Climodien (estradiol valerate 2 mg plus dienogest 2 mg) is safe and effective in the treatment of postmenopausal complaints.

OBJECTIVE: To evaluate the efficacy, safety and tolerability of continuous combined hormone replacement therapy (HRT) with Climodien (estradiol valerate 2 mg plus dienogest 2 mg). DESIGN: Open, multinational, multicenter, non-controlled phase III study. PARTICIPANTS: A total of 1501 women aged 52-65 years with postmenopausal symptoms of sufficient severity to require treatment. METHODS: Eligible patients were treated with Climodien for 12 treatment cycles (48 weeks), with assessments of efficacy, safety and tolerability (adverse events) at 8, 24 and 48 weeks. Efficacy was assessed using the Kupperman index. Safety assessments included endovaginal sonography, safety endometrial biopsies, mammography, physical and gynecological examination, vital signs, prothrombotic factors and routine laboratory safety parameters. RESULTS: The Kupperman index improved with increasing duration of treatment, accompanied by an improvement in self-reported patient well-being. Individual climacteric symptoms such as hot flushes and psychonervous disorders also improved. The most pronounced improvement was seen in women who had not previously used HRT. The incidence of breakthrough bleeding declined over time, resulting in complete amenorrhea in 86.2% of the patients after 12 cycles of treatment. Furthermore, total and low-density lipoprotein (LDL) cholesterol levels decreased and high-density lipoprotein (HDL) cholesterol levels increased. Decreases in alkaline phosphatase, pyridinoline and deoxypyridinoline demonstrated the inhibitory action of estradiol on bone resorption. Endometrial thickness remained almost constant, and the incidence of serious endometrial findings was similar to that in untreated women. CONCLUSIONS: Continuous combined estrogen-progestin therapy with Climodien is effective, safe and well tolerated in postmenopausal women, with a profile and incidence of adverse events consistent with those of existing HRT preparations.

[Amiodarone for long-term treatment of ventricular arrhythmias]. / Amiodaron zur Langzeitbehandlung ventrikulärer Arrhythmien.

As one of the causes of sudden cardiac death, recurrent ventricular arrhythmia represents a potentially life-threatening rhythm disorder. amiodarone is an effective anti-arrhythmic drug, the effectiveness of which is based on a prolongation of the action potential and thus a lengthening of the refractory period. In a multicenter, noncontrolled observational study of 482 patients aged between 21 and 89, it was found that amiodarone effectively suppressed life-threatening or crippling arrhythmias in a majority of the patients, even when they had previously been unresponsive to other anti-arrhythmic agents. Physical performance improved under the treatment. An analysis of the side effects observed revealed good tolerance at a low maintenance dose.

[Delayed-release verapamil hydrochloride in chronic atrial fibrillation. Reducing the heart rate]. / Retardiertes Verapamilhydrochlorid bei chronischem Vorhofflimmern. Senkung der Herzfrequenz.

In an open clinical trial, the therapeutic effect of sustained-release verapamil hydrochloride was investigated in 40 patients with chronic atrial fibrillation. As required, the daily dose was increased from 240 mg to 480 mg. A clinically relevant, statistically significant decrease in the heart rate was observed in almost all the patients. Since only four patients experienced mild side effects, with no major clinical significance, the preparation has a positive benefit/risk ratio for the indication investigated.

[Comparative study of diflorasone diacetate and clobetasol-17-propionate in PUVA-resistant psoriasis]. / Vergleichsstudie mit Diflorasondiacetat und Clobetasol-17-Propionat bei PUVA-resistenter Psoriasis.

In a double-blind controlled trial, we have compared the therapeutic effectiveness of Diflorason-Diacetate and Clobetasol-17-propionate with 50 PUVA-resistent psoriatics. Both externals resulted in a highly significant decline of psoriatic symptoms. The difference in therapeutic achievement between the two respective groups was statistically not significant. According to the physician's overall judgement, however, Clobetasol was favored significantly over Diflorasone-Diacetate, while the patients only showed a slight preference for Clobetasol. Based on these findings and previously published results, Diflorasone-Diacetate may be classified as one of the most effective skin corticosteroids, ranging just behind Clobetasol.