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Biomedical subjects

H Loeb

Publications and source records attributed to H Loeb.

At least 19 recordsLinked to original sources

Effect of the calcium antagonist felodipine as supplementary vasodilator therapy in patients with chronic heart failure treated with enalapril: V-HeFT III. Vasodilator-Heart Failure Trial (V-HeFT) Study Group.

BACKGROUND: Despite therapy with diuretics, ACE inhibitors and digoxin morbidity and mortality in heart failure remain high and might respond favorably to an additional vasodilator. METHODS AND RESULTS: Male patients (n=450) with chronic heart failure (cardiac dysfunction and impaired exercise performance) on optimal current therapy (97% enalapril, 89% diuretics) were randomly assigned to double-blind treatment with felodipine extended release (5 mg BID) or placebo for 3 to 39 months (average, 18 months). Felodipine significantly reduced blood pressure and, at 3 months, increased ejection fraction (2.1% versus -0.1% units in the placebo group, P=.001) and reduced plasma atrial natriuretic peptide levels (-2.9 versus 26.9 pg/mL in the placebo group, P=.01) but did not improve exercise tolerance, quality of life, or the need for hospitalization. During long-term follow-up, the favorable effects on ejection fraction and atrial peptide did not persist, but felodipine prevented worsening exercise tolerance and quality of life. In the felodipine and placebo groups, mortality (13.8% versus 12.8%, respectively) and hospitalization (43% versus 42%) rates were similar, and a higher incidence of peripheral edema was the only apparent side effect of felodipine therapy. CONCLUSIONS: Felodipine exerts a well-tolerated additional sustained vasodilator effect in patients with heart failure treated with enalapril, but the only possible long-term benefit was a trend for better exercise tolerance and less depression of quality of life in the second year of treatment. The drug appears to be safe but not clearly efficacious in patients with heart failure.

Adult↗

A clinical trial with an "anti-regurgitation" formula.

To determine whether a new "anti-regurgitation formula" containing a bean gum preparation decreases the number of regurgitations and gastro-oesophageal reflux (GOR), we studied 20 infants from 1 week to 4 months of age, referred for evaluation of regurgitation, in a double-blind prospective study. The number of regurgitations decreased significantly in both the treatment group (the formula with thickening product, positional treatment, parental reassurance) and the placebo group (the same formula without thickening product, positional treatment, parental reassurance) (P 0.002 and 0.032, respectively). The results of a 24-h oesophageal pH monitoring, performed before and during treatment, showed a significant decrease in the percentage of time oesophageal pH was < 4.0 in the treatment group. It is concluded that conservative treatment of regurgitation in infants, consisting mainly of parental reassurance and postural therapy, is sufficient to obtain clinical remission in most patients. In addition, milk thickening products tend to improve clinical remission and contribute to the normalisation of some pH metric parameters.

Double-Blind Method↗

[Extra-digestive manifestations of food allergy].

Intestinal manifestations are the predominant symptoms of food allergy. Nevertheless, it is generally accepted that dietary proteins can also induce intestinal manifestations such as systemic reactions or symptoms related to the skin, the respiratory tract, the central nervous system, the urinary tract, the vascular system, the joints. The cause-effect relationships between the contact with the dietary protein (e.g. it is unclear if direct skin contact is more relevant in patients with cutaneous manifestations than ingestion) and the symptoms if often difficult to prove. As a consequence, the number of "extra-intestinal" manifestations that are suggested to be related to food proteins is probably greater than the number of manifestations that are generally accepted as such.

Allergens↗

The nutritional value of a whey hydrolysate formula compared with a whey-predominant formula in healthy infants.

Forty-five healthy infants were included in a double-blind randomized prospective study comparing the nutritional value of two formulas. One group received a whey-predominant formula (n = 20); the other group received a whey hydrolysate formula (n = 25). Four infants of the whey hydrolysate group were dropped because they refused the formula. Although the mean daily volume intake was smaller with the whey hydrolysate formula compared with the whey-predominant formula (p < 0.001), the weight gain in the two groups after 13 weeks was identical (27.2 g/day in both groups; the mean difference in weight gain between the groups after 13 weeks was only 8 g). Length gain at 13 weeks was 10.4 cm in the whey-predominant formula group and 10.8 cm in the whey hydrolysate formula group (p = NS). After 13 weeks, blood was sampled for hemoglobin, hematocrit, red blood cell count, white blood cell count, lymphocytes, glycemia, proteins, albumin, prealbumin, calcium, phosphorus, urea, creatinine, iron, iron-binding capacity, zinc, and vitamins A and E. Except for the iron-binding capacity, zinc, urea (in plasma as well as in urine) (all three were higher in the whey hydrolysate group), no significant differences were found. According to these results, exclusive feeding of the whey hydrolysate formula from birth to 3 months of age to healthy infants appears to result in an adequate nutritional status, as assessed at 3 months of age.

