Gamma-linolenic acid levels correlate with clinical efficacy of evening primrose oil in patients with atopic dermatitis.

INTRODUCTION: Atopic dermatitis (AD) has been related to a deficiency of delta-6-desaturase, an enzyme responsible for the conversion of linoleic acid to gamma-linolenic acid (GLA). Evening primrose oil (EPO) contains high amounts of GLA. Therefore, this study investigated whether EPO supplementation results in an increase in plasma GLA and its metabolite dihomo-gamma-linolenic acid (DGLA) correlating with clinical improvement of AD, assessed by the SCORing Atopic Dermatitis (SCORAD) index. METHODS: The open study included 21 patients with AD. EPO (4-6 g) was administered daily for 12 weeks. Before treatment, and 4 and 12 weeks after initiation of EPO supplementation, objective SCORAD was assessed and plasma concentrations of GLA and DGLA were determined by gas chromatography. RESULTS: A significant increase in plasma GLA and DGLA levels and a decrease in the objective SCORAD were observed 4 and 12 weeks after initiation of EPO treatment. In the per-protocol population (n = 14), a significant inverse correlation between the changes in plasma GLA levels and SCORAD was found (P = 0.008). CONCLUSION: The clinical disease activity under EPO treatment correlates with the individual increase in plasma GLA levels. Thus, the results of this pilot study indicate that an increase in plasma GLA might be used as predictive parameter for responsiveness of AD to EPO therapy.

The effects of the "physical BEMER® vascular therapy", a method for the physical stimulation of the vasomotion of precapillary microvessels in case of impaired microcirculation, on sleep, pain and quality of life of patients with different clinical pictures on the basis of three scientifically validated scales.

As part of the statutory market monitoring of certified medical devices, 658 valid patient questionnaires were evaluated between April 2011 and March 2013. The questions consisted mainly of three scientifically recognized scales for assessing the changes of sleep, pain and quality of life in patients who had used the "physical BEMER® vascular therapy" for different diseases over 6 weeks. The result clearly shows that there are significant improvements in all areas surveyed through the application of this complementary treatment option, regardless of the underlying disease.

Dose-Dependent Effects of the Cimicifuga racemosa Extract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study.

Extracts from Cimicifuga racemosa (CR, synonym Actaea racemosa) have shown efficacy in trials in women with menopausal symptoms. Yet, dose dependency remains unclear. Therefore, 180 female outpatients with climacteric complaints were treated for 12 weeks in a randomized, double-blind, placebo-controlled, 3-armed trial (CR extract Ze 450 in 6.5 mg or 13.0 mg, or placebo). Primary outcome was the difference in menopausal symptoms (vasomotor, psychological, and somatic), assessed by the Kupperman Menopausal Index between baseline and week 12. Secondary efficacy variables were patients' self-assessments of general quality of life (QoL), responder rates, and safety. Compared to placebo, patients receiving Ze 450 showed a significant reduction in the severity of menopausal symptoms in a dose-dependent manner from baseline to endpoint (mean absolute differences 17.0 (95% CI 14.65-19.35) score points, P < 0.0001 for 13.0 mg; mean absolute differences 8.47 (95% CI 5.55-11.39) score points, P = 0.0003 for 6.5 mg). QoL and responder rates corresponded with the main endpoint. Changes in menopausal symptoms and QoL were inversely correlated. Reported adverse events and clinical laboratory testing did not raise safety concerns. The CR extract Ze 450 is an effective and well-tolerated nonhormonal alternative to hormone treatment for symptom relief in menopausal women.

Persistent dyslipidemia in statin-treated patients: the focus on comprehensive lipid management survey in Swiss patients.

PRINCIPLES: Statin therapy reduces cardiovascular morbidity and mortality. However, a substantial residual cardiovascular risk can be observed in patients receiving this therapy due to persisting lipid abnormalities as well as to the lack of a systematic global risk-reduction strategy. The objective of the study was to assess the prevalence of dyslipidemia in a cohort of patients living in Switzerland and receiving statin therapy. METHODS: This cross-sectional study was conducted by 61 primary care physicians, cardiologists, endocrinologists and internists in Switzerland. Patients were consecutive outpatients≥45 years-old, on statin therapy for at least 3 months with available lipid values. A clinical examination and a recording of the latest lipid values on statin therapy were performed in all patients. RESULTS: A total of 473 patients (age 66.3±9.41 years; 61.9% male) were included in the final analysis. Under statin therapy, 40% of the analysed patients had a normal lipid profile, 32.6% presented increased low-density lipoprotein cholesterol (LDL-C) (3.35±0.88 mmol/L), 28.8% low high-density lipoprotein-cholesterol (HDL-C) (0.95±0.18 mmol/L) and 31.1% elevated triglycerides (2.69±1.04 mmol/L). It is of note that the included population was characterised by a high prevalence of cardiovascular risk factors (86.5% patients had 10-year cardiovascular risk>20%). Nevertheless, the lipid lowering therapy was modified in only 15.4% of the patients. CONCLUSION: Persistent dyslipidemia is a reality in statin-treated patients and may contribute to their residual cardiovascular risk. Therefore, comprehensive lipid management should be preferred to aggressive LDL-C lowering alone. Moreover, strategies to assess and modify the global cardiovascular risk of patients should be taken into account as an important component of primary and secondary prevention.

