STATISTICS & TRENDS
NexgenRx Health News

Issue
1 - July 2005

NexgenRx is pleased to bring you information on selected, new single source drugs that have received approval by Health Canada as well as new indications for drugs already on the market. There are situations when a drug has received a Notice of Compliance
but the drug may not be available in the immediate future. Health News will also include brief snapshots of information on common disease states and health related issues from a variety of international sources.
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New Drugs

Brand Name:

Myfortic

Manufacturer: Novartis
Active Ingredient: Mycophenolic Acid
DIN: 02264560 Myfortic 180mg enteric coated tablet, 02264560 Myfortic 180mg enteric coated tablet
Indication: Prevention of renal transplant rejection (in conjunction with cyclosporine and corticosteroids)
Date of NOC: February 4
Status: Prescription by Law
Comment: Myfortic may replac Cellcept® since it is essentially the enteric coated version of the molecule, appears to have fewer adverse effects and is less expensive.



Brand Name:

Niaspan

Manufacturer: Oryx Pharmaceuticals
Active Ingredient: Nicotinic Acid
DIN: 02262347 Niaspan sustained release tablet 500mg, 02262355 Niaspan sustained release tablet 750mg, 02262330 Niaspan sustained release tablet 1000mg
Indication: Cholesterol Management
Date of NOC: March 3
Status: Prescription by Law
Comment: Not interchangeable with Niacin.


Brand Name:

Sativex

Manufacturer: Bayer
Active Ingredient: Delta-9-tetrahydrocannabinol, Cannabidiol
DIN: 02266121 Sativex buccal spray 27mg/ml, 25mg/ml
Indication: Analgesic in Multiple Sclerosis Neuropathic Pain
Date of NOC: April 15
Status: Prescription by Law
Comment: N/A


Brand Name:

Lyrica

Manufacturer: Pfizer Canada Inc.
Active Ingredient: Pregabalin
DIN: 02268418 Lyrica 25mg capsule, 02268426, Lyrica 50mg capsule, 02268434, Lyrica 75mg capsule, 02268442, Lyrica 100mg capsule, 02268450, Lyrica 150mg capsule, 02268469, Lyrica 200mg capsule, 02268477, Lyrica 225mg capsule, 02268485, Lyrica 300mg capsule
Indication: Analgesic
Date of NOC: June 3
Status: Prescription by Law
Comment: N/A


Brand Name:

Subutex

Manufacturer: Schering Canada Inc.
Active Ingredient: Buprenorphine
DIN: 02242962 Subutex 0.4mg sublingual tablet, 02242963 Subutex 2mg sublingual tablet, 02242964 Subutex 8mg sublingual tablet
Indication: Opiate agonist/antagonist: for substitution treatment in opioid drug dependence in adults through SUBUTEX National Education Program
Date of NOC: January 21
Status: Prescription by Law
Comment: N/A
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New Indications

Femara
received approval in April 2005 for the extended treatment of early breast cancer in post menopausal women previously treated with tamoxifen.

Alertec has a new indication, effective June 2005, as additional therapy for day time sleepiness due to sleep apnea.

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Cardiovascular Disease Updates

Statins and Coenzyme Q10

Statins are widely used to lower cholesterol in patients at risk of heart attack or stroke, either as primary prevention or after a cardiovascular event. This class of dugs includes Lipitor® (atorvastatin), Crestor® (rosuvastatin), Mevacor® (lovastatin), Lescol® (fluvastatin),Zocor® (simvastatin) and Pravachol® (pravastatin).
These drugs are effective in lowering Low Density Lipoproteins (LDL-the “bad” cholesterol) but a number of patients, particularly on higher doses, find it hard to be compliant when they suffer from muscle aches and pains
caused by these drugs. A recent double blind study in the US indicated that 100mg of coenzyme Q10 taken daily improved muscle pain associated with taking the statin and was well tolerated.

Coenzyme Q 10 is not presently eligible on the majority of drug plans.

Source:
Doctor's Guide August 2005. The complete article can be viewed by accessing www.docguide.com.

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High Dose Statin Therapy

Clinical trials have shown that lowering the LDL below the current recommended guidelines can be beneficial for cardiac patients. Cardiologists may be prescribing Lipitor® 80mg for some patients. This will require closer monitoring of enzymes that indicate if muscle damage is taking place .Since Lipitor® 40mg and 80mg are the same cost, there would be no increased cost to the patient if the dose doubles. There are no generic equivalents of Lipitor® available in Canada

Source:
New England Journal of Medicine March 8 2005.
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Low Dose ASA

How low is effective?

Clinical trials have shown that lowering the LDL below the current recommended guidelines can be beneficial for cardiac patients. Cardiologists may be prescribing Lipitor® 80mg for some patients. This will require closer monitoring of enzymes that indicate if muscle damage is taking place. Since Lipitor® 40mg and 80mg are the same cost, there would be no increased cost to the patient if the dose doubles. There are no generic equivalents of Lipitor® available in Canada.

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Hypertension
The ALLHAT (Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial) study indicates that in the US only 1 in 3 patients diagnosed with hypertension has levels indicated in clinical practice guidelines to minimize the
risk of future heart attack or stroke. Figures from other countries are worse. High blood pressure is easily treated with a variety of safe, well tolerated drugs.

Source:
MedScape 2005. The complete article can be viewed by accessing www.medscape.com.