Double-Blind Method↗

A comparative evaluation of whey hydrolysate and whey-predominant formulas. How well do infants accept and tolerate them?

Whey hydrolysate formulas are a recent and important innovation in infant feeding. This study compared clinical tolerance and acceptability of a whey hydrolysate formula (WH) with those of a whey-predominant formula (WF) in 45 infants. Four infants (16%) who refused to drink WH formula were eliminated from the study. Mean volume intake was significantly lower for WH (120 mL/kg/day) than for WF (147 mL/kg/day; P < .001). Consequently, mean caloric intake was also significantly different: 80 kcal/kg/day (WF) vs 97 kcal/kg/day (WF; P < .001). Nevertheless, weight gain from birth to 13 weeks of age was nearly identical in both groups (171% for WH vs 178% for WF). No significant differences were noted in duration of feeding, number of pauses during feeding, number of stools per day, or number of regurgitations per day. The lower rate of caloric intake and the dropout rate of 16% for WH raise questions about the use of WH formula in normal infants, as has become the case in some Western European regions.

Double-Blind Method↗

Ejection fraction, peak exercise oxygen consumption, cardiothoracic ratio, ventricular arrhythmias, and plasma norepinephrine as determinants of prognosis in heart failure. The V-HeFT VA Cooperative Studies Group.

BACKGROUND: Recognition of the complex pathophysiology of heart failure and its high mortality has emphasized the need for prognostic markers that can be used in clinical assessment as well as in the design of mortality trials. Data from the Department of Veterans Affairs Cooperative Vasodilator-Heart Failure Trials (V-HeFT I, 642 patients; V-HeFT II, 804 patients) were therefore examined to determine the influence of prerandomization measurements on subsequent mortality. METHODS AND RESULTS: Patients entered into these trials were men with cardiac dysfunction and reduced peak exercise capacity. Measurements included in this analysis were left ventricular ejection fraction (EF) measured by radionuclide angiography, peak bicycle exercise oxygen consumption (VO2), cardiothoracic ratio (CTR) measured on a chest x-ray, ventricular arrhythmias assessed in a core laboratory by short-term Holter monitoring, plasma norepinephrine and plasma renin activity measured in a core laboratory only in V-HeFT II, and a variety of diagnostic and demographic data. The variables related only weakly to each other. EF, VO2, and CTR were powerful independent predictors of all-cause mortality in both studies. Ventricular arrhythmia was a significant independent predictor in V-HeFT II but not in V-HeFT I. Plasma norepinephrine but not plasma renin activity measured in V-HeFT II also had independent prognostic value. Other variables did not exert an independent effect on mortality. CONCLUSIONS: Optimal assessment of the mortality risk in an individual or a group of individuals with heart failure uses measurement of EF, peak VO2, CTR, plasma norepinephrine, and the presence of ventricular arrhythmias.

Arrhythmias, Cardiac↗

First-phase insulin release in adult cystic fibrosis patients: correlation with clinical and biological parameters.

Adult patients with cystic fibrosis (CF) are at high risk for developing insulin-dependent diabetes mellitus. Therefore, the fast insulin release (FIR) to intravenously administered glucose was measured in 23 adult CF patients. The influence of the clinical parameters and type of gene deletion on the amplitude of the FIR, defined by the sum of the 1st- and 3rd-minute insulin concentrations was analyzed. In 11 of the 18 normoglycemic patients with exocrine pancreatic insufficiency and the 3 nontreated diabetic CF patients studied, an FIR value lower than the 3rd percentile was found. The female patients had higher mean FIR values than the male patients (62.8 +/- 39.6 vs. 27.9 +/- 17.9 mU/l; p < 0.05). No influence of age, body mass index, or pulmonary or liver involvement on the FIR was found. Subjects heterozygous for the delta F508 deletion had a similar insulin response as homozygous patients. The FIR level correlated negatively with the basal glucose level (r = 0.4; p < 0.001). In conclusion, 61% of the adult nondiabetic CF patients with exocrine pancreatic insufficiency presented a loss in acute insulin response, which could not be predicted by clinical or genetic parameters.

Adolescent↗

A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of chronic congestive heart failure.

