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Biomedical subjects

K Mikkelsen

Publications and source records attributed to K Mikkelsen.

At least 19 recordsLinked to original sources

The comparative effectiveness of anti-TNF therapy and methotrexate in patients with psoriatic arthritis: 6 month results from a longitudinal, observational, multicentre study.

OBJECTIVES: To compare the response to treatment with tumour necrosis factor (TNF) inhibitors and methotrexate (MTX) monotherapy in patients with psoriatic arthritis (PsA) within a real-life clinical setting. METHODS: We analysed data from an ongoing longitudinal, observational multicentre study in Norway. Our data comprised 526 cases of patients with PsA who received either anti-TNF treatment (n = 146) or MTX monotherapy (n = 380) and were followed for at least 6 months with measures of disease activity, health status and utility scores. A propensity score was computed to adjust for channelling bias. The changes in measures of disease activity and health-related quality of life from baseline to 3- and 6-month follow-up were compared between the groups with adjustments for the baseline value of the dependent variable and the propensity score (analyses of covariance (ANCOVA)). RESULTS: The groups were significantly different at baseline with respect to demographic and disease activity measures. The variables included in the propensity score were age, sex, number of previous disease modifying anti-rheumatic drugs (DMARDs), presence of erosive disease, treatment centre and investigator's global assessment. The adjusted changes at 6 months were significantly larger in the anti-TNF group for ESR, DAS-28, M-HAQ, patient's assessments of pain, fatigue and global disease activity on a visual analogue scale (VAS) and 4 out of 8 SF-36 dimensions. CONCLUSIONS: Clinical improvement was superior with TNF inhibitors compared to MTX monotherapy in patients with PsA, when assessed in this setting of daily clinical practice.

Adalimumab↗

Adalimumab and methotrexate is more effective than adalimumab alone in patients with established rheumatoid arthritis: results from a 6-month longitudinal, observational, multicentre study.

OBJECTIVES: To compare the effectiveness of adalimumab monotherapy and adalimumab and methotrexate (MTX) combination therapy in patients with established rheumatoid arthritis. METHODS: Data from an ongoing longitudinal observational study in Norway were used to compare response to treatment with two different adalimumab regimens (monotherapy, n = 84; combination with MTX, n = 99). Patients were assessed with measures of disease activity, health status and utility scores. Within-group changes were analysed from baseline to follow-up at 3 and 6 months and the changes were compared between groups after adjustment for the propensity score. The groups were also compared for the proportions of patients achieving European League Against Rheumatism (EULAR) good response, Disease Activity Score (DAS)28 remission and treatment terminations. RESULTS: The improvement from baseline was significant for all measures in the adalimumab and MTX group, but only for DAS28, joint counts, two Short-form Health Survey with 36 questions (SF-36) dimensions and patient's and investigator's global assessment in the monotherapy group. All between-group differences were numerically in favour of combination therapy and significant for C reactive protein, joint counts, DAS28, Modified Health Assessment Questionnaire, investigator's global assessment, four SF-36 dimensions and Short Form 6D at 6 months. More patients in the combination therapy group reached EULAR good response (p<0.001) and remission (p = 0.07). At 6 months, 80.8% of the patients in the combination therapy group and 59.5% in the monotherapy group remained on treatment (p = 0.002). More withdrawals in the monotherapy group were due to adverse events. CONCLUSIONS: Our results were consistent across several categories of end points and suggest that adalimumab combined with MTX is effective in patients with rheumatoid arthritis treated in daily clinical practice and is superior to adalimumab monotherapy.

Adalimumab↗

[Myalgia and high sedimentation rate in adults].

