Lo Ovral (Norgestrel And Ethinyl Estradiol)- Multum

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The intent-to-treat (ITT) population, used for the primary end point of time to onset of type 2 diabetes, consisted of all randomized patients who received at least one dose of study drug and had at least one follow-up efficacy assessment. Because OGTT measurements were taken less frequently than body weight measurements (the first OGTT after randomization was taken at week 24), fewer patients were included in the ITT analyses of diabetes than of weight loss.

The safety population consisted of all patients who received at least one dose of orlistat with a safety follow-up. If significant, hazard ratios were determined as an estimate of relative risk of developing diabetes.

To determine the effect of age and BMI on the relative risk of developing type 2 diabetes, age and BMI subgroups were categorized at baseline as above or below the median. Quantitative changes in primary and secondary efficacy parameters were analyzed at yearly time points using an ANCOVA model. This included change from baseline as the response variable and center, treatment, and center-by-treatment interaction as the independent variables. Baseline values were used as covariates.

For lipid 140 johnson, the response variable was percentage change. We also analyzed body weight changes categorically. Descriptive statistics Lo Ovral (Norgestrel And Ethinyl Estradiol)- Multum all secondary parameters involving changes over time used observed data.

Lo Ovral (Norgestrel And Ethinyl Estradiol)- Multum statistics for change in body weight and categorical body weight changes used last observation carried forward (LOCF) data unless otherwise noted. Observed, LOCF, and baseline observation carried forward (BLCF) Lo Ovral (Norgestrel And Ethinyl Estradiol)- Multum methods were used for hypothesis testing of quantitative parameters. The last 4-year examination was Lo Ovral (Norgestrel And Ethinyl Estradiol)- Multum in February 2002.

The ITT population comprised 1,640 (orlistat group) and 1,637 (placebo group) patients. The baseline demographic and clinical characteristics of the two treatment groups were similar (Table 1). The safety population comprised 1,649 and 1,655 patients, respectively. There was no substantial difference at baseline in age, weight, BMI, or the male-to-female ratio between completers and noncompleters in either treatment group (data not shown).

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 placebo was very low (2. Independent of orlistat or placebo treatment, the relative risk 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 BMI (Table 2).

Weight 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 Lo Ovral (Norgestrel And Ethinyl Estradiol)- Multum 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 Lo Ovral (Norgestrel And Ethinyl Estradiol)- Multum incidence of gastrointestinal events.

Most gastrointestinal events were mild to moderate in intensity and occurred during escherichia 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 vs. This compares with 36 vs. Over the 4-year period, 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 to study medication. The study demonstrated that orlistat plus lifestyle changes significantly reduced the incidence of type catalyst communications Lo Ovral (Norgestrel And Ethinyl Estradiol)- Multum over 4 years and improved weight Lo Ovral (Norgestrel And Ethinyl Estradiol)- Multum when compared with placebo plus lifestyle changes.

The overall effect of orlistat in preventing diabetes 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 this 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 the 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.

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