International Journal of Obstetric Anesthesia, 1999
There is concern regarding the interaction of magnesium sulfate and nifedipine used concomitantly... more There is concern regarding the interaction of magnesium sulfate and nifedipine used concomitantly in obstetrical patients, because both are calcium channel antagonists and may induce myocardial depression as well as peripheral vasodilatation. The objective of this study was to determine the hemodynamic consequences of concomitant administration of nifedipine and magnesium sulfate in anesthetized pigs. Twelve pigs were anesthetized with sodium pentobarbital, intubated and mechanically ventilated. Following placement of invasive monitors, baseline hemodynamic measurements were made. Animals were randomized to one of two groups. Group I received nifedipine first, and then magnesium sulfate. Group II received magnesium sulfate first, and then nifedipine. Hemodynamic measurements were recorded. Hypotension was treated with calcium chloride, ephedrine and phenylephrine. Nifedipine alone (Group I) decreased peripheral vascular resistance and mean arterial pressure (MAP) (WO.05). Magnesium sulfate alone in group II decreased the first derivative of left ventricular pressure (LVdP/dt) and increased left ventricular end-diastolic pressure (LVEDP) (WO.05). Magnesium sulfate also decreased peripheral vascular resistance and MAP The concomitant administration of nifedipine and magnesium sulfate in both groups I and II led to a further decrease in myocardial contractility, as evidenced by a decrease in LVdPldt and increase in LVEDP (P~0.05). Treatment with calcium chloride or ephedrine was only partially successful in improving myocardial contractility. Phenylephrine increased peripheral vascular resistance and MAP, but did not improve myocardial function, In conclusion, the depressive effects of nifedipine and magnesium sulfate on the cardiovascular system are potentiated when administered concomitantly.
... measured in the presence of equimolar concentrations of phenylephrine, nor-adrenaline or 5-HT... more ... measured in the presence of equimolar concentrations of phenylephrine, nor-adrenaline or 5-HT (P >0.1; Student's ?-test), sug-gesting that phenylephrine, noradrenaline and 5-HT have similar absolute mobilities, and thus similar transport numbers (see Bradshaw et al., 1981e ...
Naunyn-Schmiedeberg's Archives of Pharmacology, 1982
The technique of microelectrophoresis was used in order to examine the effects of clonidine on si... more The technique of microelectrophoresis was used in order to examine the effects of clonidine on single neurones in the somatosensory cortex of the rat, and to compare its actions with those of noradrenaline and phenylephrine. Clonidine evoked only excitatory responses on cortical neurones. The clonidine-sensitive neurones were also excited by noradrenaline and phenylephrine. Clonidine had a consistently lower apparent potency than either noradrenaline or phenylephrine. Responses to clonidine had a slower time-course than responses to the other two adrenoceptor agonists, both the latencies to onset and the recovery times being longer for responses to clonidine than for responses to noradrenaline and phenylephrine. When the mobilities of clonidine and phenylephrine were compared using an in vitro method, no significant difference was found between the mobilities of the two ionic species, suggesting that they have similar transport numbers. Thus the difference between the potencies and time-courses of responses to clonidine and phenylephrine are presumably of biological origin. Responses to clonidine were antagonised by microelectrophoretically applied prazosin; responses to phenylephrine were equally antagonised, while responses to acetylcholine were not affected. Clonidine could reversibly antagonise excitatory responses to both noradrenaline and phenylephrine, without affecting responses to acetylcholine. The results suggest that clonidine may act as a partial agonist at excitatory alpha 1-adrenoceptors on cortical neurones.
The analgesic efficacy of EMLA cream was compared with that produced by infiltration of lignocain... more The analgesic efficacy of EMLA cream was compared with that produced by infiltration of lignocaine solution when used to provide anaesthesia for cutting of skin grafts. The study was performed as an open parallel group comparison in 80 patients. Pain felt during administration of the anaesthetic and during cutting of the graft was assessed using visual analogue and verbal rating scales. During graft cutting, the anaesthesia produced by EMLA was at least as effective as infiltration. On administration, infiltration produced varying amounts of pain in all patients, but in contrast EMLA produced no discomfort. In view of this lack of discomfort and the consequent greater freedom afforded regarding the area of donor site anaesthetised, EMLA can be considered the treatment of choice when skin grafts are harvested under local anaesthetic.
