Corrigendum: Limitations in activities of daily living in old age in Germany and the EU - Results from the European Health Interview Survey (EHIS) 2.

[This corrects the article on p. 48-56 in vol. 4.].

Glycaemic status and depressive symptoms among adults in Germany: results from the German Health Interview and Examination Survey for Adults (DEGS1).

AIMS: To examine the association between glycaemic status and depressive symptoms in a nationwide sample of the adult population in Germany. METHODS: We conducted a cross-sectional analysis of data from 6385 participants aged 18-79 years in the nationwide German Health Interview and Examination Survey for Adults 2008-2011 (DEGS1). Glycaemic status was classified as follows: diagnosed diabetes (self-reported diagnosis or receiving antidiabetes medication); undiagnosed diabetes (HbA1c ≥48 mmol/mol [≥6.5%]); prediabetes (HbA1c 39-47 mmol/mol [5.7-6.4%]); or normoglycaemia (HbA1c <39 mmol/mol [<5.7%]). Current depressive symptoms were measured using the Patient Health Questionnaire depression scale (PHQ-9) and defined as elevated depressive symptoms (PHQ-9 score ≥10 points; dichotomous variable) and severity of depressive symptoms (PHQ-9 score, range 0-27 points; continuous variable). Associations of glycaemic status and HbA1c with both depressive symptoms variables were analysed using multivariable logistic (elevated depressive symptoms) and linear (severity of depressive symptoms) regression models. RESULTS: Compared with normoglycaemia, diagnosed diabetes, but not prediabetes or undiagnosed diabetes, was associated with elevated depressive symptoms (odds ratio 1.55, 95% CI 1.00-2.41) and severity of depressive symptoms (ß coefficient 0.71, 95% CI 0.23-1.19) in models adjusting for sociodemographics and health behaviours. Associations were similar among people with diagnosed diabetes taking and not taking antidiabetes medication. Among people without diagnosed diabetes, no associations between HbA1c and depressive symptoms were found. CONCLUSIONS: Diagnosed diabetes, but not prediabetes, undiagnosed diabetes or HbA1c , was associated with depressive symptoms among adults in Germany. Studies examining psychosocial and biological mechanisms that may potentially explain relationships between diagnosed diabetes and depressive symptoms are needed.

Changes in physical functioning among men and women aged 50-79 years in Germany: an analysis of National Health Interview and Examination Surveys, 1997-1999 and 2008-2011.

BACKGROUND: This study examines changes in physical functioning among adults aged 50-79 years in Germany based on data from two German National Health Interview and Examination Surveys conducted in 1997-1999 (GNHIES98) and 2008-2011 (DEGS1). METHODS: Using cross-sectional data from the two surveys (GNHIES98, n = 2884 and DEGS1, n = 3732), we examined changes in self-reported physical functioning scores (Short Form-36 physical functioning subscale (SF-36 PF)) by sex and age groups (50-64 and 65-79 years). Covariables included educational level, living alone, nine chronic diseases, polypharmacy (≥5 prescribed medicines), body mass index, sports activity, smoking and alcohol consumption. Multimorbidity was defined as ≥2 chronic diseases. Multivariable models were fitted to examine consistency of changes in physical functioning among certain subgroups and to assess changes in mean SF-36 PF scores, adjusting for changes in covariables between surveys. RESULTS: Mean physical functioning increased among adults aged 50-79 years between surveys in unadjusted analyses, but this change was not as marked among men aged 65-79 years who experienced rising obesity (20.6 to 31.5%, p = 0.004) and diabetes (13.0 to 20.0%, p = 0.014). Prevalence of multimorbidity and polypharmacy use increased among men and women aged 65-79 years. In sex and age specific multivariable analyses, changes in physical functioning over time were consistent across subgroups. Gains in physical functioning were explained by improved education, lower body mass index and improved health-related behaviours (smoking, alcohol consumption, sports activity) in women, but less so among men. CONCLUSIONS: Physical functioning improved in Germany among adults aged 50-79 years. Improvements in the population 65-79 years were less evident among men than women, despite increases in multimorbidity prevalence among both sexes. Changes in health behaviours over time differed between sexes and help explain variations in physical functioning. Targeted health behaviour interventions are indicated from this study.

Outcome of heparin-treated patients with acute cerebral venous sinus thrombosis: influence of the temporal pattern of intracerebral haemorrhage.

