Metabolic effects of carvedilol vs metoprolol in patients with type 2 diabetes mellitus and hypertension: a randomized controlled trial

Context  -Blockers have been shown to decrease cardiovascular risk in patients with hypertension and type 2 diabetes mellitus (DM); however, some components of the metabolic syndrome are worsened by some -blockers. Objective  To compare the effects of -blockers with different pharmacological profiles on glycemic and metabolic control in participants with DM and hypertension receiving renin-angiotensin system (RAS) blockade, in the context of cardiovascular risk factors. Design, Setting, and Participants  A randomized, double-blind, parallel-group trial (The Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Comparison in Hypertensives [GEMINI]) conducted between June 1, 2001, and April 6, 2004, at 205 US sites that compared the effects of carvedilol and metoprolol tartrate on glycemic control. The 1235 participants were aged 36 to 85 years with hypertension (>130/80 mm Hg) and type 2 DM (glycosylated hemoglobin [HbA_1c], 6.5%-8.5%) and were receiving RAS blockers. Participants were followed up for 35 weeks. Interventions  Participants were randomized to receive a 6.25- to 25-mg dose of carvedilol (n = 498) or 50- to 200-mg dose of metoprolol tartrate (n = 737), each twice daily. Open-label hydrochlorothiazide and a dihydropyridine calcium antagonist were added, if needed, to achieve blood pressure target. Main Outcome Measures  Difference between groups in mean change from baseline HbA_1c following 5 months of maintenance therapy. Additional prespecified comparisons included change from baseline HbA_1c in individual treatment groups, treatment effect on insulin sensitivity, and microalbuminuria. Results  The 2 groups differed in mean change in HbA_1c from baseline (0.13%; 95% confidence interval [CI], –0.22% to –0.04%; P = .004; modified intention-to-treat analysis). The mean (SD) HbA_1c increased with metoprolol (0.15% [0.04%]; P<.001) but not carvedilol (0.02% [0.04%]; P = .65). Insulin sensitivity improved with carvedilol (–9.1%; P = .004) but not metoprolol (–2.0%; P = .48); the between-group difference was –7.2% (95% CI, –13.8% to –0.2%; P = .004). Blood pressure was similar between groups. Progression to microalbuminuria was less frequent with carvedilol than with metoprolol (6.4% vs 10.3%; odds ratio, 0.60; 95% CI, 0.36-0.97; P = .04). Conclusions  Both -blockers were well tolerated; use of carvedilol in the presence of RAS blockade did not affect glycemic control and improved some components of the metabolic syndrome relative to metoprolol in participants with DM and hypertension. The effects of the 2 -blockers on clinical outcomes need to be compared in long-term clinical trials.      

Rasagiline improves quality of life in patients with early Parkinson's disease.

The objective of this study was to determine the effects of rasagiline as monotherapy on quality of life (QOL) in patients with early Parkinson's disease (PD). Rasagiline, a potent, second-generation, irreversible, selective monoamine oxidase B inhibitor improves PD symptoms in patients with early PD. Patients with early untreated PD were randomly assigned to once-daily rasagiline 1 mg/day, rasagiline 2 mg/day, or placebo in a 6-month, double-blind trial (n=404). At the end of 6 months, patients entered the preplanned, active-treatment phase in which those receiving 1 mg/day and 2 mg/day of rasagiline continued on their previously assigned dosages and those receiving placebo switched to rasagiline 2 mg/day, while maintaining blinding to treatment assignments. QOL was measured with the Parkinson's Disease Quality of Life questionnaire (PDQUALIF) at 0, 14, 26, and 52 weeks after randomization. Analysis of the change in PDQUALIF scores from baseline to 6 months showed adjusted treatment effects (with 95% confidence interval) favoring rasagiline over placebo of -2.91 units (-5.19, -0.64, P=0.01) for the 1 mg/day group and -2.74 units (-5.02, -0.45, P=0.02) for the 2 mg/day. Subscore analysis attributed most of this benefit to the self-image/sexuality domain. At 12 months (n=266), with all groups receiving rasagiline for at least 6 months, no significant differences in PDQUALIF scores were seen between groups. Rasagiline improved QOL compared with placebo. This QOL improvement appears to be accounted for primarily by the symptomatic benefit of rasagiline.     

