Newly Approved Statin to Debut in U.S. in 2010
A new statin drug is expected to be available in the United States in 2010 after recently receiving approval from the U.S. Food and Drug Administration. Livalo® (pitavastatin), a potent HMG-CoA reductase inhibitor, is indicated for the primary treatment of hypercholesterolemia and combined dyslipidemia. Livalo differs from other, currently available statins in the United States in that it has a unique cyclopropyl group on the base structure. This cyclopropyl group contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potentially affords greater low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol. In addition, pitavastatin is only minimally metabolized by the liver through the cytochrome P450 pathway, through which many other medications are metabolized.
In pivotal Phase III trials, Livalo effectively reduced LDL-C and improved other parameters of lipid metabolism in special patient populations, including older adults, patients with diabetes, and patients at higher cardiovascular risk. The overall safety and tolerability of Livalo are consistent with other commonly prescribed statin drugs.
Source.“FDA Approves Livalo®for Primary Hypercholesterolemia and Combined Dyslipidemia.” (2009, August 3). Retrieved October 2, 2009, from http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/08-03-2009/0005070988&EDATE=.
Combination Pill Approved for High Blood Pressure
The combination drug Valturna® (aliskiren and valsartan) has been approved by the U.S. Food and Drug Administration for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
Valturna combines in a single pill valsartan, the active ingredient in the blood pressure medication Diovan®, and aliskiren, the active ingredient in Tekturna®, the only approved direct renin inhibitor. Valturna, which targets two key points within the renin system—also known as the renin angiotensin aldosterone system, an important regulator of blood pressure—offers significantly greater blood pressure reduction than either valsartan or aliskiren alone.
The approval was primarily based on a pivotal 8-week randomized, double-blind, placebo-controlled clinical trial in approximately 1,800 patients, which studied aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in combination. The initial dosages of aliskiren and valsartan were 150 mg and 160 mg, respectively, and were increased at 4 weeks to 300 mg and 320 mg, respectively. Blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the 8-week primary endpoint. Mean systolic and diastolic blood pressure reductions from baseline were 17.2/12.2 mmHg for aliskiren 300 mg/valsartan 320 mg, compared with 12.8/9.7 mmHg for valsartan 320 mg, 13.0/9.0 mmHg for aliskiren 300 mg, and 4.6/4.1 mmHg for placebo (p < 0.05 for aliskiren/valsartan versus monotherapies or placebo).
Source.“Novartis Receives FDA Approval for Valturna®, a Single-Pill Combination of Valsartan and Aliskiren, to Treat High Blood Pressure.” (2009, September 17). Retrieved October 2, 2009, from http://www.novartis.com/newsroom/media-releases/en/2009/1342100.shtml.
Outpatient Procedure Aims to Reduce Bowel Incontinence
A minimally invasive outpatient procedure to treat bowel incontinence is now available. Mederi Therapeutics Inc.’s Secca® Therapy delivers radiofrequency energy to the muscles of the anal canal—tightening the muscles, producing better bowel control, and reducing the symptoms of incontinence.
Secca Therapy takes approximately 45 minutes and is performed in an endoscopy suite or ambulatory surgery unit, with the patient under general anesthesia or conscious sedation. Patients go home approximately 1 to 2 hours after the procedure and typically resume normal activities within several days. In clinical trials, as many as 8 of 10 patients had a positive clinical response to Secca Therapy and showed significant improvement in quality of life scores. In addition, recent clinical studies have shown symptom relief lasting as long as 5 years. For more information, visit http://www.secca-therapy.com.
Source.“Secca®Therapy—An Effective and Minimally Invasive Option for Treating Bowel Incontinence—Launched in the US.” (2009, August 31). Retrieved October 2, 2009, from http://www.reuters.com/article/pressRelease/idUS139761+31-Aug-2009+PRN20090831.
