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Table 9. 56-Week Trial Results

EQUIP (BMI greater than 35 kg/m2_{) CONQUER (BMI 27-45 mg/m}2 _plus

two or more comorbidities) Analysis Placebo Qsymia 3.75 mg/23 mg Qsymia 15 mg/92 mg Placebo Qsymia 7.5 mg/46 mg Qsymia 15 mg/92 mg Number 514 241 512 994 498 995 Baseline mean weight in kg 115.7 118.6 115.2 103.3 102.8 103.1 Weight loss as a percentage of baseline weight 1.6% 5.1% 10.9% 1.2% 7.8% 9.8% Percentage of patients with ≥ 5% Weight loss 17.3% 44.9% 66.7% 21% 62% 70% Percentage of patients with ≥ 10% weight loss 7% 19% 47% 7% 37% 48%

Table 10. 108-Week Extension Trial Results

SEQUEL (52 week extension trial for patients completing the CONQUER trial) Analysis Placebo Qsymia 7.5 mg/46 mg Qsymia 15 mg/92 mg Number 227 153 295 Weight loss as a percentage of baseline weight 1.8% 9.3% 10.5% Percentage of patients with ≥ 5% Wt loss 30% 75.2% 79.3% Percentage of patients with ≥ 10% weight loss 11.5% 50.3% 53.9%

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2013 review Lorcaserin (Belviq)

Lorcaserin is intended for weight management as an adjunct to life style changes of reduced calorie intake and increased activity. Patients with a BMI of > 30 kg/m2 _{or a BMI of > 27 kg/m}2 _{with an additional weight} related comorbid condition (hypertension, type 2 diabetes, dyslipidemia) qualify for lorcaserin.

Pharmacology: Lorcaserin is a selective serotonin 2C receptor agonist. The exact mechanism of action

is not known; however, it is believed to achieve satiety by selectively activating the 5-HT2c receptors on anorexigenic pro-opiomelonocortin neurons in the hypothalamus.

Extensively metabolized by the liver, lorcaserin has a half-life of 11 hours and is primarily excreted in the urine.

Dose: Recommended adult dose and maximum dose for lorcaserin is 10 mg twice daily with or without

food. Weight-loss progress should be monitored after 12 weeks. Discontinue lorcaserin if patients have not lost > 5% of their baseline weight. No dosage change has been recommended for the elderly. Lorcaserin is not recommended for children under the age of 18. Do not use lorcaserin in severe renal impairment (Clcr < 30 mL/minute) and use with caution in severe hepatic impairment. Use in ESRD is not recommended as this has not been studied.

Cautions: Lorcaserin has the potential to cause serotonin syndrome like effects and should not be used with

other drugs that can cause this potentially life-threatening syndrome. If symptoms of serotonin syndrome appear, lorcaserin should be discontinued.

Mitral valve regurgitation has been linked with lorcaserin through its seratonergic pathway. If signs and symptoms of valvular disease appear, it may be necessary to discontinue lorcaserin. Use with caution in patients with a history of bradycardia or heart block greater than first degree.

Lorcaserin can cause cognitive impairment, leading to memory and attention changes. Caution patients with the operation of hazardous machinery when starting lorcaserin.

Do not exceed the maximum dose of 10 mg twice daily, as psychiatric disorders of euphoria and dissociation have been reported. Monitor patients for suicidal thoughts.

Lorcaserin has abuse potential when taken in dosages exceeding the maximum dose of 10 mg twice daily. The U.S. Drug Enforcement Agency (DEA) is evaluating lorcaserin for abuse potential and possible controlled classification.

Monitor blood glucose when taking lorcaserin with antidiabetic drugs, as additional weight loss can cause hypoglycemia.

Priapism has been associated with lorcaserin. Use with caution in patients predisposed to priapism. Lorcaserin can cause a decrease in red and white blood cell count. Monitor patient's complete blood count while taking this drug.

Lorcaserin moderately elevates prolactin. Prolactin should be measured when patient's exhibit signs and symptoms of excessive prolactin.

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Table 11. Incidence of Adverse Reactions

Adverse Reactions Percent

Headache, hypoglycemia, decrease in lymphocytes, back pain, upper respiratory tract infection, nasopharyngitis

> 10% Peripheral edema, hypertension, valvulopathy, dizziness, fatigue, anxiety, insomnia,

depression, cognitive impairment, psychiatric disorders, rash, diabetes melatis exacerbation, prolactin increased, nausea, diarrhea, constipation, xerostomia, vomiting, gastroenteritis, toothache, appetite decreased, UTI, hemoglobin decreased, neutrophils decreased, muscle spasm, muscle pain, eye disorders, oropharyngeal pain, sinus congestion, seasonal allergy, stress

1-10%

Bradycardia, dissociation, euphoria, serotonin syndrome, suicidal ideation < 1%

Contraindications: Lorcaserin is contraindicated in pregnancy, risk factor X, and should not be taken by

nursing mothers.

Drug/Drug Interactions: Lorcaserin is a selective serotonin 2C receptor agonist with the potential to cause

serotonin syndrome (sweating, hyperthermia, tachycardia). Care should be taken when prescribing lorcaserin with other drugs that work through the seratonergic pathway, as the potential for serotonin syndrome can be enhanced.

Clinical Trials: Approval of lorcaserin was based on three one-year randomized double-blind studies in

obese and overweight adults.

In the Bloom trial, subjects who lost > 5% of their body weight in the first year were randomized to continue lorcaserin in year two or switch to a placebo. At the end of year, two patients who continued with lorcaserin had regained 25% of their initial weight loss and those who took lorcaserin during year one and were switched to a placebo for year two lost an average of 1.2 kg more than those who took placebo during year one.

Table 12. 52-week trial results