Colesevelam indications and usage: Difference between revisions

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==Indications and Usage==
 
===Primary Hyperlipidemia===
 
WELCHOL is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary [[hyperlipidemia]] (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin).
 
WELCHOL is indicated as monotherapy or in combination with a [[statin]] to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial [[hypercholesterolemia]] if after an adequate trial of diet therapy the following findings are present:
a. LDL-C remains ≥ 190 mg/dL or <BR>
b. LDL-C remains ≥ 160 mg/dL and
 
*there is a positive family history of premature cardiovascular disease or
*two or more other CVD risk factors are present in the pediatric patient.
 
Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate [See Clinical Studies (14.1)].
 
In patients with coronary heart disease (CHD) or CHD risk equivalents such as diabetes mellitus, LDL-C treatment goals are < 100 mg/dL. An LDL-C goal of < 70 mg/dL is a therapeutic option on the basis of recent trial evidence. If LDL-C is at goal but the serum triglyceride (TG) value is > 200 mg/dL, then non-HDL cholesterol (non-HDL-C) (total cholesterol [TC] minus high density lipoprotein cholesterol [HDL-C]) becomes a secondary target of therapy. The goal for non-HDL-C in persons with high serum TG is set at 30 mg/dL higher than that for LDL-C.
 
===Type 2 Diabetes Mellitus===
 
WELCHOL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 [[diabetes mellitus]] [See Clinical Studies (14.2)].
 
[[Diabetes mellitus]] is considered a CHD risk equivalent. In addition to glycemic control, intensive lipid control is warranted [See Indications and Usage (1.1) and Warnings and Precautions (5.2)].
 
===Important Limitations of Use===
 
*WELCHOL should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
*WELCHOL has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor and has not been extensively studied in combination with [[thiazolidinedione]]s.
*WELCHOL has not been studied in pediatric patients with type 2 diabetes.
*WELCHOL has not been studied in Fredrickson Type I, III, IV, and V [[dyslipidemia]]s.
*WELCHOL has not been studied in children younger than 10 years of age or in pre-menarchal girls.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = WELCHOL (COLESEVELAM HYDROCHLORIDE) TABLET, FILM COATED WELCHOL (COLESEVELAM HYDROCHLORIDE) FOR SUSPENSION [DAIICHI SANKYO, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4a06d3b2-7229-4398-baba-5d0a72f63821 | publisher =  | date =  | accessdate = 10 February 2014 }}</ref>
 
==References==
 
{{Reflist|2}}
{{Lipid modifying agents}}
 
[[Category:Hepatology]]
[[Category:Bile acid sequestrants]]
[[Category:Cardiovasuclar Drugs]]
[[Category:Drugs]]

Revision as of 13:59, 21 July 2014

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