Disinfectant Ready to Take on Flu Germs
SpectraSan™ 24 disinfectant, based on the patented silver dihydrogen citrate antimicrobial, meets the recommendations by the U.S. Centers for Disease Control and Prevention for infection control for care of patients with confirmed or suspected H1N1 virus in both home and health care settings.
SpectraSan 24’s broad spectrum power completely and rapidly eliminates bacteria, fungi, and viruses, including Influenza A. Organism kill times, registered with the Environmental Protection Agency (EPA), include:
- Standard indicator bacteria: 30 seconds, with a 24-hour residual kill.
- Some resistant strains of bacteria: 2 minutes.
- Fungi: 10 minutes.
- HIV Type I: 30 seconds.
- Other pathogenic viruses: 10 minutes.
SpectraSan 24 is 100% biodegradable, safe, and is the only registered disinfectant assigned the lowest toxicity rating by the EPA. It is available in 4-ounce pump-spray bottles, 32-ounce trigger-spray bottles, and 1 gallon jugs. For more information, visit http://www.spectrasan.com.
Source.“BioTech Medical Well-Positioned to Immediately Respond to Swine Flu Emergency with SDC-Based SpectraSan 24 Disinfectant.” (2009, April 27). Retrieved October 2, 2009, from http://www.spectrasan.com/press/well_positioned.html.
Diabetes Treatment Gets Small and Sleek
Medingo US Inc.’s miniature, tube-free insulin delivery system, cleared by the U.S. Food and Drug Administration in July 2009 and introduced at the American Association of Diabetes Educators Meeting this past summer, will be the smallest, lightest, most discreet full-featured insulin pump on the market once available for sale.
Solo™ MicroPump is made of two parts that work together wirelessly, the MicroPump and the Remote. The MicroPump is composed of a disposable insulin reservoir and a 90-day reusable pump base that stores a patient’s pump parameters for accurate and precise 24-hour basal delivery, as well as boluses on demand. The reservoir holds up to 200 units of insulin. The MicroPump is attached to the body with a cradle that allows insulin delivery through a soft tube and allows patients to attach and detach the MicroPump.
The Solo Remote is the “brains” of the operation. Approximately the size of a smart phone, the Solo Remote allows patients to program basal and bolus delivery just like any traditional pump. But instead of being connected to the pump, it wirelessly downloads all the information to the MicroPump so it can work continuously, even if the Remote is not within reach. “Pay-as-you-pump” pricing is also available. For more information about the Solo MicroPump, visit http://www.solo4you.com.
Sources.“About Solo.” (2009). Retrieved October 5, 2009, from http://www.solo4you.com/?page=AboutSolo&ID=9&pageType=0#.“Medingo Introduces Solo™MicroPump Insulin Delivery System at the American Association of Diabetes Educators Meeting After Receiving FDA Clearance.” (2009, August 5). Retrieved October 2, 2009, from http://www2.prnewswire.com/mnr/solo4you/39463/.
Reusable Charts Track Medication Information
EasyMinder Reusable Lists are low-tech yet easy-to-use supportive tools that help patients and caregivers keep track of medication regimens. EasyMinder’s laminated charts have rows to accommodate up to six different medications with columns for each day of the week. There are also spaces to record time of day the medication is to be taken, the medication’s color and shape, and important instructions for the patient or caregiver.
Both the chart and kit include two nontoxic markers: The black marker is used to write the medication information, and the red marker is used to make an “X” as each dosage is taken. The writing can be easily erased with a damp cloth or rubbing alcohol. On the back of each chart are areas to list emergency telephone numbers.
Also available is a Weekly Med-Minder Kit that includes two removable pill dispensers labeled for day and night with compartments for each day of the week attached to the Weekly Medication Chart. To view all EasyMinder products, visit http://www.easyminders.com.
Source.Helping patients be more medication compliant with the weekly Med-Minder Chart [Press release]. (n.d.). Lawrence, MA: HD Merrimack.