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  • 1
    Online Resource
    Online Resource
    Effect of a Lifestyle Intervention Program With Energy-Restricted Mediterranean Diet and Exercise on Weight Loss and Cardiovascular Risk Factors: One-Year Results of the PREDIMED-Plus Trial
    American Diabetes Association ; 2019
    In:  Diabetes Care Vol. 42, No. 5 ( 2019-05-01), p. 777-788
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 42, No. 5 ( 2019-05-01), p. 777-788
    Abstract: The long-term impact of intentional weight loss on cardiovascular events remains unknown. We describe 12-month changes in body weight and cardiovascular risk factors in PREvención con DIeta MEDiterránea (PREDIMED)-Plus, a trial designed to evaluate the long-term effectiveness of an intensive weight loss lifestyle intervention on primary cardiovascular prevention. RESEARCH DESIGN AND METHODS Overweight/obese adults with metabolic syndrome aged 55–75 years (n = 626) were randomized to an intensive weight loss lifestyle intervention based on an energy-restricted Mediterranean diet, physical activity promotion, and behavioral support (IG) or a control group (CG). The primary and secondary outcomes were changes in weight and cardiovascular risk markers, respectively. RESULTS Diet and physical activity changes were in the expected direction, with significant improvements in IG versus CG. After 12 months, IG participants lost an average of 3.2 kg vs. 0.7 kg in the CG (P & lt; 0.001), a mean difference of −2.5 kg (95% CI −3.1 to −1.9). Weight loss ≥5% occurred in 33.7% of IG participants compared with 11.9% in the CG (P & lt; 0.001). Compared with the CG, cardiovascular risk factors, including waist circumference, fasting glucose, triglycerides, and HDL cholesterol, significantly improved in IG participants (P & lt; 0.002). Reductions in insulin resistance, HbA1c, and circulating levels of leptin, interleukin-18, and MCP-1 were greater in IG than CG participants (P & lt; 0.05). IG participants with prediabetes/diabetes significantly improved glycemic control and insulin sensitivity, along with triglycerides and HDL cholesterol levels compared with their CG counterparts. CONCLUSIONS PREDIMED-Plus intensive lifestyle intervention for 12 months was effective in decreasing adiposity and improving cardiovascular risk factors in overweight/obese older adults with metabolic syndrome, as well as in individuals with or at risk for diabetes.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc18-0836
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
    detail.hit.zdb_id: 1490520-6
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  • 2
    Online Resource
    Online Resource
    Relation of Lipoprotein(a) Levels to Incident Type 2 Diabetes and Modification by Alirocumab Treatment
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 5 ( 2021-05-01), p. 1219-1227
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 5 ( 2021-05-01), p. 1219-1227
    Abstract: In observational data, lower levels of lipoprotein(a) have been associated with greater prevalence of type 2 diabetes. Whether pharmacologic lowering of lipoprotein(a) influences incident type 2 diabetes is unknown. We determined the relationship of lipoprotein(a) concentration with incident type 2 diabetes and effects of treatment with alirocumab, a PCSK9 inhibitor. RESEARCH DESIGN AND METHODS In the ODYSSEY OUTCOMES trial alirocumab was compared with placebo in patients with acute coronary syndrome. Incident diabetes was determined from laboratory, medication, and adverse event data. RESULTS Among 13,480 patients without diabetes at baseline, 1,324 developed type 2 diabetes over a median 2.7 years. Median baseline lipoprotein(a) was 21.9 mg/dL. With placebo, 10 mg/dL lower baseline lipoprotein(a) was associated with hazard ratio 1.04 (95% CI 1.02−1.06, P & lt; 0.001) for incident type 2 diabetes. Alirocumab reduced lipoprotein(a) by a median 23.2% with greater absolute reductions from higher baseline levels and no overall effect on incident type 2 diabetes (hazard ratio 0.95, 95% CI 0.85–1.05). At low baseline lipoprotein(a) levels, alirocumab tended to reduce incident type 2 diabetes, while at high baseline lipoprotein(a) alirocumab tended to increase incident type 2 diabetes