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Clinical Update for July 2017

The Ventegra® Clinical Advisory Committee (CAC) recently reviewed safety issues regarding the direct acting antiviral agents for hepatitis C. October 2016 the Federal Drug Administration (FDA) identified 3 cases of liver failure and 24 cases of hepatitis B reactivation associated with direct-acting antivirals, including daclatasvir (Daklinza™), elbasvir-grazoprevir (Zepatier®), ledipasvir-sofosbuvir (Harvoni®), paritaprevir combinations (Viekira™ Pak/Viekira™ XR/Technivie™), simeprevir (Olysio®), sofosbuvir (Sovaldi®), and velpatasvir-sofosbuvir (Epclusa®). January 2017 the ISMP (Institute for Safe Medication Practices) published a report evaluating the most recent 12 months’ FDA Adverse Event Reporting System (FAERS) data that revealed an increased number of liver injury, liver failure, and treatment failure. In all, 524 cases of liver failure and 1,058 cases of severe liver injury were reported where these agents were considered as the primary or secondary suspect drug.  The state of liver failure prior to treatment was unclear, however 90% of the reported cases were submitted by health care professionals.  Currently there are no significant changes in therapy recommended by the FDA based on these results.  Prescribers are encouraged to screen and monitor for HBV and liver dysfunction/injury, and should report any additional cases to the FDA.

The CAC reviewed the two newly approved PCSK9 inhibitors, alirocumab (Praluent®) and Evolocumab (Repatha®) last year for the treatment of hypercholesterolemia. The committee noted both drugs signficantly lowered LDL.  However, the lack of cardiovascular and long-term safety outcomes data was a committee concern. PCSK9 inhibitors were not added to the Ventegra Commercial formularies, and are  non-preferred specialty drugs with a prior authorization requirement.  The Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease trial (FOURIER ) outcome data was published in the New England Journal of Medicine, May 2017 issue.  The study compared a statin plus evolocumab vs. statin alone.  The primary efficacy endpoint was a cardiovascular composite score that included  cardiovascular death, myocardial infarction, stroke, hospitalization (unstable angina), or coronary revascularization. Patients enrolled in the study were diagnosed with atherosclerotic cardiovascular disease, with LDL levels greater than 70 mg per deciliter (median baseline LDL level of 92mg/dL), and were currently being treated with statin therapy.  A risk reduction in the primary clinical composite endpoint was seen in the treatment (9.8%) vs. placebo (11.3%); hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; (p<0.001).  There was no difference in cardiovascular death between groups, absoulute rate 1.8% (treatment) vs 1.7% (placebo).  The calculated number needed to treat (NNT) is 74 patients to prevent 1 cardiovascular death, MI or stroke over a 2 year treatment period.  Although data did demonstrate a statistically significant reduction in composite endpoint, patient population and LDL levels at baseline raises questions over the clinical relevance of the study’s findings.  No recommendation for changes were made, and the CAC maintains the position of not adding PCSK9 inhibitors to the Ventegra Commercial formularies.

May 16, 2017 the FDA announced they are requiring a new black box warning on canagliflozin drug labels (Invokana®, Invokament®, Invokamet® XR) due to final results from two clinical trials (CANVAS and CANVAS-R) showing that leg and foot amputations occurred approximately twice as often in patients treated with canagliflozin.   February 2017 the European Medical Association (EMA) put out an amputation warning for all SLGT2 inhibitors based on findings from these trials. The following CAC recommendations were made regarding SGLT2 inhibitors:


Therapeutic Class: CAC Recommendation
SGLT-2 inhibitors FDA Safety Update

Empagliflozin (Jardiance®)

Empagliflozin plus metformin (Synjardy®)

Empagliflozin plus metformin (Synjardy® XR)

Empagliflozin plus linagliptin (Glyzambi®)

Maintained recommendation to add as a preferred SGLT2 inhibitor listed on all Ventegra Commercial formularies

Canagliflozin (Invokana®)

Canagliflozin plus metformin (Invokamet®)

Cangliflozin plus metformin SR (Invokamet® XR)

CAC reversed recommendation to add.  Recommends holding the addition of canagliflozin and its combinations across all Ventegra Commercial formularies


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