Clinical Trials

Pharmacy Times
Volume 75
Issue 6

Plavix with Aspirin More Effective in Some HeartPatients

Forpatients with atrial fibrillation (AF) and increased stroke risk who cannottake an oral anticoagulant (OAC) medication, taking clopidogrel bisulfate(Plavix) in addition to aspirin significantly reduced major vascular events by11% over aspirin alone, at a median of 3.6 years of follow-up (6.8% vs 7.6% peryear,


= .01).The most significant benefit shown was a 28% decline in stroke (2.4% vs 3.3%per year,


<.001).The phase 3, double-blind, placebo-controlled trial, ACTIVE (AtrialFibrillation Clopidogrel Trial with Irbesartan for Prevention of VascularEvents) A, included 7554 patients with AF who could not take OACs and had atleast 1 major risk factor for stroke. The researchers compared the combination ofPlavix 75 mg once daily plus aspirin (75-100 mg daily recommended dose) withaspirin alone (75-100 mg daily recommended dose) for preventing the firstoccurrence of a major vascular event. The study results were recentlypresented at the 58th Annual Scientific Session of the



of Cardiology.

HE Drug May Be First New Treatment Option in 30 Years

Newdata from a phase 3, multinational, randomized, double-blind,placebo-controlled study of 299 patients showed that patients who receivedrifaximin (1100 mg/day, dosed at 550 mg twice daily) for 6 months hadsignificant protection against clinical hepatic encephalopathy (HE)breakthrough episodes (58% risk reduction,


<.0001)in the intent-to-treat population. The data showed that rifaximin had acomparable safetyprofile to placebo in patients treated for up to 6 months. Patients wererandomized to receive either rifaximin 550 mg twice daily or placebo. Theparticipants were patients with cirrhosis who had


2episodes of HE (defined as




2)within 6 months prior to screening and were currently in remission (defined as


score = 0 or 1).The primary end point was time to first breakthrough HE episode (increase of


score to


2, or a


score and asterixis grade increase of 1each, if baseline


score = 0). The results were recently presented at the annual meeting of theEuropean Association for the Study of the Liver.

Varespladib Shows Efficacy in Treating ACS

FRANCIS(Fewer Recurrent Acute coronary events with Nearterm CardiovascularInflammation

Suppression), a phase 2clinical trial observing the impact of 500 mg varespladib given to patientswithin 96 hours of an acute coronary syndrome (ACS) event, met its primary endpoint of reducing low-density lipoprotein (LDL) cholesterol. Also, efficacy analysesshowed positive results for all clinically important secondaryend points, including significant reductions in total cholesterol and non—high—densitylipoprotein cholesterol; suppressed inflammation following the index event,further proven by a significant reduction in C-reactive protein as a result ofthe drug’s immediate and selective inhibition of secretory phospholipase A2;and LDL cholesterol levels of


70 mg/dL in asignificantly greater number of patients treated with varespladib, maintainedthrough the primary end point. Patients enrolled in the trial receivedonce-daily dosesof 80 mg of atorvastatin calcium (Lipitor) and 500 mg of varespladib ormatching placebo. The prespecified primary end point analysis was conductedwhen 500 patients reached at least 8 weeks of treatment after an ACS event.

Buprenorphine Patch Shown to Reduce Pain

The buprenorphine 20 mcg/hour transdermal system (BTDS 20), aninvestigational opioid analgesic, significantly reduced pain scores in patientswith moderate-to-severe pain, according to the results of a phase 3 trial recently presented at the 28th annual scientificmeeting of the American Pain Society. The randomized, double-blind,double-dummy study analyzed “average pain over the last 24 hours” scores as theprimary efficacy end point, showing that patients treated with BTDS 20 sawconsiderable decreases in pain scores, compared with those treated with buprenorphine, 5mcg/hour (BTDS 5 [


<.001]). A total of 660 participants were randomized to receiveBTDS 5, BTDS 20, or immediate-release oxycodone (Oxy IR) 40 mg for 12 weeks, and were assessed using a repeated measuresanalysis at weeks 4, 8, and 12. The participants had moderate-to-severe backpain for at least 3 months and were receiving treatment with opioid analgesics at doses between 30 and 80 mg of morphinesulfate or the equivalent at least 4 days per week, or at least 30 days beforethe start of observation. The number of patients treated with BTDS 20 and OxyIR reporting 30% and 50% improvement from baseline screening in “average painover the last 24 hours” were significantly higher, compared with those treatedwith BTDS 5.

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