[Clinical practice data regarding tapentadol prolonged release treatment for severe chronic pain - improvement of analgesia, functional competence and quality of life in particular under tapentadol monotherapy]. / Praxisdaten zur Behandlung starker chronischer Schmerzen mit Tapentadol retard : Verbesserung von Analgesie, Funktionsfähigkeit und Lebensqualität insbesondere unter Tapentadol-Monotherapie.

STUDY OBJECTIVE: To assess effectiveness and tolerability of tapentadol prolonged release (PR, Palexia® retard) for the treatment of severe chronic pain under routine clinical practice conditions in Germany. METHODS: In this prospective non-interventional study, data regarding previous and concomitant analgesic treatment, tapentadol dosage, pain intensity, functionality, quality of life, and tolerability of tapentadol PR were collected over a 3-month observation period. A total of 5,002 patients were included in the effectiveness analysis; a subgroup analysis assessed effectiveness for all patients receiving tapentadol monotherapy (n = 1476). RESULTS: Nearly all patients of the total study population (95.9%) had already received analgesic long-term treatment (31.7% strong opioids) prior to the start of the study. Treatment with tapentadol PR (mean daily dose 216 ± 103 mg at end of observation) resulted in a reduction in pain intensity of 3.9 points from 7.2 ± 1.4 at baseline (95%CI -3.93; -3.83; p ≤ 0.001; NRS-11); clinically relevant pain relief ≥ 50% was documented for 65.1% of the patients. All 4 evaluated aspects regarding pain-related functionality, and quality of life of the patients also improved significantly. Compared to the total patient population, pain relief was greater in the subgroup receiving tapentadol monotherapy; baseline pain intensity was comparable between the groups. Pain-related functional impairment also declined to a slightly greater extent, and quality of life was rated more positively at end of observation. CONCLUSIONS: Analgesic treatment with tapentadol PR in routine clinical practice resulted in a marked reduction of severe chronic pain with significant improvements of functionality and quality of life. On the basis of these results and the favourable safety profile, tapentadol PR can thus be considered an alternative to classical opioids in the treatment of severe chronic pain.

[Conversion to tapentadol PR improves analgesia and quality of life in patients with severe and chronic pain despite using tramadol > 300 mg/d]. / Konsekutive Umstellung auf Tapentadol PR verbessert Analgesie und Lebensqualität bei Patienten mit starken und chronischen Schmerzen unter Tramadol > 300 mg/d.

STUDY OBJECTIVE: This subgroup analysis of a non-interventional study involving general practitioners and internists investigated the administration of tapentadol PR (prolonged release) in patients with widely-utilized tramadol pretreatment in routine clinical practice in Germany. METHODS: Data of all patients in the study cohort who had tramadol as the only opioid in their previous therapy were included in the analysis (n = 685); among them especially the 99 patients with tramadol dosages exceeding 300 mg/d were focused. Data collection during the 3-month observation period included previous and concomitant analgesic treatment, tapentadol PR dosage, pain intensity, sleep and quality of life parameters, and tolerability of tapentadol PR. RESULTS: Back pain was the most common cause of pain (n = 86/99), other pain diagnoses were (partly additionally) recorded in 68 cases. A mixed type of pain dominated. The previous tramadol therapy was usually combined with non-opioids (n = 74), co-analgesics (n = 44) and analgesic rescue medication (n = 35). Tapentadol PR therapy reduced the mean initial pain intensity of 7.3 ± 1.5 to 3.1 ± 1.8 points (NRS-11, 11-point pain scale, n = 96) at the end of observation, using an average dosage of 218.7 mg/d. Tapentadol PR was finally applied as the sole analgesic in 32/95 patients. 69/96 patients achieved a clinically meaningful pain relief of at least 50 %, while 63 patients gained a pain reduction of ≥ 4 NRS-points. 89/95 patients reached or exceeded their additional individual treatment goal. This was accompanied by a significant decrease in pain-related impairments of daily activities and an improvement in quality of life with an overall good tolerability of tapentadol PR. Treatment with tapentadol PR was assessed positively by physicians and patients. CONCLUSIONS: Data analysis shows a clinically relevant benefit in patients unsuccessfully pretreated with tramadol by consecutive conversion to the potent analgesic tapentadol PR.

