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Singh M.,Mayo Medical School | Rihal C.S.,Mayo Medical School | Spertus J.A.,Mayo Medical School | Nair K.S.,Diabetes | Roger V.L.,Mayo Medical School
Circulation: Cardiovascular Quality and Outcomes | Year: 2011

Background-Although older patients frequently undergo percutaneous coronary interventions (PCI), frailty, comorbidity, and quality of life are seldom part of risk prediction approaches. We assessed their incremental prognostic value over and above the risk factors in the Mayo Clinic risk score. Methods and Results-Patients ≥ 65 years who underwent PCI were assessed for frailty (Fried criteria), comorbidity (Charlson index), and quality of life [SF-36]. Of the 628 discharged [median follow-up of 35.0 months (interquartile range, 22.7 to 42.9)], 78 died and 72 had a myocardial infarction (MI) . Three-year mortality was 28% for frail patients, 6% for nonfrail patients. The respective 3-year rates of death or MI were 41% and 17%. After adjustment, frailty [hazard ratio (HR), 4.19 [95% confidence interval (CI), 1.85, 9.51], physical component score of the SF-36 (HR, 1.59; 95% CI, 1.24 to 2.02), and comorbidity, (HR, 1.10; 95% CI, 1.05, 1.16) were associated with mortality. Frailty was associated with mortality/MI (HR, 2.61, 1.52, 4.50). Models with conventional Mayo Clinic risk score had C-statistics of 0.628, 0.573 for mortality and mortality/MI, respectively. Adding frailty, quality of life, and comorbidity, the C-statistic was (0.675, 0.694, 0.671) for mortality and (0.607, 0.587, 0.576) for mortality/MI, respectively. Including frailty, comorbidities and SF-36, conferred a discernible improvement to predict death and death/MI (integrated discrimination improvement, 0.027 and 0.016, and net reclassification improvement of 43% and 18%, respectively). Conclusions-After PCI, frailty, comorbidity and poor quality of life are prevalent and are associated with adverse long-term outcomes. Their inclusion improves the discriminatory ability of the Mayo Clinic risk score derived from the routine cardiovascular risk factors. © 2011 American Heart Association, Inc.

Seaquist E.R.,University of Minnesota | Anderson J.,Frist Clinic | Childs B.,Mid America Diabetes Associates | Dagogo-Jack S.,University of Tennessee Health Science Center | And 5 more authors.
Diabetes Care | Year: 2013

OBJECTIVE-To review the evidence about the impact of hypoglycemia on patients with diabetes that has become available since the past reviews of this subject by the American Diabetes Association and The Endocrine Society and to provide guidance about how this new information should be incorporated into clinical practice. PARTICIPANTS-Five members of the American Diabetes Association and five members of The Endocrine Societywith expertise in different aspects of hypoglycemia were invited by the Chair, who is a member of both, to participate in a planning conference call and a 2-day meeting that was also attended by staff from both organizations. Subsequent communications took place via e-mail and phone calls. The writing group consisted of those invitees who participated in the writing of the manuscript. The workgroupmeeting was supported by educational grants to theAmerican Diabetes Association from Lilly USA, LLC and Novo Nordisk and sponsorship to the American Diabetes Association fromSanofi. The sponsors had no input into the development of or content of the report. EVIDENCE-The writing group considered data fromrecent clinical trials and other studies to update the prior workgroup report. Unpublished data were not used. Expert opinion was used to develop some conclusions. CONSENSUS PROCESS-Consensus was achieved by group discussion during conference calls and face-to-facemeetings, as well as by iterative revisions of the written document. The document was reviewed and approved by the American Diabetes Association's Professional Practice Committee in October 2012 and approved by the Executive Committee of the Board of Directors in November 2012 and was reviewed and approved by The Endocrine Society's Clinical Affairs Core Committee in October 2012 and by Council in November 2012. CONCLUSIONS-The workgroup reconfirmed the previous definitions of hypoglycemia in diabetes, reviewed the implications of hypoglycemia on both short- and long-term outcomes, considered the implications of hypoglycemia on treatment outcomes, presented strategies to prevent hypoglycemia, and identified knowledge gaps that should be addressed by future research. In addition, tools for patients to report hypoglycemia at each visit and for clinicians to document counseling are provided. © 2013 by the American Diabetes Association.

PLAINSBORO, N.J., Nov. 21, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for Xultophy® 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection)....

SAN DIEGO, Nov. 10, 2016 /PRNewswire/ -- Today, Dexcom, Inc. (NASDAQ:DXCM), a provider of continuous glucose monitoring (CGM) for patients with Type 1 Diabetes, announced that it has teamed up with professional soccer player Jordan Morris of Seattle Sounders FC, who will share his...