compared with placebo (treatment–baseline lipoprotein(a) interaction P = 0.006). In the alirocumab group, a 10 mg/dL decrease in lipoprotein(a) from baseline was associated with hazard ratio 1.07 (95% CI 1.03−1.12; P = 0.0002) for incident type 2 diabetes. CONCLUSIONS In patients with acute coronary syndrome, baseline lipoprotein(a) concentration associated inversely with incident type 2 diabetes. Alirocumab had neutral overall effect on incident type 2 diabetes. However, treatment-related reductions in lipoprotein(a), more pronounced from high baseline levels, were associated with increased risk of incident type 2 diabetes. Whether these findings pertain to other therapies that reduce lipoprotein(a) is undetermined.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc20-2842
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
    detail.hit.zdb_id: 1490520-6
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  • 3
    Online Resource
    Online Resource
    2368-PUB: Cost Analysis of a Flash Glucose Monitoring System in Type 1 Diabetes Vulnerable Patients, in Spain
    American Diabetes Association ; 2019
    In:  Diabetes Vol. 68, No. Supplement_1 ( 2019-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: FreeStyle Libre system is a sensor-based flash monitoring (FM) system, which assesses interstitial fluid glucose. The study aimed to estimate the cost associated with FM compared to self-monitoring of blood glucose (SMBG) in a type 1 diabetes mellitus (T1DM) adult population from the Spanish National Health System perspective The annual cost was modeled for glucose monitoring in T1DM with multiple daily insulin (MDI) doses in a vulnerable subgroup, such as disabled patients (blind, Down’s syndrome), patients with repetitive hypoglycemia or pregnancy. For the cost estimation, resource consumption was assessed for glucose monitoring (strips, lancets and FM sensors) and for clinical management of hypoglycemia. Severe hypoglycemia (SHE) and non-severe hypoglycemia (NSHE) published event rates (4.90 and 68.6 episodes/patient/year) were considered. Event reductions associated with FM use were applied (58.6% [SHE]; 32.8% [NSHE] ), derived from IMPACT trial findings. Based on published evidence, hospital attendance was required in 20.2% of SHEs (further hospitalization in 16.0%). Additional contact with health professional (HP) was required by 9% of NSHEs cases. Daily strip and lancet-consumption in T1DM vulnerable patients was fixed at 9 for those using SMBG, and at 0.5 in FM users following IMPACT findings. Unitary costs (€,2018 excluding VAT) derived from official databases and literature (€0.28/strip; €0.10/lancet; €45.45/FM sensor; €3,725/hospitalized SHE; €1,758/hospital-attended non-admitted SHE; €253/community attended SHE and €7.17/NSHE requiring additional HP contact) Yearly cost was €4,323 and €2,537 per patient using SMBG or FM, respectively. For a cohort of 1,000 T1DM MDI vulnerable patients; 2,871 SHEs (93 hospitalizations for SHE) and 22,507 NSHEs, yearly could be avoided with FM use. The use of FM in 1,000 patients could generate annual cost-savings up to €1,785,430 compared to SMBG. FM system is a potential cost-saving strategy in T1DM MDI patients in Spain. Disclosure F. Gomez-Peralta: Advisory Panel; Self; Abbott, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; Abbott, AstraZeneca, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S. I. Oyagüez: None. J.F. Merino-Torres: None. M. Brito: Advisory Panel; Self; Abbott, Merck Sharp & Dohme Corp., Sanofi. Speaker's Bureau; Self; Abbott, Almirall, S.A., Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Esteve, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Mylan, Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi. F.M. Morales-Perez: Advisory Panel; Self; Abbott. Research Support; Self; Esteve. Speaker's Bureau; Self; Lilly Diabetes, Medtronic MiniMed, Inc. Other Relationship; Self; AstraZeneca, Esteve, Lilly Diabetes, Novo Nordisk A/S. V. Bellido: None. R. Cardona-Hernandez: None. M.A. Casado: None. Funding Abbott Diabetes Care
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db19-2368-PUB
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
    detail.hit.zdb_id: 1501252-9
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