Clinical Updates
Alzheimer's
Disease
Arthritis
Asthma
Benign Prostatic Hypertrophy
Chronic
Lymphocytic Leukemia
Depression
Diabetes Mellitus
Dyspepsia
Erectile
Dysfunction
Fatty Liver
Gallstone
Hepatitis
Hypertension
Lung Cancer
Mesothelioma
Metabolic Syndrome
Obesity
Prostate Cancer
Stroke
Tinnitus
Medical Library
Breaking Medical News
Clinical Tools
Dermatology
Diabetes Corner
Evidence-Based Medicine
Free Medical Books
Free
Medical Journal
History Taking and Physical Examination
Medical Journal (popular)
Medical Notes
Medical Organizations
Palm Tools
Medical Physiology (Lecture)
Medical Resources
Medical Search
Online Clinical Calculator |
Effect of orlistat, micronised
fenofibrate and their combination on metabolic
parameters in overweight and obese patients with the
metabolic syndrome
|
BACKGROUND:
Obesity is becoming increasingly common worldwide and is strongly associated
with the metabolic syndrome (MetS). MetS is considered to be a cluster of
risk factors that increase the risk of vascular events.
OBJECTIVE:
In an open-label randomised study (the FenOrli study) we assessed the effect
of orlistat and fenofibrate treatment, alone or in combination on reversing
the diagnosis of the MetS (primary end-point) as well as on anthropometric
and metabolic parameters (secondary end-points) in overweight and obese
patients with MetS but no diabetes.
METHODS:
Overweight and obese patients (N = 89, body mass index (BMI) > 28 kg/m2)
with MetS [as defined by the National Cholesterol Education Program (NCEP)
Adult Treatment Panel (ATP) III criteria] participated in the study.
Patients were prescribed a low-calorie low-fat diet and were randomly
allocated to receive orlistat 120 mg three times a day (tid) (O group),
micronised fenofibrate 200 mg/day (F group), or orlistat 120 mg tid plus
micronised fenofibrate 200 mg/day (OF group). Body weight, BMI, waist
circumference, blood pressure, serum total cholesterol (TC), low-density
lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C),
non-HDL-C, triglyceride, creatinine (SCr) and uric acid (SUA) levels, as
well as homeostasis model assessment (HOMA) index and liver enzyme
activities were measured at baseline and after 3 months of treatment.
RESULTS:
Of the 89 patients enrolled, three (one in each group) dropped out during
the study due to side effects. After the 3-month treatment period, 43.5% of
patients in the O group, 47.6% in the F group and 50% in the OF group no
longer met the MetS diagnostic criteria (primary end-point, p < 0.0001 vs.
baseline in all treatment groups). No significant difference in the primary
end-point was observed between the three treatment groups. Significant
reductions in body weight, BMI, waist circumference, blood pressure, TC, LDL-C,
non-HDL-C, triglyceride and SUA levels, as well as gamma-glutamyl
transpeptidase activity and HOMA index were observed in all treatment
groups. In the OF group a greater decrease in TC (-26%) and LDL-C (-30%) was
observed compared with that in the O and F groups (p < 0.01) and a more
pronounced reduction of triglycerides (-37%) compared with that in the O
group (p < 0.05). SUA levels and alkaline phosphatase activity decreased
more in the F and OF groups compared with the O group (p < 0.05). Moreover,
SCr significantly increased and estimated creatinine clearance decreased in
the F and OF groups but they were not significantly altered in the O group
(p < 0.01 for the comparison between O and either F or OF groups). Glucose
(in groups O and OF), as well as insulin levels and HOMA index (in all
groups), were significantly reduced after treatment (p < 0.05 vs. baseline).
CONCLUSION:
The combination of orlistat and micronised fenofibrate appears to be safe
and may further improve metabolic parameters in overweight and obese
patients with MetS compared with each monotherapy.
Reference:
Curr Med Res Opin. 2005 Dec;21(12):1997-2006 |
|