News Article | February 27, 2017

SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announces the completion of enrollment in the Company’s Phase 2 clinical trial with its novel, small-molecule glucagon receptor antagonist LGD-6972 for the treatment of type 2 diabetes mellitus (T2DM). This randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of LGD-6972 as an adjunct to diet and exercise in subjects with T2DM whose blood glucose levels are inadequately controlled with metformin. The Company expects to report topline results in September 2017. In this Phase 2 study, subjects with T2DM are being treated with one of three doses of LGD-6972 (5 mg, 10 mg, or 15 mg) or placebo once daily for 12 weeks. The primary endpoint is change from baseline in hemoglobin A1c (HbA1c). Secondary endpoints include change from baseline in fasting plasma glucose, insulin, glucagon and GLP-1, as well as changes in lipids, blood pressure and body weight. In a subset of subjects, an oral glucose tolerance test is also being conducted at baseline and at the end of treatment. “We are pleased with the rapid enrollment of patients, an accomplishment that enables us to report topline data by the end of the third quarter of 2017, ahead of our timeline projections,” said John Higgins, Chief Executive Officer. “Antagonism of the glucagon pathway is one of the most promising new therapeutic approaches for type 2 diabetes, and we believe LGD-6972 has potential valuable therapeutic properties. We look forward to obtaining data later this year, and to exploring potential partnerships for this program, consistent with our shots-on-goal business model.” Based on Phase 1 trial results that were published in Diabetes, Obesity and Metabolism in January 20171, Ligand believes LGD-6972 holds potential to have promising and differentiating properties given its potency in lowering plasma glucose in patients with T2DM and its preliminary safety profile. Glucagon is a hormone produced by the pancreas that stimulates the liver to produce glucose (sugar). Overproduction of glucose by the liver is an important cause of high glucose levels in patients with T2DM and is believed to be due in part to inappropriately elevated levels of glucagon. Glucagon receptor antagonists (GRA) are designed to lower glucose levels by reducing the production of glucose by the liver. GRAs are novel molecules that have demonstrated a reduction of glucose and HbA1c in mid-stage clinical trials. Preclinical studies have shown that LGD-6972 is highly potent and selective, that it inhibits glucagon-induced hyperglycemia in both rats and monkeys and that it also significantly lowers glucose in a mouse model of T2DM. Additionally, LGD-6972 significantly lowered fasting and non-fasting glucose levels in a mouse model of type 1 diabetes and reduced HbA1c, ketone bodies and free fatty acids. LGD-6972 also has been shown to have additive effects when used in combination with insulin therapy and may be useful in an insulin-sparing regimen. Diabetes is a growing global epidemic that as of 2015 affected more than 415 million people worldwide2. In North America, approximately 44 million people have diabetes2. If current trends continue, by 2050 fully 33% of the U.S. population will be affected3. People with T2DM either are resistant to the effects of insulin or do not produce enough insulin to maintain a normal glucose level. Sustained high glucose levels can cause diabetic complications such as heart disease, stroke, kidney failure, neuropathy, lower-limb amputations and blindness. Although T2DM is more common in adults, it increasingly affects children as childhood obesity increases. An estimated 90% to 95% of Americans with diabetes have T2DM4. The global market for diabetes drugs is expected to nearly double to $68 billion by 20225 as treatment paradigms shift toward combination therapies and novel non-insulin drugs. Global sales of the top 10 non-insulin diabetes drugs exceeded $15 billion in 2016 and are expected to increase to $20 billion by 20206. Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly. This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding the timing of the release of topline results from the Phase 2 clinical trial of LGD-6972 with subjects with T2DM, the potential for LGD-6972 to treat patients with T2DM, the potential for LGD-6972 to exhibit best-in-class properties, Ligand’s ability to partner the program in the future, the number of patients affected by diabetes, the annual total sales of non-insulin diabetes drugs and the expected future sales of such drugs. Actual events or results may differ from our expectations. For example, patients in the Phase 2 clinical trial could drop out during the course of treatment which require additional enrollment to complete the Phase 2 clinical trial; the timing of the data from our third party clinical contractors could be delayed due to circumstances beyond Ligand’s control; Ligand could require additional time to analyze the data prior to release; the clinical trial could fail to reach its primary or secondary endpoints which could result in Ligand’s inability to partner the program; and the safety and tolerability data from a new clinical trial in LGD-6972 may conflict with the results of the Phase 1 clinical trials; the number of patients diagnosed with diabetes may be more or fewer than Ligand believes; and the total sales of non-insulin diabetes drugs is dependent on market acceptance of such drugs. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 1. Eric G. Vajda, et al. Pharmacokinetics and pharmacodynamics of single and multiple doses of the glucagon receptor antagonist LGD-6972 in healthy subjects and subjects with type 2 diabetes mellitus, Diabetes Obes Metab 2017; 19(1):24–32. 3. James P Boyle, et al. Projection of the year 2050 burden of diabetes in the U.S. adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. American Diabetes Association, Population Health Metrics. 2010 Oct 22;8:29

