[Treatment of osteoarthritis of the knee joint. Efficacy and tolerance to acemetacin slow release in comparison to celecoxib]. / Behandlung der Gonarthrose. Wirksamkeit und Verträglichkeit von retardiertem Acemetacin im Vergleich zu Celecoxib.

OBJECTIVE: The aim of this trial was to compare acemetacin (ACE) with celecoxib (CEL) in terms of tolerability and efficacy in the treatment of osteoarthritis of the knee joint. METHODS: A total of 105 patients (26-64 years old) suffering from primary osteoarthritis (OA) of the knee were enrolled in this international, multicenter, randomized, double blind controlled trial. Fifty three patients were given ACE and 52 CEL. They were treated with either 90 mg bid of slow release ACE or 200 mg bid of CEL for 6 weeks. Additional gastroprotective therapy was not provided. Tolerability was assessed by physical examination, laboratory tests, vital signs and reports of side effects, as well as by patient and physician global assessments. Efficacy parameters comprised pain assessment by visual analogue scale (VAS) and ordinal scale, WOMAC, SF-36 and patient and physician global impressions of efficacy. In addition, acetaminophen consumption was recorded. RESULTS: In 21 ACE (39.6%) and 19 CEL patients (36.5%), the number of side effects totaled 56 (ACE n=29; CEL n=27) (ns). Mean pain reduction at week 6 was highly significant ( P<0.0001) in both groups and amounted to 38.7 mm (+/-20.3) in the ACE group and to 35.1 mm (+/-18.7) in the CEL group (ns). Very similar results were seen with respect to the other efficacy parameters. CONCLUSION: ACE is not inferior to CEL for the short-term treatment of knee OA in terms of tolerability and efficacy.

Comparison of the efficacy and tolerability of dexibuprofen and celecoxib in the treatment of osteoarthritis of the hip.

CONTEXT: Osteoarthritis (OA) is often treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or selective inhibitors of cyclooxygenase-2 (COX-2). OBJECTIVE: This clinical trial aimed to assess directly the relative therapeutic efficacy of the isolated active enantiomer of ibuprofen, named dexibuprofen (S(+)-ibuprofen) in a special crystal form, and the selective COX-2 inhibitor celecoxib in adults with OA of the hip. Moreover, the hypothesis that the tolerability/safety profile of dexibuprofen is comparable to celecoxib is to be tested. METHODS: The investigation was a randomized, parallel-group, double-blind, active controlled clinical trial, conducted from January 2001 to February 2002 in 4 rehabilitation centers in Austria. 148 inpatients were randomly assigned to dexibuprofen 800 mg or celecoxib 200 mg daily. The primary criterion was the improvement in the Western Ontario and' McMasters osteoarthritis index (WOMAC OA index) after 15 days of therapy. RESULTS: Evaluation of the WOMAC OA index proved that dexibuprofen 400 mg b.i.d. is not inferior to celecoxib 100 mg b.i.d. with the Mann-Whitney estimator equal to 0.5129 and the corresponding lower boundary of the 95% confidence interval equal to 0.4409. The overall incidence of adverse drug reactions was 12.16% in the dexibuprofen group and 13.51% in the celecoxib group. 8.1% of patients on dexibuprofen and 9.5% on celecoxib suffered from gastrointestinal disorders. CONCLUSION: In the presented clinical trial dexibuprofen has at least equal efficacy and a comparable safety/tolerability profile as celecoxib in adult patients suffering from osteoarthritis of the hip.

Evaluation of the efficacy and dose-response relationship of dexibuprofen (S(+)-ibuprofen) in patients with osteoarthritis of the hip and comparison with racemic ibuprofen using the WOMAC osteoarthritis index.

