The role of besifloxacin in the treatment of bacterial conjunctivitis.

OBJECTIVE: To evaluate the role of besifloxacin in bacterial conjunctivitis treatment. DATA SOURCES: Searches were made on MEDLINE/PubMed and EMBASE (January 2007 to January 2014) using the terms besifloxacin and Besivance. References from these publications were reviewed for additional resources. Additional information was collected from Bausch & Lomb, the manufacturer of Besivance; www.clinicaltrials.gov; and American Academy of Ophthalmology. STUDY SELECTION AND DATA EXTRACTION: English-language documents were reviewed for pharmacology, pharmacokinetics, efficacy, and safety, with priority on clinical trials. DATA SYNTHESIS: Three large randomized controlled clinical trials established the safety and efficacy of besifloxacin ophthalmic suspension 0.6% compared with placebo or active comparator (moxifloxacin ophthalmic solution 0.5%) given 3 times a day for 5 days for acute bacterial conjunctivitis (BC) treatment. Compared with placebo, besifloxacin had clinically superior bacterial eradication rates and was noninferior to moxifloxacin. Besifloxacin was compared with placebo in 2 randomized, placebo-controlled trials, dosed twice a day for 3 days. Superior efficacy was seen compared with placebo, which supports the shorter dosing schedule. Ophthalmic besifloxacin is well tolerated; the most common adverse effect (conjunctival redness) occurred in 2% of patients. Adverse effects in 1% to 2% of patients included blurred vision, eye pain, eye irritation, eye pruritus, and headache. CONCLUSION: Besifloxacin 0.6% ophthalmic suspension 3 times a day for 5 days is safe and effective for BC. Twice-a-day dosing for 3 days was also effective-a simplified regimen compared with other fluoroquinolones. Disadvantages include price and lack of a generic. Further evaluation is needed to evaluate comparative efficacy among other ocular fluoroquinolones and unlabeled uses.

Alcaftadine for the prevention of itching associated with allergic conjunctivitis.

OBJECTIVE: To evaluate the safety and efficacy of alcaftadine for the prevention of itching associated with allergic conjunctivitis. DATA SOURCES: A medical literature search was conducted in MEDLINE/PubMed (2006-February 2012) and EMBASE (2006-February 2012) using the search terms alcaftadine and Lastacaft. References from these publications were reviewed for additional resources. Additional information was collected from Web sites of the US government (http://www.clinicaltrials.gov, http://www.fda.gov) and of Allergan Inc., the manufacturer of Lastacaft (http://www.lastacaft.com). STUDY SELECTION AND DATA EXTRACTION: All identified articles and publications in English were reviewed for pharmacology, pharmacokinetics, efficacy, and safety data. Priority was placed on clinical trials. DATA SYNTHESIS: Two published clinical trials evaluated the efficacy of alcaftadine in the prevention of ocular itching and conjunctival redness associated with allergic conjunctivitis. One trial compared alcaftadine to placebo, and another trial compared alcaftadine to placebo and olopatadine HCl to placebo. Both studies showed superior efficacy, both clinically and statistically, in the prevention of ocular itching associated with allergic conjunctivitis compared to placebo. Although conjunctival redness was evaluated in the 2 trials, neither trial demonstrated both clinical and statistical significance. Both trials demonstrated a rapid onset of action of less than 15 minutes, as well as a duration of action greater than 16 hours, which supports the use of once-daily administration. Overall, alcaftadine was well tolerated, and common adverse effects, reported in less than 4% of patients, included ocular irritation, pruritus, erythema, and stinging or burning upon instillation. Ocular adverse effects were typically mild in severity and self-limiting. CONCLUSIONS: Alcaftadine is a safe and effective option for the prevention of ocular itching associated with allergic conjunctivitis, is dosed once daily, and is competitively priced among prescription medications for allergic conjunctivitis. Additional studies are needed to further evaluate the comparative efficacy among ocular antihistamine/mast cell stabilizing medications.

Gold sodium thiomalate for the treatment of rheumatoid arthritis in a patient with hepatitis B.

OBJECTIVE: To describe a case of gold sodium thiomalate use for the treatment of rheumatoid arthritis (RA) in a patient with hepatitis B. CASE SUMMARY: A 53-year-old Korean American woman with mild RA and chronic hepatitis B infection was treated for worsening RA symptoms with subcutaneous injections of gold sodium thiomalate for 21 months, with the dosage decreased from the initial 40 mg per week to 40 mg every 3 weeks after 51 weeks of successful treatment. She had undergone treatment for hepatitis B in the past with lamivudine; however, she had not received that medication for at least 1 year prior to initiating treatment with gold sodium thiomalate injections. During the treatment period she achieved remission of RA without a significant elevation of her liver enzyme levels or reactivation of hepatitis B. DISCUSSION: Two main factors influence drug product selection when considering the subset of RA patients with chronic hepatitis B infection: severity of liver function compromise and treatment status of chronic hepatitis B. Our patient did not demonstrate significant liver function compromise, but was not receiving viral suppressive treatment for hepatitis B; therefore, the use of many first-line nonbiologic disease-modifying antirheumatic drugs (DMARDs) was contra-indicated based on current guideline recommendations. Additionally, because the patient had refused viral suppressive therapy, there was great concern with the use of biological DMARDs and potential reactivation of hepatitis B. In the past, gold salts were the standard of care in treating RA until the development of the newer agents and there was some evidence that gold sodium thiomalate could be used with minimal risk of hepatotoxicity. CONCLUSIONS: Gold sodium thiomalate proved to be a safe and effective treatment option in a patient with RA and hepatitis B.