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Clinical therapeutics
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Clinical therapeutics

Excerpta Medica]

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    Impact of Artificial Intelligence on Clinical Decision-Making in Health Care

    Maron J.L.
    2页
      原文链接:
    • NSTL

    Conversations with the Editors: Artificial Intelligence–Based Technologies Leading the Innovation in Surgical Care

    Ravera L.Scheeren T.W.L.Piaggio D.Federici C....
    7页
      原文链接:
    • NSTL

    Evaluation of the Pharmacokinetic Profile of Ultra Rapid Lispro Administered Subcutaneously at Different Injection Sites

    Leohr J.K.Dellva M.A.LaBell E.Coutant D.E....
    12页
    查看更多>>摘要：? 2022 The AuthorsPurpose: Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the pharmacokinetic profile and glucodynamic response of URLi when administered subcutaneously into the abdomen, upper arm, or thigh. An intravenous (IV) bolus administration was included to determine the absolute bioavailability at each injection site. Methods: In this Phase I, randomized, open-label, 4-period, crossover study, healthy subjects received a single dose of 15 U URLi subcutaneously into the abdomen, upper arm, or thigh, or by intravenous injection. Serum insulin lispro concentrations and glucodynamic response during a 10-hour euglycemic clamp procedure were assessed after URLi administration. Findings: Total insulin lispro exposure was similar for the abdomen, upper arm, and thigh, and absolute bioavailability was ～65% at each subcutaneous (SC) injection site. Total and peak insulin action were similar across these SC injection sites. The onset of appearance was <1 minute, and the time to early half-maximal drug concentration occurred at ～10 minutes across these three SC injection sites. Onset of insulin action occurred at ～22 minutes, and the early insulin action (for the first hour) was also similar across these SC injection sites. URLi was well tolerated after single SC injections and IV bolus administration. Implications: The pharmacokinetic and glucodynamic profiles of URLi were similar after a single SC dose into the abdomen, upper arm, or thigh. The rate of insulin lispro absorption and early insulin action were maintained regardless of the SC injection site. The current study supports SC injection of URLi into the abdomen, upper arm, and thigh. ClinicalTrials.gov identifier: NCT03232983.
      原文链接:
    • NSTL
    • Elsevier

    Clinical Profile and Sex-Specific Recovery With Cardiac Rehabilitation After Coronary Artery Bypass Grafting Surgery

    Safdar B.Mori M.Nowroozpoor A.Geirsson A....
    13页
    查看更多>>摘要：? 2022 Elsevier LtdBackground: Cardiac rehabilitation (CR) improves major adverse cardiac outcomes in patients recovering from myocardial infarction. CR influences outcomes through attenuation of cardiac risk factors, lifestyle changes, and biological effects on endothelial function. The clinical profile and sex-specific outcomes with CR after coronary artery bypass grafting (CABG) is less well defined. Methods: This retrospective cohort study of consecutive patients undergoing elective or urgent CABG was performed between 2014 and 2016 at a single site. Patients requiring concomitant procedures were excluded. Patients received referral to a 12-week, 36-session CR program standardized through the health care system and tracked via electronic health records. Clinical data and complications during hospitalization were abstracted from Society of Thoracic Surgeons (STS) registry and matched with 12-months outcomes from electronic health records. Primary composite outcomes were mortality and STS-defined complications within 12 months after CABG. Kaplan-Meier plots for mortality were generated from conditional 6-month survival data. Findings: Of 756 patients undergoing CABG, 420 met the eligibility criteria (mean age, 66 years). Women (18%) had a similar cardiac risk profile to men except for a higher hemoglobin A1c level and lower hematocrit before surgery. Women had similar extent of revascularization to men but had higher rates of intraoperative (30% vs 8%; p < 0.001) and postoperative blood transfusions (43% vs 29%; p = 0.014) compared with men. Only 66% of women qualified for direct discharge to home compared with 85% of men (p = 0.0003). Twelve-month mortality was 1.3% and 2%, respectively (p > 0.05). Half of the cohort got referred for CR, and 32% of men and 23% of women underwent CR. Twelve-month composite outcomes did not differ by referral to cardiac rehabilitation (odds ratio = 0.77; 95% CI, 0.36–1.64) or engagement with CR (odds ratio = 0.67; 95% CI ?0.05 to 0.086), adjusting for age, sex, body mass index, and diabetes. Kaplan-Meier analysis found no significant difference in survival between those who did and did not undergo CR. Men experienced increases in metabolic equivalents (38%, P = 0.014), grip strength (11%, P < 0.0001), and sense of physical well-being (40.9%, P < 0.0001), whereas women experienced increases in aerobic exercise duration (15.5%, P = 0.02) and a trend in improved sense for physical well-being (93.3%, P = 0.06). Implications: Sex differences exist with CR after CABG. Future studies should confirm these findings in larger cohorts and corroborate the effect on endothelial function and other biological markers.
      原文链接:
    • NSTL
    • Elsevier