BACKGROUND AND PURPOSE: The influence of temporal patterns of intracerebral haemorrhage (ICH) on the outcome of heparin-treated patients with cerebral venous sinus thrombosis (CVST) has not been examined systematically. METHODS: Temporal patterns of ICH and their influence on survival without disability (modified Rankin Scale score ≤1 point) at hospital discharge were examined in 141 consecutive hospital-admitted patients with acute CVST who were treated with intravenous unfractionated heparin. RESULTS: Of all 141 patients (median age 40 years; 73% women), 59 (42%) had ICH at the time of diagnosis (early ICH). Of these, seven (12%) subsequently had extension of ICH and 13 (22%) had additional ICHs at other locations (delayed ICH). Of 82 patients without early ICH, nine (11%) later had delayed ICH. After a median hospital stay of 26 days, 107 patients (76%) were discharged without disability. Patients with early ICH were less likely to survive without disability until discharge than those without early ICH [63% vs. 85%; risk ratio (RR) 0.73; P = 0.005]. The association was attenuated after adjusting for age, sex and impaired consciousness on admission (RR 0.83; P = 0.03). Taking temporal patterns of ICH into account, early ICH with subsequent complication (extension or delayed ICH) had a larger influence on survival without disability (RR 0.57; 95% confidence interval 0.35-0.95) than early ICH without complications (RR 0.78; 95% confidence interval 0.67-0.91). CONCLUSIONS: Heparin-treated CVST patients were less likely to survive without disability when ICH was present on admission. This association may largely be driven by subsequent extension of haemorrhage or additionally occurring delayed haemorrhage.

In vitro evaluation of nutrients that selectively confer a competitive advantage to lactobacilli.

An assay was developed that tested the ability of Lactobacillus acidophilus to outcompete a challenge of Escherichia coli in a mixed culture containing different test nutrients. Using this assay, addition of fructo-oligosaccharide to the media allowed L. acidophilus to outcompete a challenge of E. coli, whereas in a mixed culture without the prebiotic the trend was reversed. Growth curves generated for E. coli in a single culture showed that fructo-oligosaccharide did not affect growth, indicating that the carbohydrate was not toxic to E. coli. This indicates that fructo-oligosaccharides may increase the ability of beneficial microbes to outcompete a pathogenic challenge. These results were confirmed using a skin simulant model that incorporates growth of the organisms at an air-surface interface to mimic the vulvar environment. It is possible to use a co-culture assay as an in vitro screening tool to define nutrients that confer a competitive advantage to beneficial flora specific to the female urogenital tract.

[Mental disorders in the general population : Study on the health of adults in Germany and the additional module mental health (DEGS1-MH)]. / Psychische Störungen in der Allgemeinbevölkerung : Studie zur Gesundheit Erwachsener in Deutschland und ihr Zusatzmodul Psychische Gesundheit (DEGS1-MH).

BACKGROUND AND OBJECTIVES: The German health interview and examination survey for adults (DEGS1) with the mental health module (DEGS1-MH) is the successor to the last survey of mental disorders in the general German population 15 years ago (GHS-MHS). This paper reports the basic findings on the 12-month prevalence of mental disorders, associated disabilities and self-reported healthcare utilization. METHODS: A representative national cohort (age range 18-79 years, n = 5,317) was selected and individuals were personally examined (87.5 % face to face and 12.5 % via telephone) by a comprehensive clinical interview using the composite international diagnostic interview (CIDI) questionnaire. RESULTS: The overall 12-month prevalence of mental disorders was 27.7 % with substantial differences between subgroups (e.g. sex, age, socioeconomic status). Mental disorders were found to be particularly impairing (elevated number of disability days). Less than 50 % of those affected reported to be in contact with health services due to mental health problems within the last 12 months (range 10-40 % depending on the number of diagnoses). CONCLUSIONS: Mental disorders were found to be commonplace with a prevalence level comparable to that found in the 1998 predecessor study but several further adjustments will have to be made for a sound methodological comparison between the studies. Apart from individual distress, elevated self-reported disability indicated a high societal disease burden of mental disorders (also in comparison with many somatic diseases). Despite a relatively comprehensive and well developed mental healthcare system in Germany there are still optimisation needs for treatment rates.

Social characteristics of psychological distress in disadvantaged areas of Berlin.

