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Biomedical subjects

W Lehmacher

Publications and source records attributed to W Lehmacher.

At least 19 recordsLinked to original sources
PubMed2006

Trapidil is as effective as isosorbide-dinitrate for treating stable angina pectoris: a multinational, multicenter, double-blind, randomized study.

OBJECTIVE: Nitrates have long been used in the treatment of stable angina pectoris. We set out to show that trapidil, a triazolo-pyrimidine with a mode of action different from that of nitrates, is not inferior to isosorbide-dinitrate (ISDN) in the treatment of this clinical syndrome. PATIENTS AND METHODS: We studied the efficacy of 200 mg trapidil (t.i.d.) vs. ISDN (20 mg b.i.d.) in patients with chronic stable angina treated for 12 weeks. The therapeutic effect was measured in terms of responder rate as change in total exercise time (TET) by at least 60 seconds using the bicycle ergometer test. RESULTS: A total of 648 patients were included in the study. Responder rates in the Per- Protocol (PP) population (n = 529) were 50.4% (n = 133) in the trapidil group and 52.5% (n = 139) in the ISDN group (p = 0.233). As the lower non-inferiority limit (-15%) was clearly excluded from the 95% CI (pp: -10.6%, +6.4%; ITT -9.7%, 5.7%), non-inferiority of trapidil compared to ISDN can be concluded. Trapidil 200 mg t.i.d. combined with short-acting NTG prn as rescue medication over 12 weeks in subjects with chronic stable angina pectoris proved to have similar effects on TET and on other clinical endpoints as ISDN 20 mg b.i.d. The secondary efficacy analyses did not reveal any clinically relevant differences between treatment groups, and were not in conflict with the non-inferiority claim. Patients in the ISDN group had significantly more headache (34.1%; n = 110) compared to those taking trapidil (19.3%, n = 62; p <0.0001). CONCLUSIONS: Overall results of this study show that both drugs are equally effective and safe for the short-term treatment of patients with chronic stable angina pectoris and that trapidil can be considered as therapeutically equivalent to ISDN.

Adult↗
PubMed2005

Treatment of acute bronchitis in adults with a pelargonium sidoides preparation (EPs 7630): a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Acute bronchitis is a widespread medical problem, and, although predominantly caused by viruses, antibiotics are still prescribed unnecessarily. Therefore, it is of utmost importance to evaluate the use of alternative treatments for acute bronchitis. OBJECTIVE: To evaluate the efficacy and safety of a Pelargonium sidoides preparation (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany) compared with placebo in patients with acute bronchitis. DESIGN: Randomized, double-blind, placebo-controlled trial using a design with planned interim analyses. SETTING: Six outpatient clinics. PATIENTS: One hundred twenty-four adults with acute bronchitis present </=48 hours, Bronchitis Severity Score (BSS) >/=five points, and informed consent. INTERVENTION: EPs 7630 or placebo (30 drops three times daily) for seven days. MEASUREMENTS: The primary outcome criterion was the change of BSS on day seven. RESULTS: The decrease of BSS from baseline to day seven was 7.2 +/- 3.1 points with EPs 7630 (n = 64) and 4.9 +/- 2.7 points with placebo (n = 60). The 95% confidence interval for the difference of effects between the two treatment groups (EPs 7630 minus placebo) was calculated as (1.21, 3.56) showing a significant improvement of EPs 7630 compared with placebo on day seven (P < .0001). For each of the five individual symptoms, rates of complete recovery were considerably higher in the EPs 7630 group. Within the first four days, onset of treatment effect was recognized in 68.8% of patients in the EPs 7630 group compared with 33.3% of patients in the placebo group (P < .0001). Health-related quality of life improved more in patients treated with EPs 7630 compared with placebo-treated patients. Adverse events occurred in 25 of 124 patients (EPs 7630: 15/64 patients, placebo: 10/60 patients). All adverse events were assessed as nonserious. CONCLUSIONS: EPs 7630 was superior in efficacy compared with placebo in the treatment of adults with acute bronchitis. It may therefore offer an effective alternative for acute bronchitis unless antibiotics are clearly indicated.