istration of patients, the management of adverse events and the cost of medication. A 3.5% discou... more istration of patients, the management of adverse events and the cost of medication. A 3.5% discount rate was used for the case of all outcomes. Monte Carlo simulation was employed to construct the 95% uncertainty intervals (UI) and to compute cost-effectiveness acceptability curve. RESULTS: The mean total QALYs estimate in the Len/Dex arm was 2.95 (95%UI: 2.75-3.14) and 2.20 (95%UI: 1.99-2.40) in the case of bortezomib, an incremental gain of 0.75 (95%UI: 0.47-1.02) QALYs. The mean total therapy cost was estimated at €76,782 (95%UI: 75,689-€77,927) and 46.380€ (95%UI: 45,719€-47,000€) for Len/Dex and Bortezomib, respectively. For both comparators, total therapy cost is mainly attributed to medication. The cost per life year gained was estimated at €35,081 (95%UI: €19,357-€73,180) and the cost per QALY gained at €42,012 (95%UI: 29,445-64,217). The probability for Len/Dex to be a cost-effective therapy option at a threshold three times the per capital income (€60,000 per QALY), was higher than 95%. Results remained constant under several one-way sensitivity analyses. CONCLUSIONS: Therefore therapy with combination of Len/Dex appears to be a cost-effective choice compared with Bortezomib alone for multiple myeloma patients in Greece.
Introduction. A five-item Self-Assessment of Treatment (SAT) was developed to assess improvement ... more Introduction. A five-item Self-Assessment of Treatment (SAT) was developed to assess improvement and satisfaction with treatment associated with the application of a novel high concentration 8% capsaicin topical patch in clinical trials in patients with postherpetic neuralgia (PHN). This study evaluated the item performance and psychometric properties of the SAT. Methods. The SAT, Brief Pain Inventory, SF-36v2, Short-Form McGill Pain Questionnaire, and Patient and Clinician Global Impression of Change (PGIC; CGIC) scores were measured in two 12-week Phase 3 clinical trials. Factor analysis assessed the underlying factor structure, followed by examination of the reliability and validity of the multi-item domain. Results. Pooled data from 698 patients completing SAT after 12 weeks of treatment were analyzed. A one-factor model combining three of the five items emerged as the optimal solution. Internal consistency reliability of this treatment efficacy factor was high (Cronbach's alpha = 0.89). Construct validity was demonstrated by moderate to high correlations with change in other study endpoints. SAT mean scores consistently discriminated between patient change groups defined by PGIC and CGIC. Conclusions. The measurement properties of the threeitem version of SAT are valid and reliable for assessment of treatment with a high concentration capsaicin patch among patients with PHN. * In Study C116, SAT Item 4 was administered with 3 response options: "No, absolutely not" (−2), "Unsure" (0), and "Yes, definitely" (2). The item was administered in Study C117 with 5 response levels as shown above.
ABSTRACT The technique of microelectrophoresis was used in order to compare the effect of phenyle... more ABSTRACT The technique of microelectrophoresis was used in order to compare the effect of phenylephrine with those of noradrenaline and dopamine on single neurones in the somatosensory cerebral cortex of the rat. Phenylephrine evoked only excitatory responses on cortical neurones. The phenylephrine-sensitive cells, however, could either be excited of depressed by noradrenaline and dopamine. Phenylephrine appeared to be more potent than either noradrenaline or dopamine in evoking excitatory responses. Responses to phenylephrine had shorter latencies to onset and longer recovery times than excitatory responses to either noradrenaline or dopamine. When the absolute mobilities of phenylephrine, noradrenaline and dopamine were compared using an in vitro method, no significant differences were found between the mobilities of the three ionic species, suggesting that the three drugs have similar transport numbers. Thus, the difference in potency between phenylephrine and the other two drugs, and the difference in the time-courses of responses to phenylephrine and the other two drugs, are presumably of biological origin. The dopamine-receptor antagonist, haloperidol, discriminated between responses to phenylephrine and noradrenaline, the response to phenylephrine being more susceptible to antagonism by haloperidol than the response to noradrenaline; excitatory responses to acetylcholine were not affected. Haloperidol also discriminated between responses to phenylephrine and dopamine, the response to dopamine being more susceptible to antagonism by haloperidol than the response to phenylephrine; failed to discriminate between responses to phenylephrine and noradrenaline: responses to both agonists were equally antagonized, while responses to acetylcholine were not affected. It is concluded that the excitatory responses of cortical neurones to phenylephrine, noradrenaline and dopamine are likely to be mediated by at least three different receptors. It is suggested that the response to phenylephrine may reflect, primarily, the activation of α1-adrenoceptors, and the response to dopamine the activation of excitatory dopamine receptors.
