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Purpose: Painful diabetic peripheral neuropathy (DPN) is a common complication in patients with diabetes. It is associated with a poor quality of life and high costs of care. This study investigated the impact of painful DPN on healthcare costs and resource utilization., Methods: This was a retrospective analysis of administrative claims of adult patients with diabetes (type 1 or 2) from Optum's de-identified Clinformatics® Data Mart Database. Patients were assigned to four cohorts by presence of DPN and pain severity, based on diagnoses and prescription patterns in a one-year baseline. All-cause and diabetes-associated costs were calculated for the year following the index DPN diagnosis. Risk factors associated with presence of severely painful DPN were evaluated., Results: Relative to those without DPN, patients who had DPN without pain, painful DPN (PDPN), or severe PDPN incurred respective increases of $3,093, $9,349, and $20,887 in average annual all-cause costs. More than half of costs from painful/severe DPN were for prescriptions and inpatient hospitalization. Severe PDPN was associated with elevated odds of diabetic amyotrophy (OR: 8.09; 95% CI: 6.84-9.56), diabetic foot ulcers (OR: 6.54, 95% CI: 6.32-6.76), and loss of mobility (OR: 2.54, 95% CI: 2.48-2.60), among other complications., Conclusions: Painful DPN is associated with higher healthcare costs and resource utilization, and a greater risk of debilitating conditions that limit quality of life. Future research should focus on better treatment options and more aggressive pain management strategies to reduce the negative impacts of DPN., Competing Interests: Compliance with ethical standards Conflict of interest N.C.G., C.N.R., and C.W. are employees of Medtronic. T.B. has no conflicts to disclose. Consent to participate Sterling IRB (Atlanta, GA) has determined that no patient consent to participate was required. Consent to publish Sterling IRB (Atlanta, GA) has determined that no patient consent to publish was required. Ethics approval This was an observational study of deidentified data. Sterling IRB (Atlanta, GA) has determined that the study is exempt from full IRB review., (© 2024. The Author(s).)

Background: Western guidelines often recommend biguanides as the first-line treatment for diabetes. However, dipeptidyl peptidase-4 (DPP-4) inhibitors, alongside biguanides, are increasingly used as the first-line therapy for type 2 diabetes (T2DM) in Japan. However, there have been few studies comparing the effectiveness of biguanides and DPP-4 inhibitors with respect to diabetes-related complications and cardio-cerebrovascular events over the long term, as well as the costs associated., Objective: We aimed to compare the outcomes of patients with T2DM who initiate treatment with a biguanide versus a DPP-4 inhibitor and the long-term costs associated., Methods: We performed a cohort study between 2012 and 2021 using a new-user design and the Shizuoka Kokuho database. Patients were included if they were diagnosed with T2DM. The primary outcome was the incidence of cardio-cerebrovascular events or mortality from the initial month of treatment; and the secondary outcomes were the incidences of related complications (nephropathy, renal failure, retinopathy, and peripheral neuropathy) and the daily cost of the drugs used. Individuals who had experienced prior events during the preceding year were excluded, and events within 6 months of the start of the study period were censored. Propensity score matching was performed to compare between two groups., Results: The matched 1:5 cohort comprised 529 and 2,116 patients who were initially treated with a biguanide or a DPP-4 inhibitor, respectively. Although there were no significant differences in the incidence of cardio-cerebrovascular events or mortality and T2DM-related complications between the two groups (p = 0.139 and p = 0.595), daily biguanide administration was significantly cheaper (mean daily cost for biguanides, 61.1 JPY; for DPP-4 inhibitors, 122.7 JPY; p<0.001)., Conclusion: In patients with T2DM who initiate pharmacotherapy, there were no differences in the long-term incidences of cardio-cerebrovascular events or complications associated with biguanide or DPP-4 use, but the former was less costly., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Nakatani et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Painful diabetic peripheral neuropathy (pDPN) is a debilitating complication of long-term diabetes. High-frequency spinal cord stimulation (HF-SCS) was recently shown to be an effective treatment option, but the associated healthcare resource utilization (HCRU) on real-world patient populations with pDPN is unknown., Methods: Using IBM MarketScan databases, we identified patients with HF-SCS implantation between January 2016 and December 2019 who had a diagnosis of diabetes or diabetic neuropathy within two years before implant. Cost data were collected for the six months before HF-SCS implantation (baseline) and for the periods of one, three, and six months post-implantation. The six-month explant rate was calculated., Results: A total of 132 patients met inclusion criteria. The median total cost at baseline was $19 220 and was $1356 at one month post-implant, $4858 at three months post-implant, and $13 305 at six months post-implant. The median baseline out-of-pocket cost was $1477 and was $710 at six months post-implant. The average total cost reduction from baseline to six months post-implant was $5118 ( P < .001), or $853 per month. The median device acquisition cost was $35 755. The explant rate within six months was 2.1%., Conclusions: High frequency spinal cord stimulation significantly reduces total HCRU in patients with pDPN, and based on the average monthly cost reduction of $853, we estimate that the therapy recoups acquisition costs within 3.5 years. As policy increasingly focuses on value-based care, it will be critical to consider the cost and outcomes of innovative therapies., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Lad is a consultant for Abbott Laboratories, Boston Scientific, Higgs Boson Health, Medtronic, Minnetronix, Nevro, and Presidio Medical.

