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PubMed1994

Sensory and affective predictors of overall pain and emotions associated with affective pain.

OBJECTIVE: Psychological scaling techniques consistently produce separate ratings for sensory and affective components of pain. This study examines the relative contributions of these components to pain as a whole and the contributions of different emotions to the affective component of pain. DESIGN: The design was correlational. Visual analogue scales were used to quantify overall pain, sensory pain, affective pain, and individual emotions. These data lent themselves to regression techniques for expressing pain as a function of sensation and affect as a function of emotion types. SETTING: Data were collected at the Pain Clinic within the Department of Physical Medicine at the Ohio State University. PATIENTS: Subjects were 40 chronic pain sufferers admitted to an inpatient pain management program. RESULTS AND CONCLUSIONS: Ratings of overall pain were not a simple summation of sensory and affective ratings, but a linearly additive function of both component ratings each with a unique weighting. The affective component of pain was a function of three differentially weighted sets of emotions, anger, fear, and sadness being most salient. Implications arise for the broader assessment of chronic pain and the treatment of specific emotions that may be particularly associated with the pain.

Adult↗
PubMed2002

Microalbuminuria identifies overall cardiovascular risk in essential hypertension: an artificial neural network-based approach.

BACKGROUND: Ultrasound (US) examination of heart and carotid arteries provides an accurate assessment of target organ damage (TOD) and may influence the stratification of the absolute cardiovascular risk profile. Microalbuminuria has recently proved to be a useful cost-effective marker of increased cardiovascular risk but is still too often neglected in clinical practice. OBJECTIVE: To evaluate how well artificial neural networks (ANNs) predict cardiovascular risk stratification by means of routine data and urinary albumin excretion, as compared to prediction by the clinical work-up suggested by the International Society of Hypertension (ISH), with and without ultrasound-determined TOD. METHODS: A group of 346 never previously treated essential hypertensives (212 men, 134 women, mean age 47 +/- 9 years) was studied. Risk was stratified according to the criteria suggested by the 1999 WHO/ISH guidelines; first, by routine procedures alone, and subsequently by reassessment, using data on cardiac and vascular structures obtained by US evaluation. The ANN was trained and tested to predict the overall cardiovascular risk on the basis of routine clinical data and urinary albumin excretion (UAE). The impact of these three approaches on the determination of cardiovascular risk profile was evaluated. RESULTS: According to the first classification, 5.5% (n = 19) of patients were considered at low risk, 47.3% (n = 164) at medium, 26.7% (n = 92) at high and 20.6% (n = 71) at very high risk. A marked change in risk stratification, namely an increase in the prevalence of high- and very-high-risk patients (2.3% low, 29.8% medium, 42.8% high and 25.2% very high risk; chi(2) 15.201, P < 0.0001), was obtained when US examination of TOD was taken into consideration. On the basis of routine clinical data and UAE, the artificial neural network successfully predicted overall cardiovascular risk and allocated patients in different classes as accurately as the US-based evaluation. CONCLUSIONS: The use of US techniques allows a more precise stratification of absolute cardiovascular risk in hypertensive patients as compared to routine clinical data. An ANN can accurately identify the patients' risk status by using low-cost routine data and UAE. These results further emphasize the value of UAE in the stratification of cardiovascular risk.

Adult↗
PubMed1998

Convergent and discriminant validity of overall defensive functioning.

We examined the validity of the construct of overall defensive functioning and its discrimination from standard diagnostic assessments. Within a multisite field trial, patients received intake diagnostic interviews by clinicians who made standard axis I through V diagnoses, then rated defense mechanisms using the Defense Mechanism Rating Scales (DMRS). Patients filled out self-report measures of distress and defenses, the SCL-90-R, and Defense Style Questionnaire (DSQ). Overall defensive functioning (ODF) scales were derived from both the DMRS and the DSQ. Overlap between clinical and self-report ratings of defenses was modest. By two different methods of factor analysis, followed by confirmatory factor analysis, clinical ratings of ODF were clearly discriminable from axis I, axis II personality disorders, current and usual global functioning, and subjective distress. ODF measured by the DSQ was not clearly discriminated from subjective distress ratings, consistent with the hypothesis that subjective distress may distort conscious derivatives of actual defensive processes. The DSQ alone probably should not be considered as a substitute for observer-rated assessment of defensive functioning, although further study of the issue is warranted.