Acute Disease↗
PubMed2005

A randomized, double-blind, placebo-controlled, clinical dose-response trial of an extract of Baptisia, Echinacea and Thuja for the treatment of patients with common cold.

The aim of this study was to verify the efficacy and safety of an herbal medication containing an extract of a mixture of Baptisiae tinctoriae radix, Echinaceae pallidae/purpureae radix and Thujae, occidentalis herba (SB-TOX) in the treatment of upper respiratory tract infections (URIs), and to test whether SB-TOX's clinical efficacy is dose dependent. A total of 91 adults (mean age 42.1 +/- 13.0 years) were randomised to receive 19.2 mg of SB-TOX (n=31), 9.6 mg SB-TOX (n=29) or placebo (n=31) three times daily for 3-12 days. Since a "running nose" is the main symptom of a common cold, the total number of facial tissues used throughout the clinical duration of their cold was the primary efficacy parameter. In the intention-to-treat analysis, this total number of tissues decreased with increasing extract dose. The slope across groups according to the Jonckheere test was significant (p = 0.0259). In the high-dose group, the standardised effect size delta/SD was 0.46 compared with placebo. Time to relevant improvement in cold symptoms (measured as the time until less than 30 tissues per day were used) was 1.1 days (95% CI 0.52; 1.67), 0.76 days (95% CI 0.28; 1.24) and 0.52 days (95% CI 0.22; 0.82) in the placebo, low-dose and high-dose groups, respectively (p(LogRank) = 0.0175). No adverse events were reported. This study demonstrates the efficacy and safety of SB-TOX in the treatment of URIs, and that its efficacy is dose dependent.

Adult↗
PubMed2005

Closure procedures for monotone bi-factorial dose-response designs.

Two goals of multiple-dose factorial trials are (i) demonstrating improved effectiveness of a fixed combination over each of its components as well as (ii) identifying a safe and effective dose range. The authors address both goals though with focus on the second by closure procedures that guarantee strong control of the familywise error rate. Two different families of null hypotheses are investigated for bi-factorial dose-response designs that are monotone with respect to the matrix partial order. One is suitable to find the minimum effective dose(s) and the other one is large enough to identify the highest effective dose step(s). Likelihood ratio tests and appropriate multiple contrast tests are applied to an unbalanced clinical trial example taken from Hung (2000, Statistics in Medicine 19, 2079-2087). Full computer code written in the R language is available from the Internet.

Antihypertensive Agents↗
PubMed2005

Pharmacokinetics of ibuprofen sodium dihydrate and gastrointestinal tolerability of short-term treatment with a novel, rapidly absorbed formulation.

OBJECTIVE: This paper describes four studies investigating the dissolution, plasma pharmacokinetics and safety of a novel, fast-acting ibuprofen formulation, ibuprofen sodium dihydrate. MATERIAL AND METHOD: Four separate studies investigated: the in vitro dissolution rates of ibuprofen sodium dihydrate (at pH 1.2, 3.5 and 7.2); the bioavailability of ibuprofen sodium dihydrate (in two pharmacokinetic studies; combined n = 38) compared with conventional ibuprofen, ibuprofen lysinate, ibuprofen arginate and ibuprofen liquagels (all 2 x 200 mg ibuprofen); and the gastroduodenal tolerance of ibuprofen sodium dihydrate and ibuprofen arginate (both 2 x 200 mg ibuprofen t.i.d.) in an endoscopy safety study, where endoscopy was performed at baseline and at the end of each treatment period using a five-point scale to assess the integrity of the gastric and duodenal mucosa. RESULTS: Ibuprofen sodium dihydrate dissolved significantly more rapidly at pH 1.2, 3.5 and 7.2 than conventional ibuprofen, ibuprofen lysinate and ibuprofen liquagels. Ibuprofen sodium dihydrate had similar C(max) to ibuprofen lysinate and ibuprofen liquagels and significantly higher Cmax than conventional ibuprofen (p = 0.002). The mean plasma concentration for ibuprofen sodium dihydrate was significantly higher than for conventional ibuprofen (p = 0.028) 10 minutes post-dose and the t(max) for ibuprofen sodium dihydrate was reached significantly earlier than for conventional ibuprofen (p = 0.018). All three formulations were bioequivalent according to the acceptable boundaries (90% confidence intervals). No statistically significant difference was observed between the ibuprofen formulations in terms of adverse events and specifically with respect to hemorrhagic scores; 41 (46.0%) adverse events (AEs) occurred after administration of ibuprofen sodium dihydrate, and 46 (52.9%) after ibuprofen arginate. One occurrence of an invasive ulcer was observed after administration of ibuprofen arginate. CONCLUSIONS: The new formulation of ibuprofen sodium dihydrate dissolves quickly in vitro, has the same extent of absorption as other fast-acting ibuprofen formulations, and is absorbed into plasma more rapidly than conventional ibuprofen. In addition, the present studies suggest that the tolerability and safety profile of ibuprofen sodium dihydrate is comparable to existing ibuprofen formulations.