Petasol butenoate complex (Ze 339) relieves allergic rhinitis-induced nasal obstruction more effectively than desloratadine.

BACKGROUND: Allergic rhinitis symptoms of itching, sneezing, rhinorrhea, and nasal obstruction significantly decrease patients' quality of life. Compared with histamine and leukotriene receptor antagonists, the petasol butenoate complex Ze 339 displays pharmacologically distinct properties. In vitro it inhibits the biosynthesis of leukotrienes and mediator release from activated eosinophils. OBJECTIVE: This study aimed to assess the efficacy and mode of action of Ze 339, desloratadine, and placebo on allergic rhinitis symptoms, nasal airflow, and local mediator levels after unilateral nasal allergen provocation. METHODS: In this double-blind, randomized, crossover study 18 subjects with allergic rhinitis to grass pollen received Ze 339, desloratadine, and placebo for 5 days before nasal allergen challenge with grass pollen extract. Rhinomanometry, symptom assessment, and local inflammatory mediator measurement were performed during the 24 hours after allergen challenge. RESULTS: With Ze 339, the patient's time to recovery (5.4 ± 1.6 hours) from nasal obstruction after allergen challenge (time for return to 90% of baseline value ± SEM) was significantly shorter than with placebo (9.1 ± 2.3 hours, P = .035) and desloratadine (10.7 ± 2.5 hours, P = .022). Likewise, Ze 339's standardized symptom assessment for nasal obstruction (3.2 ± 1.3 hours) showed significantly faster relief (time for return to baseline value ± SEM compared with placebo, 8.3 ± 2.4 hours; P = .027) and desloratadine (4.5 ± 1.2 hours, P = .030). One interesting finding was that Ze 339 significantly reduced IL-8 and leukotriene B(4) levels in nasal secretions before challenge. CONCLUSION: When compared with desloratadine and placebo, Ze 339 shows better efficacy in relieving nasal obstruction symptoms and inhibiting critical components of the chemokine network and as such represents a novel symptomatic and possible prophylactic treatment for allergic rhinitis.

Stroke, coronary and peripheral artery disease survey on antithrombotic treatment (START IT).

QUESTIONS UNDER STUDY: To determine the perception of primary care physicians regarding the risk of subsequent atherothrombotic events in patients with established cardiovascular (CV) disease, and to correlate this perception with documented antithrombotic therapy. METHODS: In a cross-sectional study of the general practice population in Switzerland, 381 primary care physicians screened 127 040 outpatients during 15 consecutive workdays in 2006. Perception of subsequent atherothrombotic events in patients with established CV disease was assessed using a tick box questionnaire allowing choices between low, moderate, high or very high risk. Logistic regression models were used to determine the relationship between risk perception and antithrombotic treatment. RESULTS: Overall, 13 057 patients (10.4%) were identified as having established CV disease and 48.8% of those were estimated to be at high to very high risk for subsequent atherothrombotic events. Estimated higher risk for subsequent atherothrombotic events was associated with a shift from aspirin monotherapy to clopidogrel, vitamin K antagonist or aspirin plus clopidogrel (p <0.001 for trend). Clopidogrel (12.7% vs 6.8%, p <0.001), vitamin K antagonist (24.5% vs 15.6%, p <0.001) or aspirin plus clopidogrel (10.2% vs 4.2%, p <0.001) were prescribed in patients estimated to be at high to very high risk more often than in those at low to moderate risk. CONCLUSIONS: Perception of primary care physicians regarding risk of subsequent atherothrombotic events varies in patients with CV disease, and as a result antithrombotic therapy is altered in patients with anticipated high to very high risk even though robust evidence and clear guidelines are lacking.

Age-related differences in the prevalence of potential drug-drug interactions in ambulatory dyslipidaemic patients treated with statins.