Defense Mechanisms↗
PubMed1992

The impact of the Texas 1989 motorcycle helmet law on total and head-related fatalities, severe injuries, and overall injuries.

The State of Texas implemented a mandatory total motorcycle helmet law for all operators and passengers, effective September 1, 1989. In this study the impact of this intervention on frequency of both total and head-related fatalities, severe injuries, and overall injuries for operators during the subsequent year was quantified. This quantification is important because 26 states in the United States fail to have strict, mandatory helmet laws. The Box-Tiao time-series intervention methodology is used to estimate secular trends before and changes after the implementation of the law, analyzing Department of Public Safety monthly injury accident data for a period of 6 years collected from traffic accident reports filed for each motorcycle injury accident. Trends in fatalities and injuries (except for head-related deaths) estimated before implementation of the law approximated the 9.4% average annual decline in motorcycle registrations. Additional declines of 12.6% and 57.0%, respectively, were estimated for total and head-related fatalities during the year after the law was implemented. Declines of 13.1% and 54.6% were estimated for severe injuries for total and head-related accidents. Declines of 12.3% and 52.9% were found for total and head-related injuries overall.

Confidence Intervals↗
PubMed1991

Rigid lens tear pump efficiency: effects of overall diameter/base curve combinations.

The effect of changes in rigid contact lens overall and optic zone diameters on tear pump efficiency were studied using a polarographic technique. Six overall diameters ranged from 7.6 to 10.6 mm in 0.6-mm steps, with the optic zone diameter always being 1.4 mm smaller. Base curve radii were made flatter as lens overall/optic zone diameters increased in order to maintain a constant tear layer thickness. All other parameters were held constant. Oxygen uptake rates were measured for the normal, open eye, as well as after 5 min of static (without blinking) and dynamic (with blinking once every 5 s) wear of each lens design. Under both static and dynamic conditions, oxygen uptake rates increased with increase in lens overall/optic zone diameter. The differences between the static and dynamic condition data served as an index of tear pump efficiency for each lens. These differences decreased with increase in lens overall/optic zone diameter.

Analysis of Variance↗
PubMed1997

Correlation of menstrual cycle at time of breast cancer surgery to disease-free and overall survival.

The timing of surgery during the menstrual cycle of premenopausal breast cancer patients was correlated with their disease-free survival (DFS) and overall survival (OS). The study included 150 premenopausal patients treated for breast cancer between 1977 and 1992. The data were analyzed using three different menstrual cycle phase categorization schemes: (1) days 0 to 6 and 21 to 32 vs 7 to 20; (2) days 0 to 2 and 13 to 32 vs 3 to 12; and (3) days 0 to 14 vs 14 to 32. Two different surgery dates used for analysis were biopsy date and definitive surgery date. There was no association of the timing of surgery with OS. Only one categorization scheme correlated with DFS (scheme No. 2), and this correlation was significant using either surgery or biopsy dates. Thus, premenopausal breast cancer patients who have biopsy and/or definitive surgery during their perimenstrual phase (days 0 to 2 or after day 13) of the menstrual cycle may have a longer DFS than patients operated on during their midcycle phase (days 3 to 13); however, this may not affect overall survival.

Adult↗
PubMed2000

Overall rotational diffusion and internal mobility in domain II of protein G from Streptococcus determined from 15N relaxation data.