Adult↗
PubMed2005

A ruler for interpreting diagnostic test results.

OBJECTIVES: Bayes' rule formalizes how the pre-test probability of having a condition of interest is changed by a diagnostic test result to yield the post-test probability of having the condition. To simplify this calculation a geometric solution in form of a ruler is presented. METHODS: Using odds and the likelihood ratio of a test result in favor of having the condition of interest, Bayes' rule can succinctly be expressed as "the posttest odds equals the pre-test odds times the likelihood ratio". Taking logarithms of both sides yields an additive equation. RESULTS: The additive log odds equation can easily be solved geometrically. We propose a ruler made of two scales to be adjusted laterally. A different, widely used solution in form of a nomogram was published by Fagan. CONCLUSIONS: Whilst use of the nomogram seems more obvious, the ruler may be easier to operate in clinical practice since no straight edge is needed for precise reading. Moreover, the ruler yields more intuitive results because it shows the change in probability due to a given test result on the same scale.

Bayes Theorem↗
PubMed2004

[Erectile dysfunction. Are interdisciplinary diagnosis and therapy necessary?].

OBJECTIVE: The last few decades have seen a marked increase in mean life expectancy in Central Europe. This has made elderly people and their quality of life a matter of ever-increasing medical concern. Besides the lack of population based studies in Central Europe, the identifying risk factors for the development of erectile dysfunction (ED) is crucial. METHODS AND MATERIAL: A newly developed and validated questionnaire on male erectile dysfunction was mailed to a representative population sample of 8000 men 30 to 80 years of age in the Cologne urban district. RESULTS: The response included 4489 analysable replies (56,1 %). The median age was 51,8 years. Prevalence of ED was estimated at about 19.2 %, with a steep age-related increase (2,3 - 53,4 %) Therapeutic necessity (defined by co-occurrence of ED and dissatisfaction with sex life), also increases with age. The overall number of ED sufferers seeking therapy was 6,8 %. The following illnesses where seen in the ED group: heart failure (14,7 %), pelvic surgery (18,8 %), diabetes mellitus (20,2 %), peripheral arterial circulatory disorders (21,5 %), herniated disc (23,2 %) and hypertension (32,0 %). Although the pathogenetic pathway remains unclear with a prevalence of 72 % "lower urinary tract symptoms" (LUTS) seems to be an age independent risk factor. In contrast, the prevalence of ED in healthy men was around 6,6 %. CONCLUSIONS: ED is a common disorder, contributing to dissatisfaction with sex life in a considerable proportion of men. ED is frequently associated with chronic diseases. For this reason adequate interdisciplinary diagnostic workup is essential, to offer patients individually adapted treatment.

Adrenergic beta-Antagonists↗
PubMed2004

Meta-analysis of randomised controlled prostaglandin E1 studies in peripheral arterial occlusive disease stages III and IV.

