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CC Nov 2015 New weight-loss medications

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echoecho's version from 2015-11-05 13:43

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Question Answer
The 2010 Centers for Disease Control and Prevention (CDC) report of vital signs in adults in the US found that > ___ million adults were obese?72
In 2009, no state had an obesity rate < ____%, and 9 states reported an obesity rate > ___%?15; 30
In 2008 dollars, the total medical cost related to obesity rose to $____ billion?147
Apart from its economic burder on the healthcare system, obesity is a well-know, independent risk factor for many medical co-morbidities, list 5 of them?1) type 2 DM 2) dyslipidemia 3) HTN 4) OA 5) OSA
*** The USPSTF recommends screening all adults > 18 years old for obesity and that clinicians should offer or refer patients with a body mass index (BMI) > 30 to what?intensive, multi-component behavioral intervention
*** The 2013 guidelines from the American Heart Association / American College of Cardiology / The Obesity Society (AHA / ACC / TOS) for the management of overweight and obesity in adults also emphasize that ____ ____ is indispensible in any comprehensive treatment strategy of obesity?lifestyle modification (calorie restriction and increased physical activities)
*** List the type of patient where pharmacotherapy can be considered as an adjunct to the overall treatment plan?Those who are motivated to adhere to lifestyle modification AND 1) BMI > 30 OR 2) BMI > 27 with at least one obesity-associated comorbid condition
*** Achievement of a sustained wieght loss of ____ to ___ % produces clinically meaningful health benefits?3-5
Historically, clinicians have been disappointed with the medications previously approved by the FDA because of unacceptable adverse, harmful effects and have since exited the US market. List 3 of these drugs?1) fenfluramine (Pondimin) 2) sibutramine (meridia) 3) dexfenfluramine (Redux)
List 2 weight-loss medications that remain available to patients currently in 2015?1) orlistat (Xenical, Alli) 2) phentermine (Apidex)
What is the mechanism of action of orlistat (Xenical, Alli)? Side effects?1)prevents absorption of fat 2) side effects are flatulence and greasy diarrhea
What are two organ systems are affected with adverse effects by phentermine (Apidex)?1) cardiovascular 2) CNS
Recently, there is a resurgence of interest in release of new and safer weight-loss medications. In 2012, list 2 weight-loss medications approved by the FDA?1) lorcaserin (Belviq) 2) Qsymia
What is locaserin (Belviq)?a selective serotonin 2C receptor agonist
What is Qsymia?a combination of phentermine (an established anorexiant) AND topiramate (Topamax), an antiepileptic with a known welcomed side effect of weight loss
In 2014, 2 more weight-loss medications were approved in the US. List these?1) Contrave 2) Saxenda
What is Contrave?a combination of naltrexone (opioid antagonist) AND bupropion (Wellbutrin), an aminoketone antidepressant
What is Saxenda?Liraglutide (a known glucagon-like peptide-1 {GLP-1} receptor agonist that promotes satiety and delays gastric emptying
What is the indication for the above new and safer weight-loss medications?As an adjunct to a regimen of a reduced-calorie diet and increased physical activity for chronic weight loss management in adults with a baseline BMI > 30 or > 27 with at least one obesity-associated comorbid conditions
Short-term studies (1-2 years) have demonstrated efficacy with these newer weight loss medications, with a ___ to ___% weight reduction compared to placebo?5-10%
Are there currently any head-to-head studies among these newer weight loss medications?no
Regarding efficacy of the new weight-loss medications calculated as number needed to treat (NNT) vs placebo, give the statistics as to % of patients with > 5% weight loss (active medication vs. placebo); the NNT (95% CI), the % of patients with > 10% weight loss (active medication vs. placebo) as to the medication Lorcaserin (Belviq) 10 mg BID?1) 46.4 vs. 22.1 2) 5 (4-5) 3) 21.9 vs. 8.4
