Approximately 56% of patients taking current BP lowering therapies do not reach current recommended BP goal of <140/90 mm Hg or <130/80 mm Hg for patients with diabetes, chronic renal disease, or chronic cardiovascular disease. More than two-thirds of hypertensives require ≥ 2 antihypertensive medications in order to achieve goal BP control. Fixed-dose combination (FDC) treatment simplifies dosing regimens & reduces pill burden. Fixed-dose antihypertensive combination treatments may also improve patient compliance as compared to taking each medication separately.

Taking these benefits in to consideration US FDA has approved a new triple drug combination, Tribenzor , which combines olmesartan medoxomil 40 mg, amlodipine 10 mg , and hydrochlorothiazide 25 mg . It is approved for hypertensives who are not adequately controlled on any 2 of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers and diuretics. It is not approved for initial therapy.

According to the trial which contributed to the approval of this combination: 2,492 hypertensives who were switched to this combination pill from the dual combination therapies yielded a significantly greater mean reduction after 8 weeks of treatment in both systolic & diastolic BP. The most common adverse reactions seen in clinical trials were dizziness, peripheral oedema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhoea, urinary tract infection, and joint swelling.

This 3-in-1 pill thus offers a simple, convenient, and consistently effective therapy for hypertensive patients and may be effective option to achieve target BP goal.

August 2010

 

The US Food and Drug Administration (FDA) has approved besifloxacin 0.6% ophthalmic suspension for the treatment of bacterial conjunctivitis caused by susceptible isolates of CDC coryneform group G, Corynebacterium pseudodiphtheriticum , Corynebacterium striatum , Haemophilus influenza , Moraxella lacunata , Staphylococcus aureus , Staphylococcus epidermidis , Staphylococcus hominis , Staphylococcus lugdunensis , Streptococcus mitis group, Streptococcus oralis , Streptococcus pneumonia , and Streptococcus salivarius bacteria.

Approval of this topical fluoroquinolone was based primarily on data from a randomized, double-blind, multicenter clinical trial of patients aged 1 to 98 years, showing that use of besifloxacin was significantly more effective for achieving clinical resolution of bacterial conjunctivitis symptoms than the non medicated vehicle alone (45% vs. 33%; 95% confidence interval, 3% – 22%). Microbiologic outcomes also revealed a statistically significant increase in eradication rate for causative pathogens (91% vs. 60%).

Source: www.medscape.com Accessed on 19/11/2009

 

The U.S. Food and Drug Administration have approved ganciclovir ophthalmic gel 0.15% as a topical treatment for acute herpetic keratitis.

The FDA's action was based on data from an open-label, randomized clinical trial (n = 164) and 3 randomized, single-blind studies (n = 213) conducted in Europe and Asia, showing that ganciclovir 0.15% ophthalmic gel was non inferior to acyclovir 3% ophthalmic ointment for achieving clinical resolution of dendritic ulcers at day 7 (77% vs. 72% and 72% vs. 69%, respectively). Both are standard-of-care therapies outside of the United States and selectively target herpes simplex virus DNA replication.

The recommended dosing regimen for ganciclovir ophthalmic gel is 1 drop instilled in the affected eye 5 times daily until the ulcer heals, and then 1 drop 3 times daily for 7 days. Adverse events most commonly reported in clinical trials included blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Source: www.medscape.com Accessed on 19/11/2009

 

The FDA has approved bepotastine besilate 1.5% ophthalmic solution for the twice-daily treatment of ocular itching associated with allergic conjunctivitis in patients aged 2 years and older.

Approval of the histamine H1 receptor antagonist was based primarily on data from 2 phase 3 double-blind, conjunctival allergen challenge studies (n = 237) showing that bepotastine significantly decreased ocular itching relative to use of the vehicle alone at 15 minutes and 8 hours post dose.

Adverse events reported in 2% to 5% of treated patients included eye irritation, headache, and nasopharyngitis.

Source: www.medscape.com Accessed on 19/11/2009