BACKGROUND: The relevance of Prostaglandin El (PGE,) in the treatment of peripheral arterial occlusive disease stage III and IV was to be evaluated for the first time by a meta-analysis. PATIENTS AND METHODS: Altogether, 643 patients were analyzed from seven randomized, controlled PGE1 studies that were comparable with regard to patient selection, study design and endpoints. Of these, only placebo-controlled studies (n = 254) were included in the formal meta-analysis using the method of DerSimonian and Laird. Additionally, the response rate and the rate of adverse events were determined for the pooled groups of all studies. RESULTS: At the end of treatment, PGE1 showed a significantly better response (ulcer healing and/or pain reduction) as compared to placebo (47.8% for PGE1, vs. 25.2% for placebo, p = 0.0294). A significant difference in favor of PGE1 was also seen for the combined endpoint "major amputation or death" after 6-month follow-up (22.6% for PGE1 vs. 36.2% for placebo, p = 0.0150). The response rate (ulcer healing and/or pain relief) of the pooled treatment groups was 60.2% for PGE1, 25.2% for placebo, and 53.6% for iloprost. The adverse events rate of the pooled treatment groups showed good tolerability for PGE, with a rate of 39.6% in comparison to 73.9% for iloprost and 15.4% for placebo. CONCLUSION: For patients with peripheral arterial occlusive disease stage III or IV not eligible for arterial reconstruction, PGE1 therapy not only has significant beneficial effects over placebo on ulcer healing and pain relief but also increases the rate of patients surviving with both legs after 6-months follow-up.

Alprostadil↗
PubMed2004

Correlation between BMI, leisure habits and motor abilities in childhood (CHILT-project).

INTRODUCTION: The prevalence of childhood obesity is increasing with its negative medical and psychosocial consequences. This paper examines the association between body mass index (BMI), motor abilities and leisure habits of 668 children within the CHILT (Children's Health InterventionaL Trial) project. METHOD: A total of 668 children (51.0% boys; 49.0% girls) and their parents were questioned on sport and leisure behaviour of the children. The anthropometric data were measured. Motor abilities were determined by a body gross motor development test for children (Köperkoordinationstest für Kinder; KTK) and a 6-min run. RESULTS: The children were 6.70 +/- 0.42 y old, 122.72 +/- 5.36 cm tall and weighed 24.47 +/- 4.59 kg, the average BMI was 16.17 +/- 2.27 kg/m2. KTK showed an average motor quotient (MQ) of 93.49 +/- 15.01, the 6-min run an average of 835.24 +/- 110.87 m. Both tests were inversely correlated with BMI (KTK and BMI r=-0.164 (P<0.001); 6-min run and BMI r=-0.201 (P<0.001)); the group of overweight/obese children showed poorer results than the normal/underweight ones, even after adjustment for gender and age (in each case P<0.001). Children with the greatest extent of exercise achieve the highest MQ (P=0.035). SUMMARY: Overweight/obesity is associated with a poorer body gross motor development and endurance performance. On the other hand, an active lifestyle is positively correlated with a better gross motor development in first-grade children. Therefore, to prevent the negative consequences of physical inactivity and overweight/obesity early intervention to support exercise and movement is recommended.

Analysis of Variance↗
PubMed2003

[Evaluation of continuing medical education (CME) in print media].

BACKGROUND AND OBJECTIVE: In order to achieve points for the CME certificate of the German Medical Council ("Arztekammer") the reader of a CME article in a medical journal has to fill in an evaluation form that includes knowledge assessment. This article summarizes the data of the first ten CME presentations in the "Deutsche Medizinische Wochenschrift". METHODS: 4481 completed data sets were evaluated by chi-square and binomial tests using SPSS version 10.0. RESULTS: 85% of the participants were specialists, mainly in internal medicine or surgery: those working in private practice or a hospital took part. The great majority had received their licence one to 30 years ago. The topics dealt with diseases which were not uniformly often seen in clinical practice. The individually perceived changes in the strategy of diagnosis and therapy, induced by the CME article, was mainly dependent on qualification and specialization of the reader as well as on the frequency, with which the reader had been treating the respective disorder. The articles were appreciated by specialists as well as by non-specialists. Knowledge assessment was largely made on the basis of the article alone and was successfully passed by nearly 90% of the participants. CONCLUSION: For the first time this article provides detailed data on CME activities in a nation-wide available German medical journal and thus forms the basis for discussing further the definition of quality criteria for CME articles in medical journals.