Background: The costs and health effects associated with lower extremity complications in diabetes mellitus are an increasing burden to society. In selected patients, lower extremity nerve decompression is able to reduce symptoms of neuropathy and the concomitant risks of diabetic foot ulcers and amputations. To estimate the health and economic effects of this type of surgery, the cost-effectiveness of this intervention compared to current nonsurgical care was studied., Methods: To estimate the incremental cost-effectiveness of lower extremity nerve decompression over a 10-year period, a Markov model was developed to simulate the onset and progression of diabetic foot disease in patients with diabetes and neuropathy who underwent lower extremity nerve decompression surgery, compared to a group undergoing current nonsurgical care. Mean survival time, health-related quality of life, presence or risk of lower extremity complications, and in-hospital costs were the outcome measures assessed. Data from the Rotterdam Diabetic Foot Study were used as current care, complemented with information from international studies on the epidemiology of diabetic foot disease, resource use, and costs, to feed the model., Results: Lower extremity nerve decompression surgery resulted in improved life expectancy (88,369.5 life-years versus 86,513.6 life-years), gain of quality-adjusted life-years (67,652.5 versus 64,082.3), and reduced incidence of foot complications compared to current care (490 versus 1087). The incremental cost-effectiveness analysis was -€59,279.6 per quality-adjusted life-year gained, which is below the Dutch critical threshold of less than €80,000 per quality-adjusted life-year., Conclusions: Decompression surgery of lower extremity nerves improves survival, reduces diabetic foot complications, and is cost saving and cost-effective compared with current care, suggesting considerable socioeconomic benefit for society., (Copyright © 2021 by the American Society of Plastic Surgeons.)

