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Biomedical subjects

F Spengel

Publications and source records attributed to F Spengel.

At least 19 recordsLinked to original sources
PubMed2002

The efficacy and safety of a coumarin-/troxerutin-combination (SB-LOT) in patients with chronic venous insufficiency: a double blind placebo-controlled randomised study.

BACKGROUND: The objective was to evaluate the oedema-protective effect of a vasoactive drug (coumarin/troxerutin [SB-LOT]) plus compression stockings in patients suffering from chronic venous insufficiency after decongestion of the legs as recommended by the new guidelines. PATIENTS AND METHODS: 231 patients were randomly assigned medical compression stockings plus SB-LOT (90 mg coumarin and 540 mg troxerutin per day) or medical compression stockings plus placebo for the first 4 weeks and SB-LOT or placebo for the second 12 weeks of the study. The primary efficacy endpoint was the lower leg volume measured by well-established water plethysmometry. RESULTS: 226 patients were evaluated. After ceasing compression stockings, an edema protective effect was detected in the SB-LOT-group but not in the controls. Recurrence of leg volume increase was by 6.5 +/- 12.1 ml and by 36.7 +/- 12.1 ml in the SB-LOT and placebo group, respectively (p = 0.0402). The local complaint score and general aspects of quality of life were also superior for the SB-LOT-group (p = 0.0041). Significant differences were also observed with regard to clinical global impression and therapeutic effect. No serious adverse drug reaction or clinically relevant impairment of laboratory parameters occur. CONCLUSION: This study confirms the oedema-protective effect of SB-LOT in chronic venous insufficiency and provides a treatment option for patients who discontinue compression after a short time.

Administration, Oral↗
PubMed2002

Findings of the Naftidrofuryl in Quality of Life (NIQOL) European study program.

BACKGROUND: We report in this paper the findings of a pooled analysis of 3 previously published studies undertaken in Germany, France and Belgium to assess the effects of naftidrofuryl on the quality of life of patients with intermittent claudication. METHODS: A total of 754 patients were randomised in the 3 studies, 709 of whom (358 naftidrofuryl, 351 placebo) were available for the primary intention-to-treat analysis. The primary outcome variable was the change in the disease-related limitation of the quality of life as measured by the CLAU-S questionnaire. This instrument which has been validated in an international study, comprises 47 questions covering 5 dimensions: "daily living", "pain", "social life", "disease specific anxiety" and "mood". RESULTS: A multivariate analysis of covariance adjusted for baseline values, study effect and first order study treatment interaction, demonstrated the global superiority of naftidrofuryl over placebo (p<0.001). A separate covariance analysis for the 5 dimensions showed highly significant differences for "daily living", "pain", "social life" and "mood" (all p<0.01). CONCLUSIONS: In conclusion, this pooled analysis has shown that naftidrofuryl can significantly improve the quality of life of patients with intermittent claudication. These findings, taken together with evidence from previous studies that it improves treadmill walking distances, suggest that naftidrofuryl can play a useful role in the treatment of this condition.

Adult↗
PubMed1999

Naftidrofuryl can enhance the quality of life in patients with intermittent claudication.

BACKGROUND: Using a disease specific questionnaire, the CLAU-S, we undertook a double blind, placebo controlled study in patients with intermittent claudication to determine whether the increase in the pain-free walking distance, previously demonstrated with naftidrofuryl, is reflected as an improvement in the patients' quality of life. PATIENTS AND METHODS: 287 patients, with stable intermittent claudication for at least 3 months were entered into the study. Following an initial one month placebo run-in, patients were randomised to either naftidrofuryl, at a dosage of 200 mg three times daily, or matching placebo, for 6 months. All patients completed the self-administered CLAU-S questionnaire which is divided into 6 dimensions, before the start of treatment, at 3 and 6 months. Statistical analysis was undertaken on an intention-to-treat (ITT) basis which included all patients know to have taken at least one dose of the drug and to have provided key data on at least one occasion after baseline. For each of the CLAU-S dimensions the two groups were compared with respect to difference between the initial and final values. RESULTS: 255 patients (133 naftidrofuryl, 122 placebo) were eligible for the ITT analysis. Significant improvements, in favour of the active medication, were seen for the dimensions "daily living", "pain", "disease specific anxiety" and "mood". A multivariate analysis of covariance, which took into account such factors as initial score, age and sex confirmed the global superiority of naftidrofuryl (p = 0.004). CONCLUSIONS: In this placebo controlled study, using a disease specific questionnaire, naftidrofuryl has been shown to significantly improve several aspects of the quality of life of patients with intermittent claudication.

