Orlistat. How Alli really affects you during weight loss. JD Welch

Transcription

1 Orlistat How Alli really affects you during weight loss JD Welch HE 426 Tom Kelly November 24, 2008

2 Classification and Usage Orlistat is the first drug approved by the Food and Drug Administration (FDA) to aid in weight loss and to treat obesity. A new class of drugs was created known as lipase inhibitors with the creation of Orlistat. This lipase inhibiting drug prevents enzymes in the gastrointestinal tract from broking down dietary fats into smaller, more easily absorbed, molecules. Orlistat inhibits gastric and pancreatic lipase production. Since the body isn t able to break down dietary fats there is a 30 percent decrease in absorption in triglycerides. (FDA Approves Orlistat for Obersity, 1999) The decrease in absorption of fats into the body will then decrease the amount of calories the body obtains and then decreases the rate in which energy is stored in the body. Orlistat was approved by the FDA for over the counter sales in 2007 and since then has been marketed under the name of Alli. Alli is sold in a couple different ways. There is a starter pack that comes with a bottle of ninety 60mg capsules. The Alli starter pack comes with the shuttle which is something you can use to carry your capsules in and reference guides to help you to create healthy life changes. The other option for purchasing Alli (Orlistat) is to buy the 120 (60 mg) bottles. The Starter package starts at $47.99 and the 120 capsule bottles start at $ Alli (Orlistat) is to be taken before each meal that is known to have any fats in it or before any desired meal that you want to inhibit lipid break down. The recommendation is that you take no more than 3 capsules a day. A diet with reduced calories and reduced fats, and exercise program are recommended until you reach your

3 preferred weight. A bottle containing 120 capsules will last between 40 and 120 days. This means that you are expected to spend from $ to $909.55, according to amount of capsules per bottle, cost per bottle and capsules taken daily. Performance Factors Alli (Orlistat) claims that you can lose up to 50% more weight than just dieting. (Alli Overview, 2008) The American College of Sports Medicine (ACSM) states that patients who took Orlistat lost significantly more weight than patients who took a placebo. It also helps with weight maintenance, a decrease in total low-density (LDL) cholesterol, a decrease in systolic and diastolic blood pressure, a decrease in fasting insulin and glucose (Jakicic, et al., 2001), a decrease of free fatty acids (FFA) (Dimitrov, Bohchelian, & Koeva, 2005) and it reduced the number of incidences of type 2 diabetes. (Rucker, Padwal, Li, Curioni, & Lau, 2007) Effectiveness The claims made by Alli that you can lose up to 50% more weight that dieting alone is supported with the evidence that at 6 and 12 months the average person dieting alone lost about 3.7 ± 4.3 and 4.5 ± 4.1 kg. Where as a person dieting and taking Alli would lose 2.8 ± 8.7 and 3.1 ± 8.4 kg more compared to diet alone. (Marion J. Franz, et al., 2007) If someone where to lose 4 kg through diet Alli would assist them in losing and extra 2 kg in 6 months. And, in 12 months, someone who lost 5 kg through diet alone an

4 extra 2.5 kg. This is not to say that there wouldn t be an increase or decrease in weight loss with this combination of diet and Alli. The American College of Sports Medicine says that Orlistat helped with an increase it weight loss compared to someone taking a placebo. (Jakicic, et al., 2001) The first study showed that the average weight loss for men was 8.5 ± 2.3 kg and for women it was 5.6 ± 2.6 kg over a 3-month open-labeled prospective study. (Dimitrov, Bohchelian, & Koeva, 2005) Another said that their patients lost 9.2 ± 4.1 kg over an 8 week doubleblind study. (Kocelak, et al., 2008) The next study reviewed many different weight-loss techniques and found that the use of Orlistat increased weight loss by an average of 2.8 ± 8.7 for 6 months and 3.1 ± 8.4 kg at 12 months. (Marion J. Franz, et al., 2007) A metadata article found an average of 2.7 kg of weight loss compared to placebo. Within these tests, 21% of the participants lost 5% weight loss and 12% lost 10% body weight. The time in which this study took place was not mentioned. (Belinda S Drew, 2007) In a study regarding pediatric obesity, Orlistat was used as a means of weight-loss and found that an average decrease of BMI by 0.29 kg/m 2. (Lauren McGovern MD, 2008) Another of Orlistat's claims is that it can decrease the total low-density lipoprotein (LDL) cholesterol. At the end of a 2-month double-blind test, LDL was decreased by 11.6 ± 20.8 mg/dl. (Kocelak, et al., 2008) A meta-analysis of 13 studies found that an average decrease of 0.26 mmol/l. (Rucker, Padwal, Li, Curioni, & Lau, 2007) After a 6-month test, there was a decrease of 0.34 mmol/l in LDL and in type 2 diabetics. Th

