outlook: CLINICAL trials

SEPTEMBER 01, 2007
Susan Farley

Suboxone May Work as Well as Methadone for Heroin Addiction

Researchers with the National Institute on Alcohol Abuse and Alcoholism compared the effects of suboxone tablets with those of methadone for the treatment of heroin addiction. They found the stepped treatment of suboxone to be as safe and effective as a firstline treatment. Suboxone, a combination of buprenorphine and naloxone, helps addicts fight drug cravings and can later be followed by methadone, if needed.

The randomized study included 96 self-referred heroin addicts receiving either traditional methadone treatment or suboxone. At the 6-month point, 78% of the participants were still taking part in the treatment, and the researchers found outcomes for both groups to be ?virtually identical.? Eventually, 80% of both groups produced opiate-free urine samples and had no serious side effects.

Senior investigator Markus Heilig, MD, PhD, said, ?Methadone, which can be more effective but at the cost of being less safe, should be reserved for patients who do not do well on suboxone.? The results appeared in the May issue of the American Journal of Psychiatry.

Small Study Shows Positive Results for Lymphoma Drug

A radioimmunotherapy drug known as Bexxar (tositumomab and iodine I 131 tositumomab) was used as a first-line treatment for follicular non-Hodgkin?s lymphoma in a 76-patient study. Eight years later, 86% of the patients were alive, and almost two-thirds were in remission. The findings from this study were presented at the American Society of Clinical Oncology?s annual meeting in June 2006.

Follicular non-Hodgkin?s lymphoma is not considered curable by traditional methods?even if the cancer responds at first, it usually will return. To combat cancer, the compound drug incorporates an antibody that seeks out cancer cells with a radioactive form of iodine that is delivered to the cancer cells, with little effect on the surrounding healthy tissue. This therapy is a single treatment that is completed within 1 week. Researchers from the University of Michigan developed the treatment and entered into a licensing agreement with GlaxoSmith-Kline to market it.

New Migraine Drug Effectively Treats Symptoms, Multiple Attacks

Results of 2 large trials of sumatriptan/naproxen sodium (Trexima) showed the drug to be nearly twice as effective as placebo for getting rid of traditional migraine symptoms at 2 hours and 4 hours for multiple attacks. Although most studies of migraine therapies focus on relief or elimination of head pain only, this study focused on a ?migraine-free response,? which includes relief or elimination of nausea, vomiting, and sensitivity to light or sounds.

The results stem from 2 identical, multicenter, double-blind, placebo-controlled, crossover studies of adult migraine sufferers. In 4 of 5 groups, participants treated 4 of their migraine attacks?taking the combination drug for 3 of the attacks and placebo for the fourth. A fifth group of patients took the combination drug for all 4 of their attacks. About 40% of the combination-drug patients were migraine-free at 2 hours, compared with 20% of the placebo group. At the 4-hour mark, about two thirds of the combination-drug patients were migraine-free, compared with about one third of the placebo group.

Trexima is the brand name for the single-tablet formulation of 85 mg of sumatriptan and 500 mg of naproxen sodium. It is currently undergoing FDA review. The findings were presented at the 49th Annual Scientific Meeting of the American Headache Society.

Prostate Cancer Drug Boasts Long-term Efficacy

Docetaxel (Taxotere plus prednisone)? an injectable, concentrate-based chemotherapy?maintained its efficacy for at least 3 years in the treatment of metastatic, hormone-resistant prostate cancer, according to an update of the landmark TAX 327 study. In the latest study, patients were treated with 75 mg/m2 of docetaxel once every 3 weeks, combined with 5 mg of prednisone daily. Significantly more of these patients survived for 3 years, compared with patients in another study group taking the anticancer antibiotic mitoxantrone with prednisone. Patients in the docetaxel group survived an average of 3 months longer and had a 21% lower risk of dying.

The results were presented at the annual meeting of the American Society of Clinical Oncology.

Anastrozole Making Mark as More Effective Breast Cancer Drug

Trial data showed that switching from tamoxifen to anastrozole (Arimidex) significantly improved survival for postmenopausal women being treated for breast cancer. The Arimidex-Nolvadex 95 study, known as ARNO 95, showed that women who had once been treating their early breast cancer with tamoxifen reduced the chance of a cancer recurrence when they switched to anastrozole. The 979 study participants who switched to anastrozole reduced their risk of cancer recurrence by 34% and improved their chance of overall survival by 47%, with fewer serious adverse events.

The efficacy and tolerability of anastrazole over tamoxifen were explored in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) study. That study showed anastrazole to have a 26% reduction in the risk of cancer recurrence, when compared with tamoxifen. In the ARNO 95 trial, women in 1 group were taking 20 or 30 mg/day of tamoxifen for 2 years and then switched to 1 mg/day of anastrozole for up to 3 years. In the other study group, women continued to take 20 or 30 mg/day of tamoxifen for up to 3 more years.

A full analysis of the study was published in the online version of the Journal of Clinical Oncology.