July 2011 Medical Update Information

Transcription

1 July 2011 Medical Update Information Simvastatin (Zocor) new FDA restrictions FDA statement June 2011 Based on the SEARCH 7 year trial in patients who were considered stable after have had a heart attack. 6,000 were treated with 80mg of simvastatin versus 6,000 treated with 20mg of simvastatin mg dose not recommended due to risk of muscle damage. Patients currently taking 80-mg should talk to their healthcare professional and immediately report any muscle pain, tenderness or weakness, dark or red colored urine or any unexplained tiredness. 2. Medications now contraindicated with Simvastatin: a. Erythromycin b. Clarithromycin c. Cyclosporine d. Gemfibrozil. e. Itraconazole f. Ketoconazole g. Pasaconazole (New) h. Telithromycin i. HIV protease inhibitors j. Nefazodone k. Danazol 3. Do not exceed 10 mg simvastatin daily with: Amiodarone, Verapamil & Diltiazem 4. Do not exceed 20 mg simvastatin daily with: Amlodipine & Ranolzaine Take home message If you are taking Simvastatin (Zocor) or a product that contains simvastatin (Simcor), please be aware of the information above and discuss your medication with at your next appointment. If you do not have an appointment in the near future, please call the office to discuss.

2 July 2011 Medical Update Information Anti-inflammatory medications: Many people take anti-inflammatory medications for the treatment of muscle skeletal pain. These medications are called NSAIDS (non-steroidal anti-inflammatory drugs) and many can be obtained without a prescription. In a recent analysis published in the British Medical Journal, many NSAIDS were analyzed for their safety in regards to heart attack and stroke. Please be aware that: Ibuprofen was associated with a 3.36 fold increase risk of stroke while Celebrex and Naproxen showed no statistical increase in heart attack or stroke. With this information, please try to avoid Ibuprophen and utilize non pharmaceutical options for pain, such as message, exercise and physical therapy. If you do need an NSAID, it appears that Naproxen (Aleve) and the prescription Celebrex are relatively safer options than Ibuprophen. Depending on liver health, Tylenol is also a safe alternative. Calcium supplements: Calcium supplementation is a very common treatment for bone health. Recently, 30,000 women from placebo controlled trials were randomized to new supplement use (Calcium with Vitamin D). Surprisingly, calcium with or without Vitamin D was associated with a 22% increase risk of heart attack people taking calcium with or without vitamin D would cause six additional heart attacks or strokes (a number needed to harm of 178) yet prevent only three fractures (a number needed to treat of 302). I look forward to seeing you at your next appointment to discuss this information and other data associated with heart attack & stroke prevention.

3 July 2011 Update Information Regarding Medications and Cancer Risk Medication is often necessary to treat atherosclerosis (plaque in the artery wall) and the conditions that cause atherosclerosis. It is my ultimate goal that you are on the least amount of medication to maintain a safe platform of prevention eliminating your risk of heart attacks, strokes and diabetes. Along with the proven benefits of medication, we must continually be aware and appreciate the risks of taking pharmaceutical therapy. Most recently, Actos (Pioglitazone) has been evaluated for a signal related to increased Bladder Cancer. Actos (Pioglitazone) and Bladder Cancer: The French drug regulatory authority (AFSSAPS) has issued a statement based on a signal that pioglitazone may be associated with a small increase in bladder cancer in diabetics, suggesting that the risk of bladder cancer may outweigh the intended glycemic control of the drug in diabetic subjects. Recently the American Diabetic Association and the FDA analyzed Actos trials from 1/ /2009: found 31 cases of bladder cancer for patients taking Actos out of 37,841 patients. Only 4 cases in patients on Actos >24 months. Takeda is now doing a 10 year observational study. Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the United States and is thought to be higher in diabetics. It is more common in men than women. The most common type of bladder cancer is Urothelial carcinoma, comprising 90-95% of all bladder cancers and is strongly associated with cigarette smoking. The best prevention of bladder cancer is to avoid smoking. People who smoke are at a three to four fold higher risk of getting this disease. As always, we will discuss any use of Actos and weigh the risks verses benefits of all drug therapy. Atacand and Micardis (ARBs) Associated with Increased Cancer Risk Epidemiological case-control study 21,750 new diabetics treated with ARBs for an average of 603 days. There were 1,281 incident cancer cases. Candesartan associated with a 79% increased risk (OR 1.79; 95% CI ). Telmisartan was associated with a trend toward increased risk (OR 1.54; 95% CI ). The types of cancer included the following: liver (22%), colorectal (15%), lung (11%), and urologic cancer (6%).