5 is level was sustained 52 weeks as determined at a follow up. (Belinda S Drew, 2007) A decrease in LDL found with users in Bulgaria was 0.33 mmol/l. (Dimitrov, Bohchelian, & Koeva, 2005) The use of physical activity was encouraged by all the research articles that I found and this might as well be a cause for decreased LDL levels. Systolic and diastolic blood pressures are decreased with the use of Orlistat. A decrease of 1.8 mm Hg for systolic blood pressure and 1.6 mm Hg was first recorded in (Belinda S Drew, 2007) This is substantiated by the meta-analysis of 13 other research studies that found a decrease of 1.52 mm Hg of systolic blood pressure and a decrease of 1.38 mm Hg of diastolic blood pressure. (Rucker, Padwal, Li, Curioni, & Lau, 2007) This is another area where it can be argued that the physical activity also recommended by the researchers has an effect to the results compared to the drug alone. A decrease in fasting insulin and glucose levels was reported to happen during the consumption and use of Orlistat. In one study they found a decrease in an average insulin resistance from 4.54 ± 2.35 to 2.69 ± (Dimitrov, Bohchelian, & Koeva, 2005) A decrease of fasting glucose in participants with diabetes was 1.03 mmol/l. (Rucker, Padwal, Li, Curioni, & Lau, 2007) The next study found that there was an increase in glucose levels in the blood of 0.9 ± 9.8 mg/dl and insulin levels decreased by 2.4 ± 4.4 µg/dl. (Kocelak, et al., 2008) A major concern in our modern day is the risk of type 2 diabetes. Many things have been suggested that can be done to help decrease the likelihood of this disease. Orlistat states that they can decrease the percentages of incidences of type 2 diabetes in their

6 consumers. In a study that was over four years of treatment with Orlistat the risk of developing type 2 diabetes was found to be 37.3% lower compared to placebo. (Belinda S Drew, 2007) A meta-analysis of several other studies found that Orlistat reduced the incidences of type 2 diabetes by 2.8%, from 9.0% to 6.2%. (Rucker, Padwal, Li, Curioni, & Lau, 2007) Safety Since Orlistat affects parts of the gastrointestinal tact there are undoubtedly side effects that are associated with taking this drug. The more common side effects may not be detrimental to ones person s physical health but may deter another from taking it due to the psychological side effects. The side effects range from discomfort in the abdomen due to bloating to having to plan your day around where restrooms are due to an increase frequency to defecate. The American College of Sports Medicine states that predictions can be made by understanding the drug s mechanism on the body which can include changes in bowel habits, stearorrhea (fatty stool), and fecal urgency. (Jakicic, et al., 2001) One studies results found that 15 of their participants experienced loose stools and increased frequency to defecate. (Kocelak, et al., 2008) The next article stated that fatty stools were the main side effect from Orlistat. (Dimitrov, Bohchelian, & Koeva, 2005) Fatty/oily stool, fecal urgency and oily spotting occurred at a rate of 15% to 30% compared to placebo. (Rucker, Padwal, Li, Curioni, & Lau, 2007) The last metaanalysis stated that the side effects of Orlistat included steatorrhea, bloating, oily

7 spotting, fecal urgency and fecal incontinence. This study found that at least one side effect was experienced by 16% to 40% of patients. (Belinda S Drew, 2007) Gastrointestinal side effects were the major cause for participants to stop the treatments or testing. In a meta-analysis of 12 studies, containing 5994 participants, there was a 2% discontinuation due to the gastrointestinal side effects. (Rucker, Padwal, Li, Curioni, & Lau, 2007) For the most part, the side effects can be offset by a change in diet that reduces the intake of dietary fat. (Jakicic, et al., 2001) The side effects can also be counteracted by continued use of Orlistat with a decrease in side effects after about 2 weeks. (Kocelak, et al., 2008) The main purpose of Orlistat is to decrease the rate in which the body breaks down fats which means that less fat is absorbed into the body. The reduced amount of fat being absorbed into the body also affects the amount of fat soluble vitamins, vitamins A, D, E and K as well as beta carotene, being absorbed. (Jakicic, et al., 2001)(Belinda S Drew, 2007) To counter act this loss of fat soluble vitamins the participants are recommended to take a daily multivitamin. (Jakicic, et al., 2001) (Rucker, Padwal, Li, Curioni, & Lau, 2007) Though most side effects tended to be more annoying to the participant, there are cases in which Orlistat created some adverse effects. According to one article, the use of Orlistat increases the risk of breast cancer 5.9-fold greater than through placebo or 3.6-