    Efficacy and Safety of Single Inhaler Triple Therapy Versus Separate Triple Therapy in Chronic Obstructive Pulmonary Disease: A Systematic Review and Meta-analysis

    Zhang L.Wang X.Zhang Y.Chen W....
    15页
    查看更多>>摘要：? 2022 Elsevier Inc.Purpose: This study aimed to compare the efficacy and safety of single inhaler triple therapy and separate triple therapy in the treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD). Methods: PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov databases were searched, and the search date was set from database inception until February 15, 2022. Randomized controlled trials of single inhaler triple therapy versus separate triple therapy, from which the results related to efficacy and safety profiles were extracted, and the methodologic quality and risk of bias were evaluated. Findings: Five published articles (6 clinical trials) were screened from 3437 articles with a total of 4075 patients receiving single inhaler triple therapy and 3533 patients receiving separate triple therapy. Compared with separate triple therapy, single inhaler triple therapy significantly increased the change in forced expiratory volume in 1 second from baseline (mean difference = 0.02 L; 95% CI, 0.00-0.05L; P < 0.01), and there was a statistical difference between the 2 groups. No significant difference was found between the single inhaler triple therapy and separate triple therapy groups in terms of moderate to severe exacerbation rate (relative risk [RR] = 0.97; 95% CI, 0.85-1.10; P = 0.63), the change in St. George's Respiratory Questionnaire from baseline (mean difference = 0.34; 95% CI, ?0.88 to 1.57; P = 0.58), proportion of St. George's Respiratory Questionnaire responders (RR = 0.99; 95% CI, 0.92-1.06; P = 0.77), adverse events (RR= 1.07; 95% CI, 0.90-1.27; P = 0.42), serious adverse events (RR = 1.02; 95% CI, 0.88-1.18; P = 0.81), mortality (RR = 1.10; 95% CI, 0.65-1.86; P = 0.72), risk of pneumonia (RR = 0.86; 95% CI, 0.62-1.18; P = 0.34), and risk of cardiovascular events (RR = 1.22; 95% CI, 0.91-1.65; P = 0.18). Implications: Compared with separate triple therapy, single inhaler triple therapy appears to improve lung function in patients with moderate to severe COPD, especially in terms of forced expiratory volume in 1 second advantages. Single inhaler triple therapy may be a feasible and simplified option for patients with moderate to severe COPD; however, this conclusion needs to be further confirmed by future randomized controlled trials. (Clin Ther. 2022;XX:XXX–XXX) ? 2022 Elsevier HS Journals, Inc.
      原文链接:
    • NSTL
    • Elsevier

    Association of Dulaglutide Initiation Timing With Treatment Patterns and Clinical Outcomes in Patients With Type 2 Diabetes Mellitus in the United States