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Policosanol and Cholesterol Lowering
Policosanol is a product extracted from sugarcane and has been shown to reduce LDL (“bad” cholesterol) in a small clinical trial. First steps in cholesterol lowering would include lifestyle changes in terms of types of dietary fats consumed, weight reduction and increase in exercise. If these steps do not achieve acceptable levels of LDL, HDL and triglycerides then the next step is usually medication with drugs like statins that are effective in lowering LDL. Policosanol may be useful for patients with borderline high LDL. The drug is well tolerated, relatively inexpensive but is not presently eligible on the majority of drug plans. Normal dosage is 10-20mg daily.

Source:
MedScape 2005. The complete article can be viewed by accessing www.medscape.com.

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Remove the Salt Shaker
Randomized controlled trials studying 737 adults with high blood pressure demonstrated that reducing daily salt intake by 4.6gram for a period of 4 weeks resulted in decrease in systolic reading of on average 5mmHg and diastolic by 2.7mmHg . Similar studies in adults with no reported hypertension showed a decrease of 2mmHg and 1mmHg in systolic/diastolic pressure. People who are motivated can decrease blood pressure by this simple measure.

Source:
Cochrane Library.

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Heart Attacks in Young Men

Preliminary research indicates that Chlamydia pneumoniae may increase the risk
of heart attack in young men. This micro organism is related to the bacterium that causes the better known sexually transmitted Chlamydia.

C.pneumoniae is not sexually transmitted but can lead to pneumonia, bronchitis and sinus infection. It is a common illness and by age 30, half of people have evidence of previous exposure to this infection.

Source:
Doctor's Guide. The complete article can be viewed by accessing www.docguide.com

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Crestor for Cholesterol Lowering
Health Canada issued a warning to Asian patients using Crestor® that there may be an increased risk of developing muscle related adverse effects. The serum levels in Asian-Americans were found to be twice the level found in Caucasian patients.

Source:
Canadian Pharmaceutical Journal.

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Antihypertensive and Quality of Life

Patients diagnosed with high blood pressure need to take medication, often for decades, as preventative treatment. It is important that the drugs used are well tolerated otherwise the compliance rate will be further reduced.
Since most people with high blood pressure generally feel no symptoms there is a higher likelihood of non-compliance. Often the only way to gauge quality of life is by using subjective questions to assess symptoms.

The three symptoms that differed most significantly in patients with high blood
pressure were emotional distress, cardiac symptoms and concern about effects on sexual function.

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NSAIDs and Heart Attack
Researchers at Nottingham University, UK compared patients taking NSAIDs in the 3 months prior to a heart attack with patients who had not taken the drug for 3 years. The risk increased by 24% in patients taking Ibuprofen (Advil, Motrin), 55% with Diclofenac(Voltaren),Celebrex 21%, and Vioxx 32%. This group of drugs are widely used in elderly patients who are also at increased risk of heart attack.

Source:
British Medical Journal.

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Guggul for High Cholesterol
Guggul is a substance secreted from the bark of the mukol myrrh tree, native to India, when the tree is damaged. It has been used in Asia to treat high cholesterol and is gaining interest in the US as more patients seek alternative treatment for high cholesterol.

Source:
MedScape 2005. The complete article can be viewed by accessing www.medscape.com.

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10 year Survival after Minor Stroke
The Lancet reports that 43% of patients who suffer a minor stroke can expect to have a second event within 10 years. Secondary stroke prevention is essential in patients with TIA (transient ischemic attack) and their risks should be re-evaluated regularly to prevent cerebrovascular and cardiovascular events in the future.

Source:
Doctor's Guide August 2005. The complete article can be viewed by accessing www.docguide.com.

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Sleep Therapy may protect against Heart Disease
Continuous positive airway pressure, commonly used to treat sleep apnea, may protect against death related to cardiovascular disease according to a study from the US. Sleep apnea is associated with some modifiable risks such as obesity, smoking and alcohol consumption.

Source:
Doctor's Guide August 2005. The complete article can be viewed by accessing www.docguide.com.

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H.pylori and Atrial Fibrillation
A British study indicates that Helicobacter pylori. a gastric bacterium commonly found in patients with stomach ulcers, may also be linked to the development of atrial fibrillation (irregular heartbeat). H.pylori tests are available and the bacterial infection treated with a combination of antibiotics and proton pump inhibitors for a period of 7 days.

Source:
Doctor's Guide August 2005. The complete article can be viewed by accessing www.docguide.com.

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Invasive Treatment after Heart Attack
Patients who have a suspected heart attack and do not receive thrombolytic treatment (clot dissolving drugs)within 12 hours to preserve heart muscle function may benefit from having a stent, a small device inserted into the major blood vessels to maximize blood flow to the heart muscle, implanted . Patients are often seen in emergency rooms after that critical 12 hour when there is no benefit to be gained from administration of the clot buster drugs.

Source:
Doctor's Guide August 2005. The complete article can be viewed by accessing www.docguide.com.

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Cholesterol Skin Test
Prevu Skin Sterol Test should be available in Canada soon. This test takes 5 minutes, is non-invasive and does not require 12 hour fasting prior to the test. It measures the amount of cholesterol in the skin and is designed to be used in doctor’s offices, pharmacies or clinics. The test itself is $15 but requires a spectrophotometer to read the result (cost $2750 to purchase). This could be an effective screening tool to identify patients at risk prior to doctors prescribing cholesterol lowering drugs.

Source:
Pharmacist’s Letter 2005.

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