Effects of orlistat, simvastatin, and orlistat + simvastatin in obese patients with hypercholesterolemia: A randomized, open-label trial

Giuseppe Derosa, Amedeo Mugellini, Leonardina Ciccarelli, Andrea Rinaldi, Roberta Fogari

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Background: Many obese patients have comorbidities that worsen their prognoses, particularly if hypercholesterolemia is present. In these patients, dietary restrictions are not sufficient to reduce hypercholesterolemia and lose body weight. Objective: This 1-year, single-center, randomized, open-label study assessed the effects of diet and exercise plus treatment with orlistat, simvastatin, and orlistat + simvastatin on lipid profile, body composition, and blood pressure in obese patients with hypercholesterolemia. Methods: Obese, normotensive patients with hypercholesterolemia aged >45 years were eligible. Patients were prescribed a restricted-calorie diet and were randomized to receive orlistat 120 mg TID (group O), simvastatin 20 mg/d (group S), or orlistat 120 mg TID plus simvastatin 20 mg/d (group OS) for 1 year. Serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels; body mass index (BMI); waist-circumference reduction (WCR); body weight loss (BWL); and diastolic blood pressure (DBP) and systolic blood pressure (SBP) were measured at baseline and after 6 months and 1 year of treatment. Results: We enrolled 87 patients (45 women, 42 men; mean age, 55 years). Four patients dropped out due to nontransient adverse events. After 1 year of treatment, significant improvements were found in all measured parameters in all treatment groups versus baseline values, except for HDL-C in group O. Significant between-group differences at 1 year included the following: TC, LDL-C, and TG levels and BMI, WCR, and BWL were significantly decreased in group OS versus groups O and S; DBP was significantly decreased in group OS versus group O; SBP and DBP were significantly decreased in group OS versus group S. HDL-C was significantly increased in group OS but not in groups O and S. Five patients in group O and 1 patient in group OS experienced transient gastrointestinal adverse events. Conclusions: In this study population, all 3 treatments produced significant improvements in most measured parameters from baseline. The combination treatment showed significantly greater reductions in serum TC and LDL-C levels, BMI, WCR, and BWL than with either orlistat or simvastatin alone. Small but significant differences in blood pressure were found with combination treatment.

Original languageEnglish
Pages (from-to)621-633
Number of pages13
JournalCurrent Therapeutic Research
Volume63
Issue number9
DOIs
Publication statusPublished - Sep 2002

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Simvastatin
Hypercholesterolemia
Blood Pressure
Waist Circumference
Body Weight
LDL Cholesterol
HDL Cholesterol
Weight Loss
Body Mass Index
Cholesterol
Therapeutics
orlistat
Diet
Body Composition
Serum
Comorbidity

Keywords

  • Blood pressure
  • Diet
  • Hypercholesterolemia
  • Obese
  • Orlistat
  • Simvastatin

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effects of orlistat, simvastatin, and orlistat + simvastatin in obese patients with hypercholesterolemia : A randomized, open-label trial. / Derosa, Giuseppe; Mugellini, Amedeo; Ciccarelli, Leonardina; Rinaldi, Andrea; Fogari, Roberta.

In: Current Therapeutic Research, Vol. 63, No. 9, 09.2002, p. 621-633.

Research output: Contribution to journalArticle

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T1 - Effects of orlistat, simvastatin, and orlistat + simvastatin in obese patients with hypercholesterolemia

T2 - A randomized, open-label trial

AU - Derosa, Giuseppe

AU - Mugellini, Amedeo

AU - Ciccarelli, Leonardina

AU - Rinaldi, Andrea

AU - Fogari, Roberta

PY - 2002/9

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N2 - Background: Many obese patients have comorbidities that worsen their prognoses, particularly if hypercholesterolemia is present. In these patients, dietary restrictions are not sufficient to reduce hypercholesterolemia and lose body weight. Objective: This 1-year, single-center, randomized, open-label study assessed the effects of diet and exercise plus treatment with orlistat, simvastatin, and orlistat + simvastatin on lipid profile, body composition, and blood pressure in obese patients with hypercholesterolemia. Methods: Obese, normotensive patients with hypercholesterolemia aged >45 years were eligible. Patients were prescribed a restricted-calorie diet and were randomized to receive orlistat 120 mg TID (group O), simvastatin 20 mg/d (group S), or orlistat 120 mg TID plus simvastatin 20 mg/d (group OS) for 1 year. Serum total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels; body mass index (BMI); waist-circumference reduction (WCR); body weight loss (BWL); and diastolic blood pressure (DBP) and systolic blood pressure (SBP) were measured at baseline and after 6 months and 1 year of treatment. Results: We enrolled 87 patients (45 women, 42 men; mean age, 55 years). Four patients dropped out due to nontransient adverse events. After 1 year of treatment, significant improvements were found in all measured parameters in all treatment groups versus baseline values, except for HDL-C in group O. Significant between-group differences at 1 year included the following: TC, LDL-C, and TG levels and BMI, WCR, and BWL were significantly decreased in group OS versus groups O and S; DBP was significantly decreased in group OS versus group O; SBP and DBP were significantly decreased in group OS versus group S. HDL-C was significantly increased in group OS but not in groups O and S. Five patients in group O and 1 patient in group OS experienced transient gastrointestinal adverse events. Conclusions: In this study population, all 3 treatments produced significant improvements in most measured parameters from baseline. The combination treatment showed significantly greater reductions in serum TC and LDL-C levels, BMI, WCR, and BWL than with either orlistat or simvastatin alone. Small but significant differences in blood pressure were found with combination treatment.

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KW - Blood pressure

KW - Diet

KW - Hypercholesterolemia

KW - Obese

KW - Orlistat

KW - Simvastatin

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