OBJECTIVE: Treatment with non-steroidal anti-inflammatory drugs is the most common pharmacological therapy of rheumatic diseases. For the symptomatic treatment of painful disorders a dose-response relationship of the NSAID should be a basic requirement, which is difficult to be proven in studies because rheumatic diseases are heterogenous in terms of clinical involvement. The aim of this double-blind randomized trial was to compare the isolated active enantiomer dexibuprofen (S(+)-ibuprofen) with the double dose of racemic ibuprofen and to show a dose-response relationship of dexibuprofen in painful osteoarthritis of the hip. METHODS: 178 patients were randomly assigned to dexibuprofen 600/1,200 mg or racemic ibuprofen 2,400 mg daily. The primary endpoint was the improvement of the WOMAC osteoarthritis index after 15 days of therapy. The analysis was by intention to treat. RESULTS: The evaluation of the WOMAC OA index showed statistically significant equivalence of dexibuprofen 400 mg t.i.d. compared with racemic ibuprofen 800 mg t.i.d. by a Mann-Whitney statistic of 0.578 and the corresponding lower bound of the 95% confidence interval of 0.498. The test for superiority of dexibuprofen was borderline significant with p = 0.055. Dexibuprofen 400 mg t.i.d. and dexibuprofen 200 mg t.i.d. showed a statistically significant dose-response relationship in improving the WOMAC OA index (p = 0.023). Patients suffered from adverse drug reactions, mainly gastrointestinal disorders, 13.34% on dexibuprofen 200 mg, 15.25% on dexibuprofen 400 mg and 16.94% on racemic ibuprofen 800 mg. CONCLUSIONS: The active enantiomer dexibuprofen (S(+)-ibuprofen) proved to be an effective non-steroidal anti-inflammatory drug with a significant dose-response relationship in patients with painful osteoarthritis of the hip. Compared with racemic ibuprofen half of the daily dose of dexibuprofen shows at least equivalent efficacy. In contrast to pharmacokinetic data, the additional administration of R(-)-ibuprofen in form of racemate does not contribute to the clinical efficacy of racemic ibuprofen.

S(+)-ibuprofen (dexibuprofen)--Excellent tolerance has not to be combined with poor clinical efficacy.

S(+)-ibuprofen (dexibuprofen) is an NSAID offering a lot of advantages in the treatment of rheumatism and pain. A randomized double-blind, parallel group study in 110 patients showed equivalence in efficacy of 900 mg dexibuprofen (Seractil 300 mg, Gebro Fieberbrunn, Austria) vs. 150 mg diclofenac sodium. Regarding tolerance there was a trend to superiority of dexibuprofen. Therefore dexibuprofen can be characterized as an effective and very tolerable drug against inflammation and pain.

[Double-blind comparative study of the effectiveness and tolerance of 900 mg dexibuprofen and 150 mg diclofenac sodium in patients with painful gonarthrosis]. / Doppelblinde Studie zum Vergleich der Wirksamkeit und Verträglichkeit von 900 mg Dexibuprofen und 150 mg Diclofenac-Natrium bei Patienten mit schmerzhafter Gonarthrose.

In this randomized double-blind, parallel-group study the efficacy of 300 mg oral dexibuprofen three times daily and 50 mg oral diclofenac sodium three times daily was tested for equivalence in 110 patients with painful osteoarthritis of the knee. During the 15-day treatment period the functional index for knee osteoarthritis according to Lequesne was improved under dexibuprofen by a mean of 7.4 and by a mean of 7.3 under treatment with diclofenac sodium. The test for equivalence by one-sided Wilcoxon-Mann-Whitney test shows equivalent efficacy of dexibuprofen by a Mann-Whitney-statistic of 0.505 and 0.415 as its lower boundary of the 95% confidence interval. The descriptive analysis of secondary criteria such as intensity of pain, rest pain, pain at beginning, nocturnal pain, tenderness, restriction of movement, handicap, subjective estimation of disease progression, as well as global judgement of efficacy and tolerance by investigator and patient confirm equivalence of both preparations. The pooled analysis of all parameters, tolerability included, by a Mann-Whitney-statistic of 0.520 with the lower boundary of the 95% confidence interval of 0.467 shows equivalence of both drugs with a trend to superiority of dexibuprofen due to its better tolerability. 7.3% of the patients on dexibuprofen and 14.5% of the patients on diclofenac sodium dropped out because of side-effects.

Stress coping of patients with ankylosing spondylitis.

Seventy-six male patients with ankylosing spondylitis (SA) and sixteen healthy controls were assessed for their stress coping mechanisms. As compared to healthy controls, the coping behaviour of the patients with SA was characterized by a significantly higher degree of playing down the stressful situation through comparison with others and by more substitutive gratification; they also showed less self-accusation and resignation. These coping mechanisms apparently do not change significantly in the course of the illness, as in our study we found that patients with different durations of illness did not differ from each other with regard to the coping strategies they used. When comparing the different strategies of coping the subjective intensity of pain, we found at a low intensity of pain a significant positive correlation with the strategies of 'playing down the stressful situation through comparison with others' and 'positive self-instruction', and a negative correlation with 'self-accusation'.

[Spondylodiscitis as a dominant early symptom of juvenile ankylosing spondylitis]. / Spondylodiszitis als dominierendes Frühsymptom bei juveniler Spondylitis ankylosans.