BACKGROUND: To define better the efficacy of vasodilator therapy in the treatment of chronic congestive heart failure, we compared the effects of hydralazine and isosorbide dinitrate with those of enalapril in 804 men receiving digoxin and diuretic therapy for heart failure. The patients were randomly assigned in a double-blind manner to receive 20 mg of enalapril daily or 300 mg of hydralazine plus 160 mg of isosorbide dinitrate daily. The latter regimen was identical to that used with a similar patient population in the effective-treatment arm of our previous Vasodilator-Heart Failure Trial. RESULTS: Mortality after two years was significantly lower in the enalapril arm (18 percent) than in the hydralazine-isosorbide dinitrate arm (25 percent) (P = 0.016; reduction in mortality, 28.0 percent), and overall mortality tended to be lower (P = 0.08). The lower mortality in the enalapril arm was attributable to a reduction in the incidence of sudden death, and this beneficial effect was more prominent in patients with less severe symptoms (New York Heart Association class I or II). In contrast, body oxygen consumption at peak exercise was increased only by hydralazine-isosorbide dinitrate treatment (P less than 0.05), and left ventricular ejection fraction, which increased with both regimens during the 2 years after randomization, increased more (P less than 0.05) during the first 13 weeks in the hydralazine-isosorbide dinitrate group. CONCLUSIONS: The similar two-year mortality in the hydralazine-isosorbide dinitrate arms in our previous Vasodilator-Heart Failure Trial (26 percent) and in the present trial (25 percent), as compared with that in the placebo arm in the previous trial, (34 percent) and the further survival benefit with enalapril in the present trial (18 percent) strengthen the conclusion that vasodilator therapy should be included in the standard treatment for heart failure. The different effects of the two regimens (enalapril and hydralazine-isosorbide dinitrate) on mortality and physiologic end points suggest that the profile of effects might be enhanced if the regimens were used in combination.

Adolescent↗

Oral glucose tolerance testing in cystic fibrosis: correlations with clinical parameters and glycosylated haemoglobin determinations.

In 48 patients (age 2-28 years) with documented cystic fibrosis, glucose tolerance was evaluated by means of an oral glucose tolerance test (OGTT) and repeated glycosylated haemoglobin (HbA1C) measurements. An impaired OGTT was found in 15 patients. Their degree of undernutrition and severity of lung and liver involvement were no different from those with normal glucose tolerance. The mean peak insulin concentration as well as the integrated insulin concentration during the OGTT were comparable with patients with normal glucose tolerance (GT) and those with an impaired tolerance (GI). The mean time to attain peak insulin levels was significantly delayed in the GI group. (117 min vs 86 min P less than 0.01). On initial testing, elevated HbA1C levels were found in 22 patients. Mean HbA1C levels in the GI group were higher than in the GT group (8.2% vs 7.5% P less than 0.01). The HbA1C levels at the moment of OGT testing were positively correlated with the glycaemic response during the OGTT. The repeated HbA1C measurements 1 year later were no different from the initial mean HbA1C values in both groups. Two GI patients with initial HbA1C levels of 7.5% and 11% respectively developed diabetes mellitus several months after testing. The need for serial HbA1C determinations in cystic fibrosis is questioned.

Adolescent↗

Alkaline gastroesophageal reflux in infancy.

Alkaline gastroesophageal reflux is a rare disorder, although it has been suggested as a cause of esophagitis. However, up to now, there exists no unequivocally accepted diagnostic method for alkaline reflux that can be routinely applied. "Normal ranges" of episodes of pH greater than 7.0-7.5 in asymptomatic as well as in symptomatic infants are proposed. In the asymptomatic infants (n = 83), the mean percentage of time the pH was greater than 7.0 was 1.3 +/- 2.6, and the number of episodes in 24 h with a pH greater than 7.0 was 10.4 +/- 16.4. In the symptomatic group (n = 60), including infants with chronic vomiting, the mean percentage of time the pH was greater than 7.0 was 0.15 +/- 0.5, and the number of episodes with a pH greater than 7.0 was 2.8 +/- 5.5. In all but six infants the percentage of time the pH was greater than 7.5 was less than 0.1. In three of four of these infants (endoscopy was refused by two parents) whose conditions exceeded the cut-off limits, there was a histologically proven esophagitis. To evaluate the proposed "normal" ranges for episodes of pH greater than 7.0 and 7.5, 200 symptomatic children were included in a prospective study. Symptoms were repetitive vomiting (n = 110), excessive crying (n = 53), and chronic respiratory disease (n = 37). Esophagoscopy was performed in 18 babies (9%) because pH monitoring data exceeded the proposed limits for the percentage of time the pH was greater than 7.0.(ABSTRACT TRUNCATED AT 250 WORDS)

Esophagus↗

The interpretation of oesophageal pH monitoring data.

