Role of Orlistat in the Treatment of Obese Patients With Type 2 Diabetes: A 1-year randomized double-blind study

Hollander, Priscilla; Elbein, Steven C.; Hirsch, Irl B.; Kelley, David E.; McGill, Janet B.; Taylor, Terry; Weiss, Stuart; Crockett, Samuel E.; Kaplan, Roy A.; Comstock, John P.; Lucas, Charles; Lodewick, Peter A.; Canovatchel, William; Chung, Jain; Hauptman, Jonathan

doi:10.2337/diacare.21.8.1288

Cited by 580 publications

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“…The increasing prevalence of obesity over the past two decades is alarming since it translates into increased medical care and disability costs because of the relationship between excess body weight and several risk factors for disease. Obese subjects with type II DM pose a significant challenge for the clinicians responsible for their care (Maggio & Pi-Sunyer, 1997 Hollander et al, 1998). However, successful weight management in this population is often difficult to achieve.…”

Section: Discussionmentioning

confidence: 99%

“…It is well known that obesity can worsen the metabolic abnormalities often associated with DM including hyperinsulinemia, hyperglycemia, hypertension, and hyperlipidemia (Colditz et al, 1990;Chan et al, 1994;Ford et al, 1997;Maggio & Pi-Sunyer, 1997). A modest 5-10% weight loss in obese nondiabetic individuals has been shown to result in marked improvements in some of these metabolic disturbances (Wing et al, 1987;Goldstein, 1992;Davidson et al, 1999;Hollander et al, 1998).…”

Section: Introductionmentioning

confidence: 99%

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Long-term efficacy of soy-based meal replacements vs an individualized diet plan in obese type II DM patients: relative effects on weight loss, metabolic parameters, and C-reactive protein

et al. 2004

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Background: Achieving significant weight loss and glycemic control in diabetic patients remains a challenging task. Objective: This study compared the effects of a soy-based meal replacement (MR) plan vs an individualized diet plan (IDP; as recommended by the American Diabetes Association) on weight loss and metabolic profile. Design/Subjects: A total of 104 subjects were randomized prospectively to the two treatments for a total of 12 months. Results: In all, 77 of the 104 subjects completed the study. Percentage weight loss in MR group (4.5770.81%) was significantly greater (Po0.05) than in IDP group (2.2570.72%). Fasting plasma glucose was significantly reduced in MR group (126.474.9 mg/dl) compared with IDP group (152.576.6 mg/dl, Po0.0001) at 6 months but not at 12 months. Controlling for baseline levels, hemoglobin Alc level improved by 0.4970.22% for those receiving MR when compared to IDP group (Po0.05). A greater number of subjects in MR group reduced their use of sulfonylureas (Po0.0001) and metformin (Po0.05) as compared to IDP group. High-sensitivity C-reactive protein (hs-CRP) decreased À26.3% (P ¼ 0.019) in MR group compared to À7.06% (P ¼ 0.338) in IDP group at 6 months. Similar changes were observed at 12 months with MR groups, with hs-CRP decreasing by À25.0% (P ¼ 0.019) compared to À18.7% (P ¼ 0.179) in IDP group. Conclusion: This study demonstrates that MR is a viable strategy for weight reduction in diabetic patients, resulting in beneficial changes in measures of glycemic control and reduction of medications.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Long-term efficacy of soy-based meal replacements vs an individualized diet plan in obese type II DM patients: relative effects on weight loss, metabolic parameters, and C-reactive protein

et al. 2004

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“…72 No significant effect on blood pressure compared with dietary/lifestyle-only therapy occurred, except in two studies, one of which involved subjects Long-term efficacy of weight loss methods JD Douketis et al with poorly controlled hypertension. 62,71 Orlistat had inconsistent effects on glycemic control: modest but significantly greater reductions in fasting blood glucose (0.1-1.7 mmol/l) than diet-only therapy in six studies, [60][61][62][63]67,68 but no difference in two studies. 65,66 The greatest improvements in glycemic control occurred in subjects with type 2 diabetes.…”

Section: Jd Douketis Et Almentioning

confidence: 99%

Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practice

et al. 2005

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BACKGROUND: Obesity is a common health problem that requires a long-term care approach. We systematically reviewed long-term (Z2 y) studies investigating dietary/lifestyle, pharmacologic, and surgical weight loss methods to assess (1) weight loss efficacy, defined by absolute weight loss and the proportion of subjects with Z5% weight loss, (2) effects of weight loss on cardiovascular risk factors, and (3) applicability of findings from studies to everyday clinical practice. METHODS: The MEDLINE, HealthSTAR, and the Cochrane Controlled Trials databases were searched for studies investigating the long-term efficacy of weight loss methods in overweight and obese adults. Data were extracted for (i) weight loss after 1 y (pharmacologic studies only), 2 y, 3 y, and 4 y, (ii) proportion of subjects with Z5% weight loss at the end of follow-up, and (iii) changes (end-of follow-up minus baseline values) in blood lipids, fasting blood glucose, and systolic and diastolic blood pressure. RESULTS: Dietary/lifestyle therapy provides o5 kg weight loss after 2-4 y, pharmacologic therapy provides 5-10 kg weight loss after 1-2 y, and surgical therapy provides 25-75 kg weight loss after 2-4 y. Weight loss of Z5% baseline weight is not consistently associated with improvements in cardiovascular risk factors and these benefits appear to be intervention specific and occur mainly in people with concomitant cardiovascular risk factors. Weight loss studies have methodologic limitations that restrict the applicability of findings to unselected obese people assessed in everyday clinical practice. These limitations include an inadequate study duration, large proportions of subjects lost to follow-up, a lack of an appropriate usual care group, and a lack of reporting of outcomes in high-risk subgroups. CONCLUSIONS: Dietary/lifestyle and pharmacologic weight loss interventions provide modest weight loss, and may improve markers of cardiovascular risk factors although these benefits occur mainly in patients with cardiovascular risks. Studies investigating weight loss have methodologic limitations that restrict the applicability of findings to obese patients assessed in clinical practice.