Aged↗
PubMed1998

Low-dose iloprost infusions compared to the standard dose in patients with peripheral arterial occlusive disease Fontaine stage IV. DAWID Study Group.

BACKGROUND: Intravenous iloprost, titrated from 0.5 up to 2.0 ng/kg/min has been shown in patients with PAOD III/IV to significantly improve healing of trophic lesions, relief of rest pain, and reduce the rate of major amputation or death at 6 months as compared to placebo. The effect is considered related to improvement of the microcirculation. The aim of the present trial was to identify an optimum dose regarding treatment response and tolerability, by studying 4 doses of 25, 50, 75 and 100 micrograms iloprost daily. PATIENTS AND METHODS: 302 patients with PAOD IV were randomised via a double-blind fashion to one of the 4 doses. The primary endpoint was the responder rate at end of treatment. Responders were defined as patients with very good or good global efficacy, as judged by lesion healing and pain relief. Side effects were documented and a pre-defined benefit/risk index was calculated. RESULTS: No dose-dependency of iloprost regarding primary or secondary endpoints was observed. The rate of responders ranged between 48.7-53.5%. Side effects, mainly related to vasodilation, increased dose-dependently (p < 0.001, chi 2-test), with a significant decrease of the benefit/risk index from 2.19 +/- 1.19 to 1.64 +/- 0.97 (p = 0.012, ANOVA). Responders had a better outcome at 6 months than non-responders (2.6 fold higher rate of major amputation or death; life table analysis). CONCLUSIONS: It is concluded that iloprost should be titrated to the optimum rather than maximum tolerated dose, since a higher incidence of side effects not associated with an increased treatment response was observed at higher doses.

Aged↗
PubMed1997

Efficacy of a new prostaglandin E1 regimen in outpatients with severe intermittent claudication: results of a multicenter placebo-controlled double-blind trial.

For the first time efficacy and safety of a new prostaglandin E1 (PGE1) regimen in the treatment of intermittent claudication were evaluated in a randomized, double-blind, placebo-controlled multicenter clinical trial. The study involved 213 outpatients with a maximum walking distance of 50 to 200 m measured on the treadmill (3 km/hr, 12% grade). After a 2-week run-in phase they received a 2-hour intravenous infusion of 60 micrograms PGE1 or placebo 5 days a week for 4 weeks. It was followed by a 4-week interval treatment with the same medication administered only twice a week. Patients were monitored for 3 months when they received no study medication. In the PGE1 group the intention-to-treat analysis (n = 208) revealed an increase in walking distance after 4 weeks of 75% (placebo, 43%). At the end of the interval treatment the walking distance had improved to 101% (placebo, 60%). The results remained virtually constant during follow-up (PGE1, 104%, placebo, 63%). Between-group comparisons showed significant differences in favor of PGE1 for all three time points of measurement (p < 0.05, p < 0.01, and p < 0.05). PGE1 was well tolerated; the rate of adverse reactions related to the treatment was 12.8% (placebo, 7.7%). In summary, these results show that the new PGE1 regimen is effective and safe in the treatment of outpatients with intermittent claudication.

Aged↗
PubMed1997

Improvement in the quality of life after i.v. PGE1 therapy for intermittent claudication.

BACKGROUND: Increasingly and justifiably, clinical studies are now being expected to investigate the influence of therapeutic measures also on the quality of life of the patient. PATIENTS AND METHODS: Since no data on the variability of changes in the quality of life of the patient following PGE1 treatment are so far available, the initial investigation was designed as an uncontrolled pilot study. 104 patients (median age 64.5 years) with a maximum of walking distance on the treadmill (3 km/12%) of 50-250 m were included and given a daily intravenous infusion of 60 micrograms PGE1 (Prostavasin) over a period of 4 weeks excluding weekends. This was followed by a treatment-free follow-up period of 3 months. Changes in the quality of life were recorded with both the newly developed disease-specific questionnaire PAVK-86, and the generic questionnaire SF 36; in addition, the pain-free and maximum walking distances on the treadmill were also established prior to and immediately following treatment, as also at the end of the follow-up period. RESULTS: The quality of life was significantly improved in all dimensions (functional status, complaints, pain, mood, anxiety, social life, treatment expectations) in addition to a marked increase in the median pain-free walking distance from 77 to 108 m (p < 0.001) and the maximum walking distance from 118 to 171 m (p < 0.001). At the end of the 3-month observation period, the improvement was essentially still demonstrable. CONCLUSION: The study has shown for the first time that treatment with intravenous PGE1 brings about not only the already known increase in the walking distance, but also a clinically relevant and significant improvement in the patient's quality of life.