Összefoglaló. Bevezetés: Az idegrendszeri károsodás az egyik leggyakrabban kialakuló komplikáció a cukorbetegek körében, mely az egyénnek és a finanszírozónak is jelentős terhet jelent. Célkitűzés: Elemzésünk célja volt a diabeteses polyneuropathia okozta epidemiológiai és egészségbiztosítási betegségteher elemzése. Adatok és módszerek: Az adatok a Nemzeti Egészségbiztosítási Alapkezelő (NEAK) finanszírozási adatbázisából származnak, és a 2018. évet fedik le. Meghatároztuk az éves betegszámokat és a 100 000 lakosra jutó igénybevételi prevalenciát, továbbá az éves egészségbiztosítási kiadásokat korcsoportos és nemenkénti bontásban és ellátási típusonként. A vizsgált kórképet a Betegségek Nemzetközi Osztályozása (10. revízió) szerinti G6320-as kóddal azonosítottuk. Eredmények: A diabeteses polyneuropathia kezelésére a NEAK 6,63 milliárd Ft (24,52 millió USD; 20,78 millió EUR) egészségbiztosítási kiadást fordított 2018-ban. E költségek legnagyobb hányadát a gyógyszerek ártámogatása adta (78,29%). A teljes népességre számolt, 100 000 főre vetített prevalencia 862/100 000 fő volt a férfiak, 981/100 000 fő a nők esetében, együtt 924/100 000 fő a járóbeteg-szakellátásban. A 65-74 évesek jelentek meg a legnagyobb számban az egyes ellátási szinteken. A nemek eloszlása között a legtöbb vizsgált korcsoport tekintetében számottevő különbség nem tapasztalható, 65 év felett azonban már jóval magasabb a nők aránya. Következtetés: A betegség előfordulási gyakorisága a nők esetében 15,6%-kal magasabb. Idősebb korban jelentősen magasabb betegszámot figyeltünk meg. A neuropathiás szövődmények elkerülése érdekében a terápiás kezelésen túl a megelőzésre is sokkal nagyobb figyelmet javasolunk fordítani. Orv Hetil. 2021; 162(Suppl 1): 38-45., Introduction: Neurological complications are the most common type of complications among type 2 diabetes mellitus patients, which put a heavy burden on both individuals and health insurance organizations., Objective: The aim of our study was to determine the epidemiological and health insurance disease burden of non-insulin-dependent diabetes with neurological complications., Data and Methods: Data were derived from the financial database of the National Health Insurance Fund Administration (NHIFA) of Hungary for the year 2018. Data analysed included annual patient numbers and prevalence of care utilisation per 100 000 population according to age groups and sex. Patients were identified with the following code of the International Classification of Diseases, 10th revision: G6320., Results: In 2018, NHIFA spent 6.63 billion HUF (24.52 million USD; 20.78 million EUR) on treating diabetic polyneuropathy. Reimbursement of pharmaceuticals was the main cost driver (78.29% of total expenditure). Based on patient numbers in outpatient care, prevalence in 100 000 population was 862 men, 981 women, together 924 people based on outpatient-care utilization. Most patients were aged between 65-74 years in all forms of care. Regarding sex, no significant differences were found among most age groups, however, the ratio of women tends to be higher above 65 years of age., Conclusion: Prevalence was found to be by 15.6% higher among women. Significantly higher patient numbers were found in old age. Besides therapeutic interventions, prevention should gain considerably more attention to avoid polyneuropathic complications. Orv Hetil. 2021; 162(Suppl 1): 38-45.

Objective: To carry out a cost-effectiveness analysis of the use of Neuropad as a screening test for diabetic neuropathy together with the standard care tool, the 10-g monofilament, in people with diabetes., Research Design and Methods: A cost-effectiveness analysis using a Markov model was developed to assess the impact on costs and outcomes of using Neuropad as a test for diabetic neuropathy (1) as a complement to the standard test, the 10-g monofilament (Neuropad + monofilament vs. monofilament); and (2) as a substitute for the monofilament (Neuropad vs. monofilament); from the healthcare provider perspective. The time horizon was 3 years. Data on costs and health gains were extracted from the literature. The incremental cost-utility ratio was calculated. Deterministic and probabilistic sensitivity analyses were also performed., Results: Compared with standard care, Neuropad, in combination with the 10-g monofilament tool, is the dominant strategy as it leads to higher health gains and lower costs. In practice, compared with using the monofilament alone, performing both tests would lead to a savings of £1049.26 per patient and 0.044 QALY gain. Results were found to be consistent across the sensitivity analyses., Conclusions: Using both screening tools (Neuropad + monofilament) is a cost-effective strategy and the dominant alternative, when compared against using the 10-g monofilament alone. The results would be of special relevance in the early detection of diabetic peripheral neuropathy and to ensure the efficient allocation of resources and, thus, the sustainability of healthcare systems.

Purpose of Review: Diabetic peripheral neuropathy eventually affects nearly 50% of adults with diabetes during their lifetime and is associated with substantial morbidity including pain, foot ulcers, and lower limb amputation. This review summarizes the epidemiology, risk factors, and management of diabetic peripheral neuropathy and related lower extremity complications., Recent Findings: The prevalence of peripheral neuropathy is estimated to be between 6 and 51% among adults with diabetes depending on age, duration of diabetes, glucose control, and type 1 versus type 2 diabetes. The clinical manifestations are variable, ranging from asymptomatic to painful neuropathic symptoms. Because of the risk of foot ulcer (25%) and amputation associated with diabetic peripheral neuropathy, aggressive screening and treatment in the form of glycemic control, regular foot exams, and pain management are important. There is an emerging focus on lifestyle interventions including weight loss and physical activity as well. The American Diabetes Association has issued multiple recommendation statements pertaining to diabetic neuropathies and the care of the diabetic foot. Given that approximately 50% of adults with diabetes will be affected by peripheral neuropathy in their lifetime, more diligent screening and management are important to reduce the complications and health care burden associated with the disease.