The effect of Ramadan on maternal nutrition and composition of breast milk

BACKGROUND: There are many advantages of breast milk for infants. Many factors can affect the volume and composition of breast milk. One of them is the maternal diet. The objective of this study is to determine the effect of Ramadan fasting on maternal nutrition and breast milk composition. METHODS: A total of 21 breast-feeding mothers aged between 17 and 38 years who fasted during Ramadan month and volunteered to give milk samples were surveyed. The ages of the infants were between 2 and 5 months. The study was performed during Ramadan and 2 weeks after the end of Ramadan. RESULTS: The results showed that during Ramadan, zinc, magnesium and potassium levels in breast milk decreased significantly (P<0.05). The mother's weight increased approximately 1 kg after Ramadan. Changes in body mass index of the mother were not statistically significant. A significant decrease in vitamin A intake was observed after Ramadan (P < 0.05). During Ramadan, energy and most nutrient intakes except protein and vitamins A and C were found below daily recommended dietary allowances necessary for lactating women. CONCLUSIONS: Ramadan fasting had no significant effect on the macronutrient composition of the breast milk and consequently the growth of the infants. There were significant differences in some of the micronutrients such as zinc, magnesium and potassium. The nutritional status of lactating women was affected by Ramadan fasting. All of the nutrient intakes (except vitamins A, E and C) decreased during Ramadan. For these reasons, it would seem prudent to excuse lactating women from fasting during Ramadan.     

Speech-controlled generation of radiology reports

Voice entry has been successfully employed to generate radiology reports with a word recognizer with a 1,000-word lexicon capacity. About 50% of reports were able to be dictated with a single 900-word lexicon. This was split into five sections by anatomic or subspecialty application. Each was augmented to 900 words. By switching from one lexicon to another, it was possible to dictate more than 70% of reports. With exclusive use of three lexicons in subspecialty areas (gastrointestinal radiology, neuroradiology, and mammography), and with further modification of the respective vocabulary, it has been possible to employ the system 88% of the time. Twelve percent of cases included wording that was beyond the scope of the lexicon. Computer subsets that allow different translations of some words when used in different contexts have been used. Some of these are used as triggers that will print whole lines, sentences, or even complete reports. Dictation times with voice entry take about 20% longer. Recognition reliability has been greater than 95%.     

Simultaneous total arch replacement and abdominal aortic surgery

It is common to encounter patients with coexisting aortic arch aneurysm and abdominal aortic lesions. We conducted simultaneous total arch replacement and abdominal aortic surgery in 3 patients having such lesions. Mean operative time was 511 minutes and no in-hospital mortality occurred. Postoperative respiratory failure was observed in an 80-year-old patient who recovered and all three patients were discharged in good condition. No other postoperative complication was seen. Simultaneous total arch replacement and abdominal aortic surgery may thus offer advantages to patients with such double aortic lesions if it can be conducted safely.     

Benefits of early admission to a comprehensive trauma center for patients with spinal cord injury

Patients with spinal cord injury may be admitted directly to a trauma center with a dedicated rehabilitation unit or transferred there days or weeks later. This study analyzed the relationship between time of transfer to a Level I Trauma Center with a spinal cord injury service and efficacy of subsequent rehabilitation. We examined the records of all patients admitted to the service between September 1981 and August 1983 and followed at least one year. There were 197 patients, 102 quadriplegics and 95 paraplegics, aged 15 to 77 years (average = 29.4 years). Median time from injury to admission was 11 days for quadriplegics and 21 days for paraplegics; this was used to define early and late groups. The early quadriplegic group began rehabilitation 2.94 days postinjury; the late quadriplegic group, 74.87 days (p less than .01). Time in rehabilitation did not differ (128.22 days, early; 122.61, late), but total hospitalization--from injury to discharge--was 131.16 days for the early quadriplegic group and 197.27 for the late quadriplegic group (p less than .01). Average duration of prerehabilitation care for the paraplegic groups was 6.19 days (early) and 58.58 days (late) (p less than .01). Time in rehabilitation was the same for both paraplegic groups, but total hospitalization was shorter for early admissions (82.91 days vs 125.90 days, p less than .01).(ABSTRACT TRUNCATED AT 250 WORDS)     

Amplification of the c-myc gene in human medulloblastoma cell lines and xenografts

Cultured cell lines and xenografts derived from 7 human medulloblastomas were evaluated for amplification of the c-myc, N-myc, epidermal growth factor receptor, and gli genes by Southern blot analysis. Karyotypes of the original biopsies and early passaged cells demonstrated double minute chromosomes in 4 of the 7 cases. All 7 samples (3 cell lines and 4 xenografts) from the 4 tumors with double minute chromosomes contained amplification of the c-myc gene. Cell lines and xenografts derived from the 3 biopsies without double minute chromosomes failed to demonstrate amplification of the 4 genes which were tested, but a rearrangement of the c-myc gene occurred in 1 of the 3 tumors. These observations demonstrate that the c-myc gene is often amplified and/or rearranged in human medulloblastomas and suggest that amplification of this gene provides a growth advantage for medulloblastoma cells in vitro and in vivo.