scholarly journals Analysis of the Performance of the Software/Hardware Product MyDiaBase+RxChecker for Assessing Treatment Regimens

2009 ◽  
Vol 3 (3) ◽  
pp. 533-535
Author(s):  
Danny Petrasek ◽  
Marissa Bidner

In 2008, the Action to Control Cardiovascular Risk in Diabetes trial was halted due to an unexpected number of deaths in the intensive treatment group (aiming for hemoglobin A1c levels less than 6%). Hypoglycemic episodes were thought by some to be a contributing cause, underscoring again the challenge of maintaining tight control while avoiding dangerous excursions into hypoglycemic territory. Albisser and colleagues present a set of articles in this issue of Journal of Diabetes Science and Technology that describe a clinical product developed specifically for this timeless clinical conundrum.

2017 ◽  
Vol 13 (1) ◽  
pp. 73-80 ◽  
Author(s):  
Rita Magriço ◽  
Miguel Bigotte Vieira ◽  
Catarina Viegas Dias ◽  
Lia Leitão ◽  
João Sérgio Neves

Background and objectivesIn the Systolic Blood Pressure Intervention Trial (SPRINT), intensive systolic BP treatment (target <120 mm Hg) was associated with fewer cardiovascular events and higher incidence of kidney function decline compared with standard treatment (target <140 mm Hg). We evaluated the association between mean arterial pressure reduction, kidney function decline, and cardiovascular events in patients without CKD.Design, setting, participants, & measurementsWe categorized patients in the intensive treatment group of the SPRINT according to mean arterial pressure reduction throughout follow-up: <20, 20 to <40, and ≥40 mm Hg. We defined the primary outcome as kidney function decline (≥30% reduction in eGFR to <60 ml/min per 1.73 m2 on two consecutive determinations at 3-month intervals), and we defined the secondary outcome as cardiovascular events. In a propensity score analysis, patients in each mean arterial pressure reduction category from the intensive treatment group were matched with patients from the standard treatment group to calculate the number needed to treat regarding cardiovascular events and the number needed to harm regarding kidney function decline.ResultsIn the intensive treatment group, 1138 (34%) patients attained mean arterial pressure reduction <20 mm Hg, 1857 (56%) attained 20 to <40 mm Hg, and 309 (9%) attained ≥40 mm Hg. Adjusted hazard ratios for kidney function decline were 2.10 (95% confidence interval, 1.22 to 3.59) for mean arterial pressure reduction between 20 and 40 mm Hg and 6.22 (95% confidence interval, 2.75 to 14.08) for mean arterial pressure reduction ≥40 mm Hg. In propensity score analysis, mean arterial pressure reduction <20 mm Hg presented a number needed to treat of 44 and a number needed to harm of 65, reduction between 20 and <40 mm Hg presented a number needed to treat of 42 and a number needed to harm of 35, and reduction ≥40 mm Hg presented a number needed to treat of 95 and a number needed to harm of 16.ConclusionsIn the intensive treatment group of SPRINT, larger declines in mean arterial pressure were associated with higher incidence of kidney function decline. Intensive treatment seemed to be less favorable when a larger reduction in mean arterial pressure was needed to attain the BP target.


BJGP Open ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. bjgpopen20X101012
Author(s):  
Morten Charles ◽  
Niels Henrik Bruun ◽  
Rebecca Simmons ◽  
Else-Marie Dalsgaard ◽  
Daniel Witte ◽  
...  

BackgroundThere is no long-term evidence on the effectiveness of training for motivational interviewing in diabetes treatment.AimWithin a trial of intensive treatment of people with screen-detected diabetes, which included training in motivational interviewing for GPs, the study examined the effect of the intervention on incident cardiovascular disease (CVD) and all-cause mortality.Design & settingIn the ADDITION-Denmark trial, 181 general practices were cluster randomised in a 2:1:1 ratio to: (i) to screening plus routine care of individuals with screen-detected diabetes (control group); (ii) screening plus training and support in intensive multifactorial treatment of individuals with screen-detected diabetes (intensive treatment group); or (iii) screening plus training and support in intensive multifactorial treatment and motivational interviewing for individuals with screen-detected diabetes (intensive treatment plus motivational interviewing group). The study took place from 2001–2009.MethodAfter around 8 years follow-up, rates of first fatal and non-fatal CVD events and all-cause mortality were compared between screen-detected individuals in the three treatment groups.ResultsCompared with the routine care group, the risk of CVD was similar in the intensive treatment group (hazard ratio [HR] 1.11, 95% confidence interval [CI] = 0.82 to 1.50) and the intensive treatment plus motivational interviewing group (HR 1.26, 95% CI = 0.96 to 1.64). The incidence of death was similar in all three treatment groups.ConclusionTraining of GPs in intensive multifactorial treatment, with or without motivational interviewing, was not associated with a reduction in mortality or CVD among those with screen-detected diabetes.


Hypertension ◽  
2021 ◽  
Vol 77 (1) ◽  
pp. 49-58
Author(s):  
Mahboob Rahman ◽  
Nishigandha Pradhan ◽  
Zhengyi Chen ◽  
Radhika Kanthety ◽  
Raymond R. Townsend ◽  
...  

