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Pierre Piazza

SENIOR was a phase 3b, randomized, open-label, 2-arm, parallel-group, multicenter, 30-week trial. Randomization was stratified by screening HbA 1c (<8.0 vs ≥8.0 %), previous insulin use (Yes/No), and sulfonylurea or meglitinide use at screening (Yes/No). Insulin was titrated to the ADA-recommended glycemic target for healthy elderly individuals (fasting SMPG: 90–130 mg/dL [5.0–7.2 mmol/L]), a higher glycemic target than utilized previously in randomized controlled trials of insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) in adults. The aim of the SENIOR trial was to compare the efficacy and safety of Gla-300 with Gla-100.

In total, 1014 individuals (≥65 years) with T2DM were included in the trial, of whom 241 were ≥75 years old. The primary endpoint of non-inferiority of mean change in HbA 1c for Gla-300 versus Gla-100 was achieved (least squares mean difference [95% CI]: 0.02, [−0.092 to 0.129] %). Similar percentages of participants in both groups reported confirmed (≤70 mg/dL [≤3.9 mmol/L]) or severe hypoglycemia. The annualized rates of documented symptomatic (≤70 mg/dL [≤3.9 mmol/L]) hypoglycemia were lower with Gla-300 versus Gla-100, both in the overall study population (1.85 vs 2.56 events/participant-year; rate ratio [RR] 0.74 [0.56 to 0.96]) and in the ≥75 years subpopulation (1.12 vs 2.71 events/participant-year; RR 0.45 [0.25 to 0.83]). Frequency of adverse events, including cardiovascular events, falls and fractures was similar between treatments.

These results indicate that Gla-300 was effective in older people with T2DM, with a good safety profile, resulting in comparable reductions in HbA 1c and lower rates of documented symptomatic hypoglycemia versus Gla-100.

Supported By: Sanofi (clinicaltrials.gov NCT02320721)

Issue Section:
© The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America.
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Time interval between hospital admission and onset of infection for the most frequently isolated pathogens in a series of 24,179 cases of nosocomial bloodstream infection (BSI). CoNS, coagulase-negative staphylococci;

Figure 2
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Time interval between hospital admission and onset of infection for the most frequently isolated pathogens in a series of 24,179 cases of nosocomial bloodstream infection (BSI). CoNS, coagulase-negative staphylococci;

Primary BSI, in which no source could be determined, was seen in 12,893 patients (53%). Secondary BSI originated from intravenous catheters in 5749 patients (24%), from the urinary tract in 1580 patients (6.5%), and from the lower respiratory tract in 1539 patients (6%). However, culture samples from distant sites were infrequently collected; therefore, some points of origin might not have been detected.

Of the 1890 Candida isolates causing nosocomial BSI, C. albicans was the most common, accounting for 54% of cases of Candida BSI, followed in rank order by C. glabrata (19%), C. parapsilosis (11%), and C. tropicalis (11%) ( figure 3 ). Crude mortality was lowest for C. albicans infection (37%) and highest for C. krusei infection (59%) ( figure 3 ). There was an increase in the proportion of Candida species isolated from blood cultures from 8% in 1995 to 12% in 2002 ( P < .001, trend analysis). Also, the proportions of C. albicans and C. parapsilosis among these isolates increased between 1995 and 2002, but the proportions of C. tropicalis and C. glabrata decreased.

Figure 3
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Distribution of species in 1890 cases of bloodstream infection and associated crude mortality

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Distribution of species in 1890 cases of bloodstream infection and associated crude mortality

Antimicrobial susceptibility . Methicillin resistance was detected in 1699 S. aureus isolates (41% of tested isolates) and in 4946 CoNS isolates (75%). The proportion of S. aureus isolates with methicillin resistance was significantly higher among ICU patients than among ward patients (44% vs. 40%; P = .004), and there was also a trend toward a higher proportion of S. aureus isolates resistant to methicillin among patients without neutropenia than among patients with neutropenia (42% vs. 32%; P = .054, figure 4 ). The proportion of S. aureus isolates resistant to methicillin increased from 22% in 1995 to 57% in 2001 ( P < .001, trend analysis; figure 5 ).

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