FDA panel recommends second next-generation cholesterol drug.
An expert committee recommended the FDA to approve the second in a new class of drugs that can drive cholesterol levels down to unheard levels. The drug, Repatha (evolocumab) made by Amgen is a PCSK9 inhibitor, much like Sanofis’ Praluent (alirocumab). Both drugs are expected to change the landscape for heart attack prevention. Some panelists were skeptical about whether the lower LDL levels actually lead to a reduction of heart disease or is merely a surrogate endpoint. However, a majority was willing to let the drug move ahead, despite the fact that more long-term data would not be available until 2017. GlobalData, a medical analytics company group, expects the PCSK9 class to generate sales of nearly $18 billion by 2023, and the prospect of approving a pricey new class of drugs for one of the most common medical conditions in America is already drawing concerns from health insurers, employers and other payers who would absorb the costs, with some industry analysts predicting the drugs could cost $10,000 or more per year.
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Women taking SSRIs may be more likely to break a bone.
Women taking SSRIs are up to 76% more likely to break bones, according to a study published in Injury Prevention of more than 137,000 women ages 40 to 64 who started SSRIs between 1998 and 2010.The increased risk persists for at least five years following initiation of SSRI treatment.
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More on the association between SGLT2 inhibitors and DKA
A case series in Diabetes Care details the association between SGLT2 inhibitors and a serious side effect of euglycemic DKA in nine patients, seven of whom had T1D and two T2D. This case report was particularly concerning because in this instance the DKA was euglycemic, so those affected have near-normal glucose and few symptoms.
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Meeting spotlight on two big CV Trials of diabetes medications.
The ADA meeting focused on two big cardiovascular trials of diabetes medications. The full results from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) showing no increase of cardiovascular risk and no increase in hospitalizations for heart failure. The Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) trial showing not inferiority to placebo for cardiovascular safety, but not superiority in reducing cardiovascular events.
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Saxagliptin use not associated with increase in cancer incidence
The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)-TIMI 53 trial, was presented at the ADA meeting. The research indicated saxagliptin was not associated with an increase in cancer incidence or cancer-related death during 2 years of follow-up in patients with a high risk of cardiovascular disease
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T1DM patients younger than 40 may be candidates for statin use.
T1D patients younger than 40 may be candidates for statin use, as suggested at the ADA meeting. Investigators found that under the AHA/ACC definition, the 10-year cardiovascular risk was about 5% for T1D patients ages 30 to 39 and about 13% in those ages 40 to 44. Adding coronary revascularization to the definition brought the 10-year risk to 7% for T1D patients in their 30s.
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T2D patients may discontinue GLP-1 due to GI problems.
According to a poster presentation at the ADA meeting half of T2D patients on GLP-1 receptor agonists stopped taking them in the first year. Two of the top five reasons were related to GI problems. A related survey found doctors underestimated the role of GI-related problems.
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Novel basal insulin work as well as glargine, but pose liver issues.
According to research presented at the ADA meeting, the novel basal insulin peglispro works at least as well as Lantus and may hold an advantage for weight. For T2D patients, the double-blind IMAGINE 2 trial met non-inferiority criteria. In T1D patients, the open-label IMAGINE 1 trial showed for insulin peglispro’s superiority to Lantus and consistent weight loss over the 78-week follow-up, compared with weight gain in the glargine group. Both trials showed liver issues over which peglispro stumbled on the FDA way.
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Insulin pumps may improve, but not control, glycemic levels in T1D.
According to research presented at the ADA meeting, insulin pumps may improve but often don’t control glycemic levels in type 1 diabetes. The 442-patient study found that fully 38% of patients maintained a hemoglobin A1c over 8.5% on continuous subcutaneous insulin infusion and 11% were over 10% A1c.
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Sulfonylurea may not increase risk of all-cause, CV mortality.
Research presented at ADA meeting found sulfonylureas in T2D patients does not increase risk of all-cause or cardiovascular mortality, stroke or MI .
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Growing number of teens undergoing gender reassignment.
The New York Times reports that with growing tolerance for transgender individuals, the question is no longer whether gender reassignment is an option, but rather, how young should it begin. Although no law prohibits minors from receiving sex-change hormones or even surgery, insurers, both private and public, have generally refused to extend coverage for these procedures to those under 18. In 2009, a puberty-blocking protocol gained legitimacy when it was endorsed by the Endocrine Society. Used in transgender early teens, the protocol, which calls for administering puberty-blocking drugs, generally injectable Lupron (leuprolide) or the implant histrelin, provides time for teens to decide if they truly are transgender, without committing to irreversible physical changes.
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FDA Bans Trans Fats.
The FDA has officially banned trans fats, ordering food companies to phase them out over the next three years. According to the government, the ban will prevent thousands of fatal heart attacks every year.
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