Outlook: Clinical Trials

Lacosamide Reduces Seizures in Epilepsy Patients

Study results have shown that lacosamide (Vimpat), a new antiepileptic drug (AED), significantly reduces seizures in adult partial-onset epilepsy patients who have not seen improvements through the use of other AEDs. The double-blind, placebo-controlled, phase 3 study enrolled 485 patients, aged 16 to 70 years, who experienced uncontrolled partial-onset seizures for at least 2 years despite past therapy with at least 2 AEDs. The patients were randomized to receive lacosamide 200 mg/day, 400 mg/ day, or placebo, along with their previously taken AEDs. A 4-week forced titration period followed. Patients taking 200 or 400 mg of lacosamide saw reduction in seizure frequency by 35.3% and 36.4%, respectively, within 28 days, compared with 20.5% for placebo. More patients taking either dosage of lacosamide experienced total freedom from seizures than those in the placebo group, with 3.6% of those taking 200 mg/day, and 2.4% of those taking 400 mg/day remaining seizure-free, compared with 2.1% of patients taking the placebo.

Eltrombopag Increases Platelet Counts, Reduces Bleeding

Eltrombopag (Promacta/Revolade), which received accelerated FDA approval November 20, 2008, has been shown to significantly increase platelet counts and reduce bleeding in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP). Positive phase 3 data from RAISE (Randomised Placebo-controlled ITP Study with Eltrombopag) were presented at the 50th Annual Meeting of the American Society of Hematology. RAISE—a global, double-blind, placebo-controlled study— enrolled 197 patients (eltrombopag: n = 135; placebo: n = 62) who began once-daily treatment with eltrombopag at 50 mg (or matching placebo) with doses individualized based on each patient's platelet response, ranging from once-daily doses of 25 to 75 mg, or less frequently. Patients receiving eltrombopag were 8 times more likely than those on placebo to achieve an overall response of increased platelet counts of 50,000 to 400,000 µL during a 6-month treatment period. This reduced patients' bleeding symptoms and their need for concomitant and rescue ITP treatments.

Advanced Electrolyte Solution Alleviates Oral Side Effects of Chemoradiation

Patients with head and neck (HN) cancer who are undergoing chemotherapy and radiation therapies experienced low rates of oral mucositis (OM) and pain with use of supersaturated calcium phosphate rinse (Caphosol), according to data recently presented at the Advanced Practice Nursing Conference of the Oncology Nursing Society. The trial enrolled 68 HN cancer patients considered high risk for OM in an open-label, observational registry maintained at 26 treatment centers throughout the United States. All the participants received Caphosal 4 to 10 times daily for 8 weeks for radiation therapy or 2 cycles for chemotherapy, beginning on the first day of either treatment. The patients treated with Caphosol showed low levels of OM, with 13% not developing the condition at all. Grade 1 (mild) OM showed in 36% of patients, and 33% had grade 2 (moderate) OM. Grade 3 (severe) OM occurred in 16%, and grade 4 (life-threatening or disabling) OM showed in 2%. In terms of oral pain, grades 2 and 3 pain were experienced by 38% and 18% of patients, respectively. No grade 4 pain was reported. Dysphagia was not experienced at all by 18% of the participants. grade 1 dysphagia occurred in 21% of the group, grade 2 in 32%, grade 3 in 25%, and grade 4 in none of the patients.

Mifepristone and Risperidone Combo Brings Metabolic Benefits

The results of a 4-week, randomized, double-blind, controlled trial determined that adding mifepristone (Corlux) to treatment with risperidone (Risperdal) helps to mitigate weight gain and other metabolic effects experienced by patients using risperidone. The study participants included 75 lean, healthy men with a body mass index of 23 or less, who were randomized to receive either risperidone plus placebo (n = 30), risperidone plus mifepristone (n = 30), or mifepristone plus placebo (n = 15). Data were gathered and recorded daily on all the participants, including weight, abdominal fat, fasting insulin, and triglycerides. The patients who took risperidone with placebo gained an average of 9.2 lb, compared with 5.1 lb of weight gain on the part of those who took risperidone plus mifepristone (P <.0001). The increase in abdominal fat (as measured by waist circumference) was 3.57 cm in the risperidone alone group, compared with 2.03 cm in those in the risperidone plus mifepristone group (P <.05). The risperidone with placebo group saw fasting insulin increase by 10.97 mU/L, compared with 1.80 mU/L in the risperidone plus mifepristone group (P <.05). Triglycerides increased by 30.57 mg/dL in the risperidone alone group, compared with 3.13 mg/dL in the risperidone plus mifepristone group.