PURPOSE: Living in disadvantaged urban areas is associated with poor mental health. The purpose of this study was to assess which social characteristics were associated with psychological distress within a disadvantaged, multi-ethnic neighbourhood of Berlin. METHODS: The study was conducted in an area of Berlin with the highest rates of unemployment and highest density of migrants. A total of 143 participants aged 18-57 years were included from a random sample. The social characteristics educational level, employment status, marital status, living alone, per-capita income and background of migration were collected. Psychological distress was assessed using the General Health Questionnaire GHQ-28; scores ≥ 5 indicated psychological distress corresponding to psychiatric caseness. RESULTS: Psychological distress was found in 40.6% (n = 58) of the sample. Psychological distress was associated with younger age (OR = 0.95, 95% CI = 0.92-0.98, p = .004), female gender (OR = 3.51, 95% CI = 1.55-7.92, p = .003) and living alone (OR = 3.88, 95% CI = 1.58-9.52, p = .003), but not with background of migration, low educational level or with unemployment. CONCLUSIONS: Young age and female gender may predispose for psychological distress in disadvantaged areas. Living alone could be a social indicator of poor mental health within disadvantaged urban areas. The directionality of the association is unclear. BACKGROUND: of migration, low income and educational level do not seem to be associated with poor mental health within those areas.

[Prevalence of myocardial infarction and coronary heart disease in adults aged 40-79 years in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1)]. / Prävalenz von Herzinfarkt und koronarer Herzkrankheit bei Erwachsenen im Alter von 40 bis 79 Jahren in Deutschland: Ergebnisse der Studie zur Gesundheit Erwachsener in Deutschland (DEGS1).

In the German Health Interview and Examination Survey for Adults (DEGS1), data on the prevalence of myocardial infarction and coronary heart disease were collected from 2008-2011 in a representative population-based sample of 5,901 adults aged 40-79 years. The results of DEGS1 were compared with the prevalence estimates from the German National Health Interview and Examination Survey 1998 (GNHIES98). The lifetime prevalence of myocardial infarction amongst 40-79 year olds in DEGS1 is 4.7 % (women 2.5 %; men 7 %). In comparison with GNHIES98 a small increase was observed in men, but not in women. The lifetime prevalence of coronary heart disease in adults aged 40-79 years in DEGS1 is 9.3 % (women 6.4 %; men 12.3 %). In comparison to GNHIES98 there is a slight reduction only in women. There is a significant inverse relationship between disease prevalence and socioeconomic status. The trend in prevalence of coronary heart disease is comparable with that in other high-income countries. Given a falling incidence of myocardial infarction and a decrease in the mortality rates due to coronary heart disease, the basically stable prevalence rates indicate a positive development in the field of cardiovascular prevention and therapy. An English full-text version of this article is available at SpringerLink as supplemental.

[Prevalence of stroke in adults aged 40 to 79 years in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1)]. / Prävalenz des Schlaganfalls bei Erwachsenen im Alter von 40 bis 79 Jahren in Deutschland: Ergebnisse der Studie zur Gesundheit Erwachsener in Deutschland (DEGS1).

In the German Health Interview and Examination Survey (DEGS1), data on the prevalence of physician-diagnosed stroke were collected from 2008 to 2011 in a representative population-based sample of 5,901 adults aged 40-79 years. The stroke prevalence in DEGS1 was compared with prevalence estimates from the German National Health Interview and Examination Survey 1998 (GNHIES98). The lifetime prevalence of stroke in adults aged 40-79 years is 2.9 % (women: 2.5 %; men: 3.3 %). In both sexes, the prevalence increases continuously with age, up to 6.3 % in women and 8.1 % in men 70-79 years old. More pronounced in women than in men, the prevalence of stroke decreases with increasing socioeconomic status. Compared to GNHIES98, there is no evidence for a change in stroke prevalence over time. The prevalence of stroke in adults aged 40-79 years in Germany is comparable to prevalence estimates from other national and international studies. Further studies should examine the reasons behind stable prevalence rates, accounting for population ageing and changes in incidence, mortality and case fatality rates. An English full-text version of this article is available at SpringerLink as supplemental.

[Prevalence of dyslipidemia among adults in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS 1)]. / Verbreitung von Fettstoffwechselstörungen bei Erwachsenen in Deutschland: Ergebnisse der Studie zur Gesundheit Erwachsener in Deutschland (DEGS1).