    Hoog M.Smith J.L.Yu M.Peleshok J....
    15页
    查看更多>>摘要：? 2022 The Author(s)Purpose: To describe clinical characteristics and treatment outcomes for early or late initiation of dulaglutide therapy in patients with type 2 diabetes. Methods: This retrospective, claims-based analysis evaluated adults with type 2 diabetes, ≥1 claim for dulaglutide 0.75 mg or 1.5 mg once-weekly injection (between November 2014 and August 2019), and no prior use of glucagon-like peptide 1 receptor agonists or insulin. Cohorts were defined based on the number of oral antidiabetic drug (OAD) classes used within the 24-month baseline period before dulaglutide therapy initiation: 1 OAD, 2 OADs, or ≥3 OADs. The number of OAD classes used before dulaglutide therapy initiation served as a proxy for timing of initiation, with a higher number of OAD classes indicating a longer duration of T2D. Baseline demographic and clinical characteristics were compared across each cohort. Six-month follow-up outcomes, including change in glycosylated hemoglobin (HbA1c) and treatment patterns, were descriptively assessed within each cohort. Findings: The study population consisted of 18,121 patients across the 1 OAD (n = 4822), 2 OADs (n = 6293), and ≥3 OADs (n = 7006) cohorts. Mean age at baseline was 54.7 years. Males were more prevalent in the ≥3 OADs cohort. Most patients (67%–70%) initiated treatment with dulaglutide 0.75 mg. Dose escalation to 1.5 mg was uncommon (15%–20%) but trended higher in the ≥3 OAD cohort. Adherence to dulaglutide at 6-month follow-up (61%–67%) increased with higher baseline OAD use. The HbA1c assessment (n = 3178) included 761 patients in the 1 OAD cohort, 1088 patients in the 2 OADs cohort, and 1329 patients in the ≥3 OADs cohort. Baseline mean [SD] HbA1c level increased with number of OAD classes (1 OAD: 8.18% [1.80]; 2 OADs: 8.56% [1.66]; and ≥3 OADs: 8.73% [1.51]). Patients in the early dulaglutide therapy initiator group experienced larger reductions in HbA1c levels (1 OAD: ?1.39%; 95% CI, ?1.50 to ?1.27; 2 OADs: ?1.30%; 95% CI, ?1.39 to ?1.20; and ≥3 OADs: ?1.01%; 95% CI, ?1.09 to ?0.93) versus the patients in the delayed initiator group. Patients in the early dulaglutide therapy initiator group also achieved HbA1c <7% at 6-month follow-up more frequently than those in the later initiator group (1 OAD: 68%; 2 OADs: 51%; and ≥3 OADs: 33%). Implications: Cohorts of dulaglutide therapy initiators, defined by prior OAD use as a proxy of timing of initiation, differed in their baseline characteristics and short-term follow-up outcomes. Earlier dulaglutide therapy initiation was associated with lower mean HbA1c levels and increased probability of achievement of HbA1c <7% during the 6-month follow-up period.
      原文链接:
    • NSTL
    • Elsevier

    Comparative Efficacy and Safety of Fostemsavir in Heavily Treatment-Experienced People With HIV-1

    Anderson S.-J.van Doornewaard A.Turner M.Jacob I....
    15页
    查看更多>>摘要：? 2022 The AuthorsPurpose: Heavily treatment-experienced (HTE) people with multidrug-resistant HIV-1 have limited treatment options. Treatment with the first-in-class attachment inhibitor fostemsavir in addition to optimized background therapy (OBT) resulted in sustained virologic and immunologic responses in HTE participants throughout 96 weeks in the BRIGHTE trial. In the absence of long-term direct comparative evidence between fostemsavir-based and other antiretroviral regimens, this analysis indirectly compares efficacy and safety across relevant available trials, adjusting for demographic and baseline characteristics. Methods: A systematic literature review was conducted to identify trials with designs and populations comparable to BRIGHTE. Using matching-adjusted indirect comparison analyses, individual participant data from BRIGHTE were reweighted to create balanced populations across trials, and efficacy and safety outcomes were compared. Findings: Three comparator trials were identified, 2 of which reflected an optimized therapy without fostemsavir (OBT alone): TMB-301 (ibalizumab and OBT), BENCHMRK-1/-2 (OBT alone), and VIKING-3 (OBT alone). Compared with ibalizumab and OBT (N = 40), fostemsavir and OBT (unadjusted, N = 347; adjusted, N = 236) were associated with numerically higher nonsignificant odds of virologic suppression (odds ratio [OR] = 1.44; 95% CI, 0.74–2.80; P = 0.284) and a similar increase in CD4+ cell count of approximately 65 cells/mm3 from baseline through week 24 (mean difference = 7.05 cells/mm3; 95% CI, ?60.88 to 74.98 cells/mm3; P = 0.834). Compared with OBT from BENCHMRK-1/-2 (N = 237), fostemsavir and OBT (adjusted, N = 126) were associated with significantly higher odds of virologic suppression (OR = 3.26; 95% CI, 2.08–5.11; P < 0.001) and increased CD4+ cell count (135.78 cells/mm3; 95% CI, 91.93–179.63 cells/mm3; P < 0.001) at week 96. Compared with OBT from VIKING-3 (N = 183), fostemsavir and OBT (adjusted, N = 78) were associated with numerically higher odds of virologic suppression (OR = 1.34; 95% CI, 0.78–2.30; P = 0.297) and a modest CD4+ cell count increase (26.86 cells/mm3; 95% CI, ?10.79 to 64.52; P = 0.162) through week 48; however, differences were not significant. All-cause discontinuations and safety comparisons varied across studies. Implications: Although matching-adjusted indirect comparison analyses have limitations, these results support the use of fostemsavir and OBT as an important treatment option in HTE people with multidrug-resistant HIV-1.
      原文链接:
    • NSTL
    • Elsevier