Adult↗
PubMed1993

Relation of lipoprotein(a) to coronary heart disease and duplexsonographic findings of the carotid arteries in heterozygous familial hypercholesterolemia.

In familial hypercholesterolemia (FH) elevated Lp(a) concentrations are more frequent than in the general Caucasian population, but the clinical relevance of Lp(a) as a risk-factor in this group of patients is controversial. In 91 adult patients with heterozygous FH due to LDL-receptor defect we analyzed the correlation between Lp(a) concentrations, presence of coronary heart disease (CHD) and degree of atherosclerosis of the carotid arteries assessed by duplex scan. Coronary heart disease was present in 32 patients (24 males, 8 females). In the group without CHD the median of the Lp(a) distribution was 23 mg/dl, in the group with CHD 43 mg/dl (P < 0.05). The median of Lp(a) was 8 mg/dl in patients without pathological changes in the duplex scan of the carotids, 13 mg/dl in the group with intimal thickening, 25 mg/dl in patients with non-obstructing plaques, and 45 mg/dl in presence of > 30% luminal obstruction (P < 0.01). The role of Lp(a) as an independent risk factor was analyzed by stepwise logistic regression together with age, sex, LDL-, HDL-cholesterol, serum triglycerides, smoking status and presence of hypertension. For the prediction of CHD only age, HDL cholesterol and gender reached statistical significance. Lp(a) was, however, the lipoprotein parameter with the highest discriminative strength for the presence of a pathological duplex scan (P = 0.016), followed by LDL- (P = 0.03), and HDL-cholesterol (P = 0.03). These results provide direct evidence for a close correlation between Lp(a) and the rate of progression of atherosclerosis in FH, already at early, asymtomatic stages.

Adult↗
PubMed1993

Erythromelalgia unmasked during norephedrine therapy: a case report.

A thirty-eight-year-old woman presented with typical signs of erythromelalgia: burning, redness, and warm congestion of the extremities. These symptoms occurred after cessation of obesity drug therapy with norephedrine (250 mg/day) continuously over six years. The condition was refractory to treatment with acetylsalicylic acid. It is suggested that erythromelalgia in this case was unmasked by the vasoactive properties of norephedrine. Continuous drug therapy with norephedrine may have led to adaptive adrenergic subsensitivity of vascular smooth muscles. The pathomechanism of primary erythromelalgia is still unknown. Their observations suggest that an enhanced vasodilatation due to an abnormal adrenergic sensitivity may play an important role in the pathogenesis of primary erythromelalgia.

Adult↗
PubMed1992

Familial defective apolipoprotein B100: clinical characteristics of 54 cases.

Familial defective apolipoprotein B100 (FDB) is a recently identified dominantly inherited genetic disorder, which is characterized by a decreased affinity of low density lipoprotein (LDL) for the LDL receptor. FDB is caused by a G to A mutation at nucleotide 10 708 in exon 26 of the apo B gene creating a substitution of glutamine for arginine in the codon for amino acid 3500. To determine the consequences of the arginine(3500)----glutamine mutation on plasma lipid levels and other clinical features, we have investigated 54 FDB heterozygotes from Germany (24 men, 30 women, mean age 37.2 (4-73) years). The average total cholesterol level in plasma was 308 mg/dl (average LDL-cholesterol 242 mg/dl), which was 116 mg/dl (120 mg/dl) above the 50th percentile of the age and sex-matched controls reported in the LRC population studies (Lipid Research Clinics' Program 1980). Tendon xanthoma and arcus lipoides were present in 25.9% and 22.2% of the patients, respectively. Plaques in the carotid arteries, determined by duplex scanning, were present in 38.9%, and coronary artery disease was present in 22.2%. This study shows that the combination of tendon xanthoma, arcus lipoides and premature atherosclerosis is no longer totally appropriate for the diagnosis of familial hypercholesterolemia (FH). It rather seems that these features are characteristic of a defective LDL receptor pathway, which could be caused by a defective LDL receptor or a defective ligand apo B100. The distinction between FH and FDB may have therapeutic implications, because certain lipid lowering drugs act by stimulation of the LDL receptor, which has a normal function in FDB.

