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- Krarup, Anne L., et al.
(författare)
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Randomized clinical trial: inhibition of the TRPV1 system in patients with nonerosive gastroesophageal reflux disease and a partial response to PPI treatment is not associated with analgesia to esophageal experimental pain.
- 2013
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Ingår i: Scandinavian journal of gastroenterology. - : Informa UK Limited. - 1502-7708 .- 0036-5521. ; 48:3, s. 274-84
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Tidskriftsartikel (refereegranskat)abstract
- Abstract Objective. Many patients with nonerosive reflux disease (NERD) have insufficient relief on proton pump inhibitors (PPIs). Some patients have a hypersensitive esophagus and may respond to transient receptor potential vanilloid 1 (TRPV1) antagonists. Aim. To investigate the effect of the TRPV1 antagonist AZD1386 on experimental esophageal pain in NERD patients. Material and methods. Enrolled patients had NERD and a partial PPI response (moderate-to-severe heartburn or regurgitation ≥3 days/week before enrolment despite ≥6 weeks' PPI therapy). Fourteen patients (21-69 years, 9 women) were block-randomized into this placebo-controlled, double-blinded, crossover study examining efficacy of a single dose (95 mg) of AZD1386. On treatment days, each participant's esophagus was stimulated with heat, distension, and electrical current at teaching hospitals in Denmark and Sweden. Heat and pressure pain served as somatic control stimuli. Per protocol results were analyzed. Results. Of 14 randomized patients, 12 were treated with AZD1386. In the esophagus AZD1386 did not significantly change the moderate pain threshold for heat [-3%, 95% confidence interval (CI), -22;20%], distension (-11%, 95% CI, -28;10%), or electrical current (6%, 95% CI, -10;25%). Mean cutaneous heat tolerance increased by 4.9°C (95% CI, 3.7;6.2°C). AZD1386 increased the maximum body temperature by a mean of 0.59°C (95% CI, 0.40-0.79°C), normalizing within 4 h. Conclusions. AZD1386 had no analgesic effect on experimental esophageal pain in patients with NERD and a partial PPI response, whereas it increased cutaneous heat tolerance. TRPV1 does not play a major role in heat-, mechanically and electrically evoked esophageal pain in these patients. ClinicalTrials.gov identifier: D9127C00002.
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| 3. |
- Borisenko, Oleg, et al.
(författare)
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Bariatric Surgery can Lead to Net Cost Savings to Health Care Systems: Results from a Comprehensive European Decision Analytic Model
- 2015
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Ingår i: Obesity Surgery. - : Springer Science and Business Media LLC. - 1708-0428 .- 0960-8923. ; 25:9, s. 1559-1568
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Tidskriftsartikel (refereegranskat)abstract
- The objective of the present study was to evaluate the cost-utility of bariatric surgery in a lifetime horizon from a Swedish health care payer perspective. A decision analytic model using the Markov process was developed covering cardiovascular diseases, type 2 diabetes, and surgical complications. Clinical effectiveness and safety were based on the literature and data from the Scandinavian Obesity Surgery Registry. Gastric bypass, sleeve gastrectomy, and gastric banding were included in the analysis. Cost data were obtained from Swedish sources. Bariatric surgery was cost saving in comparison with conservative management. It also led to a substantial reduction in lifetime risk of events: from a 16 % reduction in the risk of transient ischaemic attacks to a 62 % reduction in the incidence of type 2 diabetes. Over a lifetime, surgery led to savings of a,not sign8408 and generated an additional 0.8 years of life and 4.1 quality-adjusted life years (QALYs) per patient, which translates into gains of 32,390 quality-adjusted person-years and savings of a,not sign66 million for the cohort, operated in 2012. Analysis of the consequences of a 3-year delay in surgery provision showed that the overall lifetime cost of treatment may be increased in patients with diabetes or a body mass index > 40 kg/m(2). Delays in surgery may also lead to a loss of clinical benefits: up to 0.6 life years and 1.2 QALYs per patient over a lifetime. Bariatric surgery, over a lifetime horizon, may lead to significant cost savings to health care systems in addition to the known clinical benefits.
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| 4. |
- Borisenko, Oleg, et al.
(författare)
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Clinical Indications, Utilization, and Funding of Bariatric Surgery in Europe
- 2015
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Ingår i: Obesity Surgery. - : Springer Science and Business Media LLC. - 1708-0428 .- 0960-8923. ; 25:8, s. 1408-1416
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Tidskriftsartikel (refereegranskat)abstract
- The objective of this study was to evaluate the current utilization, the level of endorsement by professional societies, and health technology assessment bodies, as well as the reimbursement levels for bariatric surgery in European countries. We performed an analysis of the indications for bariatric surgery based on national clinical and commissioning guidelines, current utilization of surgery, characteristics of patients who underwent surgery, and reimbursement tariffs in Belgium, Denmark, England, France, Germany, Italy, and Sweden. Data were obtained from national patient registries, administrative databases, and published literature for the year 2012. Despite clear consensus outlined in clinical guidelines, significant differences were found in the eligibility criteria for surgery. Patients with no significant comorbidities were deemed eligible if they had a body mass index (BMI) of 40 or 50 kg/m(2) in Denmark. Irrespective of the country, patients with comorbidities were eligible if they had a BMI of 35 kg/m(2). The highest utilization of bariatric surgery (number of surgeries per 1 M population) was observed in Belgium (928), Sweden (761), and France (571) while Italy (128), England (117), and Germany (72) had the lowest utilization. There was a strong negative correlation between utilization and average BMI level of the patient population (r = -.909, p = 0.005). The annual per capita spending on surgery differed significantly between countries, ranging from a,not sign0.54 in Germany to a,not sign4.33 in Belgium. There are significant variations in the clinical indications, utilization, and funding of bariatric surgery in European countries.
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