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First MRI-safe pacemaker receives conditional approval from FDA.

The scientists conclude that the variant may make alcohol consumption more rewarding for individuals who carry it, which may place such individuals at risk of heavy drinking while also making them more likely to respond to treatment with naltrexone. “It’s confirming and providing a molecular explanation for what we’ve seen in the clinical trials,” Heilig said in an interview. He noted that such confirmation is necessary because retrospective studies may be biased. Meanwhile, other scientists have identified a variant of the serotonin transporter that is associated with heavy drinking and that appears to predict the response of alcohol-dependent patients to a therapy targeting these transporters. Johnson and his colleagues categorized 283 patients with alcohol dependence involving heavy drinking by the variants they carried for the 5-HTT gene and randomized them to either treatment with 4 μg/kg twice daily of ondansetron or placebo (Johnson BA et al. Am J Psychiatry. doi:10.1176/appi.ajp .2010.10050755 [published ahead of print January 19, 2011]). All participants received 11 weeks of the drug or placebo plus standardized cognitive behavioral therapy. They found that patients with the LL/TT variant of the gene who received ondansetron had a lower mean number of drinks per drinking day (−2.63) and a higher percentage of days abstinent (16.99%) than all other genotype and treatment groups combined. The authors concluded that these reductions are clinically significant because many of the patients started out with drinking behavior considered high risk, but at the end of the study were in the low-risk drinking category. Additionally, when patients with all variants who received ondansetron were compared, only those with the LL variant showed a substantial reduction in drinks per day and days abstinent; individuals carrying other variants had a similar response to both the drug and placebo. Johnson cautioned that only about 35% of patients with alcohol dependence respond to ondansetron. However, if the findings are replicated, physicians could use genetic testing in the clinic to determine which patients are likely to respond to the therapy before treatment begins and cut out the current trial-and-error process. “It will tell you who the drug won’t work for, so you don’t have to waste your time giving it to patients who won’t respond,” he said. But Heilig cautioned that confirmatory studies and basic research on the mechanisms involved are necessary. He explained that while studies have linked variations in serotonin transporters to heavy drinking and anxiety levels in humans, the mechanisms are complex, and “the neurobiology is not yet settled.” “It’s very promising,” he said. “It’s a very interesting and sound study, but until other groups replicate it, we won’t know for sure.”