Regarding efficacy of the new weight-loss medications calculated as number needed to treat (NNT) vs placebo, give the statistics as to % of patients with > 5% weight loss (active medication vs. placebo); the NNT (95% CI), the % of patients with > 10% weight loss (active medication vs. placebo) as to the medication Phentermine / topiramate (Qysmia) 15/92 mg q AM? 1) 69 vs. 19.7 2) 2 (2-3) 3) 47.7 vs. 7
Regarding efficacy of the new weight-loss medications calculated as number needed to treat (NNT) vs placebo, give the statistics as to % of patients with > 5% weight loss (active medication vs. placebo); the NNT (95% CI), the % of patients with > 10% weight loss (active medication vs. placebo) as to the medication Naltrexone and bupropion (Contrave) 16/180 mg BID?1) 46.6 vs. 22.9 2) 5 (4-5) 3) 25.2 vs. 9.7
Regarding efficacy of the new weight-loss medications calculated as number needed to treat (NNT) vs placebo, give the statistics as to % of patients with > 5% weight loss (active medication vs. placebo); the NNT (95% CI), the % of patients with > 10% weight loss (active medication vs. placebo) as to the medication Liralutide (Saxenda) 3.0 mg subcutaneous injection daily?1) 63.5 vs. 26.6 2) 3 (2-3) 3) 32.8 vs. 0.1
List the cost of the new weight loss medications as to price for a 30 day supply?1) Lorcaserin 10 mg (Belviq) = $213 2) Phentermine/topiramate (Qysmia) 3.75 mg/23 mg = $160 3) Naltrexone/bupropion 8 mg/90 mg (Contrave) = $210 4) Liraglutide 3.0 mg/0.5 mL (5 pens) (Saxenda) = $1100
What is the category of the new weight loss medication as to pregnancy?category X
Which of the 4 new weight loss medications are DEA schedule IV medications?1) Lorcaserin (Belviq) and 2) Phentermine /topiramate (Qysmia)
Which of the 4 new weight loss medications are NOT DEA schedule IV medications?1) Naltrexone / bupropion (Contrave) 2) Liraglutide (Saxenda)
Which of the 4 new weight loss medications have a simpler dosing schedule? Which require a titration schedule?1) Lorcaserin (Belviq) and Liraglutide (Saxenda) 2) Phentermine / topiramate (Qysmia) and Naltrexon/bupropion (Contrave)
Regarding the dosing schedule of the 4 new weight loss medications, comment on the dosing schedule, renal impairment and hepatic impairment for Lorcaserin (Belviq)?1) 10 mg BID. If 5% weight loss is not achieved at the end of 12 weeks, patients should stop taking Lorcaserin (Belviq) 2) renal impairment = no dosage adjustment with mild renal impairment. Caution with moderate renal impairment. Avoid with severe renal impairment 3) Hepatic impairment = no dosage adjustment with mild hepatic impairment (Child-Pugh score 5-6), and moderate hepatic impairment (Child-Pugh score 7-9). Unknown with severe hepatic impairment
Regarding the dosing schedule of the 4 new weight loss medications, comment on the dosing schedule, renal impairment and hepatic impairment for Phentermine / topiramate (Qysmia)?1) start at the lowest daily dose (3.75/23 mg) and increase after 14 days to the target dosage (7.5/46 mg daily). If 3% weight loss is not achieved after 12 weeks, may increase to 11.5/69 mg daily for additional 14 days before escalating to the maximum dosage of 15/92 mg daily. If the patient has not lost 5% of body weight after 12 weeks at this dose, they should stop taking Qsymia entirely. 2) Renal impairment = dosage should not exceed 7.5 / 46 mg daily with creatinine clearance > 30 mL/min and < 50 mL/min 3) Hepatic impairment = dosage shouldnot exceed 7.5/46 mg daily with moderate hepatic impairment (Child-Pugh score 7-9)
Regarding the dosing schedule of the 4 new weight loss medications, comment on the dosing schedule, renal impairment and hepatic impairment for Naltrexone / bupropion 8/90 mg extended release tablet (Contrave)?1) Week 1 = 1 tablet in the morning; Week 2= 1 tablet in morning and 1 tablet in the evening; Week 3 = 2 tablets in morning and 1 tablet in the evening; Week 4 = 2 tablets in the morning and 2 tablets in the evening 2) Renal impairment = the maximum recommended daily dose is 1 tablet (am & pm) with moderate or severe renal impairment. No recommendation to guide with mild renal impairment 3) Hepatic impairment = with hepatic impairment, maximum recommended daily dosage is 1 tablet in the morning
Regarding the dosing schedule of the 4 new weight loss medications, comment on the dosing schedule, renal impairment and hepatic impairment for Liraglutide (Saxenda)?1) initiate at 0.6 mg subcutaneous injection once daily for 1 week, then increase by 0.6 mg/day in weekly intervals until a dose of 3 mg per day is attained 2) renal impairment = none 3) hepatic impairment = none