[Tapentadol prolonged release improves analgesia, functional impairment and quality of life in patients with chronic pain who have previously received oxycodone/naloxone]. / Verbesserte Analgesie, Funktionalität und Lebensqualität unter Tapentadol retard.

STUDY OBJECTIVE: This subgroup analysis of a prospective, non-interventional study involving general practitioners and internists investigated the administration of tapentadol prolonged release (tapentadol PR; Palexia retard) for the treatment of patients who have previously received oxycodone/naloxone. METHODS: From the overall effectiveness sample (n = 5,002) data of all patients who were previously treated with oxycodone/naloxone in a fixed combination (n = 382) were included in this analysis. Data collection during the 3-month observation period included previous and concomitant analgesic treatment, tapentadol PR dosage, pain intensity, functional impairment, and tolerability of tapentadol PR. Health related quality of life was documented at baseline and at the end of observation by patients using the SF-12 questionnaire. RESULTS: Back pain was the most common cause of pain. Including all pain diagnoses, mixed type of pain (nociceptive and neuropathic) predominated. The oxycodone/naloxone pretreatment was multifold combined with strong opioids (10.2%), weak opioids (29.3%), non- opioids (78.3%), co-analgesics (56.0%) and analgesic rescue medication (26.9%). Switching to tapentadol PR resulted in a mean pain reduction of 3.41 points from 7.29 ± 1.40 at baseline to 3.88 ± 1.86 at end of observation (NRS 11, 11-point pain scale; descriptive p value ≤ 0.001; n = 373), using a final average daily dosage of 252.9 mg tapentadol PR. In all four categories assessing the pain-related functional impairment, significant improvements have been achieved. In addition to significantly reduced pain-related impairments of everyday activities patients' data documented significant improvements in physical and mental SF-12 total scores, which initially were already at critically low range. A good tolerability of tapentadol PR therapy was reported. CONCLUSIONS: Patients, who were previously treated with oxycodone/naloxone, benefit from a tapentadol PR therapy as well: data analysis shows a clinically relevant improvement of analgesia, functionality and quality of life. Furthermore, the previous analgesic "co"-medication could be reduced during tapentadol PR therapy.

Extended cycles with the combined oral contraceptive chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg: pooled analysis of data from three large-scale, non-interventional, observational studies.

BACKGROUND AND OBJECTIVE: The prescribing of extended regimens of oral contraceptives (OCs) is increasing in routine gynaecological practice as a means of reducing the number of annual menstrual bleeds. Typically, this involves taking one pill per day for, say, 84 days continuously (4×21 days), followed by a 7-day pill-free interval. Low-dose OCs are suitable for extended use, and many gynaecologists in Germany prescribe the combination of chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (CMA 2 mg/EE 0.03 mg). The aim of the current study was to assess the risks and benefits of CMA 2 mg/EE 0.03 mg in extended regimens, using pooled data from observational studies. METHODS: This pooled analysis of three large-scale, non-interventional, observational studies assessed the results in women receiving Belara® (CMA 2 mg/EE 0.03 mg) according to an extended regimen compared with conventional regimens documented in the summary of product characteristics. RESULTS: A total of 625 women were identified as extended-regimen users (mean±SD age 24.9±9.0 years). Extended-cycle use was associated with decreases in skin problems, dysmenorrhoea symptoms (as shown by reductions in analgesic use; absence from school, university, or work; and restrictions in leisure and sporting activities), cycle-dependent symptoms (e.g. headache/migraine, breast tenderness), withdrawal bleeding, bleeding duration and reduced libido. Mean bodyweight remained almost constant over 6 months. Only nine adverse drug reactions, none severe, were reported in eight women (1.3%). CONCLUSION: This pooled analysis confirms that extended regimens of CMA 2 mg/EE 0.03 mg reduce cycle-related complaints and are very well tolerated.