A showcase of interesting drug study findings, relevant policy decisions and important pharmacy landscape patterns.

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First Treatment Guidelines for Pediatric Type 2 Diabetes Released

In February, the American Academy of Pediatrics issued the first set of treatment guidelines for children and adolescents with type 2 diabetes. Although type 2 diabetes remains uncommon among children younger than age 10, its incidence is increasing among children between the ages of 10 and 18. According to the National Institutes of Health, type 2 diabetes now accounts for about 25% of diabetes cases among older children and adolescents. The guidelines recommend either insulin or metformin as first-line therapy, depending on the child, and suggest that lifestyle modifications such as diet and exercise should be integrated in conjunction with medications at the time of initial treatment, rather than being implemented alone before initiating medications.1

Rising Cancer Survivor Rates Bring New Issues

As more cancer patients successfully treat their disease for longer periods of time and the number of cancer survivors increases, cancer is increasingly being treated as a chronic condition rather than a terminal illness. According to new estimates from the National Cancer Institute, about 13.7 million cancer survivors were living on January 1, 2012. As treatment improves, the number is expected to reach 18 million by 2022.2 Surviving cancer, however, does not mean being completely free from its effects. Many patients continue to need additional cancer treatment and supportive therapy for related problems such as anxiety, fatigue, pain and sleep disturbances.

More Rxs Being Moved to OTC Status

Multiple products, including allergy medications such as Claritin® (loratadine) and ulcer drugs such as Prilosec® (omeprazole), have made successful transitions from prescription-only (Rx) status to over-the-counter (OTC) dispensing in the past several years. Recognizing that many of today’s patients are better able to manage their own medications under what are called conditions of safe use, the Food and Drug Administration (FDA) has launched a broader proposal, the Nonprescription Safe Use Regulatory Expansion initiative, to investigate additional Rx-to-OTC changes. Conditions of safe use will be tailored to each drug or drug class, and they might include appropriate diagnostic testing or periodic monitoring by a pharmacist. Some classes being considered are statins for high cholesterol, certain drugs for high blood pressure, migraine treatments and inhaled medications for asthma and chronic obstructive pulmonary disease (COPD).3

Niacin Adds to Cholesterol Risks

The HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) study was designed to prove the value of niacin, which has been prescribed widely to lower harmful types of cholesterol and triglycerides. Niacin also was believed to raise levels of beneficial high-density lipoproteins (HDL). Instead, the study investigators found that adding niacin to standard therapy with a statin drug had no effect in preventing heart attacks or strokes, or in reducing the need for artery-clearing procedures. Additionally, some study participants had major adverse effects, including serious infections and bleeding into the brain.4 The use of niacin is therefore expected to be phased out as treatment for high cholesterol.

1. Copeland KC, Silverstein J, Moore KR, et al. Management of newly diagnosed type 2 diabetes mellitus (T2DM) in children and adolescents. Pediatrics. 2013. 131(2): 364-382.
2. deMoor JS, Mariotto AB, Parry C et al. Cancer survivors in the United States: prevalence across the survivorship trajectory and implications for care. Cancer Epidemiol Biomarkers Prev. 2013. 22(4): 561-570.
3. Dearment A. Rx-to-OTC switches could be boon as FDA looks at switch paradigm. Drug Store News. February 8, 2013. Available at: http://drugstorenews.com/article/rx-otc-switches-could-be-boon-fda-looks-switch-paradigm. Accessed February 12, 2013.
4. Casteel B. Niacin therapy shows no benefits, has some harmful effects. American College of Cardiology. March 9, 2013. Available at: http://www.cardiosource.org/News-Media/Media-Center/News-Releases/2013/03/HPS2-THRIVE.aspx. Accessed April 8, 2013.