INDIANAPOLIS and RIDGEFIELD, Conn., Dec. 15, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim Pharmaceuticals, Inc. announced today that BASAGLAR® (insulin glargine injection 100 units/mL) is available by prescription in the U.S. BASAGLAR is a follow-on...

Brito J.P.,Mayo Medical School | Domecq J.P.,Diabetes | Murad M.H.,Diabetes | Guyatt G.H.,McMaster University | Montori V.M.,Mayo Medical School
Journal of Clinical Endocrinology and Metabolism | Year: 2013

Context: In 2005, the Endocrine Society (TES) adopted the GRADE system of developing clinical practice guidelines. Grading of Recommendations, Assessment, Development, and Evaluation working group guidance suggests that strong recommendations based on low or very low (L/VL) confidence may often be inappropriate, and has offered a taxonomy of paradigmatic situations in which strong recommendations based on L/VL confidence estimates may be appropriate. Objective: We sought to characterize strong recommendations of TES based on L/VL confidence evidence. Data Sources and Extraction:We identified all strong recommendations based on L/VL confidence evidence published in TES guidelines between 2005 and 2011. We identified those consistent with one of the paradigmatic situations in the taxonomy. Data Synthesis: Two hundred six of 357 (58%) of the recommendations of TES were strong; of these, 121 (59%) were based on L/VL confidence evidence. Of these 121, 35 (29%) were consistent with one of the paradigmatic situations. The most common situation (13, 11%) was of a strong recommendation against the intervention because of low confidence evidence for benefit and high confidence evidence for harm. The remaining 86 (71%) comprised 43 (36%) "best practice" statements for which sensible alternatives do not exist; 5 (4%) in which recommendations were for "additional research"; 5 (4%) in which greater confidence in the estimates was warranted; and 33 (27%) for which we could not find a compelling explanation for the incongruence. Conclusions: Guideline panels should beware of formulating strong recommendations when confidence in estimates is low. Our taxonomy when such recommendations are appropriate may be helpful. Copyright © 2013 by The Endocrine Society.

RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 12, 2016 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Synjardy® XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. When used along with diet and exercise, SYNJARDY XR...

News Article | December 13, 2016

INDIANAPOLIS, Dec. 13, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that people who use Lilly insulin will be able to access discounted prices for their purchases starting January 1, 2017 via mobile and web platforms hosted by Blink Health. The discounts,...

Tanwani L.K.,Diabetes
American Journal Geriatric Pharmacotherapy | Year: 2011

Background: Most elderly patients with type 2 diabetes require, or will eventually require, insulin to achieve or maintain their glycemic goals. However, insulin therapy remains underused in this population. Objective: The goal of this review is to evaluate the role of insulin therapy in elderly patients and identify strategies to improve its use in this patient population. Methods: Searches of the MEDLINE and EMBASE databases were conducted to identify papers published in English between January 1990 and March 2010. The following search terms were used: diabetes mellitus, insulin, elderly, geriatric, analog, premix, pen device, and human insulin. Papers selected for review included meta-analyses, randomized controlled trials of insulin therapy, or evidence-based reviews and/or expert opinion regarding the use of insulin in elderly patients with diabetes. Results: Insulin therapy is the most effective antidiabetic agent when appropriately dosed; however, only a minority of elderly patients with diabetes uses it. Although there are few randomized controlled studies on insulin use in the elderly, an individualized approach to insulin therapy is recommended to account for varying clinical and practical factors that affect diabetes care in this patient population. Therapy with insulin analogs offers several advantages compared with human insulin regimens, including a more physiologic pharmacologic profile, increased convenience, and a reduced risk of hypoglycemia, which may make them particularly attractive in older adults. Premixed insulin analog therapy may provide added convenience, as well as improved glycemic control. Insulin pen devices are also recommended to facilitate insulin dosing and help patients maintain their independence. Conclusions: The improved clinical profiles of insulin analogs and the ease of use of newer insulin delivery devices may be advantageous in elderly patients with diabetes; however, additional research on the efficacy and safety of insulin regimens is urgently needed. © 2011 Elsevier HS Journals, Inc.

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