Binomial Distribution↗
PubMed2003

[Continuing medical education in Germany--the northrhenian experience].

BACKGROUND AND OBJECTIVE: For Germany there exist only very little data concerning the practice of continuous medical education (CME). The introduction of the CME certificate has made it possible to gather data about the CME activities and their evaluation which are presented here for the northrhenian chamber of physicians. METHODS: In 2002 the northrhenian academy for CME has certified more than 5500 CME activities and more than 2000 maintenance-of-quality group activities. In addition the evaluation forms of the first 4486 consecutive participants have been evaluated,including those of the northrhenian CME congress on the isle of Norderney. RESULTS: 94 % of the participants had received their license between 1 and 30 years ago and 81 % attended > or = 1 CME activity per month. Currently there exist only very few digital media certified for CME, which is dominated by oral presentations of which 85 % have gained > or = 2 points for the certificate (150 points in 3 years). General practitioners and internists together represented nearly 40 % of the participants, the others represent a broad spectrum of specialties. Topics and presentation were rated as of high quality and clinical relevance, which was also true for sponsored CME. CONCLUSION: Certified CME is currently dominated by oral presentations which mostly take place outside the working hours and which are rated as of high quality and clinical relevance.

Certification↗
PubMed2003

[Prognostic relevance of biological and molecular markers in oncology. Criteria for planning and interpreting studies].

Experts on different specialties (surgery, pathology, molecular biology and medical statistics) discussed the evaluation of prognostic factors during a workshop. The most important results presented are: (1) the prognostic relevance of new biological or molecular markers must be evaluated in a phase-III prognostic study. To establish such a marker in the UICC-TNM-classification in at least two different centers, two multivariate analyses according to defined criteria are necessary; (2) the standards of laboratory methods have to be defined, e.g.,which method to apply for RNA-analysis,which materials to used, etc; (3) intensive data analysis should be done before using methods of multivariate analysis. The criteria for the presentation of survival curves are given in detail; (4) in multivariate analysis, the Cox proportional hazard regression for survival outcomes is discussed with explanations and examples of the terms relative risk, odds-ratio, hazard and relative hazard. The arrangement and interpretation of a good prognostic study should be performed as an interdisciplinary approach.

Biomarkers, Tumor↗
PubMed2003

[Quality control of outpatient imaging examinations in North Rhine-Westphalia, part I].

PURPOSE: In the state of North-Rhine Westphalia (NRW), Germany, a survey was conducted on radiologic examinations ordered by general practitioners (GPs). Part I of this study aims to collect characteristic epidemiological data and to assess structural quality. MATERIALS AND METHODS: All GPs in NRW were asked to cooperate. Participating GPs filled out a questionnaire for each patient. The patients recorded the symptoms prompting the imaging examinations. The radiologists or other physicians performing the examinations were asked to provide the images and written reports and to complete a questionnaire. Two university radiologists documented the pertinent test data from the submitted images and written records. Independently of each other, five university radiologists anonymously reviewed the image quality of each examination using structured questionnaires. RESULTS: A total of 920 patients gave their informed consent and participated. Questionnaires from 787 patients, 852 GPs and 611 radiologists or other interpreting physicians as well as the complete survey data from 530 examinations were available. Of 1503 examinations, conventional radiography made up 52 %, sonography 17 %, computed tomography (CT) 13 % and magnetic resonance imaging (MRI) 5 %. Most indications involved the musculoskeletal (37 %) and respiratory systems (24 %). Physicians without board certification in radiology interpreted 1 % of the CT examinations, 26 % of the radiographic examinations and 71 % of the sonographic examinations. Of the 174 self-referrals, 1 % involved CT, 33 % conventional radiography and 66 % sonography. Written reports were available for 95 % of all 469 examinations performed by radiologists and 74 % of all 127 examinations conducted by non-radiologists. Only 44 % of the 23 sonographic studies were self-referrals by the patient's GP. On average, the radiographic techniques were acceptable in terms of diagnostic information and radiation hygiene. Conventional radiographs were better exposed when obtained by radiologists than by non-radiologists (p = 0.038). The delineation of anatomical structures was rated as good to acceptable for MRI, CT and conventional radiography, while the image quality was rated as diagnostically insufficient for sonography (p < 0.0001). The image quality of radiographic and sonographic examinations performed by radiologists was superior in comparison to examinations performed by physicians without board certification in radiology (p < 0.0001). CONCLUSION: Examination technique and imaging quality of MRI, CT and conventional radiography performed on outpatients were in an acceptable diagnostic range, whereas the quality of sonography was inadequate.

