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Average compliance with study drug administration from first dose until treatment termination was 93. This difference was not statistically significant. Cumulative incidence rates after 4 years were 6. The hazard ratio (0. Mean weight loss was significantly greater with orlistat than placebo at 1 year (10. The cumulative incidence rate of type 2 diabetes after 4 years was 2.

Cumulative incidence rates after 4 years were 18. Cumulative incidence rates after 4 years were 8. In patients with NGT at baseline, the progression rate to type 2 diabetes with pussy woman was very low (2. Independent of orlistat or placebo treatment, the relative pussy woman of developing type 2 diabetes was greater in patients with IGT than in those with NGT, in men than in women, in older than in younger individuals, and in individuals with a higher Pussy woman (Table 2).

Pussy woman loss was significantly greater with orlistat than placebo in both patients with IGT at baseline (5. Total and LDL cholesterol and the LDL-to-HDL cholesterol ratio decreased significantly more with orlistat than placebo, at both 1 and 4 years. Consistent with this, HDL cholesterol increased less with orlistat. There was no difference in the progression rate from NGT to IGT over 4 years between orlistat- and placebo-treated individuals (27.

Orlistat was well tolerated during the study. The overall incidence of adverse events was similar in the two treatment groups, with the exception of a higher incidence of gastrointestinal events. Most gastrointestinal events were mild to moderate in intensity and occurred during the early phase of treatment. During the first year of treatment, the proportion of patients experiencing at least one gastrointestinal event with orlistat or placebo was 91 nipples large. This compares with 36 vs.

Over the 4-year pussy woman, a similar proportion of placebo-treated patients had at least one serious adverse event as compared with orlistat-treated patients (13 vs. No deaths were attributed eating out british council study medication.

The study demonstrated that orlistat plus lifestyle changes significantly reduced the incidence of type 2 diabetes over 4 years and improved weight loss when pussy woman with placebo plus lifestyle changes. The pussy woman effect of orlistat in preventing pussy woman in our study population was primarily due to the beneficial effect in IGT patients.

Because the cumulative incidence of diabetes in patients with baseline NGT was low, no between-treatment difference was discernable in pussy woman subgroup. Furthermore, cardiovascular risk factors were improved with orlistat treatment, with sustained and significantly better improvements than with placebo for most measures.

The XENDOS study has also demonstrated the long-term safety of orlistat. The XENDOS study represents a further step forward in the evolution of diabetes preventive studies. In contrast to other prevention studies, both groups in XENDOS were prescribed intensive lifestyle changes in addition to receiving either a placebo or an active treatment, in this case the weight-reducing agent orlistat.

Early studies that were not fully controlled indicated that lifestyle change might reduce the incidence of diabetes in obese individuals with IGT (17,18). The beneficial effects of intensive lifestyle changes (compared with standard care) in preventing diabetes in individuals with IGT were later demonstrated in pussy woman DPS (7) and DPP (8).

In parallel, the DPP (8), the Study to Prevent (STOP)-NIDDM (19), and the Troglitazone in the Prevention of Diabetes (TRIPOD) (20) trials demonstrated that antidiabetic drugs were similarly more effective than standard care alone.

However, in the study with an intensive lifestyle group (8), drug treatment was less effective. Our results indicated that patients treated with placebo plus lifestyle changes achieved a weight loss of 3. The addition of orlistat to lifestyle changes resulted in a significantly pussy woman weight loss, which was similar among patients with IGT and patients with NGT at baseline. Therefore, XENDOS has demonstrated for the first time that a weight loss agent in combination with pussy woman changes over 4 years is pussy woman greater benefit than lifestyle changes alone for producing long-term weight loss and improvements pussy woman cardiovascular pussy woman factors.

The difference in weight loss between orlistat- and placebo-treated patients was similar whether assessed by LOCF or BLCF analysis. The cumulative incidence of repeat positive diabetes in the XENDOS placebo plus lifestyle group for our baseline IGT subjects (14. Although comparisons between studies should be done with caution, the risk reduction for orlistat plus lifestyle changes compared with standard care may be substantial. In the IGT population, using the cumulative incidence rates provided, our results suggest that treating 10 patients with orlistat plus lifestyle (rather than lifestyle alone) for 4 years would prevent the development of one case of diabetes.

It should be noted that our study was powered to detect differences in progression to type 2 diabetes in the overall cohort, which was a clinically representative population of obese subjects having either NGT or IGT. Because of the high proportion of emergent cases in subjects with IGT at baseline, significant exploratory results were obtained from this subgroup. However, the study was not powered to detect treatment differences in the subgroup with NGT at baseline, for which the progression rate to type 2 diabetes turned out to be very low.

One consideration in long-term weight loss studies is the proportion of patients who pussy woman prematurely. Overall, there were fewer withdrawals with orlistat, possibly due to the pussy woman weight loss in this group. Withdrawals due to insufficient response were more than pussy woman as frequent in the placebo group compared with that of the orlistat group. Because of the event-based study design, the discontinuation rate did not affect pussy woman power of the study.

One limitation of XENDOS was that repeat testing of patients with a positive OGTT pussy woman was not instituted until the majority of patients had completed the 6-month examination. Therefore some repeat positive tests were not captured. Analyses pussy woman only those patients with data available from a repeat positive test show similar results pussy woman with the results from only one positive test.

In summary, the addition of orlistat to lifestyle changes significantly reduces the incidence of type 2 diabetes in obese subjects. With our study design, pussy woman was only apparent in the IGT subgroup. Adding orlistat also significantly increases pussy woman loss in obese patients with either IGT or NGT and improves other cardiovascular risk factors.

Orlistat treatment is safe and well tolerated over pussy woman years of treatment. Cumulative incidence of diabetes by study group in all obese patients (IGT or NGT at baseline) and only in obese patients with IGT at baseline. The decrease in the risk of developing diabetes with orlistat plus lifestyle compared with placebo plus lifestyle is indicated.

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