Interview and laboratory data from the first wave of the German health interview and examination survey for adults (DEGS1) from 2008 to 2011 were used to provide current estimates of the prevalence of dyslipidemia which are representative of the population in Germany 18 to 79 years of age. A total of 56.6 % of men and 60.5 % of women 18 to 79 years have elevated serum total cholesterol concentrations in excess of the currently recommended threshold of 190 mg/dL; 17.9 % of men and 20.3 % of women have highly elevated total cholesterol concentrations ≥ 240 mg/dL. A total of 19.3 % of men and 3.6 % of women have high density lipoprotein cholesterol concentrations below 40 mg/dL. The overall prevalence of dyslipidemia (total cholesterol ≥ 190 mg/dL or medical diagnosis of dyslipidemia) is 64.5 % for men and 65.7 % for women. Of these, more than half of both men and women have previously undiagnosed dyslipidemia. Among persons with known dyslipidemia, 30.8% take lipid-lowering medication. Dyslipidemia is widely prevalent among adults in Germany. More in-depth analyses will examine time trends in the prevalence of dyslipidemia in Germany and in an international comparison. An English full-text version of this article is available at SpringerLink as supplemental.

[Physical and cognitive capabilities among persons aged 65-79 years in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1)]. / Körperliche und geistige Funktionsfähigkeit bei Personen im Alter von 65 bis 79 Jahren in Deutschland: Ergebnisse der Studie zur Gesundheit Erwachsener in Deutschland (DEGS1).

In older age, physical and cognitive capabilities play an important role for independent living. For this reason, the German Health Interview and Examination Survey for Adults (DEGS1) included the Timed Up and Go test (TUG) and a chair-rise test, balance tests, a measurement of hand grip strength and the Digit Symbol Substitution Test (DSST) in order to representatively describe physical and cognitive performance of older people in Germany. Among 1,853 persons 65-79 years of age who came to the study centre more than 90 % participated in the performance tests. The average time needed to complete the TUG and chair-rise tests were 10.7 and 11.8 s, respectively. On average, participants reached 3.9 of a maximum of 5 points in the balance tests (FICSIT4 protocol). Mean maximum grip strength was 32.3 kg. The mean number of correctly assigned symbols in the DSST was 43.8. In all functional capacity areas tested, performance declined with increasing age. There were differences by sex in the chair-rise test, hand grip strength and DSST. The objective measurement of physical and cognitive capabilities in DEGS1 contributes to describe the health status of older people with implications for health promotion and prevention. An English full-text version of this article is available at SpringerLink as supplemental.

[Prevalence of depressive symptoms and diagnosed depression among adults in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1)]. / Prävalenz von depressiver Symptomatik und diagnostizierter Depression bei Erwachsenen in Deutschland: Ergebnisse der Studie zur Gesundheit Erwachsener in Deutschland (DEGS1).

In the German Health Interview and Examination Survey (DEGS1), current depressive symptoms were assessed with the "Patient Health Questionnaire" (PHQ-9) in a representative population-based sample of 7,988 adults 18-79 years old. In addition, previously diagnosed depression was assessed by physician interview. The prevalence of current depressive symptoms (PHQ-9 ≥ 10 points) is 8.1 % (women: 10.2 %; men: 6.1 %). For both sexes, the prevalence is highest among 18- to 29-year-olds and decreases with age. Persons with higher socioeconomic status (SES) are less likely to have current depressive symptoms. The lifetime prevalence of diagnosed depression is 11.6 % (women: 15.4 %; men: 7.8 %) and is highest among persons 60-69 years old. The 12 month prevalence is 6.0 % (women: 8.1 %; men: 3.8 %) and is highest among 50- to 59-year-olds. In women, but not in men, prevalences decrease with increasing SES. The results describe the distribution of two important aspects of depression among the adult population in Germany and confirm previously observed associations with age, gender and SES. An English full-text version of this article is available at SpringerLink as supplemental.

[Chronic stress among adults in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1)]. / Chronischer Stress bei Erwachsenen in Deutschland : Ergebnisse der Studie zur Gesundheit Erwachsener in Deutschland (DEGS1).

The "German Health Interview and Examination Survey for Adults" (DEGS1) was conducted from 2008 to 2011 and comprised interviews, examinations and tests. The target population was the resident population of Germany aged 18 to 79 years. A total of 8152 persons participated. Chronic stress was assessed to examine its effects on health and mental wellbeing. The Screening Scale of the Trier Inventory for the Assessment of Chronic Stress was used to assess stress burden among participants up to the age of 64 years (N = 5850). High levels of stress are significantly more often reported by women (13.9%) than by men (8.2%). The prevalence of high stress levels decreases with a higher socioeconomic status (SES); it falls from 17.3% with low SES to 7.6% with high SES. High chronic stress levels are particularly common (26.2%) in persons who report low levels of social support. Depressive symptoms, burnout syndrome and sleep disturbances are more common in people who have high levels of chronic stress than in those without high levels of stress. The results confirm the importance of chronic stress as a health risk and underline the public health relevance of chronic stress. An English full-text version of this article is available at SpringerLink as supplemental.