The backbone dynamics and overall tumbling of protein G have been investigated using 15N relaxation. Comparison of measured R2/R1 relaxation rate ratios with known three-dimensional coordinates of the protein show that the rotational diffusion tensor is significantly asymmetric, exhibiting a prolate axial symmetry. Extensive Monte Carlo simulations have been used to estimate the uncertainty due to experimental error in the relaxation rates to be D(parallel)/D(perpendicular) = 1.68 +/- 0.08, while the dispersion in the NMR ensemble leads to a variation of D(parallel)/D(perpendicular) = 1.65 +/- 0.03. Incorporation of this tensorial description into a Lipari-Szabo type analysis of internal motion has allowed us to accurately describe the local dynamics of the molecule. This analysis differs from an earlier study where the overall rotational diffusion was described by a spherical top. In this previous analysis, exchange parameters were fitted to many of the residues in the alpha helix. This was interpreted as reflecting a small motion of the alpha helix with respect to the beta sheet. We propose that the differential relaxation properties of this helix compared to the beta sheet are due to the near-orthogonality of the NH vectors in the two structural motifs with respect to the unique axis of the diffusion tensor. Our analysis shows that when anisotropic rotational diffusion is taken into account NH vectors in these structural motifs appear to be equally rigid. This study underlines the importance of a correct description of the rotational diffusion tensor if internal motion is to be accurately investigated.

Bacterial Proteins↗
PubMed2005

Expression of the bcl-6 and MUM1/IRF4 proteins correlate with overall and disease-specific survival in patients with primary cutaneous large B-cell lymphoma: a tissue microarray study.

BACKGROUND: Systemic B-cell lymphomas have been studied using microarrays, which has led to a better understanding of their molecular characteristics. Initial microarray studies of these lymphomas have implicated several genes as important predictors of outcome. In this study, we used a tissue microarray (TMA) to characterize primary cutaneous large B-cell lymphomas (PCLBCL). METHODS: We studied 14 patients for whom clinical follow up was available, including four patients whose lesions were limited to the leg on presentation. Immunohistochemical staining with CD20, CD44, CD21, CD5, CD10, bcl-2, bcl-6, Ki67, p53, and multiple myeloma 1 (MUM1) was examined. RESULTS: Our results identify two subgroups of lymphomas. The first group showed staining with bcl-6 and had an overall survival of 176 months (p = 0.003). The majority of this group was negative for MUM1. The second group lacked staining with bcl-6 and had an overall survival of 26 months, with a majority of these cases staining with MUM1. Three of four patients with PCLBCL of the leg showed no staining with bcl-6. CONCLUSIONS: Our study demonstrates the utility of TMAs in the analysis of PCLBCL and that expression of bcl-6 and MUM1 correlates with survival.

Adult↗
PubMed2006

CLLU1 expression levels predict time to initiation of therapy and overall survival in chronic lymphocytic leukemia.

OBJECTIVES: Chronic lymphocytic leukemia (CLL) is an incurable disease with a highly variable clinical course. IgV(H) mutational status, chromosomal aberrations, CD38 expression and ZAP-70 expression are prognostic markers in CLL, however, they are not exclusively confined to this disease. We recently identified a novel CLL-specific gene (CLL upregulated gene1, CLLU1) that is exclusively upregulated in CLL cells. Here we describe our evaluation of the prognostic significance of CLLU1 in CLL. METHODS: A cohort of 59 previously untreated CLL patients was studied. We determined the expression levels of two CLLU1 transcripts, cDNA1 and CDS, by quantitative RT-PCR. The relation between CLLU1 expression and time to therapy, overall survival and presence or absence of ZAP-70, CD38, chromosomal aberrations or IgV(H) mutations in the 59 patients was analyzed. RESULTS: Analyzed as a continuous, quantitative parameter CLLU1 levels significantly predicted time from diagnosis to initiation of therapy (P < or = 0.0003) Analyzed as a categorical parameter, by segregation of the patients into groups with cDNA1 or CDS expression above or below the median, the CLLU1 levels significantly predicted time from diagnosis to initiation of therapy (P = 0.001) and predicted overall survival with borderline significance (P < or = 0.05). Patient stratification according to clinical stage, cytogenetics, IgV(H) mutational status, ZAP-70 and CD38, demonstrated significantly increased CLLU1 expression in all investigated CLL poor risk groups. CLLU1 expression levels contributed additional prognostic information to ZAP-70-positive patients. CONCLUSIONS: CLLU1 is the first identified CLL specific gene. The CLLU1 mRNA expression level can predict time to initiation of treatment and survival in CLL patients.

