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| __NOTOC__
| | #REDIRECT [[Colesevelam#Adverse Reactions]] |
| {{Colesevelam}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Adverse Reactions==
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| ===Clinical Studies Experience===
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| Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.
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| In the lipid-lowering trials, 807 adult patients received at least one dose of WELCHOL (total exposure 199 patient-years). In the add-on combination type 2 diabetes trials, 566 patients received at least one dose of WELCHOL (total exposure 209 patient-years). In the monotherapy type 2 diabetes trial, 175 patients received at least one dose of WELCHOL and had a post baseline follow up (total exposure 69 patient-years).
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| In clinical trials for the reduction of LDL-C, 68% of patients receiving WELCHOL vs. 64% of patients receiving placebo reported an adverse reaction. In add-on combination clinical trials of type 2 diabetes, 60% of patients receiving WELCHOL vs. 56% of patients receiving placebo reported an adverse reaction. In monotherapy clinical trial for type 2 diabetes, 52% of patients receiving WELCHOL vs. 45% of patients receiving placebo reported an adverse reaction.
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| Primary [[Hyperlipidemia]]: In 7 double-blind, placebo-controlled, clinical trials, 807 patients with primary [[hyperlipidemia ]](age range 18-86 years, 50% women, 90% Caucasians, 7% Blacks, 2% Hispanics, 1% Asians) and elevated LDL-C were treated with WELCHOL 1.5 g/day to 4.5 g/day from 4 to 24 weeks.<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>
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| ==References==
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| {{Reflist|2}}
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| {{Lipid modifying agents}}
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| [[Category:Hepatology]]
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| [[Category:Bile acid sequestrants]]
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| [[Category:Cardiovasuclar Drugs]]
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| [[Category:Drugs]]
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