The 2006 Medical Letter article on the then-new varicella-zoster vaccine concluded that Zostavax appears to be safe and effective in protecting patients ≥60 years old against herpes zoster and postherpetic neuralgia, especially in reducing the severity and duration of the disease.1 Some new information has recently become available.

CLINICAL STUDIES — A Veterans Administration randomized, double-blind trial enrolled more than 38,000 patients ≥60 years old and followed them for a mean of 3.4 years after administration of Zostavax or placebo. Since the efficacy of the vaccine had been demonstrated previously (51% in preventing zoster and 67% in preventing postherpetic neuralgia), the objective of this study was to examine its safety. Transient varicella-like rash occurred at the inoculation site in 0.11% of vaccine recipients and in 0.04% of patients who received a placebo injection. Erythema, swelling, pain and tenderness at the injection site were more frequent and more severe with the vaccine than with placebo. There were no other significant differences. Serious adverse events occurred in 1.4% of patients in each group.2

USE — Despite its efficacy and the frequency and morbidity of herpes zoster, this vaccine is hardly used. One study in 2007 found that only 2% of patients ≥60 years old had received it.3 A 2008 survey found that 7% of potential recipients had been vaccinated.4 A study of the reasons for such sparse usage concluded that the expense ($194 wholesale), the need for a freezer to store the vaccine (a vaccine that can be kept in a refrigerator is available in Europe), and reimbursement through Medicare Part D, which generally provides pharmacy benefits, rather than Part B, which physicians are more familiar with, were contributing factors.5

CONCLUSION — The efficacy of the herpes zoster vaccine (Zostavax) was well established before the FDA approved it in 2006. Several years’ use has now provided more data supporting the safety of the vaccine. It deserves wider use.

1. Herpes zoster vaccine (Zostavax). Med Lett Drugs Ther 2006; 48:73.
2. MS Simberkoff et al. Safety of herpes zoster vaccine in the shingles prevention study. Ann Intern Med 2010; 152:545.
3. PJ Lu et al. Herpes zoster vaccination among adults aged 60 years or older in the United States, 2007: uptake of the first new vaccine to target seniors. Vaccine 2009; 27:882.
4. JS Schiller and GL Euler. Vaccination coverage estimates from the National Health Interview Survey: United States, 2008. Atlanta: Centers for Disease Control and Prevention 2009. Accessed at www.cdc.gov/nchs/data/hestat/vaccine_coverage/vaccine_coverage.pdf on 12 May 2010.
5. LP Hurley et al. Barriers to the use of herpes zoster vaccine. Ann Intern Med 2010; 152:555.

Download: U.S. English

Two combinations of an inhaled corticosteroid with an inhaled long-acting beta2-agonist are approved by the FDA for use in patients with COPD: fluticasone/salmeterol (Advair Diskus) and budesonide/formoterol (Symbicort). A Medical Letter reader has questioned the safety of using corticosteroid inhalers in patients with this disorder. No single-agent inhaled corticosteroid inhaler is approved for this indication.

Atrial fibrillation increases the risk of stroke by a factor of 5. A randomized controlled trial (ACTIVE W) in 6706 patients with atrial fibrillation and one or more additional risk factors (≥75 years old; hypertension; previous stroke, transient ischemic attack or non- CNS embolus; left ventricular ejection fraction <45%; peripheral vascular disease; or 55-74 years old plus diabetes or coronary artery disease) found that a vitamin K antagonist such as warfarin (Coumadin, and others) was superior to clopidogrel (Plavix) plus aspirin in preventing vascular events, especially ischemic stroke.1

Now another study (ACTIVE A) from the same group of investigators has compared addition of clopidogrel to aspirin with aspirin alone in 7554 patients with atrial fibrillation and one or more additional risk factors for stroke. All of these patients were considered “unsuitable” for treatment with a vitamin K antagonist. Vascular events, primarily stroke, occurred significantly more often with aspirin alone. Major bleeding occurred significantly more often with aspirin plus clopidogrel.2

Oral anticoagulation with a vitamin K antagonist such as warfarin continues to be the treatment of choice for patients with atrial fibrillation and one or more additional risk factors for stroke.3-5 In patients who cannot or will not take a vitamin K antagonist, clopidogrel plus aspirin appears to be more effective in preventing stroke than aspirin alone.

1. ACTIVE Writing Group of the ACTIVE Investigators. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet 2006; 367:1903.

2. ACTIVE Investigators. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med 2009; 360:2066.

3. Antiplatelet and anticoagulant drugs. Treat Guidel Med Lett 2008; 6:29.

4. DE Singer et al. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133 (6 suppl): 546S.

5. AS Go. The ACTIVE pursuit of stroke prevention in patients with atrial fibrillation. N Engl J Med 2009; 360:2127.

Download: U.S. English

A new fixed-dose tablet (PrandiMet - Novo Nordisk) combining metformin (Glucophage, and others) and repaglinide (Prandin) has been approved by the FDA for treatment of type 2 diabetes in patients already taking both metformin and repaglinide, or for patients not adequately controlled on either drug alone.

Spinal decompression machines offer a motorized form of mechanical traction. These devices, which are widely advertised to the public as a noninvasive alternative to surgery, are claimed to relieve low back pain by decompressing discs, improving the flow of nutrients into the disc and rehydrating dried-out discs. Devices cleared by the FDA based on substantial similarity to previously approved power traction devices include the Accu- Spina System, DRS System, DRX9000, Lordex Traction Unit, Spinal Health Elite, SpineMED Decompression Table, SpineRx-LDM and VAX-D Therapeutic Table.

The US Centers for Disease Control and Prevention (CDC) has reported that measles outbreaks have occurred in New York City, California and Arizona in 2008, and additional cases have been confirmed in Michigan, Wisconsin, Hawaii, New York State, Pennsylvania, Illinois and Virginia (CDC Health Advisory, May 1, 2008). To date, 63 of the 64 infected patients were unvaccinated, and 54 of the cases were associated with importation of the disease. Both measles infection and vaccination (2 doses at least 28 days apart, with the first dose no earlier than 12 months of age) generally provide lifelong immunity.Patients >12 months old with no evidence of immunity (not born before 1957, no convincing history of clinical measles, no documentation of vaccination, and no laboratory evidence of immunity) should be vaccinated with MMR or monovalent measles vaccine. In an outbreak, children 6-12 months old can also be vaccinated, but they will still need 2 subsequent doses after the age of 12 months to be fully immunized.¹ Contraindications to the attenuated live-virus vaccine include pregnancy, immunosuppressive therapy, leukemia or lymphoma, and congenital or acquired immunodeficiency. Transient fever and/or rash can occur after vaccination.

1. Committee on Infectious Diseases in LK Pickering et al eds, 2006 Red Book: Report of the Committee on Infectious Diseases 27th ed, Elk Grove, Ill: American Academy of Pediatrics 2006, page 446.

Download: U.S. English

Ecamsule (terephthalylidene dicamphor sulfonic acid), the first new sunscreen agent to be approved by the FDA in 18 years, is now available in the US in a moisturizer called Anthelios SX. Ecamsule has been used in Canada and Europe for more than 10 years.