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Questran (Cholestyramine) - Summary

 
 



QUESTRAN SUMMARY

QUESTRAN® POWDER
(Cholestyramine for Oral Suspension, USP)
QUESTRAN® LIGHT
(Cholestyramine for Oral Suspension, USP)

QUESTRAN® (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 QUESTRAN is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin is contained in 9 grams of QUESTRAN POWDER.

QUESTRAN® (Cholestyramine for Oral Suspension, USP) is indicated for the following:

1) QUESTRAN (Cholestyramine for Oral Suspension, USP) 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. QUESTRAN 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 QUESTRAN, 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, 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 QUESTRAN 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 QUESTRAN therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of QUESTRAN or adding other lipid-lowering agents in combination with QUESTRAN should be considered.

Since the goal of treatment is to lower LDL-C, the NCEP 4 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.

QUESTRAN monotherapy has been demonstrated to retard the rate of progression 2,3 and increase the rate of regression 3 of coronary atherosclerosis.

2) QUESTRAN is indicated for the relief of pruritus associated with partial biliary obstruction. QUESTRAN 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.


See all Questran indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Questran (Cholestyramine)

GastroBreak: The Bile-IBS Link, Presidential Heartburn
Source: MedPage Today Gastroenterology [2014.12.10]
(MedPage Today) -- A role for bile acid sequestrants in IBS?

more news >>

Published Studies Related to Questran (Cholestyramine)

Efficacy of 10% sucralfate ointment in the reduction of acute postoperative pain after open hemorrhoidectomy: a prospective, double-blind, randomized, placebo-controlled trial. [2013]
hemorrhoidectomy... CONCLUSIONS: Sucralfate ointment reduced the acute postoperative pain after

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

The potent bile acid sequestrant colesevelam is not effective in cholestatic pruritus: results of a double-blind, randomized, placebo-controlled trial. [2010.10]
CONCLUSION: Although colesevelam significantly decreased serum bile acid levels, this trial was unable to demonstrate that it was more effective than a placebo in alleviating the severity of pruritus of cholestasis.

more studies >>

Clinical Trials Related to Questran (Cholestyramine)

PRELIMINARY EVALUATION OF PHARMACOLOGICAL LOWERING OF AGEs [Not yet recruiting]
There is evidence of the association between diabetic microangiopathy and elevated serum concentrations of advanced glycation end-products (AGEs). AGEs levels are associated with ingestion of specific foods (baked meats and milk powder); reducing their dietary intake lowers AGEs concentrations, with beneficial metabolic effects; however threre is still no evidence of whether this has an impact on microvascular complications of DM. We recently applied for funding to compare in a RCT the effects of Cholestyramine versus placebo, on visual electrophysiology. This drug is similar to Sevelamer in structure, both act as chelators of bile salts, and reduce absorption of dietary AGE, lowering serum levels. However it is essential to carry out preliminary tests to assess aspects that may imply adjustments to the proposed protocol, such as: 1) tolerance to the drug 2) short term effect of the drug versus placebo on serum levels of AGEs 3) effects of the drug versus placebo in levels of fat soluble vitamins (D and K specifically) 4) intra and interindividual variability of electrophysiological measurements of vision (ERGMF and optic nerve conduction velocity) 5) drug versus placebo in electrophysiological measurements of vision (neuroconduction ERGMF and optic nerve). Objective: The present project is planned as a

pilot study, which will clarify points 1 to 5. Methodology: patients (6 DM2, 25 - 50 y) will

be assessed through anthropometry, clinical laboratory tests (creatinine, chemistry profile, lipid profile, microalbuminuria glycosylated hemoglobin, vitamin B12, 25OH vitamin D and prothrombin), dietary recalls specifically designed to analyze the regular consumption of AGEs, serum CML and neuro-ophthalmological study (fundus, ERGMF and optic nerve conduction). Subsequently each patient will be assigned to treatment with placebo for 3 months and then Cholestyramine 6 g / day for 12 weeks and at the end of each period will be reassessed using the same methodology. If patients cannot tolerate the drug, they will be assigned to a reduced AGE diet. Expected results: Cholestyramine will have side effect similar to placebo (mainly digestive). The active drug and not placebo will reduce serum levels of AGEs and electrophysiological parameters of vision at 12 weeks. It is expected that a low AGEs diet in patients who do not tolerate the drug will also reduce serum CML although to a lesser degree and will also induce electrophysiologic changes.

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.

more trials >>

Reports of Suspected Questran (Cholestyramine) Side Effects

Constipation (4)Tumour Marker Increased (3)Hyperhidrosis (3)Abdominal Discomfort (3)Fatigue (3)DRY Mouth (3)DRY Throat (3)Blood Cholesterol Increased (3)Cough (3)Breast Mass (3)more >>


Page last updated: 2014-12-10

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