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.

Organ transplantation is a safe treatment option for patients with human immunodeficiency virus (HIV) infection who need the operation, conclude researchers who reported their findings at the International Congress of the Transplantation Society. More important, they add, the immunosuppressive drugs used to control organ rejection seem to have little effect on HIV progression.
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The advent of new treatments, such as highly active antiretroviral therapies (HAARTs), has meant that HIV patients who have liver disease are living longer— and thus are at risk for end-stage liver failure as a result of the infection or as a result of nephrotoxic drugs. The challenge, the researchers say, lies in finding the right balance between the antirejection drugs and the antiretroviral therapies. Oversuppression of the immune system might allow the HIV infection to worsen, but too low a dose puts the patient at risk for organ rejection.

Researchers at Hahnemann University Hospital in Philadelphia reported that 17 of 20 kidney transplant patients with HIV infection are alive one year after their study, with a very low to undetectable viral load. In one of the 20 patients, graft rejection developed because of an interaction with HAARTs.

In a French study, presented by a researcher from Paul Brousse Hospital in Villejuif, six patients with HIV infection and hepatitis C underwent liver transplantation. One died of liver failure, but the rest are alive more than a year later, with negligible levels of HIV viral load. However, interactions between the antirejection drug tacrolimus and protease inhibitors caused an acute rejection in one patient and toxic levels of tacrolimus in another.

In a study of seven liver and four kidney transplant patients at the University of Pittsburgh, the researchers observed profound drug interactions between tacrolimus and HAART that included a protease inhibitor. In contrast, regimens that included nucleoside reverse tran-scriptase inhibitors or non-nucleoside reverse transcriptase inhibitors resulted in less significant effects.
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A study conducted at the University of California, San Francisco, found that viral loads have remained undetectable in four liver and 10 kidney transplant recipients. One patient died as a result of a rapid recurrence of the hepatitis virus. The researchers reported no evidence of significant HIV progression and no adverse effects of the virus on organ function.

Xyrem, manufactured by Orphan Medical, has been approved for treating patients with narcolepsy who have episodes of cataplexy, a sudden loss of muscular control and weakness, usually triggered by emotions. The drug’s active ingredient is sodium oxybate, also known as gamma hydroxybutyrate (GHB).

Because of the abuse of GHB—it is used recreationally and in date rapes— distribution will be tightly controlled under Schedule III of the Controlled Substances Act. For the 20,000 to 50,000 people in the U.S. who suffer from narcolep-tic cataplexy, however, the news will be welcome, regardless of the restrictions. Cataplexy can cause a person with narcolepsy to collapse when the legs buckle. In clinical studies with 448 patients, the use of Xyrem, compared with placebo, reduced the number of cataplectic attacks.
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Xyrem can have serious side effects, including confusion, depression, difficulty breathing while sleeping, loss of consciousness, and abnormal thinking. Abuse of the drug can lead to dependence. For these reasons, and in light of the drug’s history, the FDA and the manufacturer have designed a comprehensive risk management program (the Xyrem Success Program). For instance, prescribers and patients will be able to get the drug only through a single centralized pharmacy.

About 30% of patients who have had my-ocardial infarction (MI) have a reoc-cluded artery within the first year of successful fibrinolysis, say researchers from the Interuniversity Cardiology Institute of the Netherlands. They found, however, that three months of heparin and coumarin therapy reduced reoc-clusion and recurrent events after successful thrombolysis by 45%.

The Antithrombotics in the Prevention of Reocclusion in Coronary Thrombolysis (APRICOT)-2 trial included 308 patients who had a patent infarct-related artery 48 hours after fibrinolysis. Patients were randomly assigned to standard hepariniza-tion therapy and continuation of aspirin alone or to three months of aspirin therapy with moderate-intensity coumarin as well as continued heparin.
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At three months, only 15% of patients taking coumarin plus aspirin experienced reocclusion compared to 28% taking aspirin alone. Only 2% had a new MI, compared to 8% taking aspirin. Only 13% needed revascularization, compared with 31% receiving aspirin. The reocclusion rate for patients taking fibrin-specific lyt-ics was 17%, versus 24% for those taking non–fibrin-specific agents. Bleeding was infrequent.

I can help keep glaucoma at bay, according to the Ocular Hypertension Treatment Study, cospon-sored by the National Eye Institute. Researchers found that eyedrops reduced open-eye glau­coma, the most common form of glaucoma, by more than 50%.

Of 1,636 patients between 40 and 80 years old who had elevated eye pressure but no glaucoma, half were given commercially available eyedrops daily (either singly or in combination) and the other half received no medication. The eyedrops reduced eye pressure by approximately 20%—a relatively modest reduction with an apparently protective effect. Of patients who received eyedrops, 4.4% developed glaucoma within five years, compared with 9.5% of those who did not receive the eyedrops. The researchers also found several significant risk factors associated with glaucoma: older age, African descent, higher eye pressure, certain characteristics in the anatomy of the optic nerve, and thinness of the cornea.
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Despite the benefits, the researchers say, eye care professionals should not prescribe eye-drops for all people who have elevated eye pressure but no sign of glaucoma. In fact, 90% of participants in the observation group did not develop glaucoma within five years. The research team advises factoring in individual risk, health status, and life expectancy, as well as the cost, inconvenience, and possible side effects of daily treatment. Their study took into account the fact that African Americans are three to four times more likely to develop glaucoma than Caucasians, so 25% of the study participants were African American.

In the study, patients given eyedrops did not show increased evidence of health problems compared with the observation group.

The study was published in the July 2002 issue of Archives of Ophthamology.

Otitis media is one of the most common bacterial infections in children. The Vaccines and Related Biological Products Advisory Committee to the FDA recently voted in favor of expanding the indication of Pneumococcal 7-valent Conjugate Vaccine (Diptheria CRM₁₉₇ Protein). The drug is sold as Prevnar by Wyeth Vaccines.
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The committee believed that there were adequate data to support the efficacy of the vaccine for the prevention of otitis media caused by Streptococcus pneumonia, because there are seven serotypes in the vaccine. This drug can­not prevent all middle ear infections, but it could lead to a reduction in the number of occurences.

Two studies presented at the American College of Obstetrics and Gynecology’s annual meeting suggest that a balloon device called ON-Q would provide postoperative pain control. The balloon device dispenses a local anesthetic into the surgical site. In a study of 30 women who had undergone elective abdominal hysterectomy, 10% needed no additional pain medication beyond ON-Q, and 33% used only nonsteroidal anti-inflammatory drugs. ON-Q delivered 0.5% ropivacaine, 0.5% bupivacaine, or 2% lidocaine to the surgical site at a rate of 2 ml per hour.
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Another study, conducted at the University of Tennessee in Memphis, found that ON-Q reduced opioid use by 40% and delivered equivalent pain relief to patients who had cesarean sections.