Efficacy of Orlistat versus Placebo in the Improvement of Lipid Profile Among Overweight and Obese Patients: A Meta-analysisChandy Lou P. Malong, MD & John S. Delgado, MD

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Introductionincrease of 4.5% in hypercholesterolemia from the previous prevalence rate of 4% (6th National Nutrition Health Survey 2003-04)inhibitor of pancreatic, gastric, and carboxylesterlipaseblocks absorption of cholesterol and triacylglycerolssystemic effect facilitates weight loss in obese subjectsweight loss in overweight persons associated with an improvement in the serum lipid profilePi-Sunyer FX. A review of long-term studies evaluating the efficacy of weight loss in ameliorating disorders associated with obesity. Clin Ther 1996;18:1006-1035Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord 1992;6:397-415

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ObjectivesTo determine, through a meta-analysis, the efficacy of Orlistat compared with placebo in lowering lipid levels among overweight and obese patients with or without other comorbidities

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MethodologyMEDLINE, HERDIN, Cochrane, ScienceDirect, Manual searchingRCTs: Orlistat 120mg/tab TID vs Placebo on Lipid Profile among Overweight and Obese reported as Mean Change from Baseline58 Journals to 7 RCTsPEDro Rating ScaleREVMAN 5.0: mean change in TC, LDL-C, HDL-C, and TG

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AuthorDurationPBMIWEIGHTAGE% MTCLDLHDLTGCOMORBIDLitonjua, et al 200414 wk ^~O: 300P: 286O:30.83 4.53P:30.37 4.38O:77.45 13.87P:75.82 14.22O:38.79 10.37P:39.98 10.52O:33.3P:29O:6.26 0.92P:6.33 0.9O:4.35 0.82P:4.35 0.75O:1.19 0.31P:1.23 0.35O:1.7 0.88P:1.71 0.99Metabolic SyndromeLindgarde, et al 20001y*^~O: 190P: 186O:33.2 3P:33.2 3.1O:96.1 13.7P:95.9 13.5O:53.7 9.4P:53.3 9.9O:34.7P38.2O:6.15 1.21P:6.06 1.19O:3.75 1.38P:3.66 1.41NRNRType 2 diabetesHypertensionKelley, et al 20021y^~O: 266P: 269O:35.8 3.26P:35.6 4.92O:102 16.31P101.8 116.4O:57.8 8.15P:58 8.2O:43.6P43.9O:5.49 0.07P:5.43 0.07O:3.37 0.06P:3.3 0.06O:1.07 0.02P:1.07 0.02O:2.33 0.1P:2.31 0.08Diabetes, treated with insulinFiner, et al 200048wk**^~O: 110P: 108O: 36.8 3.6P:36.8 3.7O: 97.9 12.9P: 98.4 15O: 41.5 10.5P: 41.4 10O:10.9P:12O:5.64 0.95P:5.62 0.95O:3.67 0.84P: 3.67 0.85O:1.22 0.28P:1.22 0.29NRNoneMuls, et al 200124wk*^~O: 147P: 143O:32.9 3.5P:33.0 3.7O:88.9 13.6P:89.8 14.4O:49.6 10P:47.5 11O:18.4P:20.3O:7.33 0.74P:7.28 0.77O:5.09 0.61P:5.03 0.68O:1.45 0.35P:1.49 0.37O:1.71 0.68P:1.65 0.62NoneHollander, et al 19981y***^~O:162P:159O:34.5 3.2P:34 3.4O:99.6 14.5P:99.7 15.4O:55.4 8.8P:54.7 9.7O:48.8P:53.5NRNRNRNRType 2 diabetesHill, et al 19991y****^~O: 87P: 102O:32.8 0.2P: 32.8 0.2O: 89.7 0.9P: 90.8 0.9O: 45.9 0.7P: 46.4 0.7NRNRNRNRNRNone

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Total Cholesterol

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Low Density Lipoprotein

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High Density Lipoprotein

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Triglyceride

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DiscussionCholesterol is absorbed by becoming incorporated into mixed micellesInhibition of fat digestion prevents micelle formation, and therefore, cholesterol absorptionMajority of the indication for Orlistat use is for weight reduction.Most studies show improvement in other cardiovascular risk factors different from body weight, including lipid profileNo statistically significant change in HDL-C levelFactors that may have an effect on HDL: duration of the Orlistat treatment change in initial HDL-C was observed only during the active weight loss Smoking

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ConclusionImpact to Clinical PracticeOrlistat produces statistically significant improvement in TC, LDL-C, TG levels in overweight and obese patientsThis study has established the lipid-lowering effect of Orlistat with the known benefits of weight reduction. Orlistat can be indicated for the treatment of hypercholesterolemia, hyper-LDLipidemia, and hypertriglyceridemia in addition to obesity managementImpact to ResearchEffect of Orlistat in improving Lipid Profile independent of weight lossWhether Orlistat can be used as an adjunct to standard lipid-lowering agents particularly among high risk patients

Efficacy of Orlistat versus Placebo in the Improvement of Lipid Profile Among Overweight and Obese Patients: A Meta-analysisChandy Lou P. Malong, MD & John S. Delgado, MD

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Subjects were randomly allocated to groups (in a crossover study, subjects were randomly allocated an order in which treatments were received)Allocation was concealedThe groups were similar at baseline regarding the most important prognostic indicatorsThere was blinding of all subjectsThere was blinding of all therapists who administered the therapyThere was blinding of all assessors who measured at least one key outcomeMeasures of at least one key outcome were obtained from more than 85% of the subjects initially allocated to groupsAll subjects for whom outcome measures were available received the treatment or control condition as allocated or, where this was not the case, data for at least one key outcome was analyzed by intention to treatThe results of between-group statistical comparisons are reported for at least one key outcomeThe study provides both point measures and measures of variability for at least one key outcome**Eligibility criteria were specifiedPhysiotherapy Evidence Database (PEDro) scale

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Physiotherapy Evidence Database (PEDro) scale

Criteria12345678910EligibilityScoreFiner, et al610111111119Hill, et al710011001116Hollander, et al810111011118Kelley, et al910110011117Lindgarde, et al1010111011118Litonjua, et al1110111001117Muls, et al1210111011118

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