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oai:repository.urosario.edu.co:10336/228482022-05-02T07:37:20Zcom_10336_39998com_10336_563col_10336_683

Rosenstock, Julio Hernandez-Triana, Eric Handelsman, Yehuda Misir, Soamnauth Jones, Michael R. 2020-05-25T23:58:22Z 2020-05-25T23:58:22Z 2012 Objective: To evaluate the efficacy and safety of colesevelam in Hispanic subjects with primary hyperlipidemia and prediabetes. Materials and Methods: A 16-week, randomized, double-blind, placebo-controlled, multinational study evaluating colesevelam in participants with primary hyperlipidemia (low-density lipoprotein cholesterol [LDL-C] level > 100 mg/dL) and prediabetes (fasting plasma glucose level > 110 to less than 125 mg/dL, or 2-hour postload glucose level > 140 to less than 200 mg/dL during an oral glucose tolerance test) was conducted between January 14, 2008 and April 3, 2009. Participants were randomized 1:1 to colesevelam 3.75 g/day or placebo. The primary efficacy endpoint was mean change from baseline in LDL-C level with colesevelam compared with placebo. Participants who self-identifed as Hispanic during enrollment were included in this exploratory analysis evaluating the effcacy of colesevelam in Hispanics with primary hyperlipidemia and prediabetes. Results: From a total of 216 subjects with primary hyperlipidemia and prediabetes, 153 Hispanics were included in this post hoc analysis; 77 subjects were randomized to colesevelam and 76 subjects were randomized to placebo. At week 16, LDL-C levels were significantly reduced with colesevelam compared with placebo (mean treatment difference, -19.4%; P less than 0.0001). Achievement of LDL-C level less than 100 mg/dL was more frequent with colesevelam than with placebo (27% vs 11%; P = 0.002). In addition, significant mean reductions in non-high-density lipoprotein cholesterol, total cholesterol, and apolipoprotein B levels (P less than 0.0002 for all), and a significant median increase in triglyceride levels (P = 0.003), were seen with colesevelam compared with placebo. At study end, there was a significant mean reduction in glycated hemoglobin levels and median reduction in fasting plasma glucose levels with colesevelam compared with placebo (P less than 0.02 for both). A fasting plasma glucose level less than 100 mg/dL was achieved in 44% of colesevelam recipients compared with 23% of placebo recipients (P less than 0.05). Overall, colesevelam was well tolerated. Conclusion: Colesevelam may be a treatment option for Hispanic subjects with primary hyperlipidemia and prediabetes, mainly to reduce LDL-C levels, with added beneficial effect on glucose levels. © Postgraduate Medicine. application/pdf https://doi.org/10.3810/pgm.2012.07.2564 325481 https://repository.urosario.edu.co/handle/10336/22848 eng Medquest Communications LLC 20 No. 4 14 Postgraduate Medicine Vol. 124 Postgraduate Medicine, ISSN:325481, Vol.124, No.4 (2012); pp. 14-20 https://www.scopus.com/inward/record.uri?eid=2-s2.0-84871699451&doi=10.3810%2fpgm.2012.07.2564&partnerID=40&md5=83cc0d72a003f1d86ea159230f73053e info:eu-repo/semantics/openAccess Abierto (Texto Completo) instname:Universidad del Rosario reponame:Repositorio Institucional EdocUR Apolipoprotein B Colesevelam Glucose Hemoglobin a1c Low density lipoprotein cholesterol Placebo Allylamine Apolipoprotein B Colesevelam Drug derivative Glycosylated hemoglobin High density lipoprotein Hypocholesterolemic agent Low density lipoprotein cholesterol Abdominal pain Adult Article Backache Cholesterol blood level Clinical effectiveness Clinical evaluation Constipation Controlled study Diarrhea Dizziness Double blind procedure Drug effect Drug efficacy Drug safety Drug tolerability Dyspepsia Female Glucose blood level Glycemic control Headache Hemoglobin blood level Hispanic Human Hyperlipidemia Hypertension Impaired glucose tolerance Influenza Major clinical study Male Multicenter study Nausea Primary hyperlipidemia Protein blood level Randomized controlled trial Treatment duration Treatment planning Upper abdominal pain Blood Clinical trial Controlled clinical trial Ethnology Hispanic Treatment outcome Allylamine Anticholesteremic Agents Apolipoproteins B Blood Glucose Double-Blind Method Female Hispanic Americans Humans Hyperlipidemias Male Prediabetic State Treatment Outcome Colesevelam Hispanic Hyperlipidemia Prediabetes Glycosylated LDL HDL Cholesterol Hemoglobin A Lipoproteins Clinical effects of colesevelam in hispanic subjects with primary hyperlipidemia and prediabetes article info:eu-repo/semantics/publishedVersion Artículo