Background: Diabetic peripheral neuropathy (DPN) may often be painful. Despite the high prevalence of painful DPN (pDPN) among patients with diabetes mellitus (DM), understanding of its clinical and economic burden is limited. This study aimed to describe the clinical and economic burdens faced by patients with pDPN in Japan, and compared them with those experienced by patients with DPN but without painful symptoms (non-pDPN)., Methods: This retrospective, observational study used data from a large-scale, hospital-based Japanese claims database collected from April 2008 to June 2015. Comorbidities, clinical departments visited, length of hospital stay, and medical costs for the period of ± 6 months from the diagnosis of pDPN or non-pDPN were described for each group. Glycemic control status was examined for each group for patients with glycated hemoglobin data., Results: The data of 8,740 patients with pDPN (mean age 70.0 years, 53.4% male) and 12,592 patients with non-pDPN (mean age 67.7 years, 55.7% male) were analyzed. Patients with pDPN had more comorbidities than patients with non-pDPN; 48.7% and 30.9% of patients in the respective groups had 20 or more comorbidities. The median length of hospital stay was 5 days longer in patients with pDPN. The median total medical costs were higher in patients with pDPN (\517,762) than in patients with non-pDPN (\359,909). Patients with pDPN spent higher median costs for medications, but the costs for glycemic control drugs were similar in both groups. For 3,372 patients with glycated hemoglobin data, glycemic control was similar between the two groups., Conclusion: Patients with pDPN experienced greater clinical and economic burdens than patients with non-pDPN, suggesting that patients who develop pDPN may suffer not only from the complications of DM and pain, but also from other comorbid disorders.

In this paper, we propose an adaptive randomization design for Phase 2 dose-finding trials to optimize Net Present Value (NPV) for an experimental drug. We replace the traditional fixed sample size design (Patel, et al., 2012) by this new design to see if NPV from the original paper can be improved. Comparison of the proposed design to the previous design is made via simulations using a hypothetical example based on a Diabetic Neuropathic Pain Study., (Copyright © 2017 Elsevier Inc. All rights reserved.)

The objective was to perform an economic evaluation comparing spinal cord stimulation (SCS) in combination with best medical treatment (BMT) with BMT in painful diabetic peripheral neuropathy patients. Alongside a prospective 2-center randomized controlled trial, involving 36 painful diabetic peripheral neuropathy patients with severe lower limb pain not responding to conventional therapy, an economic evaluation was performed. Incremental cost-effectiveness ratios were based on: 1) societal costs and quality-adjusted life years (QALYs), and 2) direct health care costs and the number of successfully treated patients, respectively, both with a time horizon of 12 months. Bootstrap and secondary analyses were performed to address uncertainty. Total societal cost amounted to €26,539.18 versus €5,313.45 per patient in the SCS and BMT group, respectively. QALYs were .58 versus .36 and the number of successfully treated patients was 55% versus 7% for the SCS and BMT group, respectively. This resulted in incremental cost-effectiveness ratios of €94,159.56 per QALY and €34,518.85 per successfully treated patient, respectively. Bootstrap analyses showed that the probability of SCS being cost-effective ranges from 0 to 46% with willingness to pay threshold values ranging between €20,000 and €80,000 for a QALY. Secondary analyses showed that cost-effectiveness of SCS became more favorable after correcting for baseline cost imbalance between the 2 groups, extending the depreciation period of SCS material to 4 years, and extrapolation of the data up to 4 years. Although SCS was considerably more effective compared with BMT, the substantial initial investment that is required resulted in SCS not being cost-effective in the short term. Cost-effectiveness results were sensitive to baseline cost imbalances between the groups and the depreciation period of the SCS material., Perspective: Painful diabetic peripheral neuropathy is a common complication of diabetes mellitus and the humanistic and economic burden is high. This article presents the cost-effectiveness of SCS in patients suffering from painful diabetic peripheral neuropathy from a societal and health care perspective with a time horizon of 12 months., (Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.)