8 fold greater, including post-treatment follow ups. The article states that this has been shown to be statistically significant but it doesn t state where. (M, 1998) Another serious side effect of Orlistat is that it can cause myopathy, which is a neuromuscular disease in which muscle fibers don t function properly, resulting in muscle weakness. The main use of Orlistat is to decrease the absorption of fat through the gastrointestinal tract but there are trace amounts of Orlistat also being absorbed into the blood stream. This small absorption is found to inhibit the synthesis of fatty acids in the blood. The inability of the body to break down these fatty acids decreases the amount of energy the muscles have available to create ATP. (Ringman & Mozaffar, 2008) The psychological effects of Orlistat come with the anxiety and stress of inconsistent defecation and oily spotting. This drug can create a higher stress related to self image problems. Some people might worry about what others are thinking of them having to use the restroom at an increased rate for the period they are using Orlistat. Others might worry about not making it to the restroom in time and what might happen to them in that situation. Ethical and Legal Issues There are no ethical issues related to this supplement and it is one of only two nonprescription drugs approved by the FDA to treat obesity.

9 Recommendations I would recommend this drug for anyone who is trying to lose weight. The studies show that primary weight loss is obtained within the first 6 months. (Jakicic, et al., 2001) (Marion J. Franz, et al., 2007) This is not to say that Orlistat can not be used to manage weight for a period longer than 6 months. (Jakicic, et al., 2001) (Marion J. Franz, et al., 2007) (Egger, 2008) Orlistat is a great addition to any diet and exercise due to its ability to increase the amount of weight loss by an individual. The gastrointestinal side effects can be managed through a diet low in fat and the knowledge that the side effects will diminish within 2 weeks.

10 Bibliography Alli Overview. (2008). Retrieved November 17, 2008, from Alli: Belinda S Drew, A. F. (2007). Obesity Management: Update on Orlistat. Vascular Health and Risk Management, Dimitrov, D., Bohchelian, H., & Koeva, L. (2005). Effect of Orlistat on Plasma Leptin Levels and Risk Factors for the Metabolic Syndrome. Metabolic Syndrome and Related Disrders, Egger, G. (2008). Helping Patients Lose Weight: What Works? Australian Family Physician, FDA Approves Orlistat for Obersity. (1999, April 26). Retrieved November 17, 2008, from FDA Talk Paper: Jakicic, J. M., Clark, K., Coleman, E., Donnelly, J. E., Foreyt, J., Melanson, E., et al. (2001). Position Stand: Appropriate Intervention Strategies for Weight Loss and Prevention of Weight Regain for Adults. American College of Sports Medicine, Kocelak, P., Zoharska-Markiewicz, B., Jonderko, K., Olszaneka-Glinianowicz, M., Zak-Golab, A., Holeki, M., et al. (2008). Long-term efects of lipase inhibition by orlistat on gastric emptying and orececal transit time of solid mean. Joural of Gastroenterology, Lauren McGovern MD, J. N. (2008). Treatment of Pediatric Obesity. A Systematic Review and Meta-Analysis of Randomized Trials. The Endocrine Society, M, Malone (1998). Description of Orlistat. Albany, New York, USA: Albany College of Pharmacy. Marion J. Franz, M. R., Jeffrey J. VanWormer, M., Lauren Crain, P., Jacki L. Boucher, M. R., Trina Histon, P., William Caplan, M., et al. (2007). Weight-Loss Outcomes: A Systematic Review and Meta-Analysis of Weight-Loss Clinical Trials with Minimum 1-Year Follow- Up. Journal of the American Dietetic Association, Ringman, J. M., & Mozaffar, T. (2008). Myopathy associated with chronic orlistat consumption: A case report. Neoromuscular Disorders, Rucker, D., Padwal, R., Li, S. K., Curioni, C., & Lau, D. C. (2007, November 15). Long term pharmacotherapy for obesity and overweight; updated meta-analysis. Edmonton, Alberta, Canada.