The polymyalgic syndrome may be the presenting clinical feature for several diseases such as polymyalgia rheumatica, temporal arteritis, malignancy, rheumatoid arthritis, virus infections, connective tissue diseases, and myositis. In this review we present the various diagnostic options seen from a rheumatological point of view, with emphasis on polymyalgia rheumatica, temporal arteritis and the paraneoplastic syndrome. We are of the opinion that polymyalgia rheumatica is overdiagnosed in general practice, and steroid treatment may delay diagnosis and treatment of other differential diagnosis presenting as the polymyalgic syndrome. Several recently published Norwegian epidemiological studies offer new information on various aspects of the polymyalgic syndrome, which will be discussed.

Adult↗

Hypovitaminosis D myopathy without biochemical signs of osteomalacic bone involvement.

The aims of this study were to investigate myopathy in relation to vitamin D status, and to study the muscular effects of vitamin D treatment on vitamin D-deficient individuals. Further, hypovitaminosis D myopathy was investigated in relation to alkaline phosphatase (ALP), the most commonly used marker for hypovitaminosis D osteopathy. Eight patients with osteomalacia had an isokinetic dynamometer test of all major muscle groups before and after 3 months of vitamin D treatment. The most pronounced improvements in muscle power were seen in the weight-bearing antigravity muscles of the lower limbs. A cross-sectional study was performed among 55 vitamin D-deficient veiled Arab women living in Denmark and 22 Danish controls. An isometric dynamometer model was used for determination of quadriceps muscle power. Both maximal voluntary contraction (MVC) and electrically stimulated values (single twitch, maximal production rate (MPR), and maximal relaxation rate (MRR)) were determined. The women underwent high-dose vitamin D treatment and were retested after 3 and 6 months. Prior to vitamin D treatment all parameters of muscle function in the group of vitamin D-deficient Arab women were significantly reduced compared with Danish controls. MVC: 259.4 +/- 11.0 N (Newton) versus 392.6 +/- 11. 4 N (P < 10(-6)), single twitch: 47.0 +/- 1.8 N versus 74.6 +/- 2.2 N (P < 10(-5)), MPR 8.9 +/- 0.3 N/10 ms versus 14.3 +/- 0.4 N/10 ms (P < 10(-6)), MRR 4.5 +/- 0.2 N/10 ms versus 6.2 +/- 0.2 N/10 ms (P < 10(-6)). Muscle function was affected to a similar degree in women with and without bone involvement (as indicated by elevated ALP). After 3 months of vitamin D treatment all muscle-related parameters improved significantly. After 6 months only MVC was reduced compared with Danish controls (320.7 +/- 14.3 N (P < 0.02)), whereas all other measurements were normalized. Hypovitaminosis D myopathy is a prominent symptom of vitamin D deficiency, and severely impaired muscle function may be present even before biochemical signs of bone disease develop. Full normalization of hypovitaminosis D myopathy demands high-dose vitamin D treatment for 6 months or more. Our findings indicate that serum levels of ALP cannot be used in the screening for hypovitaminosis D myopathy. Assessment of s-25OHD is the only reliable test.

Alkaline Phosphatase↗

Commonly recommended daily intake of vitamin D is not sufficient if sunlight exposure is limited.

