a concurrent control group, 29 patients ages 6 years to 37 years with HoFH received maximum daily doses of 20 mg to 80 mg of atorvastatin. The mean LDL-C reduction in this study was 18%. Twenty-five patients with a reduction in LDL-C had a mean response of 20% (range of 7% to 53%, median of 24%); the remaining four patients had 7% to 24% increases in LDL-C. Five of the 29 patients had absent LDL-receptor function. Of these, two patients also had a portacaval shunt and had no significant reduction in LDL-C. The remaining three receptor-negative patients had a mean LDL-C reduction of 22%.
In a double-blind, placebo-controlled study followed by an open-label phase, 187 boys and post-menarchal girls 10 years to 17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolemia (HeFH) or severe hypercholesterolemia, were randomized to atorvastatin (n=140) or placebo (n=47) for 26 weeks and then all received atorvastatin for 26 weeks. Inclusion in the study required 1) a baseline LDL-C level ≥ 190 mg/dL or 2) a baseline LDL-C level ≥ 160 mg/dL and positive family history of FH or documented premature cardiovascular disease in a first or second-degree relative. The mean baseline LDL-C value was 218.6 mg/dL (range: 138.5 to 385.0 mg/dL) in the atorvastatin group compared to 230.0 mg/dL (range: 160.0 to 324.5 mg/dL) in the placebo group. The dosage of atorvastatin (once daily) was 10 mg for the first 4 weeks and uptitrated to 20 mg if the LDL-C level was >130 mg/dL. The number of atorvastatin-treated patients who required uptitration to 20 mg after Week 4 during the double-blind phase was 78 (55.7%).
Atorvastatin significantly decreased plasma levels of total-C, LDL-C, triglycerides, and apolipoprotein B during the 26-week double-blind phase (see Table 11).
The mean achieved LDL-C value was 130.7 mg/dL (range: 70.0 to 242.0 mg/dL) in the atorvastatin group compared to 228.5 mg/dL (range: 152.0 to 385.0 mg/dL) in the placebo group during the 26-week double-blind phase.
The long-term efficacy of atorvastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.
Additional pediatric use information is approved for Pfizer’s LIPITOR (atorvastatin calcium) tablets. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Atorvastatin calcium tablets, USP are available containing atorvastatin calcium, USP equivalent to 20 mg, 40 mg of atorvastatin.
The 20 mg tablets are white to off-white, film-coated, oval shaped tablet plain on one side and debossed with ’114′ on other side. They are available as follows:
Unit of Use Bottles of 30 — 20mg NDC 68645-591-54
The 40 mg tablets are white to off-white, film-coated, oval shaped tablet plain on one side and debossed with ’115′on other side. They are available as follows:
Unit of Use Bottles of 30 — 40mg NDC 68645-592-54
Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Patients taking atorvastatin calcium tablets should be advised that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment.
Patients should be advised about substances they should not take concomitantly with atorvastatin [ see Warnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking atorvastatin calcium tablets.
All patients starting therapy with atorvastatin calcium tablets should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing atorvastatin calcium tablets. The risk of this occurring is increased when taking certain types of medication or consuming larger quantities (>1 liter) of grapefruit juice. They should discuss all medication, both prescription and over the counter, with their healthcare professional.
It is recommended that liver enzyme tests be performed before the initiation of atorvastatin calcium tablets and if signs or symptoms of liver injury occur. All patients treated with atorvastatin calcium tablets should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)].
The brand names listed are trademarks of their respective owners and are not trademark of the Graviti Pharmaceuticals Private Limited.
Graviti Pharmaceuticals Private Limited.
Biocon Pharma Inc.,
Iselin, NJ 08830-3009 USA
Legacy Pharmaceutical Packaging, LLC, Earth City, MO 63045
The Kroger Co., Cincinnati, OH 45202
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