Antibiotic Treatment of Acute Lower Respiratory Infection
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Acute lower respiratory tract infection (bronchitis) is the most common complaint bringing patients to the doctor in England, where it is estimated that 75% of these patients receive an antibiotic at the first visit. A new study from England defines acute lower respiratory tract infection as an uncomplicated acute illness, with cough as the primary symptom and at least one symptom or sign localized to the lower respiratory tract including sputum, chest pain, dyspnea, or wheeze.
In a recently published study, 807 patients were randomized to an information leaflet, no leaflet, immediate antibiotics, delayed antibiotics, or no antibiotics. Patients with chronic lung disease and those with suspected pneumonia were excluded. A total of 562 patients subsequently returned diaries regarding duration and severity of symptoms. Cough lasted a mean of 11.7 days after the initial visit. Antibiotics, either delayed or immediate, had no effect on cough duration (delayed, 0.75 days; 95% CI, -0.37 to 1.88; immediate, 0.11 days; 95% CI, -1.01 to 1.24). The information leaflet also had no effect on the main outcomes. There were slightly more return visits for patients who were not prescribed antibiotics and also for patients who received information leaflets. Patients with colored sputum were no better with antibiotics, and elderly patients were actually less likely to benefit from antibiotics than younger patients. The authors conclude that withholding or delaying antibiotics has no effect on the course uncomplicated lower respiratory tract infections and is an acceptable alternative to immediate antibiotic treatment. They also found that most patients are agreeable to this strategy as long as it is explained to them (Little P, et al. JAMA. 2005;293:3029-3035). An accompanying editorial reviews the data in the United States that suggests that most patients with presenting complaint of cough and diagnosis of acute bronchitis received an antibiotic in 2002. The editorial suggests that these antibiotics are generally of no value, and that patients will have 3 weeks of cough with or without antibiotic treatment. The editorial states ". . . physicians have no duty to fill patients’ expectations for inappropriate care, such as prescribing antibiotics when they are not indicated. . ." and urges physicians to hold off on antibiotics for acute uncomplicated lower respiratory tract infections (Ebell MH. JAMA. 2005;293:3062-3064).
Similarly, the use of antibiotics in children with infective conjunctivitis may be unnecessary in the majority of cases. In a study also from England, 326 children aged 6 months to 12 years with the clinical diagnosis of conjunctivitis were randomized to chloramphenicol eye drops or placebo eye drops. The primary outcome was clinical cure at day 7. All children were followed for 6 weeks to identify relapse. Clinical cure by day 7 occurred in 83% of children in the placebo group, compared with 86% of children in the chloramphenicol group (risk difference 3.8%; 95% CI, -4.1% to 11.8%). Four percent of children in the chloramphenicol group and 3% of children in the placebo group had further conjunctivitis episodes within 6 weeks. Adverse reactions were rare and evenly distributed between the groups. The authors suggest that acute infective conjunctivitis in children does not require treatment with an antibiotic (Rose PW, et al. Lancet. 2005;366:37-43).
What to do with the Cox-2s
A Canadian advisory panel has opened the door for rofecoxib (Vioxx) to be reintroduced to the Canadian market. An expert panel met at the request of the Canadian government to review all Cox-2 inhibitors including celecoxib (Celebrex) which has remained on the market, rofecoxib (Vioxx), which was voluntarily withdrawn from the market in September of 2004, and valdecoxib (Bextra), which was withdrawn from both the Canadian and US markets in April 2005. The panel reviewed cardiovascular data from the 3 drugs and recommended that Celebrex stay on the market and Vioxx be allowed back on the market with appropriate labeling and patient warnings. They also voted to keep Bextra off the market because of lack of data on the drug's safety and efficacy. Bextra has also been associated with severe skin disorders, as well as cardiovascular disease. Cox-2 inhibitors, especially Vioxx, have been associated with increased cardiovascular mortality in several studies. The Canadian panel felt, however, that with appropriate patient selection, that the drug may be safely offered as an alternative for pain relief.
Can Mucomyst Prevent CIN?
The practice of using N-acetylcysteine (Mucomyst) to prevent contrast-induced nephropathy (CIN) in patients undergoing cardiac catheterization may be of no value according to new study from Brazil. Patients who were at low-to-moderate risk of CIN were randomized to N-acetylcysteine 600 mg orally twice a day for 2 days or placebo prior to coronary angiography or percutaneous coronary intervention. Only low osmolality ionic contrast medium was used in the procedures. Of the 156 patients enrolled, 16 patients developed CIN within 48 hours; 8 of 77 patients in the N-acetylcysteine group and 8 of 79 patients in the placebo group (P = 1.00). The mean serum creatinine was similar in both groups, and no difference was observed in the change in creatinine clearance between the N-acetylcysteine and placebo. The authors conclude that N-acetylcysteine does not prevent contrast-induced nephropathy in patients at low to moderate risk who are undergoing cardiac catheterization with low osmolality contrast medium. The authors recommend appropriate hydration and a small volume of contrast medium in patients at risk (Gomes VO, et al. Heart. 2005;91:774-778).
Benzodiazepines and Medicare Coverage
Congress is debating a controversial aspect of the Medicare Part D prescription benefit plan that excludes benzodiazepines from coverage. Mental health experts are lobbying to add coverage for the drug class which includes diazepam (Valium), alprazolam (Xanax), lorazepam (Ativan), and clonazepam (Klonopin). A bipartisan bill has been introduced to reverse the exclusion which would affect approximately 1.7 million low income seniors currently taking the drugs. Initially excluded because benzodiazepines are thought to be generally inappropriate for elderly patients, Congress may need to rethink the policy. Sponsors of the bill to reverse the exclusion include the AMA, the American Psychiatric Association, and the National Alliance for the Mentally Ill.
FDA Actions
The FDA has approved sildenafil citrate for the treatment of early-stage pulmonary hypertension. The approval was based on a priority review of a randomized, double-blind trial in 277 patients that showed that sildenafil significantly increased exercise ability from baseline, compared with placebo. Pfizer, which also markets sildenafil for erectile dysfunction under the trade name Viagra, will market the drug for this indication of the trade name Revatio.
The FDA has approved insulin detemir injection, a new long-acting subcutaneous insulin preparation. The drug is approved for adults who require once or twice a day administration of a basal insulin to control hyperglycemia. Insulin detemir is active for up to 24 hours, but is generally active in a relatively flat action profile from 2 to 14 hours. Insulin detemir will be marketed by Novo Nordisk as Levemir.
This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5416. E-mail: [email protected].
What to do with the Cox-2s; Can Mucomyst Prevent CIN?; Benzodiazepines and Medicare Coverage; FDA Actions.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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