A 12-year-old female (HLA-B27 negative) presented with unilateral low back pain and sterno-clavicular arthritis. Six months after onset the clinical and radiological findings determined spondylodiscitis L1/2. On the basis of the clinical findings (oligoarthritis, symptomatic sacroilitis, spondylodiscitis), juvenile ankylosing spondylitis was suspected. The diagnosis was corroborated 18 months after the first occurrence of symptoms by the appearance of typical changes in the sacroiliac joint that are indicative of juvenile ankylosing spondylitis. Because of persisting antibodies against Borrelia burgdorferi, the possibility of B. burgdorferi-induced reactive arthritis with involvement of the axial division of the skeletal system was considered. After 3.5 years of observation the condition showed a benign course with radiologically observable consolidation of the spondylodiscitis. To our knowledge, this is the second case described of juvenile ankylosing spondylitis with spondylodiscitis as a dominating feature.

Testicular cancer: prognostic implications of vascular invasion.

In a retrospective study the primary tumors of 33 patients with seminomas and 53 with nonseminomatous germ cell tumors were re-evaluated for vascular invasion. The significance of vascular invasion was analyzed in respect to the appearance of visceral metastases and the effect of adjuvant chemotherapy. Vascular invasion was demonstrated in 27 per cent of the patients with seminomas and 53 per cent with nonseminomatous germ cell testis tumors, while visceral metastases appeared in 9 and 32 per cent, respectively. Without adjuvant chemotherapy all 13 patients with nonseminomatous germ cell testis tumors and vascular invasion had metastases, compared to only 3 of 13 without vascular invasion (p less than 0.0005). Of 9 patients with seminoma and vascular invasion 3 had tumor progression, compared to 1 of 24 without vascular invasion (p greater than 0.05). With adjuvant chemotherapy only 1 of 15 patients (7 per cent) with nonseminomatous germ cell testis tumors and vascular invasion had metastases, compared to 100 per cent of 13 without this treatment. No significant correlation was noted between pT stage versus vascular invasion and pT stage versus tumor progression. The results demonstrate the importance of vascular invasion in the staging of and choice of treatment for early nonseminomatous germ cell testis tumors.

[Spinal involvement in chronic Reiter's syndrome]. / Achsenskelettbefall bei chronischem Reitersyndrom.

From a retrospective analysis (1980-1984) we found 32 cases of chronic Reiter's syndrome with spinal involvement on the radiographs (as sacroiliitis, parasyndesmophytes, and rarely syndesmophytes). In these 32 case histories spinal pain was a rather frequent symptom, often beginning with the onset of the disease, whereas severe functional spinal impairment was seldom found. Joints were only mildly affected, organic symptoms were found chiefly in clinical history, but were often incomplete. Trigger infections were known in 40%, and 87% of the patients were HLA B27 positive. These 32 patients with mainly spinal symptoms represent 75% of all cases (n = 43) suffering from chronic Reiter's syndrome within the period of observation. Previous observations as well as our experience point to the fact that the chronic course of disease in Reiter's syndrome mainly affects the spinal structure with comparatively mild clinical symptoms.

[Special disco-vertebral forms of ankylosing spondylitis]. / Besondere discovertebrale Verlaufsformen bei der Spondylitis ankylosans.

In a retrospective study 10 cases (6 males, 4 females) of special disco-vertebral forms of ankylosing spondylitis were evaluated. In all cases radiographs showed bilateral sacroiliitis and destructive-sclerotic disco-vertebral lesions but hardly any syndesmophytes considered typical for ankylosing spondylitis. We found a rather striking diversity of morphologic changes caused by spondylodiscitis, polysegmental involvement, the simultaneous and successive appearance (in the cause of the disease) of shiny corner, as well as anterior spondylitis and spondylodiscitis. All cases had clinical and humoral signs of disease activity, and some even had extravertebral manifestations. Radiographs and clinical findings indicate that an inflammatory process causes the disco-vertebral lesions. The special forms of ankylosing spondylitis as described in this article are in accordance with the polymorphism frequently observed in this disease.

[Efficacy and tolerance of Proxen 500 mg film-coated tablets in coxarthrosis]. / Wirksamkeit und Verträglichkeit von Proxen 500 mg-Filmtabletten bei Koxarthrose.

29 patients exhibiting primary and secondary arthritic changes in the joints (mainly patients with osteoarthritis of the hip) were treated with a new naproxen formulation (proxen 500 mg film-coated tablets). The tablets were taken twice daily and the period of observation was four weeks. Therapeutic efficacy was assessed on the basis of clinical findings (active and passive articular function and in some cases morning stiffness and articular swelling) and also the improvement in painful symptoms (night and spontaneous pain, pain on standing and walking). There was a distinct improvement in the clinical symptoms in 25 patients and unsatisfactory results were only obtained in three cases. Summing up, naproxen is a proven antirheumatic. The new formulation with the 500 mg film-coated tablet provides a simplified dosage regimen and simple therapy for the physician with increased patient compliance and a lower rate of drug intake errors.