OBJECTIVES: Sunlight exposure of the skin is known to be the most important source of vitamin D. The aims of this study were: (i) to estimate vitamin D status amongst sunlight-deprived individuals (veiled Arab women, veiled ethnic Danish Moslem women and Danish controls); and (ii) through food intake analysis to estimate the oral intake of vitamin D necessary to keep a normal vitamin D status in sunlight-deprived individuals. DESIGN: Cross-sectional study amongst randomly selected Moslem women of Arab origin living in Denmark. Age-matched Danish women were included as controls. To control for racial differences, a group of veiled ethnic Danish Moslem women (all Caucasians) was included. SETTING: Primary Health Care Centre, City Vest and Department of Endocrinology and Metabolism C, University Hospital of Aarhus, Aarhus Amtssygehus, Aarhus, Denmark. SUBJECTS: Sixty-nine Arab women (60 veiled, nine non-veiled) and 44 age-matched Danish controls were randomly selected amongst patients contacting the primary health care centre for reasons other than vitamin D deficiency. Ten ethnic Danish Moslem women were included through a direct contact with their community. MAIN OUTCOME MEASURES: Serum levels of 25-hydroxyvitamin D were used as estimates of vitamin D status. Intact parathyroid hormone (PTH) was used to control for secondary hyperparathyroidism. Alkaline phosphatase and bone-specific alkaline phosphatase were used as markers for osteomalacic bone involvement. Oral intake of vitamin D and calcium were estimated through a historical food intake interview performed by a trained clinical dietician. RESULTS: Veiled Arab women displayed extremely low values of 25-hydroxyvitamin D: 7.1 +/- 1.1 nmol L-1, compared with 17.5 +/- 2. 3 (P < 0.002) in ethnic Danish Moslems and 47.1 +/- 4.6 (P < 10-17) in Danish controls. PTH was increased amongst veiled Arab women: 15. 6 +/- 1.8 pmol L-1, compared with 5.7 +/- 1.4 in ethnic Danish Moslems and 2.7 +/- 0.3 (P < 10-6) in Danish controls. The vitamin D intake (including food supplementation) was very low amongst Arab women: 1.04 microg day-1, compared with 13.53 amongst ethnic Danish Moslems and 7.49 amongst Danish controls (P < 0.0005). CONCLUSIONS: Severe vitamin D deficiency is prevalent amongst sunlight-deprived individuals living in Denmark. In veiled Arab women, vitamin D deficiency is the result of a combination of limitations in sunlight exposure and a low oral intake of vitamin D. The oral intake of vitamin D amongst veiled ethnic Danish Moslems was, however, very high, at 13.53 microgram (approximately 600 IU), but they were still vitamin D-deficient. Our results suggest that the daily oral intake of vitamin D in sunlight-deprived individuals should exceed 600 IU; most probably it should be 1000 IU day-1 to secure a normal level of 25-hydroxyvitamin D. This finding is in contrast with the commonly used RDA (recommended daily allowance) for adults in Europe: 200 IU day-1.

Adult↗

Recycling of hard-core smokers with nicotine nasal spray.

The primary aim of this smoking cessation study was to evaluate the effect of long-term treatment with nicotine nasal spray in a group of hard-core smokers. A further aim was to compare the effect of ad libitum with fixed dosage of nasal nicotine spray. Eighty nine smokers, failures from two earlier studies with nicotine patches, were enrolled in an open smoking cessation study with nicotine nasal sprays, to be used ad libitum (n=45) or on a fixed schedule of 1 mg x h-1 during the day (n= 44). Carbon monoxide-verified continuous abstinence from smoking beyond Week 2, was 39% at 3 weeks, 12% at 3 months, 10% at 6 months and 6% after 1 yr, with no significant difference in success rate between ad libitum and fixed dosing. Mean daily nicotine dose was 15-16 mg during the first 3 months (range 2-65 mg). Tolerance to local irritating side-effects of nicotine developed during the first weeks of use. Although short-term outcome was promising, the long-term success rate in this group of hardcore smokers was low. Other recycling set-ups are warranted, which might include more aggressive nicotine dosing.

Administration, Intranasal↗

Nurse-conducted smoking cessation with minimal intervention in a lung clinic: a randomized controlled study.