ADP-ribosyl Cyclase 1↗
PubMed2000

A computational model for quantitative analysis of cell cycle arrest and its contribution to overall growth inhibition by anticancer agents.

Most anticancer agents induce cell cycle arrest (cytostatic effect) and cell death (cytotoxic effect), resulting in the inhibition of population growth of cancer cells. When asynchronous cells are to be examined, the currently used flow cytometric method can not provide checkpoint-specific and quantitative information on the drug-induced cell cycle arrest. Hence, despite its significance, no good method to analyze in detail the mechanism of cell cycle arrest and its contribution to overall growth inhibition induced by an anticancer agent has yet been established. We describe in this study the development of a discrete time (Markov model)-based computational model for cell cycle progression / arrest with transition probability (TP(i)) as a model parameter. TP(i) was calculated using model equations that include easily measurable parameters such as the fraction of cells in each cell cycle phase and population doubling time. The TP(i) was then used to analyze checkpoint-specific and quantitative changes in cell cycle progression. We also used TP(i) in a Monte-Carlo simulation to predict growth inhibition caused by cell cycle arrest only. Human SCLC cells (SBC-3) exposed to UCN-01 were used to validate the model. The model-predicted growth curves agreed with the observed data for SBC-3 cells not treated or treated at a cytostatic concentration (0.2 mM) of UCN-01, indicating validity of the present model. The changes in TP(i) indicated that UCN-01 reduced the G(1)-to-S transition rate and increased the S-to-G(2) / M and G(2) / M-to-G(1) transition rates of SBC-3 cells in a concentration- and time-dependent manner. When the model-predicted growth curves were compared with the observed data for cells treated at a cytotoxic concentration (2 mM), they suggested that 22% out of 65% and 32% out of 73% of the growth inhibition could be attributed to the cell cycle arrest effect after 48 h and 72 h exposure, respectively. In conclusion, we report here the establishment of a novel method of analysis that can provide checkpoint-specific and quantitative information about cell cycle arrest induced by an anticancer agent and that can be used to assess the contribution of cell cycle arrest effect to the overall growth inhibition.

Alkaloids↗
PubMed2006

Diet and physical activity in relation to overall mortality amongst adult diabetics in a general population cohort.

OBJECTIVES: To evaluate the effect on overall and cardiovascular mortality of diet and physical activity amongst diabetic persons. DESIGN: Population-based prospective investigation, from 1993 to mid-2004, in the Greek arm of the European Prospective Investigation into Cancer and Nutrition. SETTING: Volunteers from the general adult Greek population. SUBJECTS: From an original sample of 28 572 volunteers, 1013 were taking at enrolment drugs for diabetes mellitus, had no missing information on the study variables and no comorbidity. Diet was assessed at baseline through a validated questionnaire. Proportional hazards regression was used to assess the relation of dietary factors and physical activity with mortality. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Mortality ratios overall and from cardiovascular causes. RESULTS: During 4579 person-years, 80 deaths have occurred, 46 of which from cardiovascular causes. Physical activity was strongly inversely associated with mortality. Two nutritional variables were significantly associated with diabetic mortality, with hazard ratios for increases of daily intake by one standard deviation being 1.31 for eggs [95% confidence interval (95% CI) 1.07 to 1.60] and 1.82 for saturated lipids (95% CI, 1.14 to 2.90). These two associations were considerably stronger for cardiovascular mortality. Waist-to-height ratio was positively, whereas hip circumference inversely associated with mortality. No significant interactions with gender for any of the study variables were evident. DISCUSSION: Amongst confirmed diabetic persons, increased physical activity is associated with significant reduction of mortality, whereas increased consumption of eggs and saturated fats is associated with significant increase of mortality. Monounsaturated lipids are preferable for diabetic persons.

