Barbara K.
Age 51
Height 5'5"
Weight 188 lbs
BP 160/90
Fasting Insulin
191 pmol/L
HbA1c 8.1%
Lipid Profile:
HDL 30 mg/dL
LDL 178 mg/dL
LDL/HDL ratio 5.9
TC 270 mg/dL
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Multiple Risks: Dyslipidemia, Type 2 Diabetes, Hypertension, BMI 31
Profile and History:
Barbara K., 51, is a new patient. She has dyslipidemia, type 2 diabetes and hypertension.
- A review of her current medications indicates that she is taking lisinopril 20 mg/day for her recently diagnosed hypertension, and lovastatin 40 mg/day for elevated cholesterol.
- She's also taking metformin, 850 mg bid, and glipizide extended-release, 20 mg/day, for diabetes.
- She's a full-time student who also works a part-time job.
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Diagnosis and Identification:
- Barbara is 5'5", weighs 188 lbs and has a BMI of 31. Given her complex medical issues, Barbara needs to lose weight to avoid potential cardiovascular complications.
- Her HDL is 30 mg/dL, her LDL is 178 mg/dL, her LDL/HDL ratio is 5.9, her TC is 270 mg/dL and her triglyceride level is 310 mg/dL.
- Her blood pressure is 160/90.
- Her fasting insulin level is high (191 pmol/L) and her HbA1C is 8.1%.
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Counseling:
When you broach the subject of weight loss with Barbara, she seems to accept this recommendation. Barbara does express concern, however, about her ability to stick to a diet that doesn't accommodate her schedule.
- She's heard about XENICAL and asks you to discuss with her the possibility of using this drug.
- XENICAL will help her lose weight if she uses it as part of a complete diet program. Aside from counting calories, she'll have to make sure what she eats has no more than 30% fat.
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Treatment:
- Your treatment goals include weight loss, improved glycemic control to minimize risk of microvascular disease, improved lipid profile, optimal blood pressure and reduced cardiovascular risk.
- A regimen including XENICAL and a 1200-calorie per day diet is advisable.
- You address Barbara's lifestyle challenges by recommending immediate enrollment
in the XENICare® support program and that she
signs up for one of the low-fat prepared meal plans, such as MenuDirect®,
that are specifically designed for people with diabetes, hypertension
and other diseases.
- Barbara should also be encouraged to maintain a diet diary and to schedule regular follow-up visits.
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Follow-Up:
Barbara calls your office 2 weeks after her visit. She's started using MenuDirect meals and has found that she can really take the time to make a low-calorie, low-fat meal when she comes home. She's lost 2½ lbs, and feels sure that this will continue.
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Outcomes:
Population with Abnormal (Untreated) Risk Factors at Randomization
Weight Loss with XENICAL Plus Diet: Improved Lipid Levels, Fasting Insulin and Blood Pressure
- The changes from randomization following 1-year treatment in the population with abnormal lipid levels (LDL >130 mg/dL, LDL/HDL >3.5, HDL <35 mg/dL) were greater for patients on XENICAL plus diet compared to patients on placebo plus diet with respect to LDL cholesterol (-7.83% vs. +1.14%) and the LDL/HDL ratio (-0.64 vs. 0.46). HDL cholesterol increased in the placebo group by 20.1% and in the XENICAL group by 18.8%.
- In patients with abnormal baseline values of fasting insulin
(>120 pmol/L), weight loss with XENICAL plus diet resulted in a greater decrease in fasting insulin than did placebo (-39 pmol/L vs. -16 pmol/L, respectively) from randomization to 1 year.
- In the population with abnormal blood pressure at baseline (systolic BP >140 mm Hg), the change in systolic blood pressure from randomization to 1 year was greater for patients on XENICAL plus diet (-10.89 mm Hg) than for patients on placebo plus diet (-5.07 mm Hg). Patients with diastolic blood pressure >90 mm Hg on XENICAL plus diet also had greater changes in diastolic blood pressure (-7.9 mm Hg) than those on placebo plus diet did (-5.5 mm Hg).
Population as a Whole
XENICAL Plus Diet: Successful Weight Loss
In clinical trials involving 1064 patients, 69% on XENICAL plus diet lost 3% or more of initial body weight within 3 months, with a mean loss of 13 lbs.18
The mean change in total cholesterol was -2.0% for patients on XENICAL plus diet and +5.0% for patients on placebo plus diet. The mean change in LDL cholesterol was
-4.0% for patients on XENICAL plus diet and +5.0% for patients on placebo plus diet. The mean change in HDL cholesterol was +9.3% for patients on XENICAL plus diet and +12.8% for patients on placebo plus diet. The mean change in fasting insulin was -6.7 pmol/L for patients on XENICAL plus diet and +5.2 pmol/L for patients on placebo plus diet. The mean change in systolic blood pressure was -1.01 mm Hg for patients on XENICAL plus diet and +0.58 mm Hg for patients on placebo plus diet. The mean change in diastolic blood pressure was -1.19 mm Hg for patients on XENICAL plus diet and +0.46 mm Hg for patients on placebo plus diet.
In clinical trials, the overall mean weight loss from randomization to the end of 1 year in the intent-to-treat population was 13.4 lbs in patients treated with XENICAL plus diet versus 5.8 lbs in placebo-treated patients.
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The long-term effects of orlistat on morbidity and mortality associated with obesity have not been established.
The patient depicted here is fictitious and is intended to illustrate an obesity-related comorbidity for which a treatment regimen including XENICAL plus a reduced-calorie diet is appropriate.
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