Exposure to capsaicin 8% patch (SAS). Bar chart of number of patients by number of capsaicin trea... more Exposure to capsaicin 8% patch (SAS). Bar chart of number of patients by number of capsaicin treatments. (DOCX 143 kb)
Are treatment benefits in neuropathic pain reflected in the self assessment of treatment question... more Are treatment benefits in neuropathic pain reflected in the self assessment of treatment questionnaire?
Journal of Current Medical Research and Opinion, 2019
Objective: To determine long-term safety and effectiveness of repeat treatments with a high conce... more Objective: To determine long-term safety and effectiveness of repeat treatments with a high concentration capsaicin patch. Methods: In this 52-week, open-label, randomized controlled study, patients with painful diabetic peripheral neuropathy (PDPN) received either capsaicin patch: (30or 60-min; 1-7 treatments to the feet) plus SOC or SOC alone. Effectiveness was assessed, by changes from baseline to end of study (EoS), in average and severity of pain, pain interference with daily function (Brief Pain Inventory-Diabetic Neuropathy version), responder rates, Patient Global Impression of Change (PGIC), and EuroQol 5-dimension (EQ-5D) questionnaire. Results: 468 patients were randomized (n=156 and n=157, 30 and 60-min respectively; SOC alone, n=155). Safety data have been reported previously. Changes in average pain from baseline to EoS (mean percentage (SD)) were: 30-min, −37.5% (32.9); 60-min, −40.8% (39.7); SOC alone, −13.9% (74.6). The difference between groups increased progressively from −17.7% and −18.6% at Month 1 for 30-and 60-min., respectively, to −21.9% and −24% at Month 12. More 30% responders occurred in the capsaicin groups (30-min, 67.3%; 60-min, 67.5%) and more felt: very much or much improved" (30-min, 24.2%; 60-min, 24.5%), compared with SOC alone (40.6% and 9.5% respectively). A greater mean improvement in EQ-5D utility index and EQ-5D visual analog scale score, from baseline to Month 12, was observed with the 30-min (0.12) and 60-min (0.15) versus SOC alone (0.07) and mean (SD), 30-min (10.4 [18.5]) and 60-min (11.2 [21.4]) versus SOC alone (5.5 [18.1]) respectively. Conclusion: Capsaicin 8% patch showed differential effectiveness over SOC alone, further increasing with repeat treatments.
Sensory and reflex testing categories at baseline and end of study (SAS). Table of absolute mean ... more Sensory and reflex testing categories at baseline and end of study (SAS). Table of absolute mean values. (DOCX 35 kb)
Sensory and reflex testing categories at baseline and end of study (capsaicin seven treatment coh... more Sensory and reflex testing categories at baseline and end of study (capsaicin seven treatment cohort). Table of absolute mean values. (DOCX 35 kb)
Change in proportion of patients reporting sensory and reflex testing categories from baseline to... more Change in proportion of patients reporting sensory and reflex testing categories from baseline to EoS (capsaicin seven treatment cohort). Bar chart of change from baseline in patients reporting category by sensory or reflex function. (DOCX 280 kb)
Proportion of patients who reported improved, unchanged, or worsened sensory reflex function by E... more Proportion of patients who reported improved, unchanged, or worsened sensory reflex function by EoS (capsaicin seven treatment cohort). Bar char of proportion of patients by sensory or reflex function. (DOCX 171 kb)
Change in proportion of patients reporting sensory and reflex testing categories from baseline to... more Change in proportion of patients reporting sensory and reflex testing categories from baseline to EoS (capsaicin seven treatment cohort). Bar chart of change from baseline in patients reporting category by sensory or reflex function. (DOCX 254 kb)
Maximum number of treatments with capsaicin 8% patch (SAS). Bar chart of number of patients by ma... more Maximum number of treatments with capsaicin 8% patch (SAS). Bar chart of number of patients by maximum number of capsaicin treatments. (DOCX 138 kb)
Use of concomitant medications at baseline and at end of study. Table of number of antidepressant... more Use of concomitant medications at baseline and at end of study. Table of number of antidepressants, antiepileptic drugs and opioids. (DOCX 33 kb)
A381 on the prevalence of the disease has led to a cost study using a "top-down" method. Sensitiv... more A381 on the prevalence of the disease has led to a cost study using a "top-down" method. Sensitivity analyses were conducted on the following cost parameters: medical and drugs costs in primary care, costs of public and private hospitalizations-chosen according to their weight in the pathway described by the Delphi Panel. Results: The social security paid a total of € 5,612,842 for 1377 AI patients in 2011. The annual cost per patient is therefore € 4,076, including 62% for primary care expenses, 29% for public hospital expenses and 9% for private hospital. The total population with AI is estimated between 26,000 and 30,000 patients, leading to a total cost ranging from € 106M and € 122M. A 1% reduction in hospital spending would generate a gain of € 430,000 to € 500,000 per year. ConClusions: Despite AI concerns few patients, significant costs are borne by Social Security. An increased compliance and a better management of symptoms such as fatigue could help optimizing this cost.