List the common adverse effects, common drug-drug interaction and contraindications of the new weight-loss medications as it relates to Lorcaserin (Belviq)?1) discontinuation because of headache (most common - 2%); discontinuation because of dizziness - 1%; dry mouth and constipation; for diabetic patients - hypoglycemia 2) SSRIs (selective serotonin reuptake inhibitors) - serotonin syndrome; SNRIs (serotonin-norepinephrine reuptake inhibitors) - serotonin syndrome; monoamine oxidase inhibitors; triptans; bupropion 3) pregnancy; avoid with severe renal and hepatic impairment
List the common adverse effects, common drug-drug interaction and contraindications of the new weight-loss medications as it relates to Phentermine / topiramate (Qysmia)?1) paresthesia (the most common); dose-dependent including dry mouth, constipation, paresthesia, insomnia, irritability and altered taste sensation 2) CNS depressants including alcohol; oral contraceptives 3) pregnancy, glaucoma, hyperthryoidism
List the common adverse effects, common drug-drug interaction and contraindications of the new weight-loss medications as it relates to Naltrexone / bupropion (Contrave)?1) nausea (most common), constipation, diarrhea, hedache, vomiting, dizziness, insomnia, dry mouth 2) drugs metabolized by CTP2D6; Bupropion inhibits CYP2D6 and can increase the concentration of SSRIs and TCAs, antipsychotics, beta-blockers and type 1C antiarrhythmics (propafenone and flecainide); concomitant use of CYP 286 inhibitors (clopidogrel) can increase serum level of bupropion; phenytoin may reduce efficacy by reducing bupropion level; avoid drugs that lower seizure threshold 3) pregnancy, uncontrolled HTN, seizure disorders, chronic opiiod use, use of other bupropion-containing products; within 14 days of taking monoamine oxidase inhibitors
List the common adverse effects, common drug-drug interaction and contraindications of the new weight-loss medications as it relates to Liraglutide (Saxenda)?1) nausea, diarrhea, vomiting; hypoglycemia when combining with sulfonylureas; acute pancreatitis, acute gallstone, injection site reaction; thyroid C-cell turmor risk 2) anti-diabetic medications (sulfonylureas and insulin); drugs that delay gastric emptying 3) may impact absorption of concomitantly administered oral medications 3) personal or family hx of medullary thyroid carcinoma; multiple endocrine neoplasm syndrome type 2; severe gastroparesis; hx of pancreatitis; type 1 diabetes; pregnancy
List the black-box warning for Naltrexon / bupropion (Contrave)?suicidal thoughts and behaviors and neuropsychiatric reactions
List the black-box warning for Liraglutide (Saxenda)?thyroid C-cell tumor risk
*** List the published guidelines to help clinicans choose which medication should be used first, and long-term benefits and safety of these medications?there are no such guidelines available which are well defined
Why should clinicians have a thorough discussion of the benefits and risks of these weight-loss medications with their patients before initiating therapy?because of the potential adverse effects (valvulopathy, increased blood pressure and heart rate, suicidal risks)
*** Considering efficacy, cost, tolerability, safety, simplicity and patient perference will enhance what?patient adherence and better outcomes
Clinics should closely monitor for what?adverse side effects
Pts should d/c the med if appropriate weight loss is not attained w/ the maximal daily dosage at the end of ____ weeks or if unacceptable adverse effects occur?12
*** SUMMARY = Multiple new weight loss medications are now available, are there any guidelines regarding first-line therapy or long term safety?no
*** SUMMARY = All the new medications are pregnancy category ____?X
*** SUMMARY = List the two of the four new weight loss medications that are schedule IV medications?1) Lorcaserin (Belviq) 2) phentermine / topiramte (Qsymia)
*** SUMMARY = Liraglutide (Saxenda) has the warning of what tumor risk?thyroid C-cell tumor
*** SUMMARY = What black-box warning does Naltrexone / bupropion (Contrave) carry?suicidal thoughts and behaviors and neuropsychiatric reactions
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