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“…19,20 In clinical trials orlistat treatment was associated with gastrointestinal adverse events including oily spotting from the rectum (27%), flatus with discharge (24%), faecal Safety profile of orlistat NV Acharya et al urgency (22%) and faecal incontinence (8%). 5,6 In this study, diarrhoea was the most frequently reported gastrointestinal event with 4.9% (789) of patients reported to have experienced this event during treatment. The other gastrointestinal events described above were each reported in o1% of patients in this study: flatulence (122; 0.8%); faecal incontinence (86; 0.5%) rectal discharge (77; 0.5%).…”

Section: Discussionmentioning

confidence: 58%

“…4 Published studies have shown that treatment with orlistat improves many outcome measures such as decrease in cholesterol and LDL cholesterol levels, lowering of both systolic and diastolic blood pressure and finally improvement in glycaemic control and reductions in cardiovascular risk factors in patients with Type 2 diabetes. 5,6 Postmarketing surveillance is essential because the safety database on newly licensed drugs is limited by both the number and characteristics of the patients involved in prelaunch clinical studies. 7 The Drug Safety Research Unit (DSRU) provides a postmarketing drug surveillance scheme, which monitors the safety of newly marketed drugs during their immediate postmarketing period in England, using the observational cohort technique of prescription-event monitoring (PEM).…”

Section: Introductionmentioning

confidence: 99%

Safety profile of orlistat: results of a prescription-event monitoring study

2006

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Introduction: Orlistat, the first of a new class of drugs for the treatment of obesity, was launched in the UK in December 1998. The prescribing information recommends that treatment with orlistat should be discontinued after 12 weeks if the patient has not achieved a specified loss of weight. Objective: To monitor the safety of orlistat prescribed in the primary care setting in England using prescription-event monitoring (PEM). Methods: A postmarketing surveillance study using the observational cohort technique of PEM. Patients were identified from dispensed prescriptions issued by primary care physicians for orlistat between December 1998 and November 1999. The outcome data were event reports obtained by sending questionnaires (green forms) to the prescribing doctor at least 6 months after the first prescription for an individual patient. Incidence densities, expressed as number of first reports of an event/1000 patient-months of exposure, were calculated. Significant differences between incidence densities (IDs) for events reported in the 1st month (ID 1 ) and months 2 and 3 (ID 2-3 ) of exposure were regarded as potential signals. Reasons for stopping orlistat were analysed. Follow-up information was requested for selected events and used to assess the causal association with orlistat. Results: Green forms containing clinically useful information on 16 021 patients (median age 45 years (interquartile range 35-54); 80.1% females) were received. The events reported most frequently during the 1st month of treatment were 'not effective' (639; 4.0% of cohort), diarrhoea (371; 2.3%) and weight loss (230; 1.4%). Twelve clinical adverse events were identified for which ID 1 was significantly greater than ID 2-3 . These included non-specific events (e.g. intolerance, malaise/ lassitude, unspecified side effects), weight loss and vaginitis/vulvitis. The remaining events were gastrointestinal in nature and included diarrhoea, pain abdomen, flatulence, nausea/vomiting, rectal discharge, faecal incontinence and 'gastrointestinal unspecified' events. A similar pattern of predominately gastrointestinal events was seen for reasons for stopping and suspected adverse drug reactions. Review of selected events for causality revealed 45 events which were assessed as possibly or probably related to orlistat. Conclusions: This study shows that orlistat is fairly well tolerated. The safety profile of orlistat was similar to the prescribing information and experience reported in the literature.

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Role of Orlistat in the Treatment of Obese Patients With Type 2 Diabetes: A 1-year randomized double-blind study

Abstract: Orlistat is an effective treatment modality in obese patients with type 2 diabetes with respect to clinically meaningful weight loss and maintenance of weight loss, improved glycemic control, and improved lipid profile.

Cited by 580 publications

References 0 publications

Long-term efficacy of soy-based meal replacements vs an individualized diet plan in obese type II DM patients: relative effects on weight loss, metabolic parameters, and C-reactive protein

Long-term efficacy of soy-based meal replacements vs an individualized diet plan in obese type II DM patients: relative effects on weight loss, metabolic parameters, and C-reactive protein

Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practice

Safety profile of orlistat: results of a prescription-event monitoring study

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