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Biomedical subjects

Steinar Madsen

Publications and source records attributed to Steinar Madsen.

17 recordsLinked to original sources
PubMed2006

[Clinical use of COX inhibitors--a consensus].

BACKGROUND: Many physicians have been uncertain about treatment options following reports that linked cyclooxygenase (COX) inhibitors to serious cardiovascular events and the subsequent withdrawal of two selective COX-2 inhibitors. Therefore, on June 14, 2005, the Norwegian Medicines Agency and the Department of Pharmacotherapeutics, University of Oslo, held an expert meeting on COX inhibitors. METHODS: Presentations and discussions based on existing literature and statements from European (EMEA) and American (FDA) medicine authorities. This constitutes the basis for the current recommendations. RESULTS AND INTERPRETATION: COX inhibitors have solely symptomatic effects, and there are no differences in analgesic and anti-inflammatory efficacy between the various COX-inhibitors. These drugs should, if possible, be used at the lowest effective dose and for as short a time as possible. Some of the COX-2 selective inhibitors show a lower incidence of gastrointestinal side effects than unselective COX inhibitors, but this advantage can be outweighed by increased occurrence of cardiovascular side effects. Generally, the cardiovascular adverse effects are more serious, and more often irreversible, than the gastrointestinal adverse effects. Patients with established or increased risk of cardiovascular disease should not use COX-2-selective inhibitors. In general, COX inhibitors should, if possible, not be administered to individuals with previous peptic ulcer disease, hypertension, heart failure, or kidney disease. There is a need for more data on the effect and safety of COX inhibitors.

Adult↗
PubMed2004

[Clinical trials in Norway--completion and reporting are not satisfactory].

OBJECTIVE: To investigate how drug trials are carried out and reported in Norway and to what extent they are published. MATERIAL AND METHODS: All drug trials notified in 1996 were included in the study. Data were obtained from the standard notification form, correspondence with investigators, end-of-study reports, and a questionnaire designed for this study. RESULTS: A total of 208 drug trials were notified. Most trials were initiated by the pharmaceutical industry (85%) and international multicenter studies constituted a major part (73%). Mandatory end-of-study reports were submitted to the health authorities on 48 (23%) of the trials. Out of a total of 159 trials for which we have data, 39 (25%) were interrupted or not started. Out of a total of 143 trials for which we have data on publishing, 77 (54%) were not published. Trials with a positive conclusion (54%) were more likely to be published than those with a negative conclusion (38%). INTERPRETATION: The reporting of drug trials is not satisfactory. Because of low reporting frequency, health authorities do not obtain a comprehensive overview. The pharmaceutical industry initiates the majority of the trials and clinical researchers in Norway increasingly participate in international multicentre trials. Many trials are not carried out as planned; less than half are published.

Clinical Trials as Topic↗
PubMed2004

[Modern diagnosis and treatment of heart failure].

Chronic heart failure is a prevalent condition associated with high morbidity, high mortality and reduced quality of life. Chronic heart failure is the end-stage of various forms of heart disease. The prognosis is poor, worse than for patients with various forms of cancer. The diagnosis of heart failure is made in the presence of multiple symptoms and signs combined with objective evidence of cardiac dysfunction. Treatment consists of pharmacological as well as non-pharmacological approaches. ACE inhibitors and beta-blockers are the basis of treatment, while diuretics and other medications are given on an individual basis. The aim of treatment is to reduce progression of the underlying disease and to reduce mortality and morbidity.

Chronic Disease↗
PubMed2003

[Pulmonary arterial hypertension treated with prostacyclin or calcium blockers].

BACKGROUND: Until recently, medical treatment of pulmonary arterial hypertension in Norway has included diuretics, anticoagulation and calcium channel blockers. We describe our experience with prostacyclin (epoprostenol) in the treatment of this disease. MATERIALS AND METHODS: After diagnostic procedures, 11 patients with pulmonary arterial hypertension in functional class III or IV were treated with oral calcium channel blockade or intravenous epoprostenol. Choice of medical agent was based on right heart catheterisation with acute vasodilator testing. Functional capacity and haemodynamics were assessed at referral and after three months of therapy. RESULTS: Acute vasodilator testing revealed a much greater improvement in haemodynamics in the two patients subsequently treated with nifedipine than in the nine patients found to be candidates for epoprostenol. In the latter group, a significant median reduction in pulmonary arterial pressure of 23% and pulmonary vascular resistance of 59% together with a significant increase in cardiac index of 90% and mixed venous oxygen saturation of 17% was found after three months of treatment. All 10 survivors significantly improved their functional class to I or II and peak exercise oxygen consumption by 60%. INTERPRETATION: Epoprostenol is a valuable agent in severe pulmonary arterial hypertension for non-responders to acute vasodilator testing. The treatment is complex and demands considerable patient involvement.