BACKGROUND AND OBJECTIVE: Elderly patients may be at higher risk of drug-drug interactions (DDIs) because of polypharmacy. This study evaluated age-specific differences in the prevalence of clinically relevant potential DDIs (pDDIs) in ambulatory dyslipidaemic patients treated with an HMG-CoA reductase inhibitor (statin). We hypothesised that elderly patients are at higher risk for pDDIs because of the presence of more drugs and drugs with a higher potential for DDIs in this age group. METHODS: A total of 2742 dyslipidaemic ambulatory patients treated with a statin were included in this cross-sectional study. Drug treatment was screened for clinically relevant pDDIs using an electronic drug interaction program (DRUG-REAX System). RESULTS: The study sample consisted of 483 (17.6%) patients aged < or = 54 years, 732 (26.7%) aged 55-64 years, 924 (33.7%) aged 65-74 years and 603 (22.0%) patients aged > or = 75 years. Patients > or =75 years had significantly more pharmacologically active substances prescribed than patients aged < or =54 years (mean 5.8 vs 3.8, respectively; p < 0.001). Cardiovascular diseases such as coronary heart disease, heart failure or arrhythmias were also significantly more prevalent in patients aged > or = 75 years than in younger patients. The overall prevalence of pDDIs increased significantly from 7.9% in those aged < or = 54 years to 18.4% in patients aged > or = 75 years (p < 0.001). The frequency of both pDDIs associated with statins and non-statin pDDIs increased with age. Risk factors for pDDIs in patients aged > or = 75 years were arrhythmias, heart failure and the number of pharmacologically active substances prescribed. The more frequent prescription of cardiovascular drugs with a high potential for pDDIs (e.g. amiodarone and digoxin) in patients aged > or = 75 years was mainly responsible for the observed increases in statin and non-statin pDDIs in this age group. CONCLUSIONS: Compared with younger patients, elderly dyslipidaemic patients are at a higher risk for clinically relevant pDDIs, mainly because of a higher number of drugs prescribed. In addition, patients aged > or = 75 years were prescribed more drugs with a high potential for DDIs, especially drugs used for the treatment of arrhythmias and heart failure. The risk for adverse reactions associated with pDDIs may often be reduced by dose adjustment, close monitoring or selection of an alternative drug.

Antipsychotic use in patients with schizophrenia treated in private psychiatry.

QUESTIONS UNDER STUDY: The aim of this study was to assess antipsychotic treatment practices among private psychiatrists in Switzerland. METHODS: For each patient seen during 4 consecutive weeks, 101 participating private psychiatrists documented psychiatric diagnosis. For each schizophrenic patient, demographic details as well as treatment issues were assessed in a questionnaire-based survey. Participating psychiatrists were representative for Swiss private psychiatry with regards to gender distribution and region of practice. RESULTS: Overall, 8425 patients were assessed in our survey. Of these, 905 patients (10.7%) received a diagnosis of schizophrenic psychoses, of whom 733 details on antipsychotic treatment were documented. 73.1% of these patients received second generation antipsychotics. Most private psychiatrists prescribed antipsychotic monotherapy and maintained antipsychotic treatment according to recommendation from international guidelines. Almost half of these patients had a history of medication non-adherence, with non-compliance being the most frequent reason. CONCLUSION: The findings of this survey suggest that Swiss private psychiatrists prescribe according to international guidelines in terms of drug choice as well as maintenance treatment. Moreover they show low rates of polypharmacy and comedication practice as compared to their colleagues in other European countries. This may reflect solid experience in prescribing second-generation antipsychotics of a subgroup of private psychiatrists in Switzerland.

Prevalence of potentially severe drug-drug interactions in ambulatory patients with dyslipidaemia receiving HMG-CoA reductase inhibitor therapy.

BACKGROUND: Drug-drug interactions (DDIs) are a well known risk factor for adverse drug reactions. HMG-CoA reductase inhibitors ('statins') are a cornerstone in the treatment of dyslipidaemia and patients with dyslipidaemia are concomitantly treated with a variety of additional drugs. Since DDIs are associated with adverse reactions, we performed a cross-sectional study to assess the prevalence of potentially critical drug-drug and drug-statin interactions in an outpatient adult population with dyslipidaemia. METHODS: Data from patients with dyslipidaemia treated with a statin were collected from 242 practitioners from different parts of Switzerland. The medication list was screened for potentially harmful DDIs with statins or other drugs using an interactive electronic drug interaction program. RESULTS: We included 2742 ambulatory statin-treated patients (mean age +/- SD 65.1 +/- 11.1 years; 61.6% males) with (mean +/- SD) 3.2 +/- 1.6 diagnoses and 4.9 +/- 2.4 drugs prescribed. Of those, 190 patients (6.9%) had a total of 198 potentially harmful drug-statin interactions. Interacting drugs were fibrates or nicotinic acid (9.5% of patients with drug-statin interactions), cytochrome P450 (CYP) 3A4 inhibitors (70.5%), digoxin (22.6%) or ciclosporin (cyclosporine) [1.6%]. The proportion of patients with a potential drug-statin interaction was 12.1% for simvastatin, 10.0% for atorvastatin, 3.8% for fluvastatin and 0.3% for pravastatin. Additionally, the program identified 393 potentially critical non-statin DDIs in 288 patients. CONCLUSIONS: CYP3A4 inhibitors are the most frequent cause of potential drug interactions with statins. As the risk for developing rhabdomyolysis is increased in patients with drug-statin interactions, clinicians should be aware of the most frequently observed drug-statin interactions and how these interactions can be avoided.

