Clinical Trials

JUNE 15, 2009

Plavix with Aspirin More Effective in Some Heart Patients

For patients with atrial fibrillation (AF) and increased stroke risk who cannot take an oral anticoagulant (OAC) medication, taking clopidogrel bisulfate (Plavix) in addition to aspirin significantly reduced major vascular events by 11% over aspirin alone, at a median of 3.6 years of follow-up (6.8% vs 7.6% per year, P = .01). The most significant benefit shown was a 28% decline in stroke (2.4% vs 3.3% per year, P <.001). The phase 3, double-blind, placebo-controlled trial, ACTIVE (Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events) A, included 7554 patients with AF who could not take OACs and had at least 1 major risk factor for stroke. The researchers compared the combination of Plavix 75 mg once daily plus aspirin (75-100 mg daily recommended dose) with aspirin alone (75-100 mg daily recommended dose) for preventing the first occurrence of a major vascular event. The study results were recently presented at the 58th Annual Scientific Session of the American College of Cardiology.

HE Drug May Be First New Treatment Option in 30 Years

New data from a phase 3, multinational, randomized, double-blind, placebo-controlled study of 299 patients showed that patients who received rifaximin (1100 mg/day, dosed at 550 mg twice daily) for 6 months had significant protection against clinical hepatic encephalopathy (HE) breakthrough episodes (58% risk reduction, P <.0001) in the intent-to-treat population. The data showed that rifaximin had a comparable safety profile to placebo in patients treated for up to 6 months. Patients were randomized to receive either rifaximin 550 mg twice daily or placebo. The participants were patients with cirrhosis who had ≥2 episodes of HE (defined as Conn score ≥2) within 6 months prior to screening and were currently in remission (defined as Conn score = 0 or 1). The primary end point was time to first breakthrough HE episode (increase of Conn score to ≥2, or a Conn score and asterixis grade increase of 1 each, if baseline Conn score = 0). The results were recently presented at the annual meeting of the European Association for the Study of the Liver.

Varespladib Shows Efficacy in Treating ACS

FRANCIS (Fewer Recurrent Acute coronary events with Nearterm Cardiovascular Inflammation  Suppression), a phase 2 clinical trial observing the impact of 500 mg varespladib given to patients within 96 hours of an acute coronary syndrome (ACS) event, met its primary end point of reducing low-density lipoprotein (LDL) cholesterol. Also, efficacy analyses showed positive results for all clinically important secondary end points, including significant reductions in total cholesterol and non—high—density lipoprotein cholesterol; suppressed inflammation following the index event, further proven by a significant reduction in C-reactive protein as a result of the drug’s immediate and selective inhibition of secretory phospholipase A2; and LDL cholesterol levels of ≤70 mg/dL in a significantly greater number of patients treated with varespladib, maintained through the primary end point. Patients enrolled in the trial received once-daily doses of 80 mg of atorvastatin calcium (Lipitor) and 500 mg of varespladib or matching placebo. The prespecified primary end point analysis was conducted when 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), an investigational opioid analgesic, significantly reduced pain scores in patients with moderate-to-severe pain, according to the results of a phase 3 trial recently presented at the 28th annual scientific meeting of the American Pain Society. The randomized, double-blind, double-dummy study analyzed “average pain over the last 24 hours” scores as the primary efficacy end point, showing that patients treated with BTDS 20 saw considerable decreases in pain scores, compared with those treated with buprenorphine, 5 mcg/hour (BTDS 5 [P <.001]). A total of 660 participants were randomized to receive BTDS 5, BTDS 20, or immediate-release oxycodone (Oxy IR) 40 mg for 12 weeks, and were assessed using a repeated measures analysis at weeks 4, 8, and 12. The participants had moderate-to-severe back pain for at least 3 months and were receiving treatment with opioid analgesics at doses between 30 and 80 mg of morphine sulfate or the equivalent at least 4 days per week, or at least 30 days before the start of observation. The number of patients treated with BTDS 20 and Oxy IR reporting 30% and 50% improvement from baseline screening in “average pain over the last 24 hours” were significantly higher, compared with those treated with BTDS 5.



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