Continuous monitoring of oesophageal pH is regarded as the gold standard for all reflux investigations. However, since gastro-oesophageal reflux is considered a normal phenomenon which occurs to a certain extent in each individual, the distinction between "normal" and "abnormal" is not always obvious and is not possible to achieve with a single test. Moreover, data depend on technical hardware such as recording devices and electrodes together with such patient characteristics as age, position, activity, and medication. Although much literature on pH monitoring has appeared recently, many investigations have failed to take into account the basic principles that are of major importance for any biomedical test such as reproducibility, sample reliability, and indications. There is a need to standardize the technique in order to compare studies performed in different centres, provided the technique is reproducible.

Adult↗

Milk-sensitive eosinophilic gastroenteritis in a 10-day-old boy.

Eosinophilic gastroenteropathy in children is a rare, idiopathic disease characterized by eosinophilic infiltration of the gastrointestinal tract. We describe a 10-day-old boy with aspecific clinical manifestations (unconsolable crying). Treatment with a semi-elemental diet was successful, suggesting a "milk-sensitive enteropathy", although he had been exclusively breast fed. Recent literature is reviewed.

Animals↗

Tannin-rich carob pod for the treatment of acute-onset diarrhea.

Infants aged 3-21 months with acute diarrhea of bacterial and viral origin were treated as inpatients with oral rehydration fluid and randomly received for up to 6 days either a tannin-rich carob pod powder (40% tannins or 21.2% polyphenols and 26.4% dietary fiber), 1.5 g/kg/day (n = 21) to a maximum of 15 g, or an equivalent placebo (n = 20). The duration of the diarrhea from admission was 2.0 +/- 0.27 days in the test group and 3.75 +/- 0.30 days in the placebo group (p less than 0.001). Normalized defecation, body temperature, and weight and cessation of vomiting were reached more quickly by the patients who received the test substance. The test substance was well accepted and tolerated.

Acute Disease↗

PH monitoring in children.

Long-term oesophageal pH monitoring has become the preferred technique for detection and quantification of gastro-oesophageal reflux (GOR). The most obvious advantages of pH monitoring are the duration of the investigation, the possibility of being able to relate "events" (emesis, heartburn, apnoea) to pH changes (and to study "occult GOR"), the physiological conditions in which the data are recorded (sleep, work), and the possibility of repeating the investigation in treatment conditions. However, it has been reported that the accuracy of pH monitoring is no higher than 90%, because the intermittent presence of acid in the oesophagus is only one of the various abnormalities in the syndrome of GOR. A tremendous number of technique- (pH monitoring system, type of electrode, location of the electrode) and patient-related factors influence pH data. Age, position (both for adults and for infants), duration of the investigation (day/night), feeding and drugs are patient-related factors. Finally, the question arises (which is still unanswered) whether the indication for pH monitoring should be considered in the interpretation of the data: are the same criteria valid for GOR in children presenting with emesis and oesophagitis as for children with GOR resulting in chronic respiratory disease or "near-miss sudden infant death syndrome".

Child↗

Preliminary data on a field study with a new hypo-allergic formula.

The incidence of atopic manifestations due to cow's milk proteins was analysed in five groups of 15 newborns considered to be at risk for atopy because of a positive family history. All infants were studied over a 4-month period. The infants received either an adapted formula (AdFo), breast milk or a new hypo-allergic formula (HAF). Atopic manifestations appeared in 1 out of 15 breast-fed infants compared with 18 out of 45 infants fed with an AdFo. None of the infants receiving the HAF (exclusively from birth for 2-4 months) developed symptoms of atopy. Symptoms in each infant receiving an AdFo (n = 18) disappeared with the HAF. Although the results of this study are promising, data on a larger population and double-blind investigations are needed before firm conclusions can be drawn.

Animals↗

Effects of formula feeding on gastric acidity time and oesophageal pH monitoring data.

Gastro-oesophageal reflux (GOR) occurs mainly during postcibal (PC) periods. The duration of PC gastric acidity and the incidence of GOR were analysed in 11 asymptomatic premature infants. GOR was studied during PC periods of 120 min and also during the following 120 min defined as fasting (FT) periods. These infants were subjected to simultaneous continuous gastric and oesophageal pH monitoring using a double-blind crossover technique. Two formulae with different fat contents (2.6 vs 3.6 g/100 ml) and different carbohydrate concentrations (8.1 vs 7.3 g/100 ml; malto-dextrin 2.8 vs 1.9 g/100 ml) were given. Gastric acidity (pH less than 4) in the PC periods lasted significantly (P less than 0.001) longer (68 min +/- 10) with the low fat/high malto-dextrin formula versus 43 min +/- 11 with the high fat/low malto-dextrin formula. Oesophageal pH monitoring data were within normal limits for the total investigation time in all infants. During PC periods acid GOR was detected more frequently in the group with a low fat formula. More PC GOR was recorded when the gastric acidity time was longer.

Dietary Carbohydrates↗