The higher a patient’s International Normalized Ratio (INR) value, the higher the risk of death, according to a study by researchers from the Hospital of Kungalv in Sweden. The INR is a measurement used in patients who are receiving oral anticoagulation therapy. The degree of anticoagulation is calculated from the prothrombin time (which measures the efficacy of the therapy) and is expressed as the INR.

The investigators analyzed 1.25 million INR measurements and the records of 42,451 patients receiving anticoagula-tion therapy at 46 clinics. Of those patients, 3,533 died. The mortality rate was lowest among patients with an INR of 2.2 to 2.3—regardless of the indication for anticoagulation treatment. However, 1,069 patients died within seven weeks after an INR of 3.0 or higher.
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The researchers estimated risk to be such that at least 500 deaths were associated with, but not necessarily caused by, a high INR. Not enough autopsies were performed to accurately determine the number of deaths that were caused by bleeding.

The researchers expected that bleeding would be the only cause of death that increased with increasing INR, but their analysis suggests that other causes predominated. A high INR has been reported to suggest a final stage of disease; malnutrition, diarrhea, and other factors probably influence the INR.

Just as many women are throwing out their hormone replacement prescriptions, an ongoing study has shown a link between prior use of hormone replacement therapy (HRT) and a reduced risk of Alzheimer’s disease. However, the data suggest that the benefits can take 10 years to appear, say researchers for the Cache County Study.

In this long-term trial, 1,889 women and 1,357 men were first assessed between 1995 and 1997. Between the initial interview and follow-up, 88 women (4.7%) and 35 men (2.6%) were found to have Alzheimer’s disease. Among those over 80 years of age, the risk for women was double that for men; however, in women who reported earlier use of HRT, the risk was 41% lower. Alzheimer’s disease developed in 26 of 1,066 women who had received HRT compared with 58 of 800 women who had never used HRT. The risk varied with the duration of therapy, and this sex-specific increased risk disappeared with more than 10 years of treatment.
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If the theory about the10-year lag time is correct, one of the study coauthors stated that “it explains a very large and seemingly conflicted literature” on the relationship between HRT and Alzheimer’s disease. The study findings corroborate other recent research suggesting that HRT may help prevent Alzheimer’s disease.

Rosiglitazone maleate in combination with metformin hydrochloride (Avandamet drug, GlaxoSmithKline) has been approved for long-term control of glucose levels in patients with type 2 diabetes. The additive effect of the two drugs has been found to reduce hemoglobin A1c levels more than the action of tablet metformin alone. (A high hemoglobin A1c score is associated with the risk of diabetes.) Intended for use as an adjunct to exercise and diet, this “two-in-one” therapy offers cost savings and simplified dosing.

For a full description of this drug, see the Pharmaceutical-Approval Update feature in this issue.

Children and adolescents with attention deficit hyperactivity disorder (ADHD) have smaller brains than children without the disorder—but medication treatment is not the reason, say researchers from the National Institute of Mental Health (NIMH). Moreover, although the brains of ADHD children were smaller, they developed in the same way as those of patients without ADHD. This suggests that whatever caused the disorder probably occurred before the medication was given; in fact, the researchers add, the medication may actually help to mature the brain.

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Antihypertensive treatment with nitrendipine, a dihydropyridine calcium channel blocker, reduced the incidence of dementia by 55%, according to new data from the Systolic Hypertension in Europe Study.

After earlier findings from the study showed that the incidence of dementia was halved, from 7.7 cases to 3.8 per 1,000 patients, the researchers extended their study into an open-label, active-treatment, follow-up trial. At the same time, they also continued the Vascular Dementia Project to review their original estimates of the drug’s benefit.
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The data are based on 5,849 patient-years of follow-up in the former placebo group and on 6,359 patient-years in the active treatment group. The overall incidence of dementia was 5.2 cases per 1,000 patient-years, 43 in the control group, and 21 in the active treatment group. The incidence of both Alzheimer’s disease and mixed or vascular dementia was reduced.

The findings, say the researchers, imply that treating 1,000 patients for five years might prevent 20 cases of dementia. These results, as well as those from other overviews, suggest that calcium channel blockers offer better protection against stroke than diuretics and beta blockers do.

The Food and Drug Administration (FDA) has approved adefovir dipivoxil tablets (Hepsera™, Gilead Sciences) for patients with chronic hepatitis B, a serious infection that can cause cirrhosis, liver cancer, liver failure, and death. Hepsera^TM slows the progression of the infection by interfering with viral replication and causing deoxyribonucleic acid (DNA) chain termination after its incorporation into viral DNA.

The FDA’s approval is based on two randomized, double-blind, placebo-controlled studies. At week 48, 53% of patients in one study and 64% in the other study showed significant improvement in liver inflammation caused by the hepatitis B virus (HBV), compared with 25% and 35% of patients receiving placebo. Patients taking Hepsera^TM also showed statistically significant improvement in the degree of liver fibrosis. Hepsera^TM has also been shown to be effective in treating patients with clinical evidence of HBV that is resistant to lamivudine, an antiviral agent.
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The major adverse events included severe, acute exacerbation of hepatitis B after the drug regimen was discontinued; this result has also been seen with other hepatitis treatments.

Patients who stop taking Hepsera^TM should be monitored for hepatic function at regular intervals over a period of time. Kidney toxicity was reported in patients who were at risk for or who had underlying kidney dysfunction. The FDA has noted a theoretical concern that resistance to HIV might emerge in patients who have chronic hepatitis B with unrecognized or untreated HIV infection.

When a stroke leaves a patient with disabling spasticity, botulinum toxin type A (Botox^TM, Allergan) may help restore enough muscle function to make life easier. In a multicenter trial of 126 patients, those who were given one-time intramuscular injections of botulinum toxin type A experienced greater improvement in flexor tone in the wrist and fingers at all follow-up visits through 12 weeks compared with patients who received placebo. Each patient (or care-giver) chose a principal target of treatment from four areas of disability: hygiene (e.g., ease of cleaning and nail trimming), dressing, limb position, and pain. At week six, 40 of 64 patients given botulinum toxin type A reported improvement in the individual principal target of treatment compared with 17 of 62 in the placebo group. No major adverse events were associated with the injection.
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The researchers point out that botu-linum toxin type A has a localized effect, which minimizes the risk of systemic adverse events.