Adolescent↗
PubMed1991

The spontaneous course of small abdominal aortic aneurysms. Aneurysmal growth rates and life expectancy.

Since abdominal ultrasonography has become a routine diagnostic procedure, increasing numbers of small asymptomatic abdominal aortic aneurysms are detected incidentally. Of 128 patients (108 male, 20 female) with abdominal aortic aneurysms, 96 patients were observed clinically and by repeated ultrasound studies for an average of 3.47 years, adding up to a total observation period of 333 patient-years. Among these 96 patients, 72 had small aneurysms (averaged diameters less than 5 cm). Three of them were lost to follow up. None of the remaining 69 patients died from rupture, 20 died from other causes and 8 patients were successfully operated. Of the patients with a large aneurysm one was lost to follow up. Five patients of the remaining 23 died as a result of rupture, 7 were successfully operated. The average growth rate of small aneurysms was 0.18 cm/year, whereas the larger aneurysms showed a growth rate of 0.28 cm/year (diameter). The survival rate of patients with small aneurysms was 94% after one year, 80% after 3 years, and 73% after 5 years, indicating that life expectancy is reduced in patients with an aneurysm of the abdominal aorta, but not because of complications of the aneurysm.

Adult↗
PubMed1990

[Successful drug therapy in Aspergillus endocarditis].

A 74-year-old man who had a weight loss of 7 kg in three months, with fever up to 38 degrees C and anaemia (Hb 9.4 g/dl) began to have pain and blue discoloration of fingers II-V of the right hand. Echocardiography demonstrated vegetation on the aortic valve cusps and blood culture grew Aspergillus fumigatus, indicating Aspergillus endocarditis. There were no predisposing factors. Valve replacement was contraindicated because of the age of the patient, the presence of peripheral arterial disease, and previous myocardial infarction. Treatment was started with amphotericin B i.v. (dosage increasing to 50 mg daily) and 1.5 g daily of flucytosine by mouth, to a total of 1.1 g amphotericin B and 41.5 g flucytosine in five weeks. During this time there was a gradual decrease in symptoms and the valve vegetations. Nine months later there has been no recurrence.

Aged↗
PubMed1989

Intravenous treatment of chronic peripheral occlusive arterial disease: a double-blind, placebo-controlled, randomized, multicenter trial of pentoxifylline.

A multicenter, prospective, placebo-controlled, double-blind trial was conducted to investigate the efficacy of intravenous infusion therapy with pentoxifylline over fourteen days in patients suffering from angiographically confirmed chronic peripheral occlusive arterial disease, Fontaine stage II, with at least a six-month history. After a washout phase of one week, the patients received in accordance with a randomization scheme either an i.v. infusion of 300 mg of pentoxifylline (15 mL ampoules) or 15 mL of a 0.9% NaCl solution in 250 mL of 5% laevulose, administered over three hours twice daily. The main efficacy parameters were treadmill-assessed initial claudication distance (ICD) and absolute claudication distance (ACD). Baseline testing revealed a mean ICD of 131 m in the pentoxifylline group and 126 m in the placebo cohort; mean ACD values were 239 m and 225 m respectively. The group of patients treated with pentoxifylline (n = 75) displayed a significantly greater improvement (p less than 0.0001) in ICD (+70%) and ACD (+60%) than the placebo group did (+33%) and 32%, respectively) (n = 79). The infusions were well tolerated in both groups.

Adult↗
PubMed1988

[ECG-triggered magnetic resonance tomographic measurement of blood flow velocity in the carotid arteries: comparison with duplex sonography].

Blood flow velocity in the common carotid arteries was measured for 30 vessels by MRI with a multiecho SE-sequence and compared with the results from duplex ultrasound. MR blood flow velocity was measured for a time interval of 390 ms every 30 ms using a EKG-triggered data acquisition. The time-velocity curves measured by MRI and duplex ultrasound were in good agreement. The correlation coefficient for the peak velocity was r = 0.83. Mean peak velocity as measured by MRI was 59 +/- 8% of peak velocity as measured by duplex ultrasound.

Blood Flow Velocity↗