Background: Sustained efforts at preventing diabetic foot ulcers (DFUs) and subsequent leg amputations are sporadic in most health care systems despite the high costs associated with such complications. We sought to estimate effectiveness targets at which cost-savings (i.e. improved health outcomes at decreased total costs) might occur., Methods: A Markov model with probabilistic sensitivity analyses was used to simulate the five-year survival, incidence of foot complications, and total health care costs in a hypothetical population of 100,000 people with diabetes. Clinical event and cost estimates were obtained from previously-published trials and studies. A population without previous DFU but with 17% neuropathy and 11% peripheral artery disease (PAD) prevalence was assumed. Primary prevention (PP) was defined as reducing initial DFU incidence., Results: PP was more than 90% likely to provide cost-savings when annual prevention costs are less than $50/person and/or annual DFU incidence is reduced by at least 25%. Efforts directed at patients with diabetes who were at moderate or high risk for DFUs were very likely to provide cost-savings if DFU incidence was decreased by at least 10% and/or the cost was less than $150 per person per year., Conclusions: Low-cost DFU primary prevention efforts producing even small decreases in DFU incidence may provide the best opportunity for cost-savings, especially if focused on patients with neuropathy and/or PAD. Mobile phone-based reminders, self-identification of risk factors (ex. Ipswich touch test), and written brochures may be among such low-cost interventions that should be investigated for cost-savings potential., (Published by Elsevier Inc.)

Aim: The study was designed for comparing the efficacy and cost effectiveness of Pregabalin and Duloxetine used in Diabetic Neuropathic Pain., Methods: The prospective interventional 6 month study was conducted in a diabetic clinic of a 500 bedded tertiary care hospital in South India. The subjects having diagnosed with diabetic neuropathy and not treated with Pregabalin and Duloxetine or any other drugs of its class were selected. The data were collected using NPS and Neuro QoL questionnaires. The cost of both drugs used in the study was calculated as the mean of the price of 3 leading common brands of those drugs. The comparative efficacy was calculated by comparing the mean difference produced by both drugs in NPS and QoL scores. The cost effectiveness were calculated by ICER ratio., Results: The results have shown a significant improvement in the mean difference of NPS and Neuro QoL scores of both Pregabalin (p=<0.001) and Duloxetine (p=<0.001) before and after the therapy, the Duloxetine dominates over Pregabalin in both. The mean cost of Pregabalin for 3 months therapy was found to be INR 668.7 and that for Duloxetine was INR 756. Duloxetine showed a better effect but more expensive. ICER ratio was calculated and found that a cost of INR 61.47 per extra QoL gained by Duloxetine., Conclusion: The study have revealed that, both drugs are found to be effective.On conducting cost effective analysis, a significant better improvement in QoL of patients was obtained by Duloxetine with comparatively mild increase in the price., (Copyright © 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.)

Background: To determine the therapeutic efficacy and cost-effective of pancreatic kininogenase (PKase) on treatment of diabetic peripheral neuropathy (DPN) compared with Prostaglandin E1 (PGE1) in patients with type 2 diabetes. Methods: 104 patients with DPN receiving standard glucose control therapy were randomly assigned into 3 groups: Group-A received PKase treatment, Group-B received PGE1 treatment, and Group-C received only standard glucose control therapy. Michigan neuropathy screening instrument (MNSI) score, neurophysiology examination, and nerve conduction velocity were measured. Results: Standard glucose control therapy significantly reduced hyperglycemia to a similar level in all groups. Questionnaire grading and neurophysiology examination both indicated that no significant difference was found at the end of treatment between Groups -A and -B. Except for the ulnar nerve sensory conduction velocity that was significantly improved in Group-B, the remaining nerve conduction velocity (regardless of sensory or motor nerve conduction velocities) was improved to a similar level in Groups -A and -B. Group-A had significantly reduced questionnaire grading and better improvement in motor nerve conduction velocity of the common peroneal nerve, ulnar nerve, and sensory nerve conduction velocity of the sural nerve as compared with Group-C. However, the medical cost of PKase was only 18.9% of that of PGE1 during one course of treatment. Conclusions: PKase has the similar therapeutic efficacy as PGE1 on treatment of DPN in patients with type 2 diabetes. However, the medical cost of PKase is one fifth of that of PGE1. Thus, PKase is a cost-effective drug for treatment of DPN., (© Georg Thieme Verlag KG Stuttgart · New York.)

