Americans prefer drugs to talk therapy for depression, with nearly 80 percent taking a pill for the condition, Consumer Reports said on Tuesday.

The most popular class of drugs remain the so-called SSRIs such as Prozac, the group found. People found newer, pricier antidepressants less desirable because of side-effects.

Patients benefited just as much from therapy — almost any kind of therapy, the consumer group found in its survey of 1,500 readers.

Those surveyed said they improved just as much after seven or more sessions of talk therapy as if they took drugs and it did not matter if the therapist was a psychiatrist, psychologist or social worker.

Nearly 80 percent of people who had been diagnosed with depression or anxiety were prescribed antidepressants.

Patients were happiest with the selective serotonin reuptake inhibitors or SSRIs, a class that includes Eli Lilly and Co’s Prozac or its generic equivalent fluoxetine;, Pfizer Inc’s Zoloft or sertraline, and Celexa or citalopram and Lexapro or escitalopram from Forest Laboratories Inc.

People complained of more side-effects from serotonin-norepinephrine reuptake inhibitors or SNRIs, a newer, often more expensive class of antidepressants, the survey found.

These include venlafaxine, made by Pfizer-owned Wyeth under the Effexor brand name and Lilly’s duloxetine, sold as Cymbalta.

The survey found a range of side-effects, but the most common one — loss of sexual interest or ability — was less common than in past surveys, the consumer group said.

Source: Reuters

Popularity: 5% [?]

Results from a meta-analysis conducted by FDA researchers suggested that the risk of suicidality associated with antidepressant use “is strongly age dependent.” According to the findings published in the BMJ, adults under 25 years of age who took antidepressants were more than twice as likely to exhibit suicidal behaviour compared with those on placebo, while those over the age of 65 had a reduction in risk, the study authors stated.

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Researchers analysed 372 clinical trials involving a total of 99 231 adults who had been randomly assigned either antidepressant therapy or placebo. The analysis found there was no increased risk of suicidal behaviour for patients between 25 and 64 years of age, and that the net effect of antidepressant use was “possibly protective” for suicidal ideation in this group. Researchers also noted that the risk of suicidal behaviour and ideation was age-related for patients taking antidepressants for psychiatric indications, while the risk was “extremely rare” among patients taking the drugs for non-psychiatric conditions.

In an accompanying commentary, John Geddes of Oxford University and colleagues noted that the FDA study found differences in risk among specific selective serotonin reuptake inhibitors. Data showed Pfizer’s Zoloft (sertraline) decreased the likelihood of suicidal behaviour by about half compared with placebo, while Forest’s Celexa (citalopram) and Lexapro (escitalopram) “seemed to increase the risk of suicidal events,” the commentators noted. They also said “it is becoming apparent that antidepressants vary in both their efficacy and adverse effects.”

The study authors from the FDA indicated that more research is required to understand the varying effects of antidepressant use in the different age groups. In addition, they commented that the findings of the analysis support the agency’s past decision to require warnings on antidepressant drug labels for patients in the under-25 age group.

Source: FirstWord

Popularity: 9% [?]

Lundbeck’s shares traded as much as 16 percent lower on Monday after the company and co-development partner Takeda announced that the US filing for investigational drug Lu AA21004 to treat major depressive disorder will be delayed by up to two years because of disappointing late-stage study results. Lundbeck’s Chief Scientific Officer Anders Pedersen explained that “studies of the lower doses did not show an adequate effect. Thus we don’t have sufficient data to support the timetable for registering the drug.”

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The drugmakers indicated that the 2.5-milligram and 5-milligram strengths of the drug “did not reach significance across studies when compared with placebo,” according to results from two trials. Meanwhile, data from a third trial showed that the 2.5-milligram dose did not reach statistical significance compared to placebo, while the 5-milligram and 10-milligram strengths demonstrated “separation from placebo, although not in all analyses.” The findings also suggested that a higher dose may be more efficacious, the companies stated.

Lundbeck and Takeda noted that they must identify the most appropriate dose of Lu AA21004, and expect to postpone submission of the compound’s US application by about 18 to 24 months, to late 2011 at the earliest, Pedersen remarked. The drugmakers also said they “will continue to work with the FDA and other regulatory agencies on the clinical development programme and submission plans.”

Commenting on the news, Sydbank analyst Rune Dahl noted that Lu AA21004 “is probably the most important drug in [Lundbeck's] pipeline… This is very negative. It shows the tested doses didn’t have any effect and raises questions whether [the compound] will ever reach the market.” He also said he believes “it’s impossible to avoid a decline in revenues” when the patent on Lundbeck’s and Forests’ Lexapro (escitalopram) expires in the US in 2012.

Source: FirstWord

Popularity: 4% [?]

Results from a study presented at ASCO demonstrated that women who took certain antidepressant drugs while taking tamoxifen to treat their breast cancer had more than double the risk of cancer recurrence, compared with those who took tamoxifen alone. Researchers stated that this is “the first time that a comparative analysis has been done looking at various selective serotonin reuptake inhibitors [SSRIs] and what’s clear is that several of these drugs are extremely risky for women to take with tamoxifen, while others don’t present a problem.”

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The retrospective analysis examined the pharmacy and medical records for nearly 1300 women with breast cancer who were newly prescribed tamoxifen between 2003 and 2005 and who were followed up for an average of 2.7 years. The initial analysis involved one group of 353 women who were taking tamoxifen plus a moderate-to-potent CYP2D6 inhibitor, which included several types of SSRIs but was not limited to antidepressants, and a second group of 945 women who were taking tamoxifen and no CYP2D6 inhibitor.