This study aimed to evaluate the effect of a motivational, minimal intervention approach to smoking cessation in an open, randomized design conducted by nurses as routine work in a lung clinic. Subjects who smoked less than 10 cigarettes x day(-1), and subjects who smoked > or = 10 cigarettes x day(-1) and who had refused to participate in a smoking cessation trial with nicotine replacement therapy, were randomly allocated to a motivational approach to smoking cessation or to a control group. The motivational approach consisted of a nurse-conducted 5 min consultation concerning reasons to quit smoking, brochures about smoking cessation and advice about how to quit. After 4-6 weeks, subjects in the motivational group received a letter encouraging them to quit smoking. After 1 year, all subjects were contacted by phone and smoking status reported. Subjects claiming to be abstinent attended the clinic for carbon monoxide verification. A total of 507 subjects were enrolled, 254 in the motivational group and 253 in the control group. The mean age of the motivational group was 51 yrs, 50% were males and they smoked a mean of 13 cigarettes x day(-1). The mean age of the control group was 53 yrs, 61% were males and they smoked a mean of 12 cigarettes x day(-1). At the 1 year follow-up, the success rate for point prevalence (no smoking at 1 year and during the preceding month) was 8, 7% in the motivational group versus 3.6% in the control group (p=0.025). The 12 months sustained success rate (no smoking at all during the year) was 3.1 versus 1.2% (p=0.22). The point prevalence for light smokers (<10 cigarettes x day(-1)) was 13.9% in the motivational group versus 6.3% in control group (p=0.12), and for heavy smokers (10 or more cigarettes x day(-1)) 5.2% versus 1.9% (p=0.20). In conclusion, the effect of this nurse-conducted, minimal intervention, motivational approach seems promising as the quit rate at 1 year follow-up had doubled.

Adult↗

A double-blind trial of a nicotine inhaler for smoking cessation.

OBJECTIVE: To evaluate the efficacy of a new nicotine inhaler system for smoking cessation. DESIGN: A 1-year, randomized, double-blind, placebo-controlled study. SETTING: Medical outpatient clinic with physicians experienced in smoking cessation assistance. SUBJECTS: A total of 286 volunteers who smoked at least 10 cigarettes daily recruited through a local newspaper. INTERVENTION: Subjects were randomly allocated to nicotine inhalers (n = 145) or placebo (n = 141) to be used for 3 months followed by tapering for 3 months in the context of minimal levels of advice and support. MAIN OUTCOME MEASURE: Continuous smoking abstinence at weeks 6, 12, 24, and 52, verified by measurements of carbon monoxide in expired air. RESULTS: Continuous smoking abstinence was significantly higher for the active nicotine inhaler group compared with the placebo inhaler group. The respective success rates were 28% and 12% after 6 weeks, 21% and 9% after 12 weeks, 17% and 8% after 6 months, and 15% and 5% after 1 year (P = .02 to .001). The mean nicotine substitution based on cotinine determinations after 2 weeks was 43% (SD, 45%) of smoking levels. The treatment was well tolerated, and no serious adverse events were reported. CONCLUSIONS: In this setting the nicotine inhaler appeared safe to use and increased success rates of smoking cessation attempts.

Adult↗

Dietary omega-3 fatty acid supplementation and naproxen treatment in patients with rheumatoid arthritis.

In a controlled, double blind, clinical trial we tested the effect of dietary omega-3 fatty acid supplementation with and without naproxen and placebo, respectively, in 67 patients with active rheumatoid arthritis. The patients were randomized into 3 groups that received the following treatment: Group 1, corn oil ("placebo omega-3 fatty acids"), 7 g/day for 16 weeks, and naproxen, 750 mg/day for 10 weeks followed by a stepwise reduction to 0 mg/day during the following 3 weeks; Group 2, omega-3 fatty acids, 3.8 g of eicosapentaenoic acid plus 2.0 g of docosahexaenoic acid, and naproxen, 750 mg/day for 16 weeks; and Group 3, omega-3 fatty acids as Group 2 and naproxen as Group 1. At the end of the trial, patients in Group 2 had improved with respect to duration of morning stiffness and global assessment by physician and patient. In Groups 1 and 3 there was a significant deterioration for most of the variables measured. However, for duration of morning stiffness the deterioration was significantly less pronounced in Group 3 compared with Group 1. These effects might be ascribed to the dietary omega-3 fatty acid supplementation.

Adult↗

[Preoperative and postoperative magnetoencephalography in a patient with partial epilepsy].

