What is the difference between tricor and crestor

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Of these post-approval cases, one case of rhabdomyolysis occurred in the United States, where the drug had only been on the market for little over five months, as did two cases of kidney toxicity.

The other cases of rhabdomyolysis and drug-induced kidney disease occurred in the UK or Canada, where the drug had been on the market for a longer time. We have now obtained new information from the FDA about many additional post-marketing cases of rhabdomyolysis and kidney toxicity in reports updated to April 13th.

In the relatively short interval since our first petition, 11 additional cases of rhabdomyolysis in patients using rosuvastatin, including at least 10 in the United States, have been reported to the FDA, as have three additional cases of renal failure or renal insufficiency in the United States, all in people using 10 milligrams. Of the 10 new U. Five of the eight U. Despite the fact that the majority of U. AstraZeneca have written [on May 14th] to healthcare professionals to warn prescribers to initiate Crestor rosuvastatin at a dose of 10mg.

The manufacturer recommends that those patients who have already been started on doses greater than 10 mg should be reviewed at their next appointment, and appropriate down-titration of dose should be considered. Patients should be asked to report muscle pain, weakness or cramps immediately, and if symptoms are severe or if the CPK is greater than 5 times the upper limit of normal, treatment should be stopped. Dear Healthcare Professional issued 14 May Pharmacokinetic studies revealed no significant interactions with the concomitant use of rosuvastatin and fenofibrate or its active metabolite fenofibric acid.

Safety data from clinical trials reveal no major adverse reactions. However, case reports of adverse events have been published and monitoring for potential adverse reactions of the individual agents is advised. Overall, current data suggest the combination of rosuvastatin and fenofibrate or fenofibric acid is a safe combination to utilize when managing difficult to treat mixed dyslipidemia patients.

Mixed or atherogenic dyslipidemia is characterized by a lipid triad of elevated triglycerides TG , elevated low-density lipoprotein-cholesterol LDL-C and reduced high-density lipoprotein-cholesterol HDL-C.

A higher risk of coronary heart disease CHD has been associated with mixed dyslipidemia. A new fibrate, fenofibric acid, is available for treating mixed dyslipidemia to lower TG and increase HDL-C in patients already receiving optimal statin doses. This article will evaluate the efficacy and safety of the concomitant use of rosuvastatin with fenofibrate or fenofibric acid for mixed dyslipidemia.

A literature search was conducted using the terms rosuvastatin, fenofibrate, fenofibric acid, and ABT All English-based articles and abstracts obtained from the literature searches were reviewed. Additional information was obtained from references cited in the articles. Mean percent changes in lipid parameters in patients with hyperlipidemia and mixed dyslipidemia 15 — Fenofibrate is rapidly metabolized by esterases to its active form of fenofibric acid.

The effects of fenofibrate and fenofibric acid monotherapy on lipid parameters are summarized in Table 1. The major individual pharmacokinetic properties of fenofibrate, fenofibric acid and rosuvastatin are summarized in Table 2. Gemfibrozil has been shown to have a significant pharmacokinetic interaction with rosuvastatin as the concentrations of rosuvastatin were approximately doubled. A study by Prueksaritanont et al evaluated the metabolism of fibrates and statins when used together and suggests that all fibrates may not be the same in regards to interacting with statins.

Pharmacokinetic properties 15 — Pharmacokinetic studies evaluating the concomitant use of fenofibrate or fenofibric acid plus rosuvastatin have been conducted. A 3-way crossover study by Martin et al evaluated the pharmacokinetics of rosuvastatin 10 mg daily and fenofibrate 67 mg 3 times daily. A 3-week washout period was required between treatments.

Both of these increases were not statistically significant. The Cmax and AUC of fenofibrate were not affected by concomitant rosuvastatin therapy. This data suggests no clinically significant pharmacokinetic interaction exists between rosuvastatin and fenofibrate. However it should be noted that the population was limited to healthy, Caucasian males, and higher doses of rosuvastatin were not evaluated.

The pharmacokinetics of concomitant fenofibric acid and rosuvastatin were evaluated by Zhu et al in a 3-period crossover trial. A 2-week washout period occurred between treatments. Results of this study revealed rosuvastatin had no effect on the half-life, time to maximum concentration Tmax , Cmax, minimum concentration Cmin , AUC or oral clearance of fenofibric acid.

Analysis of rosuvastatin pharmacokinetics demonstrated fenofibric acid had no effect on the half-life, Tmax, Cmin, AUC, and oral clearance of rosuvastatin. The authors proposed this effect may be attributed to the mild to moderate inhibition of fenofibric acid on CYP 2C9, but determined that the small increase was not likely to have clinical implications.

Durrington et al studied the effect of fenofibrate alone or in combination with rosuvastatin in type 2 diabetics with elevated TG and TC. A total of patients were enrolled in the study.

After 6 weeks of the NCEP diet, patients were randomized to a 6-week fixed dose phase of rosuvastatin 5 mg, rosuvastatin 10 mg, or placebo divided into 2 groups. This was followed by an week dose-titration period with options of increasing the rosuvastatin dose, adding fenofibrate, or receiving fenofibrate alone Table 3. Table 4 summarizes the outcomes. No subject had a clinically significant increase in CK of greater than ten times upper limit of normal ULN.