[Primary and secondary prevention of stroke]. / Primär- und Sekundärprävention des Schlaganfalls.

Despite considerable advances in acute stroke therapy, stroke prevention remains the most promising approach for reducing the burden of stroke. A healthy lifestyle and the treatment of cardiometabolic risk factors are the cornerstones of both primary and secondary stroke prevention. Due to a proportionately higher risk of bleeding complications, platelet inhibitors are not recommended for primary stroke prevention. Platelet inhibitors are effective in the secondary prevention of stroke with acetyl salicylic acid (ASS) and clopidogrel showing the most consistent data. New oral anticoagulants are slightly more effective than coumarin and significantly reduce the risk of intracranial hemorrhage. They offer the opportunity to bring more patients with atrial fibrillation at risk for stroke into anticoagulation particularly those on ASS therapy. Surgery for patients with asymptomatic carotid artery stenosis should be viewed critically with respect to an only marginal benefit and improvement in medical therapies. Carotid endarterectomy remains the gold standard for patients with symptomatic carotid stenosis because of an increased procedural stroke risk with carotid stenting. Patients with symptomatic intracranial stenosis or cryptogenic stroke and a patent foramen ovale should receive only medical treatment.

Depression in middle-aged and older first generation migrants in Europe: results from the Survey of Health, Ageing and Retirement in Europe (SHARE).

OBJECTIVE: To determine the prevalence of depression in migrants aged 50 years or older in comparison to residents without a history of migration in 11 European countries. METHODS AND SUBJECTS: The Survey of Health, Ageing and Retirement in Europe (SHARE), a cross-national, multidisciplinary, household-based panel survey using nationally representative probability samples (n=28,517) of 11 European countries of the non-institutionalized population aged 50 years and older. Depression was measured using the EURO-D scale, and odds ratios (OR) were estimated for migration status. Effects of sociodemographic variables, somatic comorbidities, functional impairment, cognitive function, geographic region, and time lived in current country of residence were assessed in multivariate logistic regression analysis. RESULTS: Adjusting for confounds, the OR for depression in migrants was 1.42 (95% CI, 1.28-1.59). The influence of migration status on the prevalence of depression was significantly greater in Northern (OR, 1.85; 95% CI, 1.39-2.46) and Western Europe (OR, 1.38; 95% CI, 1.22-1.57), compared to Southern Europe (OR, 1.16; 95% CI, 0.79-1.70) (p<0.05 for the interaction). CONCLUSION: We found a higher prevalence of depression in first-generation migrants aged 50 years or older, together with relevant geographical variation. This difference was not due to other known predictors of depression in older age.

Sociodemographic differences in return to work after stroke: the South London Stroke Register (SLSR).

BACKGROUND: Loss of employment contributes significantly to the burden of stroke on individuals and society. There is limited information on factors influencing return to work after stroke. OBJECTIVES: To investigate the frequency and determinants of return to paid work after stroke in a multi-ethnic urban population. METHODS: Patterns of return to work were examined among people with first ever stroke registered in the population based South London Stroke Register. Employment status and functional outcome (Barthel Index (BI), Frenchay Activity Index (FAI)) were assessed 1 year after stroke. Associations between baseline characteristics and return to paid work were analysed by multivariable logistic regression analysis. RESULTS: Among 2874 patients with first ever strokes in 1995-2004, 400 (15%) were working before the stroke. At 1 year, 94 (35%) of 266 survivors had returned to paid work. Black ethnicity (OR 0.41; 95% CI 0.19 to 0.88), female sex (0.43; 0.21 to 0.91), older age (p<0.001), diabetes (0.25; 0.08 to 0.79) and dependence (BI < or = 19) in the acute phase (0.24; 0.11 to 0.49) were independently associated with lower odds of return to work in multivariable analysis. Better functional outcome at 1 year was associated with return to paid work (p<0.001) but 53% of 161 independent (BI > 19) and 39% of 96 very active (FAI > 30/45) individuals had not resumed work. CONCLUSIONS: There were important sociodemographic differences in return to work after stroke that were independent of clinical and service use variables included in the analysis. A large proportion of patients did not resume work despite excellent functional outcome.

