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Drugs Today – January 2009

Antihypertensives: Finding a better combination
Combining an angiotensin-converting enzyme (ACE) inhibitor with a calcium channel blocker instead of a diuretic may provide a greater cardiovascular benefit, reports the New England Journal of Medicine. In a randomized, double-blind trial called ACCOMPLISH, more than 11,500 hypertensive adults at high risk for cardiovascular events received the ACE inhibitor benazepril (Lotensin) plus either the calcium channel blocker amlodipine (Norvasc) or the diuretic hydrochlorothiazide.
After 3 years of follow-up, the incidence of cardiovascular events was 9.6% with benazepril and amlodipine and 11.8% with benazepril and hydrochlorothiazide. Blood pressure reductions were similar in the groups.

Approval for new analgesic
The Food and Drug Administration (FDA) has approved tapentadol, an analgesic with opioid and nonopioid modes of action. The centrally acting synthetic analgesic is an opioid receptor agonist and a norepinephrine reuptake inhibitor. In placebo-controlled trials, tapentadol provided significant relief of moderate-to-severe pain in patients with end-stage joint disease and other conditions, says the manufacturer.
The drug will be available in oral tablets in doses of 50, 75, and 100 mg. The drug’s label will carry warnings common to opioids.

A drug for jet lag
A study of 450 people with simulated jet lag found that those who took the highest of four doses of tasi­melteon had 89% sleep efficiency the first night, compared with 71% of those who took a placebo. Tasimelteon imitates the function of melatonin, a hormone that regulates the body’s sleep-wake cycle. Though the results are promising, more research is needed to prove the effectiveness of the drug.

Prenatal anticonvulsant exposure link to autism?
Children exposed prenatally to anticonvulsants, particularly valproate (Depakene), may have an increased risk of autism spectrum disorders, according to the interim results of an ongoing prospective study.
The study participants include 249 children whose mothers took an anticonvulsant during pregnancy and 338 children of women who did not. Ten of the children were diagnosed with an autism spectrum disorder: three from the control group and seven who were exposed to an anticonvulsant. Of the seven, four were exposed to valproate.
The authors emphasize that many of the children in the study were under the usual age for a diagnosis of autism spectrum disorders and acknowledge the limitations of their small, ongoing study. However, they conclude that women taking valproate should be counseled about the potential risk before they become pregnant.

More study for off-label uses
A recent study has found that off-label uses of 14 broadly prescribed drugs need further analysis of their safety and efficacy. Most of the drugs are antidepressants, including escitalopram (Lexapro) and antipsychotics, including quetiapine (Seroquel).
The researchers aren’t advocating an end to off-label prescriptions, just increased efforts to monitor their effects.

Answers on medication guides for erythropoiesis-stimulating agents
The FDA has posted common ques­tions and FDA answers regarding the medication guides for the erythropoiesis-stimulating agents (ESAs) epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp). The questions and answers explain why the guides were created, how ESAs work, and which risks they pose. The FDA also explains that a medication guide must be given to the patient or the patient’s caregiver when the drug is dispensed.

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