Treatment groups in the Durrington study Lipid outcomes in the Durrington study at 6 and 24 weeks The efficacy and safety of fenofibric acid ABT with low or moderate dose rosuvastatin was evaluated by Jones et al in a phase 3 multicenter, randomized, double-blind, active-controlled trial.

A day safety period evaluation followed the week treatment phase. Extensive inclusion and exclusion criteria were previously published. Statistical comparisons were with fenofibric acid plus rosuvastatin compared to rosuvastatin alone for HDL-C, TG, and secondary endpoints. The primary and secondary efficacy endpoints are summarized in Table 5. The high dose rosuvastatin 40 mg was not evaluated for statistical significance due to low enrollment in this treatment group.

The safety profile assessed specific adverse effects along with laboratory monitoring Table 6. The most common adverse event was myalgia which was slightly lower in occurrence when fenofibric acid was combined with rosuvastatin.

Creatine kinase elevation greater than 5 times the ULN was reported in 7 patients receiving fenofibric acid with rosuvastatin compared to 5 patients using rosuvastatin alone. No cases of rhabdomyolysis were documented. Lipid outcomes in the Jones study Following the conclusion of the initial study by Jones et al subjects were eligible to enroll in a week open label extension trial of fenofibric acid mg with moderate dose rosuvastatin at 20 mg.

Published efficacy results in this 1-year follow-up trial did not separate the statin utilized; therefore reported efficacy results include a moderately dosed statin simvastatin 40 mg, atorvastatin 40 mg or rosuvastatin 20 mg plus fenofibric acid mg. The incidence of treatment-related adverse effects when combining all fenofibric acid and statin groups was Specific analysis of the rosuvastatin and fenofibric acid combination treatment arm showed a similar adverse effect profile as the combined statin groups plus fenofibric acid Table 7.

Of the patients receiving fenofibric acid and rosuvastatin, treatment-related adverse effects occurred in Treatment-related serious adverse events were reported in 0. Following the completion of the week trial by Bays et al subjects were eligible to enroll in a week extension study year 2 conducted by Kipnes et al. Of the patients included in the year 2 trial, subjects received fenofibric acid mg and rosuvastatin 20 mg.

A sustained effect on lipid efficacy variables was reported with this combination. The first occurrence of an adverse effect was tracked over the study period. The majority of adverse effects occurred early in therapy. Two patients discontinued treatment due to myalgia; however no rhabdomyolysis or deaths were reported.

The combined treatment group adverse effects were elevated CK 1. Further details on adverse effects are listed in Table 7. Lipid outcomes in the Kipnes trial Statistically significant results, when comparing rosuvastatin to fenofibric acid with rosuvastatin, were a mean percent change from baseline of HDL-C rosuvastatin The use of fenofibric acid with rosuvastatin was well tolerated.

The occurrence of side effects may vary with dosage. This is not a full list of side effects. Other, serious side effects may occur. Talk to your healthcare provider about what side effects to expect from Crestor or Lipitor, and how to address them.

An important reaction to know about Lipitor is that you should not drink an excess amount of grapefruit juice more than 1. Too much grapefruit juice can increase Lipitor levels in your body, making you more likely to experience myopathy muscle weakness and rhabdomyolysis muscle tissue breakdown, which can be very damaging. These muscle problems are more likely to occur with higher consumption of grapefruit juice, but could potentially occur with lower amounts.

If you eat grapefruit or drink grapefruit juice and take Lipitor, ask your doctor how much is safe to consume, or if it would be better to take a different medication that does not interact with grapefruit. Crestor does not have a grapefruit juice interaction. Crestor and Lipitor have some of the same drug interactions, for example, with cyclosporine , gemfibrozil , niacin , fenofibrate , colchicine , and certain antiviral medications used for HIV.

Combining Crestor or Lipitor with one of these drugs can increase the statin levels, leading to a higher risk of myopathy and rhabdomyolysis. Before taking Crestor or Lipitor, tell your doctor about all of the medications you take, including prescription, over-the-counter OTC , and vitamins, so they can determine if Crestor or Lipitor is safe for you.

Its generic name is rosuvastatin. Crestor is available in both brand and generic form and as a tablet. Lipitor, like Crestor, is a statin medication used for high cholesterol. Its generic name is atorvastatin.

It is available in tablet form, in both brand and generic. Crestor and Lipitor are both statins. They work the same way and have some similarities. However, they are not exactly the same.

You can read about their differences in the information outlined above. Other statins you may have heard of include Pravachol pravastatin , Zocor simvastatin , Livalo pitavastatin , Lescol fluvastatin , and Mevacor lovastatin. Studies show both drugs to be effective in lowering cholesterol see above section. Some studies show Crestor to be slightly more effective; however, both drugs are effective and well-tolerated. Ask your healthcare provider if one of these drugs would be more appropriate for you, based on your medical history.

Crestor or Lipitor should never be taken by a pregnant woman. Both medications are specifically contraindicated for use during pregnancy. They can cause harm to an unborn baby.