Swiss Hypertension and Risk Factor Program (SHARP): cardiovascular risk factors management in patients with type 2 diabetes in Switzerland.

The prevalence of hypertension in type 2 diabetics is high, though there is no published data for Switzerland. This prospective cohort survey determined the frequency of type 2 diabetes mellitus associated with hypertension from medical practitioners in Switzerland, and collected data on the diagnostic and therapeutic work-up for cardiovascular risk patients. The Swiss Hypertension And Risk Factor Program (SHARP) is a two-part survey: The first part, I-SHARP, was a survey among 1040 Swiss physicians to assess what are the target blood pressure (BP) values and preferred treatment for their patients. The second part, SHARP, collected data from 20,956 patients treated on any of 5 consecutive days from 188 participating physicians. In I-SHARP, target BP?135/85 mmHg, as recommended by the Swiss Society of Hypertension, was the goal for 25% of physicians for hypertensives, and for 60% for hypertensive diabetics; values >140/90 mmHg were targeted by 19% for hypertensives, respectively 9% for hypertensive diabetics. In SHARP, 30% of the 20,956 patients enrolled were hypertensive (as defined by the doctors) and 10% were diabetic (67% of whom were also hypertensive). Six per cent of known hypertensive patients and 4% of known hypertensive diabetics did not receive any antihypertensive treatment. Diabetes was not treated pharmacologically in 20% of diabetics. Proteinuria was not screened for in 45% of known hypertensives and in 29% of known hypertensive diabetics. In Switzerland, most physicians set target BP levels higher than recommended in published guidelines. In this country with easy access to medical care, high medical density and few financial constraints, appropriate detection and treatment for cardiovascular risk factors remain highly problematic.

Reasons for not intensifying antihypertensive treatment (RIAT): a primary care antihypertensive intervention study.

OBJECTIVE: Hypertension is often poorly controlled, despite its importance and despite the availability of very effective treatments. An under-recognized problem is the failure of consensus guidelines to acknowledge the important difference between efficacy in clinical trials and effectiveness in clinical practice. The present survey was designed to prospectively assess what is the target blood pressure (BP) goal defined by a general practitioner (GP) for an individual patient, and what are the reasons for not modifying an antihypertensive drug regimen, when pre-defined individual BP goals are not achieved. DESIGN: Family practice based, open intervention survey. SUBJECTS: Participating GPs enrolled 2621 hypertensive patients. At the first visit each physician was required to assess the cardiovascular risk profile of each patient and to define individual BP targets. INTERVENTIONS: Treatment was started with irbesartan alone or in fixed combination with hydrochlorothiazide. Follow-up visits were suggested after 1 month, 2 months and 4 months. Physicians were asked to report BP values under the new treatment regimen and to indicate whether in their opinion pre-defined BP targets set at baseline were achieved or not and whether the antihypertensive regimen was modified or maintained in relation to whether target BP was reached or not. MAIN OUTCOME MEASURE: To provide reasons for not changing the treatment even though BP goals were missed. RESULTS: Average target BP values defined by the physicians at baseline were 138 +/- 8 mmHg for systolic and 84 +/- 5 mmHg for diastolic BP. Among GPs, defined target BP values did not depend on individual risk stratification, but rather depended on baseline BP values. At baseline systolic and diastolic BP averaged 165/97 +/- 17/10 mmHg, while at the last visit achieved BP averaged 140/84 +/- 14/8 mmHg. There were three main reasons for not intensifying antihypertensive treatment when BP targets were not achieved. These reasons were: (1). the assumption that the time after starting the new drug was too short to appreciate its full effect (44% at first, 14% at last follow-up), (2). that there was a clear improvement or the target BP was almost reached (24% at first, 34% at last follow-up) or (3). that self-measurements were considered satisfactorily (10% at the last visit). CONCLUSIONS: Failure of physicians to follow guidelines is apparently dependent on the belief that baseline BP dictates the target, that a clear improvement in BP might be sufficient and that the full drug effect may take up to 4 months or more to be attained.