A network meta-analysis (NMA) was performed, aiming to assess the relative efficacy and tolerabil... more A network meta-analysis (NMA) was performed, aiming to assess the relative efficacy and tolerability of the capsaicin 179-mg (8% weight for weight) cutaneous patch (capsaicin 8% patch) compared with oral, centrally acting agents (ie, pregabalin, gabapentin, duloxetine, amitriptyline) in patients with painful diabetic peripheral neuropathy (PDPN). A systematic search of EMBASE/MEDLINE, Cochrane Library, and the National Health Service Centre for Reviews and Dissemination Database of Abstracts of Reviews of Effects was conducted to identify all randomized controlled trials. Data from eligible studies according to predefined inclusion and exclusion criteria were extracted, and analyses were based on aggregate-level data. Efficacy outcomes were the proportions of patients with ≥30% and ≥50% reductions in pain, and tolerability outcomes were somnolence, dizziness, nausea, diarrhea, constipation, headache, fatigue, insomnia, and rate of discontinuation due to adverse events (AEs). Data we...
International Journal of Obstetric Anesthesia, 1999
There is concern regarding the interaction of magnesium sulfate and nifedipine used concomitantly... more There is concern regarding the interaction of magnesium sulfate and nifedipine used concomitantly in obstetrical patients, because both are calcium channel antagonists and may induce myocardial depression as well as peripheral vasodilatation. The objective of this study was to determine the hemodynamic consequences of concomitant administration of nifedipine and magnesium sulfate in anesthetized pigs. Twelve pigs were anesthetized with sodium pentobarbital, intubated and mechanically ventilated. Following placement of invasive monitors, baseline hemodynamic measurements were made. Animals were randomized to one of two groups. Group I received nifedipine first, and then magnesium sulfate. Group II received magnesium sulfate first, and then nifedipine. Hemodynamic measurements were recorded. Hypotension was treated with calcium chloride, ephedrine and phenylephrine. Nifedipine alone (Group I) decreased peripheral vascular resistance and mean arterial pressure (MAP) (WO.05). Magnesium sulfate alone in group II decreased the first derivative of left ventricular pressure (LVdP/dt) and increased left ventricular end-diastolic pressure (LVEDP) (WO.05). Magnesium sulfate also decreased peripheral vascular resistance and MAP The concomitant administration of nifedipine and magnesium sulfate in both groups I and II led to a further decrease in myocardial contractility, as evidenced by a decrease in LVdPldt and increase in LVEDP (P~0.05). Treatment with calcium chloride or ephedrine was only partially successful in improving myocardial contractility. Phenylephrine increased peripheral vascular resistance and MAP, but did not improve myocardial function, In conclusion, the depressive effects of nifedipine and magnesium sulfate on the cardiovascular system are potentiated when administered concomitantly.
... measured in the presence of equimolar concentrations of phenylephrine, nor-adrenaline or 5-HT... more ... measured in the presence of equimolar concentrations of phenylephrine, nor-adrenaline or 5-HT (P >0.1; Student's ?-test), sug-gesting that phenylephrine, noradrenaline and 5-HT have similar absolute mobilities, and thus similar transport numbers (see Bradshaw et al., 1981e ...