Oral transmucosal fentanyl citrate in the management of breakthrough pain in cancer: an open, multicentre, dose-titration and long-term use study.

Sixty-six patients with cancer-related pain entered an open multicentre study to examine the safety and efficacy of oral transmucosal fentanyl citrate (OTFC) in the treatment of breakthrough pain. Patients were eligible for the study if they were stabilized on a long-acting opioid but were experiencing up to four episodes of breakthrough pain a day and achieving at least partial relief from breakthrough pain using conventional medication (normal release oral morphine in the majority of patients). The efficacy of the conventional medication was documented in a run-in phase and patients then changed to OTFC. All patients were treated initially with a 200 mcg unit of OTFC and the dose was increased if necessary to a level that produced relief of breakthrough pain without troublesome adverse effects. Fifty-eight patients completed the run-in phase using their usual medication and entered the dose titration phase with OTFC and 57 patients received at least one dose of OTFC. Forty-two patients (72%) found a successful dose of OTFC. The primary outcome measures were the Summed Pain Intensity Differences (SPID) and Total Pain Relief (TOTPAR) scores at 60 min. There was a significant difference in both measures in favour of OTFC compared with conventional medication in these patients. Twenty-eight of the 42 patients (67%) preferred OTFC to their usual medication. The most common adverse effects attributed to OTFC were nausea, stomatitis, vomiting and dizziness but there were no unpredicted or severe problems. Thirty-seven patients continued into the long-term study and 12 of these completed six months treatment. Most drop-outs in this phase were associated with progression of the underlying disease. No patient stopped using OTFC because of dissatisfaction with the drug. OTFC appears to be a safe and effective treatment for breakthrough pain in cancer patients and may have advantages over currently available opioid formulations.

Interaction between electron transport at the plasma membrane and nitrate uptake by maize (Zea mays L.) roots.

In the present study nitrate uptake by maize (Zea mays L.) roots was investigated in the presence or absence of ferricyanide (hexacyanoferrate III) or dicumarol. Nitrate uptake caused an alkalization of the medium. Nitrate uptake of intact maize seedlings was inhibited by ferricyanide while the effect of dicumarol was not very pronounced. Nitrite was not detected in the incubation medium, neither with dicumarol-treated nor with control plants after application of 100 microM nitrate to the incubation solution. In a second set of experiments interactions between nitrate and ferricyanide were investigated in vivo and in vitro. Nitrate (1 or 3 mM) did neither influence ferricyanide reductase activity of intact maize roots nor NADH-ferricyanide oxidoreductase activity of isolated plasma membranes. Nitrate reductase activity of plasma-membrane-enriched fractions was slightly stimulated by 25 microM dicumarol but was not altered by 100 microM dicumarol, while NADH-ferricyanide oxidoreductase activity was inhibited in the presence of dicumarol. These data suggest that plasma-membrane-bound standard-ferricyanide reductase and nitrate reductase activities of maize roots may be different. A possible regulation of nitrate uptake by plasmalemma redox activity, as proposed by other groups, is discussed.

Long-term safety of oral transmucosal fentanyl citrate for breakthrough cancer pain.

This open-label study evaluated the long-term safety and tolerability of oral transmucosal fentanyl citrate (OTFC) in ambulatory cancer patients with breakthrough pain undergoing cancer care at 32 university- or community-based practices. Patients had participated in a previous short-term titration trial of OTFC, were experiencing at least one episode per day of breakthrough pain, and had achieved relief of their breakthrough pain with an opioid. Patients received OTFC units at a starting dosage strength determined in the short-term trial (200-1600 microg). Outcome measures included number of successfully treated breakthrough pains, global satisfaction rating (0 = poor through 4 = excellent), and side effects. In total, 41,766 units of OTFC were used to treat 38,595 episodes of breakthrough pain in 155 patients. Number of treatment days ranged from 1 to 423 (mean, 91 days). Patients averaged 2.9 breakthrough pain episodes per day. About 92% of episodes were successfully treated with OTFC and there was no trend toward decreased effectiveness over time. Most patients (61%) did not require dose escalation during treatment. Global satisfaction ratings were consistently above 3, indicating very good to excellent relief. Common adverse events associated with OTFC were somnolence (9%), constipation (8%), nausea (8%), dizziness (8%), and vomiting (5%). Six patients (4%) discontinued therapy due to an OTFC-related adverse event. There were no reports of abuse and no concerns about the safety of the drug raised by patients or families. OTFC was used safely and effectively during long-term treatment of breakthrough pain in cancer patients at home.