Drug Topics - November 10, 2008 - (Page 47)

CONTINUING EDUCATION countries, rimonabant has not met U.S. approval standards because of concerns about psychiatric side effects (i.e., anxiety, depression, and suicidal ideation).49,50 On October 23, 2008, the European Medicines Agency (EMEA) recommended suspending use of rimonabant in the European Union (EU) subsequent to a review by the Committee for Medicinal Products for Human Use (CHMP). CHMP concluded that the beneﬁts of rimonabant no longer outweigh the risks. The risk assessment conﬁrmed that there is a doubling of the risk of psychiatric disorders in obese or overweight patients taking rimonabant. Data from ongoing clinical trials also note that serious psychiatric disorders may be more common than earlier, pre-approval clinical trials had identiﬁed.51 Drugs on the Horizon Several different types of antiobesity agents are under clinical development.52 Some include selective 5-HT2C receptor agonists, selective 5-HT6 receptor antagonists, leptin analogues, human ciliary neurotrophic factor, neuropeptide Y antagonists, melanin-concentrating hormone antagonists, and selective cholecystokinin receptor A agonists. In addition, cetilistat is another lipase inhibitor that may gain FDA approval but has yet to do so. AOD9604 is a modiﬁed fragment of growth hormone and is completing phase 2 clinical trials. It is anticipated that with so many drugs under investigation, we will have better options for treatment in the near future. The hope is that newer medications will have limited adverse effects while providing weight loss safely and effectively. Surgical Candidacy Bariatric surgery may be necessary in patients with severe obesity who have failed to lose weight with nonsurgical therapy.53 Surgical procedures are an option for obese patients who have a BMI >40 kg/m2 or a BMI >35 kg/m2 with concomitant serious obesity-related disease.54 Absolute contraindications to bariatric surgery are psychiatric disorders (i.e. schizophrenia, active suicidal ideation, uncontrolled depression) and active substance abuse. There are no speciﬁc age restrictions for these surgical procedures. Although long-term studies are currently unavailable, bariatric procedures have been performed in both children and adolescents.55 Patients are evaluated individually to assess candidacy. For patients older than 60 years of age, the main concern is quality of life. Available procedures include Roux-en-Y gastric bypass, vertical banded gastroplasty, laparoscopic adjustable gastric banding, and biliopancreatic bypass with duodenal switch.56 Considered the surgical treatment of choice for most patients with severe clinical obesity, Roux-en-Y gastric bypass is the most popular bariatric surgery in the U.S.57 It involves closing off the ﬁrst 20 to 30 ml of the stomach with staples and anastomosing it to the jejunum, thereby bypassing most of the stomach, all of the duodenum, and the ﬁrst 15 cm of the jejunum. Mean excess weight loss is 50 to 60% at ﬁve years postoperatively. In addition, studies have found that type 2 diW W W.D R U GTO P I C S .C O M abetes is reversed in approximately 80% of patients after surgery if the procedure is performed early enough in the disease process.53 Deﬁciencies of iron, calcium, vitamin D, and vitamin B are common in these patients due to malabsorption. Rapid emptying from the gastric pouch into the jejunum can result in dumping syndrome, with symptoms of nausea, lightheadedness, bloating, and diarrhea. Perioperative mortality is less than 1%. The remaining three procedures are not performed as often, mainly because in the case of vertical banded gastroplasty and gastric banding they have not been successful in maintaining long-term weight loss, and in the case of biliopancreatic bypass because long-term data are lacking. Nonetheless, regardless of which surgical method is chosen, lifelong monitoring of diet, weight, and surgical complications is an essential component of follow-up in these patients.56-57 Pharmacist’s Role As highly trusted members of the healthcare team, pharmacists can promote healthy behavioral modiﬁcation through counseling activities, including helping patients achieve and maintain a healthy weight. Pharmacists can build their efforts in this area by collaborating with physicians and other appropriate professionals, identifying target patients who have obtained services at the pharmacy or outpatient clinic, contacting patients in at-risk populations within the pharmacy’s patient base and/or the community, and helping patients maintain efforts for sustained time periods. Both community pharmacists and those in outpatient ambulatory care clinics have the potential to expand their involvement in self-care and affect the overall well-being of patients by taking the initiative to identify and counsel overweight and obese patients. Clinician-initiated discussions on obesity and weightloss-related beneﬁts should be encouraged, since patients who report receiving weight-loss advice from their healthcare providers are more likely to report trying to lose weight than those who do not receive such advice. In addition, for patients with co-morbidities on therapy, pharmacists can assist in improving adherence to medication, diet, and other lifestyle modiﬁcations. Ultimately, improving health outcomes for overweight and obese patients can be achieved through the coordinated efforts of pharmacists and their patients. References available upon request. ONLINE RESOURCES National Heart and Lung Institute BMI calculator www.nhlbisupport.com/bmi/ Portion Control Tools http://www.theportionplate.com/ http://www.portiondoctor.com/ http://wwww.portionpal.com/ http://www.quakeroatmeal.com) http://hp2010.nhlbihin.net/portion/ N OV. 10, 2008 DRUG TOPICS 47 http://www.nhlbisupport.com/bmi/ http://www.theportionplate.com/ http://www.portiondoctor.com/ http://wwww.portionpal.com/ http://www.quakeroatmeal.com http://hp2010.nhlbihin.net/portion/ http://WWW.DRUGTOPICS.COM

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Drug Topics - November 10, 2008 Contents Up Front Up Front in Depth Letters Rx Care Government Community Practice First Responders Clinical Practice Self-Care FDA Safety Page Weighing the Complications of Obesity New Products Viewpoint

Drug Topics - November 10, 2008

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