Active Ingredient: Orlistat
After randomization, the subjects were advised not to modify their eating habits throughout the study.
Clinical and biochemical assessments were performed at randomisation and at the end of the 3-month period. The subjects attended an interim check 6 wk after start of medication for a compliance check and to record any side effects.
The primary end points of the study were change in total testosterone and weight. Study measurements After an overnight fast, weight and blood pressure were measured and blood samples were taken at screening, randomization, and on completion of the 12-wk study period.
Compliance was monitored based on counting returned medication.
Fasting venous blood was collected into serum gel and fluoride oxalate tubes. Samples were separated by centrifugation at gfor 15 min at 4 C, and the aliquots stored at —20 C within 1 h of collection.
Low-density lipoprotein cholesterol was calculated using the Friedewald equation. The coefficient of variation for this assay was 1. Different anthropometric and endocrine parameters were also assessed as possible predictors of ovulation.
Among these factors, a low baseline LH was found to be the only independent predictor of ovulation area under curve. The presence of a low baseline serum LH was found to be the most important predictor of ovulation.
The study was registered at clinicaltrials. Consequently, there is an increase in the preva- lence of obesity-related reproductive disorders, particularly anovula- tion and infertility.
The main treatment of obesity and its associated reproductive dis- orders is by weight loss, achieved mainly by dietary changesand increased physical activity. These lifestyle changes alone have been shown to be highly effective in improving ovarian function Clark et al.
There are two other secondary approaches to treating this group of patients; namely the use of insulin sensitizing agents such as metformin or the use of weight reduction agents such as orlistat. However, the study found no statistically significant differences in blood pressure between groups, and both groups showed small reductions in blood pressure parameters in association with weight loss.
However, children with hypertension and tachycardia were excluded from the study. Of note, the FDA recently added additional warnings to the labeling of sibutramine to include the potential for serotonin syndrome, especially in association with the use of selective serotonin reuptake inhibitors SSRIs, monoamine oxidase inhibitors MAOIs, serotonergic drugs such as triptans or some antipsychotics, but also when used alone.
Three randomized clinical trials of orlistat therapy pooled in a meta-analysis 52 demonstrated a significant reduction in BMI of 0. In, a small open-label study of 20 participants treated for 6 months in association with a lifestyle modification program was completed.
The 3-month 72 and 6-month 73 data revealed a significant reduction in BMI of 1. One double-blind, placebo-controlled, 6-month clinical trial in 40 participants, performed by Maahs et al 76 demonstrated no significant difference in BMI between the medication and placebo groups.