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.

A new breast cancer treatment uses an unusual method of administering chemotherapy— patients soak their breasts in hot water, which forces the chemotherapy drugs that are encapsulated in liposomes to release most of their contents into the breast tissue. The liposomal packaging melts above the usual body temperature (in this study, 104° F).

The encapsulation allows delivery of 30 times more of the drug to the breast tissue, without poisoning the rest of the body, according to researchers who reported on their study at the annual meeting of the American Society of Clinical Oncology. The 12-week, phase I trial of doxorubicin encased in liposomes (Myocet, The Liposome Company Inc.) and paclitaxel (Taxol, Bristol-Myers Squibb Company) is the only clinical trial of its kind in the U.S.

Of the 21 patients with newly diagnosed, large invasive breast tumors, 33% had complete remission; 17% were able to have lumpec-tomy instead of mastectomy, and 11% had complete pathologic responses. Tumor growth was arrested in all women in the study and half of the women had at least partial tumor shrinkage, even though many of the tumors were initially inoperable. Moreover, the researchers observed that nausea, fatigue, and cardiac tox-icity were lower than with traditional chemotherapy.

The study reversed the usual order of surgery, followed by chemotherapy and radiation. After a traditional infusion of chemotherapy, patients underwent hyperthermia drug treatments every three weeks for four cycles, followed by the least invasive surgery needed to remove the tumor. Additional chemotherapy and radiation might be needed postoperatively, the researchers say.

Etoricoxib, a highly selective COX-2 inhibitor, was evaluated in two recent trials: one for patients with rheumatoid arthritis, the other for patients with acute gouty arthritis.

In the first study, conducted for the Etoricoxib Rheumatoid Arthritis Study Group, 687 patients completed 12 weeks of treatment with placebo, etoricoxib 90 mg/day, or naproxen 500 mg BID. The study was conducted at 67 sites in 28 countries. Compared with patients on placebo, patients in both drug groups showed significant improvements in all endpoints. Similar percentages (58% and 59%) of naproxen and etoricoxib patients, respectively, responded according to American College of Rheumatology criteria: tender joint and swollen joint counts, patient and investigator assessment of disease activity. Etoricoxib treatment effects were rapid, the investigators say, occurring at the earliest time measured (week two) and were maintained over the entire study period. Both drugs were similarly well-tolerated. Only three serious clinical adverse events were judged to be drug-related: two patients on etoricoxib (duodenal ulcer and hip pain), and one on naproxen (hypertension).

In the second trial, of 150 patients in 11 countries with acute gouty arthritis, a once-daily dose of etoricoxib 120 mg worked as well for symptoms as did indometacin 50 mg three times daily for eight days. There were also controls for each drug. Both etoricoxib and indometacin groups experienced comparable pain relief, starting four hours after the initial dose. The two drugs were well-tolerated. Four patients in the indometacin group reported serious adverse events (vomiting and headache). Etoricoxib was associated with a lower incidence of drug-related adverse events (P=0.003) than indometacin.

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.

In clinical tests, involving more than 6,000 patients with type 2 diabetes who took rosiglitazone throughout North America and Europe, researchers found no hepatotoxic effects.

Researchers wondered whether rosiglitazone (Avandia tablet, GlaxoSmithKline) would act similar to another thiazolidine-dione, troglitazone (Rezulin, Warner-Lambert), which has been associated with idiosyncratic hepatic reactions leading to liver failure and death. They analyzed data from 13 double-blind clinical trials of rosiglitazone monotherapy and two ongoing, active-comparator clinical trials. No evidence of liver toxicity was observed either in monotherapy or in combination therapy for 5,006 patients.

The results aren’t unexpected, the researchers say, because rosiglitazone and troglitazone are markedly different in their biochemical and metabolic features and hepatic effects. Rosiglitazone is a PPAR-y agonist that is 100 times more effective than troglitazone. Both compounds have a thiazolinedione core, but they have different side chains. Unlike troglitazone, which has been shown to be directly toxic to cultured rat hepatocytes, rosiglitazone does not concentrate significantly in the liver, nor does it recirculate through the biliary system. The kidneys excrete 65% of the rosiglitazone generic. The researchers note that liver toxicity is unlikely to be a thiazoline-dione or PPAR-y agonist class effect.

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.

At the annual meeting of the American Diabetes Association (ADA), many studies presented data indicating that insulin aspart (rDNA origin) injection (Novolog, Eli Lily and Company) maintains adequate control of blood sugar levels for people with type 1 diabetes if the injection is administered right before or just after a meal. Human insulin has to be injected 30 minutes before a meal, which is problematic for many people with type 1 diabetes, because they need to calculate their insulin dose based on the amount of carbohydrates to be consumed in a meal.

The mealtime dosing study compared the use of insulin aspart before and after a meal. Results showed that postprandial glycemic control was adequate regardless of when the drug was administered, but glycemic response was 25% lower when insulin aspart was administered before a meal rather than after it.
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Two other studies presented at the ADA showed that insulin aspart provided better glycemic control than regular human insulin (RHI). In one study, insulin aspart given just before a meal was compared with RHI given 30 minutes before the meal. Peak glucose levels were 25 minutes shorter, postprandial glucose surges were 20°% lower (P=0.034), and peak insulin levels were reached 27 minutes earlier with insulin aspart than with RHI. The other study compared treatment with insulin aspart with or without bedtime insulin, RHI with or without NPH insulin, and human premixed insulin. Insulin aspart had greater reductions in HbA1c than the RHI group or the insulin premix group. Postprandial glucose levels decreased the most with insulin aspart.

Another study on insulin aspart focused on gestational diabetes. It included 15 women who were 18 to 28 weeks pregnant and unable to achieve adequate glycemic control through diet alone. The women underwent a series of tests on three different days in random order. In one test, no insulin was administered; in the other two tests, they received either insulin aspart or RHI. The study showed that insulin aspart was more effective than RHI in blunting the postprandial glucose peak 60 minutes after the meal and reducing the overall amount of glucose in the bloodstream (to which the fetus is exposed) following the meal.