March  2002                                                                                                       

From: BAUSCH & LOMB

Dear Pharmacist:

The long-awaited results from the Age-Related Eye Disease Study (AREDS) conducted by the National Eye Institute (NEI)/National Institutes of Health (NIH) are in!  Bausch & Lomb is proud to have been a partner with the NEI in this study, where a unique high-potency formulation of antioxidants and zinc supplied by Bausch & Lomb was clinically proven to reduce the progression of visual acuity loss in AMD (age-related macular degeneration) patients.  This prospective, multicenter, 10-year study demonstrated a significant benefit for this unique high-potency antioxidant and zinc formulation in preventing the progression of AMD and in slowing visual acuity loss associated with select AMD patients.

This study and its key findings are outlined below:

Study:             NEI/NIH Age-Related Eye Disease Study

Title:               A Randomized, Placebo-Controlled Clinical Trial of High-Dose Supplementation With Vitamins C            

                       and E, Beta-carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss.

Publications:  Archives of Ophthalmology; October 2001; JAMA October 2001

Design:           An 11-center, double-blind clinical trial enrolled 4,757 total participants* aged 55 to 80 years from

                       November 1992 through January 1998 and followed them until April 2001.  Study subjects were 

                       divided into four categories based on clinical characteristics.

Treatment interventions were oral daily supplementation with either high-poteen antioxidants (vitamin C, vitamin E, beta-carotene), high-potency zinc, high-potency antioxidants and zinc combined, or placebo.

Category Definitions:

1.  No AMD -- essentially free of AMD, with less than 5 small drusen(<(3pm) and 20/32 vision or better in both eyes.

2.  Early AMD -- mild or borderline AMD (multiple small drusen, single or none dersive intermediate drusen (63 to 124pm), pigment abnormalities, or any combination of these) in one or both eyes, with 20/32 vision or better in both eyes.

3.  Intermediate AMD -- absence of advanced AMD in both eyes and at least one eye with 20/32 vision or better with at least one large drusen (<125pm), extensive intermediate drusen, geographic atrophy not involving the center of the macula, or any combination of these.

4.  Advanced AMD -- visual acuity of 20/32 or better and no advanced AMD (geographic atrophy involving the center of the macula or features of choroidal nonvascularization) in the study eye; (other eye had either lesions of advanced AMI) or <20/32 vision and AMD abnormalities sufficient to explain reduced visual acuity.

Key Findings:  Category 3 and 4

Advanced AMD

• For those patients taking the high-potency antioxidants and zinc combined formulas, there was a decrease (vs placebo) in the percent of patients who progressed to advanced AMD at 5 years.

• Estimated probability of progression to advanced AMD at 5 years is placebo 28% and high-potency antioxidants and zinc 20%.

• Effect of treatment on risk of progression to advanced AMD (n=2.556) odds ratio is 0.66 (99% CI:0:47-0.91), P=.001 for high-potency antioxidants and zinc vs. placebo.

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April 2001 

From: Novartis

Novartis is pleased to inform you about a new addition to the range of DIOVAN® (valsartan) dosing options.  NEW DIOVAN HCT 160/25 MG IS NOW AVAILABLE, and because we expect prescriptions for this new dose to rise over the next several months, please order early!

DIOVAN is available to more than 90% of HMO/PBM lives and is the most widely prescribed ARB in the United States.  It is proven effective regardless of age, race, or gender, is well tolerated, and offers patients the convenience of QD dosing.  So you can feel confident about filling a DIOVAN prescription in any of the 6 DIOVAN/DIOVAN HCT strengths (DIOVAN 80 mg, 160 mg, 320 mg, and DIOVAN HCT 80/12.5 mg, 160/12.5 mg, and NEW DIOVAN HCT 160/25 mg).

In general, antihypertensive drugs that affect the renin-angiotensin system have been found to be less effective in low-renin hypertensives (frequently blacks) than high-renin hypertensives (frequently whites).

When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.  When pregnancy is detected, DIOVAN OR DIOVAN HCT should be discontinued as soon as possible.

There were no significant differences in adverse events (AEs) between DIOVAN OR DIOVAN HCT and placebo.  AEs more frequent with DIOVAN than placebo; viral infections (3% vs 2%), fatigue (2% vs 1%), abdominal pain (2% vs 1%); the most common AEs; headache and dizziness.  An increase in dizziness was observed with 320 mg (8%) vs 10 mg to 160 mg (2% to 4%).  AEs more frequent with DIOVAN HCT than placebo; dizziness (9% vs 7%, viral infection (3% vs 1%), fatigue (5% vs 1%), pharyngitis (3% vs 1%), coughing (3% vs 0%), and diarrhea (3% vs 0%); the most common AEs; headache and dizziness.  A dose-related increase in the incidence of dizziness was observed in DIOVAN HCT treated patients from 80/12.5 mg (6%) to 160.25 mg (16%).

DIOVAN and DIOVAN HCT are contraindicated in patients who are hypersensitive to any component of these products.  DIOVAN HCT is not indicated for initial therapy.  Because of the hydrochlorothiazide component, DIOVAN HCT is contraindicated in patitents with anuria or hypersensitivity to other sulfonamide-derived drugs.  Volume and/or salt-depletion should be corrected in patients prior to administering DIOVAN or DIOVAN HCT or symptomatic hypotension may occur.

