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 language | English |
|---|---|
| Pages (from-to) | 621-633 |
| Number of pages | 13 |
| Journal | Current Therapeutic Research |
| Volume | 63 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - Sep 2002 |
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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 journal › Article
}
TY - JOUR
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
Y1 - 2002/9
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.
AB - 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.
KW - Blood pressure
KW - Diet
KW - Hypercholesterolemia
KW - Obese
KW - Orlistat
KW - Simvastatin
UR - http://www.scopus.com/inward/record.url?scp=0036748432&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0036748432&partnerID=8YFLogxK
U2 - 10.1016/S0011-393X(02)80066-2
DO - 10.1016/S0011-393X(02)80066-2
M3 - Article
AN - SCOPUS:0036748432
VL - 63
SP - 621
EP - 633
JO - Current Therapeutic Research - Clinical and Experimental
JF - Current Therapeutic Research - Clinical and Experimental
SN - 0011-393X
IS - 9
ER -