This study compared patient characteristics and health care costs between newly treated diabetic painful neuropathy (DPN) patients receiving mono- pharmacotherapy and those receiving combination pharmacotherapy. A retrospective cohort was developed through Inovalon's Medical Outcomes Research for Effectiveness and Economics Registry (MORE2) database. Patients included were ≥18 years on the date of first DPN prescription: tricyclic antidepressant, opioids, duloxetine, gabapentin, pregabalin, or lidocaine. The authors conducted a simple proportional hazards model comparing times to discontinuation, switch, or addon. Multiple logistic regression was used to identify predictors of combination pharmacotherapy. There were 7145 patients on mono-pharmacotherapy and 421 patients on combination pharmacotherapy. Patients receiving combination pharmacotherapy were 130% more likely to discontinue their medications than patients receiving mono-pharmacotherapy. Female patients and those with > 7 comorbidities were more likely to be started with combination pharmacotherapy. Elderly patients were less likely to be started with combination pharmacotherapy. The total cost of care difference between mono- and combination pharmacotherapy was not statistically significant (P = .66); therefore, newly treated DPN patients should add on another medication sooner than 30 days when considering combination pharmacotherapy. All first-line medications have similar efficacy; for this reason, cost should be considered in the treatment decision.

Objective: To summarize characteristics of Medicare beneficiaries with type 2 diabetes and to describe changing trends in care and outcomes., Methods: We conducted a retrospective cohort study of a nationally representative 5% sample of fee-for-service Medicare beneficiaries 65 years and older with prevalent type 2 diabetes, between January 1, 2002, and December 31, 2011. The main outcome measures were diabetes-related screening tests, mortality, hospital admissions, dialysis, and lower extremity amputation., Results: The average age of Medicare beneficiaries with diabetes was 76.5 years, 56% were women, and 83% were white. Screening practices in beneficiaries with diabetes improved from 2002 to 2011, with rising rates of foot exams, renal screening, hemoglobin A1c tests, and lipid profile tests. The prevalence of nephropathy and neuropathy increased. Although inpatient admissions declined from 2002 to 2011, diabetes-related emergency department visits increased. Amputation and end-stage renal disease remained static, while 1-year mortality declined over the study period., Conclusion: In this medically complex group of patients with high comorbidity, we observed improvements in screening practices and room for further improvement. Although the mortality rate decreased, other outcomes did not improve consistently. Health care resource has changed over time, with decreased hospital admissions and increased emergency department visits., Abbreviations: CCW = Chronic Conditions Data Warehouse ESRD = end-stage renal disease HbA1c = hemoglobin A1c HEDIS = Healthcare Effectiveness Data and Information Set ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification.

Aims: The purpose of this study was to portray the impact of comorbidities on inpatient cost and utilization in Charcot neuroarthropathy (CN) patients., Methods: Two cohorts, CN and diabetic peripheral neuropathy (DPN), were identified by ICD-9 codes in the California Office for Statewide Health Planning and Development 2009-2012 public patient discharge files. DPN and CN costs and length of stay (LOS) were compared adjusting for the number of chronic conditions. The impact of the Elixhauser comorbidity measures and other comorbidities on costs and LOS in CN subjects was evaluated., Results: CN was associated with 17.2% higher costs and 1.4 days longer LOS compared to DPN alone. Adjusting for 0.71 additional chronic conditions in CN patients accounted for 79.8% of variance and estimated a 13.9% cost difference between cohorts. Subjects averaged 4.5 Elixhauser comorbidities with higher scores corresponding to increased cost, LOS, and inpatient mortality. Other diabetic foot risk factors demonstrated that foot ulcers, foot infections, and osteomyelitis had significantly higher costs. Patients with foot ulcers, osteomyelitis, and depression had significantly increased LOS., Conclusions: Systemic and local comorbidities significantly impact the cost, utilization, and inpatient mortality in inpatient management of Charcot foot., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Aims: The aim of this study is to assess the impact of the diabetes-related complications on costs and to shed light on the potential savings that could be obtained by the National Healthcare System if better glycemic control was to be achieved in the type 1 diabetes population., Methods: Epidemiologic data were used to distribute diabetes type 1 patients into A1c levels, and the relative risk of diabetes-related complications associated with the level of A1c was extrapolated from published risk curves. The costs associated with all complications in the Italian settings, retrieved from published literature, were used to estimate the economic impact of complications in each A1c level from the NHS perspective and the potential savings that could be obtained should a treatment strategy allow to achieve better metabolic control., Results: The reduction in the number of complications translates into consistent monetary savings compared to current scenario. Within 5 years, €29 and €33 million would be saved if all patients reduced their A1c level by 1 % and within the range 7-8 % (53-64 mmol/mol), respectively., Conclusions: This work allows focusing on the impact of managing the diabetes-related complications on the overall costs, not yet reported in the literature. It was shown that the potential savings for the National Healthcare Service associated with a more effective glycemic control are substantial.