    Early Initiation of Evolocumab Treatment in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

    Zhang B.Chen Z.Wei Y.Chen P....
    12页
    查看更多>>摘要：? 2022 Elsevier Inc.Purpose: Evolocumab has been shown to improve cardiovascular outcomes in patients with stable atherosclerotic disease. Whether this benefit persists in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) remains undetermined. This study aimed to evaluate the efficacy and safety of the early initiation of evolocumab in Chinese patients with ACS undergoing PCI. Methods: This retrospective cohort study involved 1564 consecutive patients who had been hospitalized with ACS and underwent PCI, and who had elevated LDL-C levels (≥1.8 mmol/L after receiving high-intensity statin therapy for ≥4 weeks; ≥2.3 mmol/L after receiving low- or moderate-intensity statin; or ≥3.2 mmol/L without statin therapy). Patients who received evolocumab (initiated in-hospital and after 18 months) were included in the evolocumab group (n = 414), and all other patients were included in the control group (n = 1150). The primary outcome at 18 months was a composite of ischemic stroke, cardiovascular death, myocardial infarction, hospitalization for unstable angina, or coronary revascularization. The evolocumab treatment effect on the primary outcome was assessed in all prespecified subgroups. Findings: At 18 months, evolocumab combined with statins reduced LDL-C levels from baseline levels by 42.48% compared with statins alone. After multivariable adjustment, evolocumab combined with statins significantly reduced the primary outcome (8.2% vs 12.4%; adjusted hazard ratio, 0.65; 95% CI, 0.45–0.95; P = 0.025). In addition, evolocumab consistently reduced the primary outcome across the major subgroups. For the safety outcomes, no significant differences between the groups were observed in any adverse events. Implications: Among Chinese patients who underwent PCI for ACS, the early initiation of evolocumab combined with statin treatment effectively reduced LDL-C levels and lowered the incidence of recurrent ischemic cardiovascular events, with satisfactory tolerability and safety. Chinese Clinical Trial Registry identifier: ChiCTR2100049364.
      原文链接:
    • NSTL
    • Elsevier

    Reproductive Health and Coronavirus Disease 2019–Induced Economic Contracture: Lessons From the Great Recession

    Louis L.Frankel A.Ayub A.Williamson T....
    8页
    查看更多>>摘要：? 2022 Elsevier LtdThe coronavirus disease 2019 (COVID-19) pandemic has magnified disparities in care, including within reproductive health. There has been limited research on the implications of the financial calamity COVID-19 has precipitated on reproductive health, including restricted access to contraception and prenatal care, as well as adverse perinatal outcomes resulting from economic contracture. We therefore examined the Great Recession (the period of economic downturn from 2007–2009 also referred to as the 2008 recession) to discuss how the current financial difficulties may influence reproductive health now and in the years to come. The existing literature examining the impacts of economic downturn on reproductive health provides a resounding body of evidence supporting the need for state and federal investment in comprehensive reproductive health care. Policies directed at expanding access to programs such as Special Supplemental Nutrition Program for Women, Infants, and Children and Medicaid (WIC), extending Medicaid coverage to 12 months’ postpartum, continuing coverage for telehealth services, and lowering barriers to access through mobile care units would help mitigate anticipated effects of a recession on reproductive health.
      原文链接:
    • NSTL
    • Elsevier

    Second Opinion in Pharmacotherapy of ADHD: Do Not Postpone It!

    Schjott J.
    2页
      原文链接:
    • NSTL
    • Elsevier