Family Practice↗
PubMed2003

[Quality control of outpatient imaging examinations in North Rhine-Westphalia, Part II].

PURPOSE: In the state of North Rhine-Westphalia (NRW), Germany, a survey was conducted on radiologic examinations ordered by general practitioners (GPs). Part II of this study aims to determine the quality of the process and outcome. The reference standard is the assessment of both radiologists and physicians without board certification in radiology working at a university hospital and in outpatient facilities. MATERIALS AND METHODS: AllGPs in NRW were asked to cooperate. Participating GPs filled out a questionnaire for each patient. The patients recorded the symptoms prompting the imaging examinations. The radiologists or other physicians performing the examinations were asked to provide the images and written reports and to complete a questionnaire. A file was created for each of the 394 patients with image documentation of at least one examination. Each file, which included medical history, physical findings, imaging documentation and written report, was sequentially forwarded to a board-certified radiologist and to a physician without board certification in radiology working in a university hospital and in an outpatient facility. All physicians were requested to complete a structured questionnaire for each file. RESULTS: The referral diagnoses were rated as medically plausible in 81%, the indications for imaging found correct in 76%, the examination techniques considered appropriate in 69%, the clinical question answered in 63%, the interpretation judged medically correct in 50% and all incidental findings documented in 49%. In retrospect, 32 % of the examinations were judged superfluous. The sequence of multiple examinations performed on a particular patient was rated as appropriate in 51%. The interpretation revealed specialty-related differences. The plausibility of the referral diagnoses had a significant impact on the appropriateness of subsequent diagnostic investigations. Marked deficits showed sonography, performance by non-radiologists, self-referrals by GPs, gastroenterologic radiology and the ICD-10 coding (suspicion of cardiovascular disease). CONCLUSION: In the "best-case" scenario, the process quality proved to have moderate deficiencies and the outcome quality severe deficiencies. In consequence, GPs and radiologists should be more communicative by sharing information and exchanging opinions. GP self-referrals should be restricted. Sonography and examinations performed by physicians without board certification in radiology should undergo stricter quality controls. A more intensive interdisciplinary collaboration is needed to determine the optimum implementation of diagnostic imaging of gastroenterologic and cardiovascular diseases.

Ambulatory Care↗
PubMed2003

Adjuvant autologous tumour cell-lysate vaccine versus no adjuvant treatment in patients with M0 renal cell carcinoma after radical nephrectomy: 3-year interim analysis of a German multicentre phase-III trial.

