Retrospective post-authorisation safety study investigating the relationship of first-generation antihistamines with sedative effect and the risk of falls in older patients.

For patients at the age of 65 years or older an increased risk of falls in association with the intake of first-generation antihistamines with sedative effect is discussed. Currently, there are no valid data that can either confirm or disprove this risk. In this retrospective non-interventional safety study, the primary objective was to investigate a possible causal relationship between falls in patients ≥ 65 years of age and the intake of first-generation antihistamines. Secondary objectives were to investigate a possible causal relationship of falls after taking first-generation antihistamines for the subgroups < 65 years, 65-84 years and ≥ 85 years; to determine the fall rate of patients ≥ 65 years of age and of the subgroups < 65 years, 65-84 years and ≥ 85 years; and to identify causes of falls in patients ≥ 65 years. Out of the 13,866 physicians who were invited to participate in the study, 524 (3.8%) opened the link to the survey. The evaluation included verified data sets of 169 physicians who were either general practitioners or resident neurologists who had in total treated 313,046 patients within the previous six months. 9,922 patients had fallen at least once (total fall rate 3.2%). The rate of falls increased with age (< 65 years 1.1%; 65-84 years 3.9%; ≥ 85 years 9.9%). The fall rate of patients aged 65 years and older was 5.4%. Only a small proportion (2.9%, 8,942 patients) of the altogether 313,046 patients recorded had taken a first-generation antihistamine at any time within the previous six months. In the records of 9.5% (940 patients) of the 9,922 patients who had fallen the intake of first-generation antihistamines was documented. Detailed information was available for 379 of these patients with a total of 505 falls. The analysis of these cases indicates that in almost three quarters of falls (72.5%, 366 falls) there is no causal link between the intake of first-generation antihistamines and the fall. In almost 95% of the remaining 123 falls, the physicians suggested between one and seven possible alternative causes of falls (mainly underlying and concomitant diseases). This suggests that first-generation antihistamines do not play a relevant role in the fall incidents.

Evaluation of the efficacy of a combined formulation (Grippostad-C) in the therapy of symptoms of common cold: a randomized, double-blind, multicenter trial.

BACKGROUND: The aim of the present trial was to evaluate the efficacy of a combined product in the treatment of common cold and to examine the contribution of the separate components. In the published literature there is conflicting data on the efficacy of agents used in the treatment of common cold, especially when given in drug combinations. METHODS: A prospective, randomized, double-blind, multicenter, 4-arm, controlled trial was carried out in 1,167 patients with common cold treated with one of the following medications: Grippostad-C, a combination of acetaminophen, caffeine, chlorpheniramine and ascorbic acid (verum), ascorbic acid (control), chlorpheniramine and ascorbic acid (reference 1), as well as acetaminophen, caffeine, and ascorbic acid (reference 2). A score of common cold symptoms (headache, throat pain, extremities and joint pain, cough, blocked nose, and disturbances of sleep quality) was the primary outcome. The test drug was first compared with the control using a hierarchic test strategy, then with reference 1, followed by reference 2 with the aim of proving superiority. FINDINGS: A clinically relevant and statistically significant difference was demonstrated at each level of the hierarchy. Grippostad-C was significantly superior to all other treatment groups, the combination of acetaminophen, caffeine, and ascorbic acid was significantly superior to the control, and the combination of chlorpheniramine and ascorbic acid was not statistically different from the control. INTERPRETATION: The efficacy of Grippostad-C for the treatment of common cold was proven. The findings demonstrate that the combination is superior to each of its separate components and each of the components has its own distinctive contribution to the efficacy of the combination product.

[Recall dermatitis caused by re-exposure to docetaxel following irradiation of the brain. Case report and review of the literature]. / Recall-Dermatitis durch Docetaxel-Reexposition nach Gehirnbestrahlung. Fallbeobachtung und Literaturübersicht.

BACKGROUND: Together with radiation therapy the taxanes Paclitaxel and Docetaxel are more and more integrated into multimodal therapy regimens concerning breast- and lung cancer as well as squamous cell carcinoma of the head and neck. Especially in palliative situations we have to be aware of increasing side effects caused by interaction of the different treatment components. Therefore we report on a severe recall dermatitis that occurred in two breast-cancer patients following irradiation of the brain and reexposition to Docetaxel. PATIENTS AND METHOD: From January until March 1999 two female patients suffering from metastatic breast cancer and newly diagnosed cerebral metastases respectively carcinomatous meningitis underwent irradiation of the whole brain (2 Gy 5 days/week up to a reference dose of 50 Gy) in our department. Both patients had several courses of Docetaxel (Taxotere) 30 mg/m2 BSA weekly respectively 100 mg/m2 BSA/month since October and November 1998. After completion of radiotherapy chemotherapy with Docetaxel was continued. RESULTS: Both patients tolerated Docetaxel well before and during radiotherapy. However, after having finished irradiation of the brain and receiving Docetaxel again a severe erythema of the irradiated skin and large areas of moist epitheliolysis with crust occurred (CTC grade IV). CONCLUSION: The dermatitis related to irradiation and reexposition to Docetaxel observed in our two cases is interpreted as a recall reaction. The basic initiating pathologic mechanism has not been solved completely. Further investigation is needed to find out how the taxanes can be used in combination radiochemotherapy regimens without causing severe toxicity to the irradiated skin or mucosa.