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By William T. Elliott, MD, FACP
The FDA has approved Astrazeneca’s esomeprazole (Nexium), a new proton pump inhibitor for the treatment of gastroesophageal reflux disease (GERD). The drug, commonly called "Son of Prilosec," is being introduced just as the company is losing its patent for omeprazole (Prilosec), AstraZeneca’s billion dollar drug. Esomeprazole is the S-isomer of omeprazole. The new drug was also approved for treatment of erosive esophagitis and as part of a multidrug regimen for treatment of Helicobacter pylori.
The FDA has also approved the first non-CFC propelled steroid inhaler for the long-term treatment of asthma. Marketed under the name QVAR, 3M pharmaceuticals has formulated beclomethasone dipropionate in a solution that results in smaller particle sizes and better lung penetration. This increased penetration allows for twice-a-day dosing and the option of not using a spacer device, since little of the medication is deposited in the mouth and throat. QVAR is indicated for the long-term treatment of asthma in patients 12 years of age and older.
The nations three largest pharmacy benefit management companies (PBMs) are joining together to provide each other with electronic information, linking patients, pharmacies, and health plans. The new joint venture, called RxHub LLC, is the result of a collaboration between PBM giants Merck-Medco, AdvancePCS, and Express Scripts, companies that provide pharmaceutical coverage accounting for more than 1 billion prescriptions per year. The basis of the new company is electronic prescribing, allowing doctors to send electronic prescriptions from their offices to pharmacies, thus saving time, cutting down on errors, and alerting physicians of potential drug interactions. The system will also be able to help doctors with formulary compliance and suggest generic drugs when available. RxHub will be funded by the PBMs and will be free to participating physicians.
Many patients swear by dietary supplements, claiming improved sense of well-being and sleep. If they have been taking Anso Comfort Capsules made by NuMeridian, the reason could be that the capsules contain chlordiazepoxide (Librium). The FDA ordered a nationwide recall of the capsules after an investigation showed the capsules contained the Schedule IV drug benzodiazepine. Company officials report that the raw materials for the Comfort Capsules were imported from China.
Are there patients that should not be taking aspirin? A new study suggests that patients at low risk for heart disease will not benefit from daily aspirin and may actually be harmed by the drug. The findings are the result of a meta-analysis of 4 large, randomized, controlled trials of aspirin for primary prevention. Aspirin significantly reduced the risk of cardiovascular events and myocardial infarction but increased the risk of bleeding complications. In patients with high or moderate risk of cardiovascular disease, the benefit outweighed the risk. But in patients with low risk of cardiovascular disease (defined as coronary event risk < 0.5%/y), aspirin was associated with higher mortality (Heart. 2001;85:265-271). The findings from a different study point out how useful aspirin is within the first 48 hours of acute myocardial infarction (AMI). Researchers in Germany compared the outcomes of AMI patients who did not receive aspirin to those who did and found that no aspirin was associated with a 27% in-hospital mortality, while only 11% of those who received aspirin in the first 48 hours died (Am Heart J. 2001;141:200-205).
Eli Lilly is losing patent protection on its antidepressant fluoxetine (Prozac) later this year. The August patent expiration means that the market will soon be flooded with inexpensive generic Prozac capsules, with Lilly losing one of its major revenue sources. But the company is not going down without a fight. Last year Lilly reformulated fluoxetine and reintroduced it as "Sarafem" for the treatment of premenstrual dysphoria; now, the company has received FDA approval to market a once-a-week fluoxetine under the trade name "Prozac Weekly." The new preparation provides 90 mg of fluoxetine in an enteric-coated tablet. The drug is indicated for depression in patients who are being treated with long-term therapy and have been stabilized.
Inhaled insulin may soon be a reality. Type 1 diabetics were given preprandial inhaled insulin along with a bedtime injection of a long-acting insulin in a recent study. After close monitoring and adjustments in dose at 12 weeks, HbA1c levels, as well as fasting and postprandial glucose levels, and the incidence of hypoglycemia was not significantly different than in a control group using injectable insulin (Lancet. 2001;357:331-335). The inhaled insulin preparation was also found to be well tolerated in type 2 diabetics, improving glycemic control and showing no short-term adverse pulmonary effects (Ann Intern Med. 2001;134:203-207).
The selective estrogen receptor modulator (SERM) raloxifene (Evista Eli Lilly) has been shown to reduce the risk of breast cancer in women who are taking it for osteoporosis. SERMs have pro-estrogen effects on some tissues, and anti-estrogen effects in others. The Multiple Outcomes of Raloxifene Evaluation (MORE) trial is following more than 7500 women, with one-third each randomly assigned to raloxifene 60 mg/d, raloxifene 120 mg/d, or placebo.
Women taking raloxifene were found to have lower incidence of all breast cancers. The incidence of invasive breast cancer was reduced by 72% in women taking the drug. Side effects such as hot flashes were more common in the treatment group, and the incidence of thromboembolic disease was double in the treatment group (Breast Cancer Res Treat. 2001;65:125-134).
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