Administration, Oral↗
PubMed2003

[Warfarin treatment and bleeding].

BACKGROUND: Warfarin is involved in the majority of fatal adverse drug events in Norway. The aim of this study is to identify risk factors behind the haemorrhagic complications. MATERIAL AND METHODS: We analysed all adverse event reports involving bleeding related to warfarin that were received by the Norwegian Medicines Agency from 1990 to 2000. RESULTS: 713 reports were included; 71% of the patients were above 70 years of age. The most frequent diagnosis was atrial fibrillation (39%). Cerebral bleedings were reported in 57% of the cases, 73% of which were fatal, as were 39 % of gastrointestinal bleedings and 14% of other bleedings. International normalised ratio values (INR values) at the time of bleeding were reported in 83% of the cases; mean INR value was 4.4 (range 1.2 - > 8.0). INR values above recommended limits at the time of bleeding were found in 74% of the patients. In 63%, bleedings occurred during the first month; in 30% during the first five days. Median duration of treatment was shorter in fatal (16 days) than in non-fatal cases (24 days). INTERPRETATION: Our results show that haemorrhagic complications are associated with high INR values and initiation of treatment. Simple strategies for reducing bleedings include better monitoring of patients, careful dose adjustment, and INR values in the lower end of the recommended ranges.

Adult↗
PubMed2003

[Secondary prevention after acute myocardial infarction: aspirin, warfarin or both?].

BACKGROUND: In patients suffering from acute myocardial infarction (AMI), new cardiovascular events can be prevented by aspirin or warfarin or a combination of both. Results from studies examining this issue have been published in recent years. We have evaluated the study results together with other factors that are decisive for implementation of the findings in clinical practice. MATERIAL AND METHODS: The following four studies were evaluated: the Coumadin Aspirin Reinfarction Study (CARS); the Combination Hemotherapy and Mortality Prevention (CHAMP) Study; the Warfarin, Aspirin Reinfarction Study (WARIS)-II; the Antithrombotics in the Secondary Prevention of Events in Coronary Thrombosis (ASPECT)-2 Study. RESULTS: The studies had somewhat different design, particularly with regard to the intensity of anticoagulation. CARS and CHAMPS did not show any benefit with combined therapy. WARIS II concluded that warfarin had better preventive effect than aspirin; so had the two drugs in combination. ASPECT-2 suggested a benefit with the combined treatment (coumadin and aspirin) but had limited study power. In all studies, bleedings occurred most frequently in groups of patients treated with anticoagulants. In clinical practice, relatively few AMI patients would be candidates for warfarin treatment, as this drug is not recommended for the oldest patients. Adverse event profile, guidance of treatment and relation to invasive treatment procedures are factors in favour of aspirin. INTERPRETATION: Aspirin should be the antithrombotic agent of choice in secondary prevention after acute myocardial infarction. Warfarin could be used when there are specific additional indications. Combining these two agents is not recommended as a routine treatment.

Anticoagulants↗
PubMed2002

[Dnitrophenol--a dangerous doping agent].

BACKGROUND: Performance-enhancing drugs are frequently used by bodybuilders: anabolic steroids, growth hormone and insulin, only to mention a few. Many little known drugs are also used. MATERIAL AND METHODS: Two men aged 20 and 32 years, both active bodybuilders, complained about lassitude and malaise. Clinical and laboratory evaluation revealed an unusual cause of their complaints. RESULTS: Laboratory investigation showed very low serum levels of free thyroxin and thyroid stimulating hormone (TSH), suggesting central depression of thyroid function. Both men then admitted taking dinitrophenol (approximately 5 mg/kg bodyweight/day) to "burn fat" before body-building competitions. INTERPRETATION: Doctors should be aware that bodybuilders might use dinitrophenol. This toxic compound has severe metabolic effects. Overdose may cause hyperpyrexia and death. Use should be strongly discouraged.

2,4-Dinitrophenol↗