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3/10/2014
DRUG THERAPY UPDATE
Benjamin Gross, Pharm D, BCPS, BCACP, BC‐ADM, CDE
Associate Professor
Director of Residency Programs
Lipscomb University College of Pharmacy and Health Sciences
DISCLOSURE
• CONSULTANT FOR BRISTOL MYERS SQUIBB AND ASTRAZENCA
Contact
• Email:
– [email protected]
– [email protected]
• Office
– One University Park Drive
– Nashville, TN 37204
– Phone: 615.966.7195
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Objectives
• Discuss common medication issues impacting patient care
• Discuss adverse effects of medications and their impact on treatment plans
• Discuss new medications and their impact on patient care treatment
• Discuss new medications, adverse effects, or restrictions for the general population. Obesity Guidelines
Jensen, et al. Circulation. 2013; 01.cir.0000437739.71477.eepublished online before print November 12 2013, doi:10.1161/01.cir.0000437739.71477.ee 2
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Obesity Guidelines
Jensen, et al. Circulation. 2013; 01.cir.0000437739.71477.eepublished online before print November 12 2013, doi:10.1161/01.cir.0000437739.71477.ee Phentermine/Topiramate • Qysmia®
– Phentermine: • Discussed earlier
– Topiramate: • Appetite suppressant and induces satiety
Phentermine/Topiramate • Dosage: extended release
– Initial: 14 days
• 3.75 mg phentermine/23 mg topiramate
– Increase:
• 7.5 mg/46mg daily
– Increase dose to 15 mg/92 mg if 3% weight loss is not achieved after 12 weeks
– Discontinue if 5% weight loss is not achieved after 12 weeks
– Avoid higher doses in moderate‐to‐severe renal impairment and moderate hepatic impairment
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Phentermine/Topiramate • Adverse effects: >5%
– Paresthesia
– Dizziness
– Dysgeusia
– Insomnia
– Constipation
– Dry Mouth
Phentermine/Topiramate • Drug Interactions
– MAOIs: off medication for 14 days or more
– Non‐potassium sparing diuretics
• Hypokalemia
• Contraindications
– Glaucoma
– Hyperthyroidism
• Avoid alcohol
Phentermine/Topiramate • Patient counseling
– Do not stop abruptly
• Tapered off
– Category X
• Risk Evaluation and Mitigation Strategy (REMS)
– Schedule IV
– Monitoring heart rate
– Suicidal behavior and ideation
– Cognitive impairment
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Phentermine/Topiramate Garvey, et al. 2012; 95:297‐308
Phentermine/Topiramate Gadde, et al. Lancet 2011; 377:1341‐52
Phentermine/Topiramate Garvey, et al. 2012; 95:297‐308
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Lorcaserin
• Belviq®
• Selective Serotonin (5‐HT2c) Lorcaserin • Indication:
– BMI ≥30 – BMI ≥ 27
• At least one weight‐related comorbid condition
• Dosage: 10 mg twice daily
– If weight loss < 5% of body weight at week 12
• Discontinue
– No adjustment for renal or hepatic disease
Lorcaserin
• Adverse effects:
–
–
–
–
–
–
–
Headache (18% vs. 11%)
Upper respiratory infections (14.8% vs. 11.9%)
Nasopharyngitis (13.4% vs. 12.0%)
Sinusitis (7.2% vs. 8.2%)
Nausea and vomiting (7.5% vs. 5.4%)
Dizziness
Others:
•
•
•
•
•
Fatigue
Dry Mouth
Constipation
Hypoglycemia
Hematologic changes
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Lorcaserin
• Drug Interactions
–
–
–
–
–
–
–
–
–
–
–
–
–
Monoamine oxidase inhibitors (MAOIs)
Triptans
Linezolid
Selective Serotonin Reuptake inhibitors (SSRIs)
Selective Serotonin‐Norepinephrine Reuptake Inhibitors (SSNRIs)
Dextromethorphan
Tricyclic Antidepressants (TCAs)
Bupropion
Lithium
Tramadol
Tryptophan
St. John’s Wart
CYP 2D6 substrates
Lorcaserin
