outlook: CLINICAL trials

Pharmacy Times, Volume 0, 0

Ms. Farley is a freelance medical writer based in Wakefield, RI.

Suboxone May Work as Well asMethadone for Heroin Addiction

Researchers with the National Instituteon Alcohol Abuse and Alcoholismcompared the effects of suboxonetablets with those of methadone for thetreatment of heroin addiction. Theyfound the stepped treatment of suboxoneto be as safe and effective as a firstlinetreatment. Suboxone, a combinationof buprenorphine and naloxone, helpsaddicts fight drug cravings and can laterbe followed by methadone, if needed.

The randomized study included 96self-referred heroin addicts receivingeither traditional methadone treatmentor suboxone. At the 6-month point, 78%of the participants were still taking partin the treatment, and the researchersfound outcomes for both groups to be?virtually identical.? Eventually, 80% ofboth groups produced opiate-free urinesamples and had no serious side effects.

Senior investigator Markus Heilig, MD,PhD, said, ?Methadone, which can bemore effective but at the cost of beingless safe, should be reserved for patientswho do not do well on suboxone.? Theresults appeared in the May issue of theAmerican Journal of Psychiatry.

Small Study Shows PositiveResults for Lymphoma Drug

A radioimmunotherapy drug knownas Bexxar (tositumomab and iodine I 131tositumomab) was used as a first-linetreatment for follicular non-Hodgkin?slymphoma in a 76-patient study. Eightyears later, 86% of the patients werealive, and almost two-thirds were inremission. The findings from this studywere presented at the American Societyof Clinical Oncology?s annual meeting inJune 2006.

Follicular non-Hodgkin?s lymphoma isnot considered curable by traditionalmethods?even if the cancer respondsat first, it usually will return. To combatcancer, the compound drug incorporatesan antibody that seeks out cancer cellswith a radioactive form of iodine that isdelivered to the cancer cells, with littleeffect on the surrounding healthy tissue.This therapy is a single treatment that iscompleted within 1 week. Researchersfrom the University of Michigan developedthe treatment and entered into alicensing agreement with GlaxoSmith-Kline to market it.

New Migraine Drug EffectivelyTreats Symptoms, Multiple Attacks

Results of 2 large trials of sumatriptan/naproxen sodium (Trexima) showedthe drug to be nearly twice as effectiveas placebo for getting rid of traditionalmigraine symptoms at 2 hours and 4hours for multiple attacks. Althoughmost studies of migraine therapies focuson relief or elimination of head pain only,this study focused on a ?migraine-freeresponse,? which includes relief or eliminationof nausea, vomiting, and sensitivityto light or sounds.

The results stem from 2 identical, multicenter,double-blind, placebo-controlled,crossover studies of adult migrainesufferers. In 4 of 5 groups, participantstreated 4 of their migraineattacks?taking the combination drugfor 3 of the attacks and placebo for thefourth. A fifth group of patients took thecombination drug for all 4 of theirattacks. About 40% of the combination-drugpatients were migraine-free at 2hours, compared with 20% of the placebogroup. At the 4-hour mark, about twothirds of the combination-drug patientswere migraine-free, compared with aboutone third of the placebo group.

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

Prostate Cancer Drug BoastsLong-term Efficacy

Docetaxel (Taxotere plus prednisone)?an injectable, concentrate-basedchemotherapy?maintained its efficacyfor at least 3 years in the treatment ofmetastatic, hormone-resistant prostatecancer, according to an update of thelandmark TAX 327 study. In the lateststudy, patients were treated with 75mg/m2 of docetaxel once every 3 weeks,combined with 5 mg of prednisone daily.Significantly more of these patients survivedfor 3 years, compared withpatients in another study group takingthe anticancer antibiotic mitoxantronewith prednisone. Patients in the docetaxelgroup survived an average of 3months longer and had a 21% lower riskof dying.

The results were presented at theannual meeting of the American Societyof Clinical Oncology.

Anastrozole Making Mark as MoreEffective Breast Cancer Drug

Trial data showed that switching fromtamoxifen to anastrozole (Arimidex) significantlyimproved survival for postmenopausalwomen being treated forbreast cancer. The Arimidex-Nolvadex95 study, known as ARNO 95, showedthat women who had once been treatingtheir early breast cancer with tamoxifenreduced the chance of a cancerrecurrence when they switched to anastrozole.The 979 study participants whoswitched to anastrozole reduced theirrisk of cancer recurrence by 34% andimproved their chance of overall survivalby 47%, with fewer serious adverseevents.

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

A full analysis of the study was publishedin the online version of the Journalof Clinical Oncology.