Overall, results showed that the breast cancer recurrence rate for women using a CYP2D6 inhibitor plus tamoxifen was 13.9 percent, compared with a rate of 7.5 percent for those using only tamoxifen. Further analyses showed that the rate of recurrence for women whose treatment included use of moderate-to-potent CYP2D6 inhibitor SSRIs, such as Eli Lilly’s Prozac (fluoxetine), GlaxoSmithKline’s Paxil (paroxetine) and Pfizer’s Zoloft (sertraline), was 16 percent. In addition, data showed that those whose treatment included “weak” CYP2D6 inhibitor SSRIs, such as Forest’s Celexa (citalopram) and Lexapro (escitalopram) and Solvay’s Luvox (fluvoxamine), had a recurrence rate of 8.8 percent, which was considered to demonstrate no increase in risk for the disease.

Robert Epstein, one of the study’s authors, remarked that scientists were aware that CYP2D6 inhibitor drugs blocked the activation of tamoxifen chemically “but this is the first time there’s evidence that these drugs are putting women at a much higher risk for recurrent breast cancer.”

Popularity: 5% [?]

Forest announced the FDA approved a new indication for Lexapro (escitalopram), for the acute and maintenance treatment of major depressive disorder (MDD) in 12- to 17-year-old patients.

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The drugmaker said the authorisation was granted based on positive results from two 8-week, placebo-controlled studies, one examining the use of Lexapro in adolescents; and the second examining the use of Forest’s antidepressant Celexa (citalopram) in children and adolescents.

Lexapro is already indicated in the US to treat MDD and generalised anxiety disorder in adults.

Source: FirstWord

Popularity: 5% [?]

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The US Department of Justice filed civil charges against Forest Laboratories in a federal court in Massachusetts on Wednesday, alleging that the company illegally marketed antidepressants Celexa (citalopram) and Lexapro (escitalopram) for off-label paediatric use, and paid “kickbacks to induce physicians” to prescribe the treatments. Forest shares dropped 5.3 percent on Wednesday.

Government authorities claim that Forest promoted the antidepressants for paediatric use, but failed to disclose study results demonstrating that Celexa was ineffective in children. The complaint also alleges that the company violated federal anti-kickback laws by offering doctors cash payments disguised as grants and consulting fees, as well as expensive meals and other valuables in order to boost prescriptions of the antidepressants.

Frank Murdolo, Forest’s vice president of investor relations, stated that “we’ll look at the complaint, see what’s there. We’ll see what the next steps are.”

Source: FirstWord

Popularity: 5% [?]

Two antidepressants, Zoloft and Cipralex, work slightly better and are better tolerated compared with 10 other similar drugs for moderate to severe depression, a new review has found.

In Thursday’s online issue of the medical journal The Lancet, an international team of doctors looked at more than 100 previous studies on antidepressants involving nearly 26,000 patients from 1991 to 2007.

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They concluded that Zoloft, or sertraline, and Cipralex, or escitalopram, were the best options when considering benefits, side-effects, and cost.

Edronax was considered the least effective.

“Such findings have enormous implications,” wrote Dr. Sagar Parikh, a psychiatrist at the University of Toronto, in a commentary accompanying the study.

“Now a clinician can identify the four best treatments, identify individual side-effect profiles, explore costs and patients’ preferences and collaborate in identifying the best treatment.”

The study’s authors weighed the drugs based on whether it reduced depression scores on two standardized tests by at least half and if patients had not stopped taking the medication in the last two months.

All of the antidepressants helped and there were no major differences, said the study’s lead author, Dr. Andrea Cipriani of the University of Verona in Italy.

“If a patient is taking a drug and doing well, he should not stop and switch drugs,” Cipriani said.

The other drugs reviewed were:

• Celexa (citalopram)
• Cymbalta (duloxetine)
• Effexor (venlafaxine)
• Ixel (milnacipran)
• Luvox (fluvoxamine)
• Prozac (fluoxetine)
• Seroxat (paroxetine)
• Remeron (mirtazapine)
• Zyban (bupropion)

Side-effects for the various drugs include nausea, sleeplessness, and sexual dysfunction.

The findings may lead doctors to prescribe Zoloft and Cipralex more often, but psychiatrists should also consider alternatives such as behavioural therapy, said Irving Kirsch, a professor of psychology at Britain’s University of Hull.

The study was paid for by the authors’ academic institutions in Britain, Greece, Italy, and Japan.

Cipriani has not received any grants from pharmaceutical companies. Several of his co-authors reported receiving funding from various makers of antidepressants.

Source: cbc.ca

Popularity: 14% [?]

According to a report in the Irish Independent that did not cite any sources, Lundbeck may be considering acquiring Elan.

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Lundbeck spokesperson Mads Kronborg said that he believed the rumours were based on an analysis published in the Danish newspaper Borsen, which suggested that Elan would make a favourable takeover target. “That was based on speculation, and…we never respond to or comment on rumours,” Kronborg stated.

The Danish drugmaker has said it will seek out potential deals to bolster revenue in light of looming generic competition for its antidepressant Cipralex (escitalopram), which loses exclusivity in 2012. An analyst suggested that although Lundbeck may be considering a takeover, acquiring Elan was likely too big a step in light of the current financial situation.

Last week, the Irish drugmaker indicated it was undertaking a strategic review of its options, which could include a sale of the company.

Source: FirstWord

Popularity: 4% [?]