Naunyn-Schmiedeberg's Archives of Pharmacology, 1982
The technique of microelectrophoresis was used in order to examine the effects of clonidine on si... more The technique of microelectrophoresis was used in order to examine the effects of clonidine on single neurones in the somatosensory cortex of the rat, and to compare its actions with those of noradrenaline and phenylephrine. Clonidine evoked only excitatory responses on cortical neurones. The clonidine-sensitive neurones were also excited by noradrenaline and phenylephrine. Clonidine had a consistently lower apparent potency than either noradrenaline or phenylephrine. Responses to clonidine had a slower time-course than responses to the other two adrenoceptor agonists, both the latencies to onset and the recovery times being longer for responses to clonidine than for responses to noradrenaline and phenylephrine. When the mobilities of clonidine and phenylephrine were compared using an in vitro method, no significant difference was found between the mobilities of the two ionic species, suggesting that they have similar transport numbers. Thus the difference between the potencies and time-courses of responses to clonidine and phenylephrine are presumably of biological origin. Responses to clonidine were antagonised by microelectrophoretically applied prazosin; responses to phenylephrine were equally antagonised, while responses to acetylcholine were not affected. Clonidine could reversibly antagonise excitatory responses to both noradrenaline and phenylephrine, without affecting responses to acetylcholine. The results suggest that clonidine may act as a partial agonist at excitatory alpha 1-adrenoceptors on cortical neurones.
The analgesic efficacy of EMLA cream was compared with that produced by infiltration of lignocain... more The analgesic efficacy of EMLA cream was compared with that produced by infiltration of lignocaine solution when used to provide anaesthesia for cutting of skin grafts. The study was performed as an open parallel group comparison in 80 patients. Pain felt during administration of the anaesthetic and during cutting of the graft was assessed using visual analogue and verbal rating scales. During graft cutting, the anaesthesia produced by EMLA was at least as effective as infiltration. On administration, infiltration produced varying amounts of pain in all patients, but in contrast EMLA produced no discomfort. In view of this lack of discomfort and the consequent greater freedom afforded regarding the area of donor site anaesthetised, EMLA can be considered the treatment of choice when skin grafts are harvested under local anaesthetic.
istration of patients, the management of adverse events and the cost of medication. A 3.5% discou... more istration of patients, the management of adverse events and the cost of medication. A 3.5% discount rate was used for the case of all outcomes. Monte Carlo simulation was employed to construct the 95% uncertainty intervals (UI) and to compute cost-effectiveness acceptability curve. RESULTS: The mean total QALYs estimate in the Len/Dex arm was 2.95 (95%UI: 2.75-3.14) and 2.20 (95%UI: 1.99-2.40) in the case of bortezomib, an incremental gain of 0.75 (95%UI: 0.47-1.02) QALYs. The mean total therapy cost was estimated at €76,782 (95%UI: 75,689-€77,927) and 46.380€ (95%UI: 45,719€-47,000€) for Len/Dex and Bortezomib, respectively. For both comparators, total therapy cost is mainly attributed to medication. The cost per life year gained was estimated at €35,081 (95%UI: €19,357-€73,180) and the cost per QALY gained at €42,012 (95%UI: 29,445-64,217). The probability for Len/Dex to be a cost-effective therapy option at a threshold three times the per capital income (€60,000 per QALY), was higher than 95%. Results remained constant under several one-way sensitivity analyses. CONCLUSIONS: Therefore therapy with combination of Len/Dex appears to be a cost-effective choice compared with Bortezomib alone for multiple myeloma patients in Greece.
Introduction. A five-item Self-Assessment of Treatment (SAT) was developed to assess improvement ... more Introduction. A five-item Self-Assessment of Treatment (SAT) was developed to assess improvement and satisfaction with treatment associated with the application of a novel high concentration 8% capsaicin topical patch in clinical trials in patients with postherpetic neuralgia (PHN). This study evaluated the item performance and psychometric properties of the SAT. Methods. The SAT, Brief Pain Inventory, SF-36v2, Short-Form McGill Pain Questionnaire, and Patient and Clinician Global Impression of Change (PGIC; CGIC) scores were measured in two 12-week Phase 3 clinical trials. Factor analysis assessed the underlying factor structure, followed by examination of the reliability and validity of the multi-item domain. Results. Pooled data from 698 patients completing SAT after 12 weeks of treatment were analyzed. A one-factor model combining three of the five items emerged as the optimal solution. Internal consistency reliability of this treatment efficacy factor was high (Cronbach's alpha = 0.89). Construct validity was demonstrated by moderate to high correlations with change in other study endpoints. SAT mean scores consistently discriminated between patient change groups defined by PGIC and CGIC. Conclusions. The measurement properties of the threeitem version of SAT are valid and reliable for assessment of treatment with a high concentration capsaicin patch among patients with PHN. * In Study C116, SAT Item 4 was administered with 3 response options: "No, absolutely not" (−2), "Unsure" (0), and "Yes, definitely" (2). The item was administered in Study C117 with 5 response levels as shown above.
