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Prevalite (Cholestyramine) - Summary

 
 



PREVALITE SUMMARY

PREVALITE®
(Cholestyramine for Oral Suspension, USP)

Prevalite (Cholestyramine for Oral Suspension, USP), the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. The cholestyramine resin in Prevalite is not absorbed from the digestive tract. 5.5 grams of Prevalite contain 4 grams of anhydrous cholestyramine resin.

Cholestyramine resin adsorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the feces.

Prevalite is indicated for the following:

1) Prevalite is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low-density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Prevalite may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern.

Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight.

Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess total cholesterol (Total-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation:

  • LDL-C = Total Cholesterol - [(TG/5) + HDL-C]

For TG levels >400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated.

Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered.

Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year.

Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis.

2) Prevalite is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.


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NEWS HIGHLIGHTS

Media Articles Related to Prevalite (Cholestyramine)

Sanofi and Regeneron report positive top-line results from nine phase 3 trials of alirocumab in people with hypercholesterolemia
Source: Cholesterol News From Medical News Today [2014.08.01]
Sanofi and Regeneron Pharmaceuticals, Inc. have announced that nine new Phase 3 ODYSSEY trials of alirocumab in people with hypercholesterolemia met their primary efficacy endpoint of a greater...

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Published Studies Related to Prevalite (Cholestyramine)

The effect of gemfibrozil, niacin and cholestyramine combination therapy on metabolic syndrome in the Armed Forces Regression Study. [2011.05]
INTRODUCTION: Metabolic syndrome is a powerful predictor of cardiovascular events independent of overt diabetes. Dietary restriction and weight loss modify metabolic syndrome components. This study addresses whether combination pharmacologic therapy focused on dyslipidemia provides additional benefit... CONCLUSIONS: The combination of gemfibrozil, niacin and cholestyramine has profound, beneficial effects on the components of metabolic syndrome. These benefits are additive to those seen with aggressive diet and lifestyle modification.

Colesevelam hydrochloride powder for oral suspension versus cholestyramine powder for oral suspension: comparison of acceptability and tolerability. [2011.03]
OBJECTIVE: To compare tolerability of colesevelam hydrochloride powder versus a cholesterol-lowering equivalent dose of generic cholestyramine powder, each mixed in water, by means of the validated Bile Acid Sequestrant Acceptability (BASA) Scale... CONCLUSION: Although study participants thought that the orange-colored generic cholestyramine powder had a better appearance, they also reported that colesevelam hydrochloride for oral suspension tasted better. A minority of study participants thought appearance was "very important"; a substantial majority thought taste was "very important" for potential long-term compliance.

The effect of gemfibrozil, niacin and cholestyramine combination therapy on metabolic syndrome in the Armed Forces Regression Study. [2011]
pharmacologic therapy focused on dyslipidemia provides additional benefit... CONCLUSIONS: The combination of gemfibrozil, niacin and cholestyramine has

Low doses of cholestyramine in the treatment of hyperthyroidism. [2008.12]
The enterohepatic circulation of thyroid hormones is increased in thyrotoxicosis... We conclude that low dose of cholestyramine is an effective and well-tolerated adjunctive agent in the treatment of hyperthyroid Graves' disease.

Low doses of cholestyramine in the treatment of hyperthyroidism. [2008.10.23]
The enterohepatic circulation of thyroid hormones is increased in thyrotoxicosis... We conclude that low dose of cholestyramine is an effective and well-tolerated adjunctive agent in the treatment of hyperthyroid Graves' disease.

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Clinical Trials Related to Prevalite (Cholestyramine)

Colesevelam Versus Placebo in Cholestatic Pruritus [Recruiting]
38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid sequestrant much more potent than cholestyramine but free of adverse effects. It is registered as a lipid lowering agent. The intensity of symptoms will be scored by means of daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions will also be evaluated using quantitative instruments.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Prevalite has an overall score of 6. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Prevalite review by 40 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   diarreah
Dosage & duration:   1/2 hour before each meal (dosage frequency: usually 3 x a day) for the period of perspcription was for 3 months
Other conditions:   irritable bowel syndrome
Other drugs taken:   thyroid medication
  
Reported Results
Benefits:   The benefits of this treatment was there was a decreased amount of bowel movements per day. Also severe cramping and urgency to empty the bowel was decreased by 50% and meals could be enjoyed, even when out in public places where a washroom might not be available.
Side effects:   Somtimes constipation would occur, and there would be a tight, bloating feeling in the lower abdomen.
Comments:   Treatment was to take this medication one half an hour before eating a meal. Powder was to be mixed in water or other fluid except carbonated beverages. Medication was to be taken for one month to see if there was an improvement in the symptoms of constant diareah after meals.

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Page last updated: 2014-08-01

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