Aged↗
PubMed1983

Inter-animal variation and its influence on the overall precision of morphometric estimates based on nested sampling designs.

This paper provides additional experimental evidence that biological variation between individuals is likely to be the major factor influencing the overall precision and efficiency of nested sampling schemes for morphometric analysis of thin sections. Four distinct experimental systems (two based on nervous tissue and two on epithelia) have been investigated. Morphometric estimates were obtained from measurements made on micrographs generated by sampling tissues at several levels. Sources of sampling variation were isolated so that the contributions to overall variance made by inter-animal differences could be evaluated. In each case, biological variation was the cardinal component of total observed variance between animals. Relative contributions ranged from 53% to 78%. Examining more animals would be the most efficient way of reducing the variance of the group mean in these sampling designs.

Animals↗
PubMed1995

Which birthweight groups contributed most to the overall reduction in the neonatal mortality rate in the United States from 1960 to 1986?

We determined the relative contributions of individual birthweight groups to the reduction in neonatal mortality rate (NMR) of US singleton livebirths from 1960 to 1986, the period during which neonatal intensive care was introduced and became established. Changes in the NMR for each race (non-white/white) and birthweight group were assessed in terms of three components of NMR (1) birthweight-specific neonatal mortality rate (BWS-NMR), (2) birthweight distribution, and (3) the interaction resulting from simultaneous changes in BWS-NMR and birthweight distribution. Overall, NMR decreased from 16.7 per 1000 livebirths in 1960 to 5.5 per 1000 livebirths in 1986. This reduction was achieved mainly by improvements in the BWS-NMRs of all birthweight groups. Neonates who weighted > 1.5 kg at birth were the major contributors to the overall reduction in the NMR; approximately two-thirds of total reduction in NMR between 1960 and 1980 and 52.6% of the total reduction between 1980 and 1986 occurred in the > 1.5 kg birthweight groups. Our study demonstrates that with the introduction of neonatal intensive care, survival of infants with birthweights > 1.5 kg improved markedly and that this improvement accounted for most of the decline in the neonatal mortality rate in the United States from 1960 to 1986. Therefore, in measuring the effectiveness of neonatal intensive care, the assessment should include not only very low birthweight (< 1.5 kg) but all birthweight groups.

Birth Weight↗
PubMed2004

Impact of body mass index on graft failure and overall survival following liver transplant.

GOALS: To assess the influence of body mass index (BMI) in the outcome of liver transplantation. BACKGROUND: Body mass index appears to affect liver transplantation, independently of several risk factors. STUDY: A review of the United Network for Organ Sharing database included 32 515 liver transplants from 1992 through 2000 with at least one follow-up visit, of which 26 920 had information for determining BMI. The overall impact of elevated BMI (>25), and the impact of increasingly elevated BMI (25-40+) on graft failure rates and overall survival rates are assessed using proportional hazards regression. RESULTS: Controlling for follow-up time, age, gender, race, number of comorbidities, and status 1 designation, the impact of BMI on survival was mixed. The risk of death was elevated for patients with low BMI (<19) and BMI values of >/=40. Compared with patients with BMI of 19-22, those with BMI > 25 had a decreased likelihood of death. This decrease was seen among patients with BMI of 25-34. CONCLUSION: BMI did not significantly affect rates of graft failure. Compared with patients with a BMI in the 'normal' range, those with moderately elevated BMI had decreased likelihood of death while patients with low BMI or extremely high BMI had increased likelihood of death.