Magnetoencephalography (MEG) is a non-invasive method with a potential of clinical diagnostic use to localize epileptogenic foci in the brain. The aim of this study was to investigate whether the pathological focus localized by MEG was concurrent with the conventional preoperative examinations in a patient with medically intractable epilepsy who underwent surgery (left side uncohippocampectomy). A conventional preoperative test battery had already documented a left-hemisphere fronto-temporal epileptogenic focus. Postoperatively the patient was seizure free. MEG was performed three months before and ten months after the operation. The analysis of the MEG data indicated a left hemisphere fronto-temporal focus in agreement with results obtained by means of the conventional methods used for locating epileptic foci. Postoperatively the focus had disappeared.

Adult↗

Antral vagotomy in parietal cell vagotomized dogs with a Heineke-Mikulicz pyloroplasty. Effect upon gastric emptying and motility, serum gastrin concentration, and Heidenhain pouch acid secretion.

In 6 Heidenhain pouch (HP) dogs who previously had undergone parietal cell vagotomy (PCV) with a Heineke-Mikulicz pyloroplasty (Ppl), the antral nerves were cut. No significant changes in HP acid secretion or serum gastrin concentration occurred. In a similar previous study using HP dogs with a PCV and a gastroduodenostomy (GD), a significant rise in HP acid secretion without concomitant changes in serum gastrin concentration were observed after antral denervation. These findings indicate that the antral vagal nerves have no direct influence on HP acid secretion, but the rised HP acid secretion in the GD dogs after antral denervation may be related to the changed gastroduodenal emptying pattern which partly excludes the food acid stream from the acid inhibitory mechanism in the duodenal bulb.

Animals↗

Antral denervation of parietal cell vagotomized dogs. Effect upon gastric emptying and motility, Heidenhain pouch acid secretion and serum gastrin concentration.

In ten Heidenhain pouch (HP) dogs who previously had undergone parietal cell vagotomy (PCV) with gastroduodenostomy, the antral nerves were cut, and the PCV thus converted to a selective gastric vagotomy (SGV). Mean gastric emptying rate was unaffected but antral motility changed considerably, the stomach became big and slack, and the emptying of a food-barium meal became purely passive. While the duodenal bulb was often filled with gastric content before antral denervation, this happened very seldom afterwards. Fasting, food-stimulated and 24-hour HP acid secretion increased significantly after denervation, but this was not accompanied by any significant changes in serum gastrin concentration. This indicates that other factors than gastrin must be responsible for the increased HP acid response to a meal after antral denervation.

Animals↗

Gastroduodenostomy in dogs with and without parietal cell vagotomy. Effect upon gastric emptying and motility, Heidenhain pouch acid secretion and serum gastrin concentration.

Heidenhain pouch (HP) dogs were studied. After gastroduodenostomy (GD) gastric emptying time was unaffected, but cineradiography showed that the strength of the antral contractions diminished considerably, while the number of peristaltic waves increased. "Circus movements" of the barium meal through the GD to the duodenum and back to the stomach through the pylorus occurred. No significant changes in food-stimulated HP acid secretion or serum gastrin response were observed. After parietal cell vagotomy (PCV) gastric emptying and motility was unaffected, but food-stimulated HP acid secretion and serum gastrin response increased significantly. After addition of a GD to PCV gastric emptying time decreased significantly but similar changes in antral motility occurred as after GD alone. The food-stimulated HP acid secretion and serum gastrin response became significantly reduced. Fasting HP acid secretion and serum gastrin concentration were not significantly altered by any of the surgical procedures.

Animals↗

Duodenal denervation in dogs. Effect upon gastroduodenal emptying and motility, Heidenhain pouch acid secretion and serum gastrin concentration.

In dogs with the continuity of the stomach and duodenum intact the peristaltic and antiperistaltic waves in the duodenum disappeared completely and gastric emptying became faster after selective duodenal denervation. No significant changes occurred in fasting and food-stimulated Heidenhain pouch acid secretion or in serum concentration. It is concluded that the duodenal vagal nerves have importance for duodenal motility, but do not influence the gastrin release from the antrum and the small bowel or the acid secretion from a Heidenhain pouch.

Animals↗