ABSTRACT The technique of microelectrophoresis was used in order to compare the effect of phenyle... more ABSTRACT The technique of microelectrophoresis was used in order to compare the effect of phenylephrine with those of noradrenaline and dopamine on single neurones in the somatosensory cerebral cortex of the rat. Phenylephrine evoked only excitatory responses on cortical neurones. The phenylephrine-sensitive cells, however, could either be excited of depressed by noradrenaline and dopamine. Phenylephrine appeared to be more potent than either noradrenaline or dopamine in evoking excitatory responses. Responses to phenylephrine had shorter latencies to onset and longer recovery times than excitatory responses to either noradrenaline or dopamine. When the absolute mobilities of phenylephrine, noradrenaline and dopamine were compared using an in vitro method, no significant differences were found between the mobilities of the three ionic species, suggesting that the three drugs have similar transport numbers. Thus, the difference in potency between phenylephrine and the other two drugs, and the difference in the time-courses of responses to phenylephrine and the other two drugs, are presumably of biological origin. The dopamine-receptor antagonist, haloperidol, discriminated between responses to phenylephrine and noradrenaline, the response to phenylephrine being more susceptible to antagonism by haloperidol than the response to noradrenaline; excitatory responses to acetylcholine were not affected. Haloperidol also discriminated between responses to phenylephrine and dopamine, the response to dopamine being more susceptible to antagonism by haloperidol than the response to phenylephrine; failed to discriminate between responses to phenylephrine and noradrenaline: responses to both agonists were equally antagonized, while responses to acetylcholine were not affected. It is concluded that the excitatory responses of cortical neurones to phenylephrine, noradrenaline and dopamine are likely to be mediated by at least three different receptors. It is suggested that the response to phenylephrine may reflect, primarily, the activation of α1-adrenoceptors, and the response to dopamine the activation of excitatory dopamine receptors.
Exposure to capsaicin 8% patch (SAS). Bar chart of number of patients by number of capsaicin trea... more Exposure to capsaicin 8% patch (SAS). Bar chart of number of patients by number of capsaicin treatments. (DOCX 143 kb)
Are treatment benefits in neuropathic pain reflected in the self assessment of treatment question... more Are treatment benefits in neuropathic pain reflected in the self assessment of treatment questionnaire?
Journal of Current Medical Research and Opinion, 2019
Objective: To determine long-term safety and effectiveness of repeat treatments with a high conce... more Objective: To determine long-term safety and effectiveness of repeat treatments with a high concentration capsaicin patch. Methods: In this 52-week, open-label, randomized controlled study, patients with painful diabetic peripheral neuropathy (PDPN) received either capsaicin patch: (30or 60-min; 1-7 treatments to the feet) plus SOC or SOC alone. Effectiveness was assessed, by changes from baseline to end of study (EoS), in average and severity of pain, pain interference with daily function (Brief Pain Inventory-Diabetic Neuropathy version), responder rates, Patient Global Impression of Change (PGIC), and EuroQol 5-dimension (EQ-5D) questionnaire. Results: 468 patients were randomized (n=156 and n=157, 30 and 60-min respectively; SOC alone, n=155). Safety data have been reported previously. Changes in average pain from baseline to EoS (mean percentage (SD)) were: 30-min, −37.5% (32.9); 60-min, −40.8% (39.7); SOC alone, −13.9% (74.6). The difference between groups increased progressively from −17.7% and −18.6% at Month 1 for 30-and 60-min., respectively, to −21.9% and −24% at Month 12. More 30% responders occurred in the capsaicin groups (30-min, 67.3%; 60-min, 67.5%) and more felt: very much or much improved" (30-min, 24.2%; 60-min, 24.5%), compared with SOC alone (40.6% and 9.5% respectively). A greater mean improvement in EQ-5D utility index and EQ-5D visual analog scale score, from baseline to Month 12, was observed with the 30-min (0.12) and 60-min (0.15) versus SOC alone (0.07) and mean (SD), 30-min (10.4 [18.5]) and 60-min (11.2 [21.4]) versus SOC alone (5.5 [18.1]) respectively. Conclusion: Capsaicin 8% patch showed differential effectiveness over SOC alone, further increasing with repeat treatments.
