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Content Update

August 1, 2018

Use of Lofexidine in Opioid Withdrawal: In May 2018, the FDA approved lofexidine (Lucemyra), a central alpha-2 adrenergic agonist, for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in dependent adults. Results from two phase 3 clinical trials showed statistically significant improvement in withdrawal symptoms vs. placebo, but the improvements seen were modest and only assesed in the short-term (7 days of therapy). Use of lofexidine for opioid withdrawal symptoms in the U.S. will likely be limited to short-term, adjunctive therapy in select qualifying patients until further information becomes available.

KEY CONCEPTS

KEY CONCEPTS

  • Image not available. Chronic kidney disease (CKD) results in minimal alterations in the absorption or bioavailability of most drugs.

  • Image not available. The volume of distribution (VD) of many drugs is increased in the presence of acute and CKD as a consequence of volume expansion and/or reduced protein binding.

  • Image not available. In addition to the expected decrement in renal clearance, nonrenal clearance (ie, gastrointestinal and hepatic drug metabolism) of several drugs is also reduced in CKD patients.

  • Image not available. Individualization of a drug dosage regimen for a patient with reduced kidney function is based on the pharmacodynamic/pharmacokinetic characteristics of the drug, the patient’s degree of residual renal function, and their overall clinical condition.

  • Image not available. The drug dosing guidelines for CKD patients in many drug information resources are highly variable and many are not optimal for clinical use.

  • Image not available. The effect of hemodialysis (HD) or peritoneal dialysis on drug elimination is dependent on the characteristics of the drug and the dialysis prescription.

  • Image not available. HD clearance data can be used to guide the initial drug dosage regimen recommendation for HD patients; however, prospective monitoring of serum concentrations is often warranted especially for narrow therapeutic index drugs.

Chronic kidney disease (CKD) is defined by the presence of abnormalities of kidney function or structure.1 In its earliest stages it is characterized by either an estimated glomerular filtration rate (eGFR) less than 89 mL/min/1.73 m2 or the persistence of one or more markers of kidney damage (eg, albuminuria) for more than 3 months in those with eGFR more than or equal to 90 mL/min/1.73 m2. (see Chapters e42 and 44)1 The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for evaluation and management of CKD eGFR and albuminuria categories are outlined in Tables 44-1 and 44-6. It is estimated that 10% to 15% of the global population has CKD and the number of deaths from CKD has risen by more than 80% in the past two decades.2,3,4 The prevalence varies widely across the world in part because of true differences in the prevalence of CKD; heterogeneity of the laboratory methods used to detect CKD; environmental factors, public health policies, and genetics.4 The incidence of CKD has more than doubled in the past 20 years in adults older than 65 years.5 In part due to age-related reductions in ...

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