4 Niaspan (Vitamin B3) - AIM-HIGH Trial NHLBI announced that the AIM-HIGH study has been stopped. AIM-HIGH, a randomized, multicenter clinical trial sponsored by the NHLBI was designed to answer the question of whether raising high-density lipoprotein cholesterol (HDL-C) in patients with a history of stable, non-acute pre-existing cardiovascular disease and well controlled low-density lipoprotein cholesterol (LDL-C) would lower the rate of CV events. All AIM-HIGH participants were treated with simvastatin, with the possible addition of ezetimibe, to achieve an LDL-C between 40 and 80 mg/dl. Patients were randomly assigned to also receive either Niaspan or placebo. The AIM-HIGH data and safety monitoring board recommended stopping the trial as of May 25, 2011 because of lack of efficacy. The data from the interim analysis indicated that the trial does not show a significant difference in cardiovascular outcome event rates between the two study arms. There were 249 primary outcome events (15%) in the simvastatin arm and 262 (15%) in the Niaspan plus simvastatin (p=0.561). There were a total of 28 ischemic strokes (1.6%) in the Niaspan plus simvastatin arm and a total of 12 such events (0.7%) reported in the simvastatin arm. At this point we can only speculate on these surprising findings. Many concerns are drawn from the trial design, including: Intent to treat: AIM HIGH was designed as an intent to treat study, which allows for individuals to be included in the treatment arm without daily compliance monitoring of medication adherence. Nine of the ischemic stroke events reported in the Niaspan arm occurred after the subjects had stopped taking Niaspan for days. Confounding therapies: Ezetimibe was used in 515 participants as an add-on therapy to the statin therapy with the intent to get LDL to the treated goal of It remains yet unclear how many participants in the Niacin/statin ischemic stroke arm were also taking ezetimibe. The potential interaction between Niaspan and ezetimibe has never been formally evaluated. Population: Inclusion criteria for the study subjects included established cardiovascular disease and atherogenic dyslipidemia. This demographic possesses a multi-factorial treatment challenge, often including obesity, hypertension, insulin resistance and metabolic syndrome. This study was designed to treat the lipid portion of this risk factor profile. In this difficult to treat population, therapy beyond the lipids is essential. Treatment issues include blood pressure management, psychosocial management, exercise support, diet support, sleep management and optimal treatment of insulin resistance. Clearly, this trial perhaps supports the opportunity to recognize the multifactorial treatment necessary to treat stroke risk in this complicated patient population.

5 Stroke Prevention: The INTERSTROKE trial provides the best insight into the most common causes of ischemic stroke. The most common cause of ischemic stroke, worldwide, was determined to be blood pressure. We do not know how well BP was controlled in these patients. Heart Attack Prevention: The INTERHEART trial looked at a worldwide population and it was determined that lipids were the number one risk factor for heart attacks. AIM- HIGH is a lipid trial and, according to the preliminary release, heart attack concerns were not raised by the NHLBI safety board. Arterial Inflammation: Events are triggered by inflammation. Eradication of arterial inflammation in individuals who are resistant to insulin frequently requires therapy beyond statin and niacin. It will be interesting to see the trial results in regards to biomarkers of inflammation. I am committed to follow this data closely, as it is with due diligence that we prevent potential harm with all pharmaceutical treatment. The story regarding AIM HIGH is yet to unfold and I will be watching the daily press releases with the intent to determine the true reason for this rather surprising announcement. I share the same concerns as many providers who are dedicated to the prevention of heart attacks, ischemic stroke and diabetes. The story will continue.