Painful diabetic neuropathy (PDN) affects nearly half of patients with diabetes. The objective of this study was to compare the cost-effectiveness of starting patients with PDN on pregabalin (PRE), duloxetine (DUL), gabapentin (GABA), or desipramine (DES) over a 10-year time horizon from the perspective of third-party payers in the United States. A Markov model was used to compare the costs (2013 $US) and effectiveness (quality-adjusted life-years [QALYs]) of first-line PDN treatments in 10,000 patients using microsimulation. Costs and QALYs were discounted at 3% annually. Probabilities and utilities were derived from the published literature. Costs were average wholesale price for drugs and national estimates for office visits and hospitalizations. One-way and probabilistic (PSA) sensitivity analyses were used to examine parameter uncertainty. Starting with PRE was dominated by DUL as DUL cost less and was more effective. Starting with GABA was extendedly dominated by a combination of DES and DUL. DES and DUL cost $23,468 and $25,979, while yielding 3.05 and 3.16 QALYs, respectively. The incremental cost-effectiveness ratio for DUL compared with DES was $22,867/QALY gained. One-way sensitivity analysis showed that the model was most sensitive to the adherence threshold and utility for mild pain. PSA showed that, at a willingness-to-pay (WTP) of $50,000/QALY, DUL was the most cost-effective option in 56.3% of the simulations, DES in 29.2%, GABA in 14.4%, and PRE in 0.1%. Starting with DUL is the most cost-effective option for PDN when WTP is greater than $22,867/QALY. Decision makers may consider starting with DUL for PDN patients.

Introduction: Painful diabetic peripheral neuropathy affects 40-50% of patients with diabetic neuropathy, leading to impaired quality of life and substantial costs. Duloxetine and pregabalin have evidence-based support, and are formally approved for controlling painful diabetic peripheral neuropathy., Methods: We used a 12-week decision model for examining painful diabetic peripheral neuropathy first-line therapy with daily doses of duloxetine 60mg or pregabalin 300mg, under the perspective of the Instituto Venezolano de los Seguros Sociales. We gathered model parameters from published literature and expert´s opinion, focusing on the magnitude of pain relief, the presence of adverse events, the possibility of withdrawal owing to intolerable adverse events or due to lack of efficacy, and the quality-adjusted life years expected in each strategy. We analyzed direct medical costs (which are expressed in Bolívares Fuertes, BsF) comprising drug acquisition besides additional care devoted to treatment of adverse events and poor pain relief. We conducted both deterministic and probabilistic sensitivity analyses., Results: Total expected costs per 1000 patients were BsF 1 046 146 (26%) lower with duloxetine than with pregabalin. Most of these savings (91%) corresponds to the difference in the acquisition’s cost of each medication. duloxetine also provided 23 more patients achieving good pain relief and a gain of about two quality-adjusted life years per 1000 treated. Model was robust to plausible changes in main parameters. Duloxetine remained the preferred option in 93.9% of the second-order Monte Carlo simulations., Conclusions: This study suggests duloxetine dominates (i.e., is more effective and lead to gains in quality-adjusted life years), remaining less costly than pregabalin for treatment of painful diabetic peripheral neuropathy.

Aims: To develop a health economic model to evaluate the cost-effectiveness of new interventions for Type 1 diabetes mellitus by their effects on long-term complications (measured through mean HbA1c ) while capturing the impact of treatment on hypoglycaemic events., Methods: Through a systematic review, we identified complications associated with Type 1 diabetes mellitus and data describing the long-term incidence of these complications. An individual patient simulation model was developed and included the following complications: cardiovascular disease, peripheral neuropathy, microalbuminuria, end-stage renal disease, proliferative retinopathy, ketoacidosis, cataract, hypoglycemia and adverse birth outcomes. Risk equations were developed from published cumulative incidence data and hazard ratios for the effect of HbA1c , age and duration of diabetes. We validated the model by comparing model predictions with observed outcomes from studies used to build the model (internal validation) and from other published data (external validation). We performed illustrative analyses for typical patient cohorts and a hypothetical intervention., Results: Model predictions were within 2% of expected values in the internal validation and within 8% of observed values in the external validation (percentages represent absolute differences in the cumulative incidence)., Conclusions: The model utilized high-quality, recent data specific to people with Type 1 diabetes mellitus. In the model validation, results deviated less than 8% from expected values., (© 2014 Research Triangle Institute d/b/a RTI Health Solutions. Diabetic Medicine © 2014 Diabetes UK.)