Sensory and reflex testing categories at baseline and end of study (SAS). Table of absolute mean ... more Sensory and reflex testing categories at baseline and end of study (SAS). Table of absolute mean values. (DOCX 35 kb)
Sensory and reflex testing categories at baseline and end of study (capsaicin seven treatment coh... more Sensory and reflex testing categories at baseline and end of study (capsaicin seven treatment cohort). Table of absolute mean values. (DOCX 35 kb)
Change in proportion of patients reporting sensory and reflex testing categories from baseline to... more Change in proportion of patients reporting sensory and reflex testing categories from baseline to EoS (capsaicin seven treatment cohort). Bar chart of change from baseline in patients reporting category by sensory or reflex function. (DOCX 280 kb)
Proportion of patients who reported improved, unchanged, or worsened sensory reflex function by E... more Proportion of patients who reported improved, unchanged, or worsened sensory reflex function by EoS (capsaicin seven treatment cohort). Bar char of proportion of patients by sensory or reflex function. (DOCX 171 kb)
Change in proportion of patients reporting sensory and reflex testing categories from baseline to... more Change in proportion of patients reporting sensory and reflex testing categories from baseline to EoS (capsaicin seven treatment cohort). Bar chart of change from baseline in patients reporting category by sensory or reflex function. (DOCX 254 kb)
Maximum number of treatments with capsaicin 8% patch (SAS). Bar chart of number of patients by ma... more Maximum number of treatments with capsaicin 8% patch (SAS). Bar chart of number of patients by maximum number of capsaicin treatments. (DOCX 138 kb)
Use of concomitant medications at baseline and at end of study. Table of number of antidepressant... more Use of concomitant medications at baseline and at end of study. Table of number of antidepressants, antiepileptic drugs and opioids. (DOCX 33 kb)
A381 on the prevalence of the disease has led to a cost study using a "top-down" method. Sensitiv... more A381 on the prevalence of the disease has led to a cost study using a "top-down" method. Sensitivity analyses were conducted on the following cost parameters: medical and drugs costs in primary care, costs of public and private hospitalizations-chosen according to their weight in the pathway described by the Delphi Panel. Results: The social security paid a total of € 5,612,842 for 1377 AI patients in 2011. The annual cost per patient is therefore € 4,076, including 62% for primary care expenses, 29% for public hospital expenses and 9% for private hospital. The total population with AI is estimated between 26,000 and 30,000 patients, leading to a total cost ranging from € 106M and € 122M. A 1% reduction in hospital spending would generate a gain of € 430,000 to € 500,000 per year. ConClusions: Despite AI concerns few patients, significant costs are borne by Social Security. An increased compliance and a better management of symptoms such as fatigue could help optimizing this cost.
A network meta-analysis (NMA) was performed, aiming to assess the relative efficacy and tolerabil... more A network meta-analysis (NMA) was performed, aiming to assess the relative efficacy and tolerability of the capsaicin 179-mg (8% weight for weight) cutaneous patch (capsaicin 8% patch) compared with oral, centrally acting agents (ie, pregabalin, gabapentin, duloxetine, amitriptyline) in patients with painful diabetic peripheral neuropathy (PDPN). A systematic search of EMBASE/MEDLINE, Cochrane Library, and the National Health Service Centre for Reviews and Dissemination Database of Abstracts of Reviews of Effects was conducted to identify all randomized controlled trials. Data from eligible studies according to predefined inclusion and exclusion criteria were extracted, and analyses were based on aggregate-level data. Efficacy outcomes were the proportions of patients with ≥30% and ≥50% reductions in pain, and tolerability outcomes were somnolence, dizziness, nausea, diarrhea, constipation, headache, fatigue, insomnia, and rate of discontinuation due to adverse events (AEs). Data we...
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