If you have any questions about DIOVAN HCT 160/25 mg, or to place an order, please call customer service at 1-800-526-0175.  Thank you for your continued support.

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December  2002                                                                                           

From: Lilly

We are providing to you a ClingZ® with infomration on EVISTA® (raloxifene HCl) that you can use for reference when counseling your postmenopausal patients about prevention and treatment of osteoporosis.  The ClingZ will adhere to any surface (i.e. refrigerator, wooden message boards, plastic or metal shelving) and should be placed behing the pharmacy counter for your professional use only.  Just peel the ClingZ away from the cadboard back and place it in an appropriate place for your reference.  We hope that you find the "If she asks about alterantives to HRT, talk  to her about EVISTA for osteoporosis" Cling Z a helpful resource.

We recognize that your customers may be asking you for clarification of the recent news about the findings of the Estrogen Plus Pregestin Arm of the Women's Health Initiative (WHI) Randomized Controlled Trial.  In light of that, we want to ensure that you include EVISTA as aprt of your discussio s with customer about alternative therapy for osteoporosis.  It has come to our attention that a number of healthcare professionals are undet eh impression that EVISTA was studied as part of the WHI.  We wish to clarify that EVISTA was NOT studied in the WHI for either its safety of efficacy.  The recently reported results from the WHI focused only on a comparison between placebo and conjugated equine estrogen (CEE), 0.625 mg, and medroxyprogesterone acetate (MPA), 2.5 mg, given as a combined daily tablet.

As your customers make decisions about their care, you can help them by providing information about the benefits of EVISTA.  It is important to clarify that EVISTA is not an estrogen, pregestin, or a hormone.  The dta that have led to the approved use of EVISTA for the prevention and treatment of osteoporosis in postmenopausal women have been derived from some of the largest prospective double-blind, randomized, clinical trials ever conducted by Eli Lilly and Company, inlucding the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, involving 7705 postmenopausal women with osteoporosis.  Widely accepted risk factors of osteoporosis in postmenopausal women include: Caucasian or Asian descent, slender body build, early estrogen defiency, smoking, excessive use of alcohol, low calcium diet, sedentary lifestyle, and family history of osteoporosis.  Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.

more.....

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September, 2002

From: Abbott Pharmaceuticals

Dear Pharmacist:

Please find enclosed some important information regarding Biaxin® XL (clarithromycin extended release tablets) and its patient benefits - greater tolerability than Biaxin (clarithromycin) tablets and convenient QD dosing.  Biaxin XL is readily available in bottles and pacs.

Biaxin XL is widely prescribed by the physician community, with approximately 59% of all new Biaxin/Biaxin XL tablet prescriptions being written for the extended release formulation - Biaxin XL.  Furthermore, nearly 27% of Biaxin XL prescriptions are written for the Biaxin XL pac, a convenient 7-day patient pack.

Biaxin XL extended release tablets provide patients with greater tolerability vs. Biaxin tablets, the original formulation of Biaxin.  In fact, in clinical trials, patients experienced 67% fewer discontinuations due to GI events or abnormal taste with Biaxin XL than Biaxin.

An improvement over Biaxin tablets, Biaxin XL offers patients convenient QD dosing and a short course therapy.  Biaxin XL should be prescribed 2 x 500 mg QD for 7 days for the treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis and for 14 days for the treatment of acute maxillary sinusitis.

To order Biaxin XL, please order from your usual source or call Abbott customer service at 1-800-255-5162.

Biaxin XL Indications

BIAXIN XL is indicated for mild to moderate infections in adults for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to H Influenzae, H parainfluenzae, M catarrhales, or S pneumoniae; community-acquired pneumonia due to H influenzae, H parainfluenzae, M catarrhalis, S pneumoniae, C pneumoniae (TWAR), or M pneumoniae and for acute maxillary sinusitis (AMS) due to H influenzae, M catarrhalis, or S pneumoniae.

The efficacy and safety of BIAXIN XL in treating other infections for which other formulations of BIAXIN are approved have not been established. 

Common Adverse Events

The most frequently reported adverse events in adults taking BIAXIN XL were diarrhea (6%), abnormal taste (7%), and nausea (3%).  Overall gastrointestinal adverse events were reported by a similar proportion of patients taking either BIAXIN XL or BIAXIN tablets; however patients taking Biaxin XL tablets reported significantly less severe gastrointestinal symptoms compared to patients taking BIAXIN tablets.  In addition, patients taking BIAXIN XL had significantly fewer discontinuations for drug-related gastrointestinal adverse events or abnormal taste compared to BIAXIN tablets.

Other Safety Considerations

Clarithromycin is contraindicated in patients taking cisapride, pimozide, astemizole. or terfenadine due to the potential for cardiac arrhythmias when taken in combination; and in patients with a know hypersensitivity to clarithromycin or any macrolide antibiotic.

Clarithromycin may elevate digoxin serum concentrations.  Serum digoxin concentrations should be carefully monitored while digoxin and clarithrymycin are taken concomitantly.

Clarithromycin should not be used in pregnant women except in circumstances for which no alternative therapy is appropriate.

We hope you find these materials to be educational and useful.  If you have any questions regarding Biaxin XL, please call (800) 633-9110.

Sincerely,

Tip Parker, R.Ph.                                                                                                                                                                     Sr. Manager, Trade Relations and National Accounts

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