• Patient Counseling
– When to discontinue medication
– Conjunction with diet and physical activity
– Serotonin syndrome
– Valvulopathy
– Abuse
• Schedule IV
– Pregnancy Category X
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Lorcaserin Lorcaserin Naltrexone SR/Bupropion SR
• Contrave®
• FDA: June 10, 2014
• Bupropion
– Increased energy expenditure
– Reduction in appetite
• Naltrexone
– Blocks opioid receptors
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Naltrexone SR/Bupropion SR
• Adverse effects
– Nausea (30%)
– Headache (14%)
– Constipation (15%)
– Other: vomiting, dizziness, insomnia, dry mouth, and diarrhea
• Lowers seizure threshold
Naltrexone SR/Bupropion SR
• Dosages
– 32 mg naltrexone/360 mg bupropion
– 16 mg naltrexone/360 mg bupropion
• Studies
– Contrave Obesity Research I and II
– Contrave Obesity Research‐Diabetes
– Contrave Obesity Research‐Behavior Modification
Naltrexone SR/Bupropion SR
Smith, et al. Diabetes, Obesity, and Metabolism 2013;15;863‐866
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Neurogenic Orthostatic Hypotension
• Midodrine
• Fludrocortisone
• Non‐Pharmacologic
– Increase fluid/salt
– Compression garments
Droxidopa
• Droxidopa (Northera™)
– Symptomatic neurogenic orthostatic hypotension
– First and only therapy approved by the FDA
– Prodrug of Norepinephrine
Droxidopa
• Starting Dose: 100 mg three times daily
– Upon arising in the morning
– At midday
– Late afternoon
• 3 hours prior to bedtime
• Titrate to response every 24‐48 hours
– 100 mg three times daily increments
– Max daily dose 1800 mg: 600 mg three times daily
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Droxidopa
Study 301 and Study 302
Placebo (N=132)
N(%)
Droxidopa
(N=131)
N(%)
Study 306
Placebo
(N=108)
N(%)
Droxidopa
(N=114)
N(%)
Headache
4(3.0)
8(6.1)
8(7.4)
15(13.2)
Dizziness
2(1.5)
5(3.8)
5(4.6)
11(9.6)
Nausea
2(1.5)
2(1.5)
5 (4.6)
10(8.8)
0
2(1.5)
1(0.9)
8 (7.0)
Hypertension
Droxidopa
• Supine Hypertension
• Hyperpyrexia and Confusion
• Exacerbate: Ischemic Heart Disease, arrhythmias, and congestive heart failure
• Drug Interactions: Anything medication that can increase blood pressure
– Increased risk of supine hypertension
New Medications
• Opsumit™ (Macitentan): pulmonary arterial hypertension
• Brintellix™ (Vortioxetine): antidepressant
• Fetzima™ (Levomilnacipran): antidepressant
• Breo ellipta™ (Fluticasone/Vilanterol): COPD
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New Medications
• Zohydro ER™ (Hydrocodone): Pain
• OTC: Nasacort Allergy 24 hour
• Duavee™ (Conjugated Estrogen/Bazedoxifene Acetate): Women’s Health/Osteoporosis
Generics
Generics
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Generics
Generics
IN THE NEWS
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In The News
Vitamin E and Alzheimer Disease
Dysken et al. 2014 JAMA; 311(1): 33‐44
Balgent et al. Lancet 2013; 382:769‐79
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Balgent et al. Lancet 2013; 382:769‐79
Balgent et al. Lancet 2013; 382:769‐79
Balgent et al. Lancet 2013; 382:769‐79
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NSAID Recommendation
Low GI risk
Moderate GI risk
High GI risk
Low CV risk
Ibuprofen or other low‐GI risk NSAID
1. Celecoxib alone
2. NSAID plus PPI or misoprostol
3. NSAID plus double‐
dose H2 blocker (second line)
1. Avoid NSAIDs if possible
2. Celecoxib plus PPI or misoprostol
High CV risk
Naproxen
1. Naproxen plus PPI or misoprostol
2. Naproxen plus double‐dose H2 blocker (second line)
Avoid NSAIDs
Questions
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