Even M0 RCC is associated with tumour progression in approximately 30% of all patients after radical nephrectomy. Nevertheless, no effective adjuvant treatment after radical nephrectomy has been established. In a multicentre phase-III trial we investigated the impact of an adjuvant autologous tumour cell-lysate vaccination on the progression-free survival of patients with M0 RCC after radical nephrectomy. Between January 1997 and August 1998 a total of 558 patients with a renal tumour were enrolled at 55 different centres (study group) in Germany. Prior to radical nephrectomy all patients were centrally randomized (Quintiles Germany) to either receive an adjuvant autologous tumour cell-lysate vaccine (6 applications at 4-week intervals after radical nephrectomy) or to receive no adjuvant treatment (control group) after radical nephrectomy. All patients were evaluated following standardized diagnostic investigations at 6-month intervals. Following the inclusion criteria (RCC stages pT2-3bpN0-3M0, TNM-classification, UICC 1993), 365 patients were evaluable for the 3-year progression-free survival analysis. There were 240 patients with stage pT2pN0M0 (104 in the vaccine group and 136 patients in the control group) and 89 patients with stage pT3pN0M0 (46 in the vaccine group and 43 patients in the control group). The remaining 36 patients had positive lymph nodes. The trial was performed according to ICH-GCP guidelines. The 3-year progression-free survival rate for all tumour stages was 84.7% in the vaccine group and 80.9% in the control group. Patients with RCC stage pT3pN0-3M0 in the vaccine group demonstrated an advantage (74.4% in the vaccine group vs 65.9% in the control group). For RCC stage pT2pN0-3M0 the 3-year progression-free survival rate in the vaccine group was 89.7% compared to 85.7% in the control group. Follow-up of all patients enrolled in this trial is ongoing. This is the first randomized trial indicating a benefit from an adjuvant vaccination in patients with M0 RCC after radical nephrectomy. The advantage in terms of progression-free survival was more pronounced in patients with T3-tumours. However, it must be emphasized that the results of the final study report (2003) must be awaited before definite recommendations can be made.

Adjuvants, Immunologic↗
PubMed2002

Low molecular weight heparin for prevention of thromboembolic complications in cardioversion--rationale and design of the ACE study (Anticoagulation in Cardioversion using Enoxaparin).

The modality and duration of anticoagulation before, during, and after cardioversion of atrial fibrillation--either with or without guidance by transesophageal echocardiography (TEE)--is still an unresolved issue. Intravenous infusion of unfractionated heparin until effective anticoagulation with phenprocoumon or warfarin is used as the standard therapy. However, this approach may be associated with several days of hospitalization because of the necessity for intravenous heparin administration. Moreover, there may be an increased risk of bleeding complications or, conversely, episodes of undercoagulation. Low-molecular weight heparin is an attractive alternative as it not only provide a safe and predictable level of anticoagulation with fewer side effects but can also be administered safely on an outpatient basis. In addition, no anticoagulation monitoring is needed. The ACE study (Anticoagulation in Cardioversion using Enoxaparin) is a randomized, prospective, open-label multicenter trial comparing the safety and efficacy of subcutaneous enoxaparin with intravenous heparin/oral phenprocoumon before and after cardioversion (stratified to TEE guidance or no TEE guidance). This article presents the rationale, design and status of the ACE study.

Administration, Oral↗
PubMed2000

Efficacy of trospium chloride in patients with detrusor instability: a placebo-controlled, randomized, double-blind, multicentre clinical trial.

OBJECTIVES: To assess the efficacy and safety of trospium chloride (TCl, 20 mg twice daily) in the treatment of detrusor instability, compared with placebo. PATIENTS AND METHODS: In all, 208 patients were allocated at random to either TCl or placebo in a double-blind clinical study; the patients were treated for 3 weeks. Urodynamic values were measured at the beginning and end of the treatment period. Adverse events were recorded on patient diary cards. A confirmatory adaptive procedure with one planned interim analysis was used to evaluate efficacy. RESULTS: Trospium chloride produced significant improvements in maximum cystometric bladder capacity (median treatment effect 22.0 mL, mean 37.3 mL, one-sided P = 0. 0054) and urinary volume at first unstable contraction (median treatment effect 45.0 mL, mean 63.6 mL, one-sided P = 0.0015). The patients' assessment of efficacy showed significantly greater clinical improvement in the TCl group than in the placebo group (two-sided P = 0.0047). Furthermore, TCl was well tolerated, with similar frequencies of adverse events reported in both groups (68% in the TCl and 62% in the placebo group). CONCLUSION: Trospium chloride (20 mg twice daily) is an effective and safe option for the treatment of detrusor instability.

Adult↗