We evaluated the association between orthostatic hypertension and cardiovascular outcomes and the effect of intensive blood pressure (BP) control on cardiovascular outcomes in patients with orthostatic hypertension. Post hoc analyses of the SPRINT (Systolic Blood Pressure Intervention Trial) data were conducted; orthostatic hypertension was defined as increase in systolic BP≥20 mm Hg or increase in diastolic BP≥10 mm Hg with standing. Of 9329 participants, 1986 (21.2%) had orthostatic hypertension at baseline. Within the intensive treatment group, participants with orthostatic hypertension were at higher risk of developing the composite cardiovascular outcome (hazard ratio, 1.44 [95% CI, 1.1–1.87], P =0.007) compared with participants without orthostatic hypertension. Within the standard treatment group, there were no significant differences in cardiovascular outcome between participants with and without orthostatic hypertension. In participants with orthostatic hypertension, there was no statistically significant difference in risk of the composite cardiovascular outcome between the intensive and the standard BP treatment group (hazard ratio, 1.07 [95% CI, 0.78–1.47], P =0.68). In participants without orthostatic hypertension at baseline, the intensive treatment group was associated with a lower risk of the composite cardiovascular outcome (hazard ratio, 0.67 [95% CI, 0.56–0.79], P <0.0001). Orthostatic hypertension was associated with a higher risk of cardiovascular outcomes in the intensive and not in the standard treatment group; intensive treatment of BP did not reduce the risk of cardiovascular outcomes compared with standard treatment in patients with orthostatic hypertension. These post hoc analyses are hypothesis generating and will need to be confirmed in future studies.


Author(s):  
Krishna K Patel ◽  
Suzanne V Arnold ◽  
Paul S Chan ◽  
Yuanyuan Tang ◽  
Yashashwi Pokharel ◽  
...  

Introduction: In SPRINT (Systolic blood PRessure INtervention Trial), non-diabetic patients with hypertension at high cardiovascular risk treated with intensive blood pressure (BP) control (<120mmHg) had fewer major adverse cardiovascular events (MACE) and all-cause deaths but higher rates of serious adverse events (SAE) compared with patients treated with standard BP control (<140mmHg). However, the degree of benefit or harm for an individual patient could vary due to heterogeneity in treatment effect. Methods: Using patient-level data from SPRINT, we developed predictive models for benefit (freedom from death or MACE) and harm (increased SAE) to allow for individualized BP treatment goals based on projected risk-benefit for each patient. Interactions between candidate variable and treatment were evaluated in the models to identify differential treatment effects. We performed 10 fold cross-validation for both the models. Results: Among 9361 patients, 8606 (92%) patients had no MACE or death event (benefit) and 3529 (38%) patients had a SAE (harm) over a median follow-up of 3.3 years. The benefit model showed good discrimination (c-index= 0.72; cross-validated c-index= 0.72) with treatment interactions of age, sex, and baseline systolic BP (Figure A), with more benefit of intensive BP treatment in patients who are older, male, and have lower baseline SBP. The SAE risk model showed moderate discrimination (c-index=0.66; cross-validated c-index= 0.65) with a treatment interaction of baseline renal function (Figure B), indicating less harm of intensive treatment in patients with a higher baseline creatinine. The mean predicted absolute benefit of intensive BP treatment was of 2.2% ± 2.5% compared with standard treatment, but ranged from 10.7% lower benefit to 17% greater benefit in individual patients. Similarly, mean predicted absolute harm with intensive treatment was 1.0% ± 1.9%, but ranged from 15.9% lesser harm to 4.9% more harm. Conclusion: Among non-diabetic patients with hypertension at high cardiovascular risk, we developed prediction models using basic clinical data that can identify patients with higher likelihood of benefit vs. harm with BP treatment strategies. These models could be used to tailor the treatment approach based on the projected risk and benefit for each unique patient.


2015 ◽  
Vol 17 (6) ◽  
Author(s):  
C. Recarti ◽  
S. J. S. Sep ◽  
C. D. A. Stehouwer ◽  
T. Unger

1989 ◽  
Vol 7 (10) ◽  
pp. 1447-1456 ◽  
Author(s):  
J A Laurie ◽  
C G Moertel ◽  
T R Fleming ◽  
H S Wieand ◽  
J E Leigh ◽  
...  

A total of 401 eligible patients with resected stages B and C colorectal carcinoma were randomly assigned to no-further therapy or to adjuvant treatment with either levamisole alone, 150 mg/d for 3 days every 2 weeks for 1 year, or levamisole plus fluorouracil (5-FU), 450 mg/m2/d intravenously (IV) for 5 days and beginning at 28 days, 450 mg/m2 weekly for 1 year. Levamisole plus 5-FU, and to a lesser extent levamisole alone, reduced cancer recurrence in comparison with no adjuvant therapy. These differences, after correction for imbalances in prognostic variables, were only suggestive for levamisole alone (P = .05) but quite significant for levamisole plus 5-FU (P = .003). Whereas both treatment regimens were associated with overall improvements in survival, these improvements reached borderline significance only for stage C patients treated with levamisole plus 5-FU (P = .03). Therapy was clinically tolerable with either regimen and severe toxicity was uncommon. These promising results have led to a large national intergroup confirmatory trial currently in progress.


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