Body Mass Index↗
PubMed1993

Modification of the E1ATP binding site of Na+/K(+)-ATPase by the chromium complex of adenosine 5'-[beta,gamma-methylene]triphosphate blocks the overall reaction but not the partial activities of the E2 conformation.

The chromium complex of adenosine 5'-[beta,gamma-methylene]triphosphate, Cr(H2O)4AdoPP[CH2]P, inactivates Na+/K(+)-ATPase from pig kidney at 37 degrees C with an inactivation velocity constant of 7.1 x 10(-3) min-1 by binding to the high-affinity ATP site (E1ATP site). The dissociation constant (Kd) of the analogue at this site is 26 microM, and of ATP 0.8 microM. Inactivation of the overall reaction of Na+/K(+)-ATPase by Cr(H2O)4AdoPP[CH2]P did not alter the activities of the E2 conformational state such as K(+)-activated p-nitrophenylphosphatase, 86Rb+ occlusion and [3H]ouabain binding by the 'backdoor' phosphorylation. However, [3H]ouabain binding via the forwards reaction from E1ATP in the presence of Na+ + Mg2+ is inhibited. K(+)-activated p-nitrophenylphosphatase activity of the Cr(H2O)4AdoPP[CH2]P-inactivated enzyme decreases when an MgATP analogue, the tetraammine cobalt complex of ATP, Co(NH3)4ATP, is used additionally to inactivate the E2ATP site. The enzyme activity of K(+)-activated phosphatase is also lost if the beta,gamma-bidentate chromium(III) complex of ATP, Cr(H2O)4ATP, which may form a stable E1-chromo-phosphointermediate, is used for the inactivation of Na+/K(+)-ATPase. We conclude that the phenomenon of a blockade of the overall reaction of Na+/K(+)-ATPase by the formation of a stable E1.CrAdoPP[CH2]P complex, leading thereby to a loss of the partial activities of the E1 conformation, but not of the E2 conformation, is consistent with the postulate of an (alpha beta)2 diprotomeric nature of the sodium pump. The observation, moreover, that treatment of the sodium pump with Cr(H2O)4ATP but not with Cr(H2O)4AdoPP[CH2]P leads to an inactivation of K(+)-activated phosphatase seems to indicate that the formation of a E1-phosphointermediate affects the E2ATP site.

4-Nitrophenylphosphatase↗
PubMed1996

1H-NMR-derived secondary structure and the overall fold of the potent anti-mammal and anti-insect toxin III from the scorpion Leiurus quinquestriatus quinquestriatus.

We describe the secondary structure and the overall fold of toxin III from the venom of the scorpion Leiurus quinquestriatus quinquestriatus determined using two-dimensional-1H-NMR spectroscopy. This protein, which contains 64 amino acids and 4 disulfide bridges, belongs to the long-chain toxin category and is highly toxic to both mammals and insects. The overall fold was determined on the basis of 1208 inter-proton-distance restraints derived from NOE measurements and 90 psi, phi dihedral-angle restraints derived from NOE connectivities and 3JNH-alphaH coupling constants using the HABAS program. This fold, which mainly consists of an alpha-helix packed against a small antiparallel three-stranded beta-sheet, and of several turns and loops, is similar to that of other long-chain scorpion toxins. Aromatic and non-polar residues form several patches on the surface of the protein which alternate with patches of charged and polar residues. Such a topology should be important in the interactions of toxin III with sodium channels in membranes. Two weakly constrained loops introduce some flexibility to the structure which could be related to the activity of this toxin. The central core of toxin III is compared with the cysteine-stabilized alpha beta motif (an alpha-helix connected to a beta-sheet through two disulfide bridges) found in insect defensins and plant thionins. Defensins and thionins are small proteins (approximately 40--50 amino acid residues) containing three or four disulfide bridges, respectively. This comparison confirms that the cysteine-stabilized alpha beta motif is a common core to a number of small proteins from different origins and having different activities.

Amino Acid Sequence↗
PubMed2001

Waist to hip circumference ratio as a significant predictor of preeclampsia, irrespective of overall adiposity.

OBJECTIVE: To investigate whether abnormal body fat distribution is a significant predictor of the development of preeclampsia, irrespective of overall adiposity. METHODS: Twenty-six women with preeclampsia and 198 control women were enrolled. Waist to hip circumference ratio (WHR), body weight (BW), and body mass index (BMI, wt/ht2) were measured early in pregnancy (< 9 weeks of gestational age). Age, height, parity, tobacco usage, education period, gestational duration, and weight gain during pregnancy were also recorded for each subject. RESULTS: WHR, BMI, and BW early in pregnancy were significantly higher in the preeclampsia group (p < 0.0001). WHR, BMI, and BW positively correlated with the development of preeclampsia on univariate regression analysis (Standardized regression coefficient = 0.410, 0.387, and 0.363, respectively, p < 0.0001). On stepwise multiple regression analysis, WHR still correlated with the development of preeclampsia irrespective of BMI and BW. When the WHR predictive of the development of preeclampsia was set at 0.9, the sensitivity was 46.2% (12/26), which was significantly better than that of 25 of BMI (19.2%, 5/26; p < 0.05). CONCLUSION: Higher WHR is a significant predictor of the development of preeclampsia. This relation is irrespective of overall adiposity.

Adipose Tissue↗
PubMed2005

Twice-daily pre-mixed insulin rather than basal insulin therapy alone results in better overall glycaemic control in patients with Type 2 diabetes.

AIMS: To compare the glycaemic control of an insulin lispro mixture (25% insulin lispro and 75% NPL) twice daily in combination with metformin to that of once-daily insulin glargine plus metformin in patients with Type 2 diabetes inadequately controlled with intermediate insulin, or insulin plus oral agent(s) combination therapy. RESEARCH DESIGN AND METHODS: Ninety-seven patients were randomized in a multicentre, open-label, 32-week crossover study. Primary variables evaluated: haemoglobin A1c (A1c), 2-h post-prandial blood glucose (BG), hypoglycaemia rate (episodes/patient/30 days), incidence (% patients experiencing > or = 1 episode) of overall and nocturnal hypoglycaemia. RESULTS: At endpoint, A1c was lower with the insulin lispro mixture plus metformin compared with glargine plus metformin (7.54% +/- 0.87% vs. 8.14% +/- 1.03%, P < 0.001). Change in A1c from baseline to endpoint was greater with the insulin lispro mixture plus metformin (-1.00% vs. -0.42%; P < 0.001). Two-hour post-prandial BG was lower after morning, midday, and evening meals (P < 0.001) during treatment with the insulin lispro mixture plus metformin. The fasting BG values were lower with glargine plus metformin (P = 0.007). Despite lower BG at 03.00 hours (P < 0.01), patients treated with the insulin lispro mixture plus metformin had a lower rate of nocturnal hypoglycaemia (0.14 +/- 0.49 vs. 0.34 +/- 0.85 episodes/patient/30 days; P = 0.002), although the overall hypoglycaemia rate was not different between treatments (0.61 +/- 1.41 vs. 0.44 +/- 1.07 episodes/patient/30 days; P = 0.477). CONCLUSION: In patients with Type 2 diabetes and inadequate glucose control while on insulin or insulin and oral agent(s) combination therapy, treatment with a twice-daily insulin lispro mixture plus metformin, which targets both post-prandial and pre-meal BG, provided clinically significant improvements in A1c, significantly reduced post-prandial BG after each meal, and reduced nocturnal hypoglycaemia as compared with once-daily glargine plus metformin, a treatment that targets fasting BG.

Adult↗