Aims: Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus. A systematic literature review was conducted to provide an overview of published literature in the last 10-years on the epidemiology, humanistic burden and economic burden of PDPN in Europe., Methods: A search was performed according to pre-defined strategy and review criteria in Embase, Pubmed, and conference proceedings databases from 2003 till December 2012. In total, 30 publications written in English covering the relevant patient population and topics of interest., Results: European prevalence ranges from 6% to 34% in diabetes mellitus patients. PDPN has a significant humanistic and economic impact. Patients are limited in their general functioning and their ability to sleep and often experience anxiety and depression. Not surprisingly, PDPN is associated with reduced Health-Related-Quality-of-Life (HRQoL). PDPN patients incur high health care costs due to hospitalizations and outpatient visits. In addition, the painful symptoms cause impaired work productivity. Studies suggest both humanistic and economic burden increase with higher pain severity., Conclusions: The burden from PDPN appears to be higher with increasing pain severity. More severe pain leads to a higher impairment in daily functioning, sleep and HRQoL. Higher pain intensity also leads to increasing healthcare costs and work productivity losses., (Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.)

Background: Polypharmacy or the concomitant use of three or more medications, may increase the complexity of health care and its costs., Aim: To determine the costs of polypharmacy in patients with Type 2 Diabetes Mellitus in a Mexican population sample., Patients and Methods: Analysis of health care costs in 257 patients with Type 2 Diabetes Mellitus from two family care facilities, who had at least five consultations during one year. The cost of professional care by family physicians, pharmacological care and medications were considered to calculate the total expenses. The price of medications and the number of units consumed in one year were used to determine pharmacological expenses. Medications were grouped to determine costs derived from complications and concomitant diseases. Costs were calculated in US dollars (USD)., Results: The mean cost derived from family physician fees was USD 82.32 and from pharmacy fees USD 29.37. The mean cost of medications for diabetes treatment was USD 33.31, for the management of complications USD 13.9 and for management of concomitant diseases USD 23.7, rendering a total cost of USD 70.92. Thus, the total annual care cost of a diabetic patient was USD 182.61., Conclusions: Medications represent less than 50% of total expenses of diabetic patients with polypharmacy.

Background: Anticipating and controlling drug-drug interactions (DDIs) in older patients with painful diabetic peripheral neuropaty (pDPN) presents a significant challenge to providers. The purpose of this study was to examine the impact of newly initiated pregabalin or duloxetine treatment on Medicare Advantage Prescription Drug (MAPD) plan pDPN patients' encounters with potential drug-drug interactions, the healthcare cost and utilization consequences of those interactions, and opioid utilization., Methods: Study subjects required a pregabalin or duloxetine pharmacy claim between 07/01/2008-06/30/2012 (index event), ≥1 inpatient or ≥2 outpatient medical claims with pDPN diagnosis between 01/01/2008-12/31/2012, and ≥12 months pre- and ≥6 post-index enrollment. Propensity score matching was used to balance the pregabalin and duloxetine cohorts on pre-index demographics and comorbidities. Potential DDIs were defined by Micromedex 2.0 and identified by prescription claims. Six-month post-index healthcare utilization (HCU) and costs were calculated using pharmacy and medical claims., Results: No significant differences in pre-index demographics or comorbidities were found between pregabalin subjects (n = 446) and duloxetine subjects (n = 446). Potential DDI prevalence was significantly greater (p < 0.0001) among duoxetine subjects (56.7%) than among pregabalin subjects (2.9%). There were no significant differences in HCU or costs between pregablin subjects with and without a potential DDI. By contrast, duloxetine subjects with a potential DDI had higher mean all-cause costs ($13,908 vs. $9,830; p = 0.001), more subjects with ≥1 inpatient visits (35.6% vs 25.4%; p = 0.02), and more subjects with ≥1 emergency room visits (32.8% vs. 20.7%; p = 0.005) in comparison to duloxetine subjects without a potential DDI. There was a trend toward a difference between pregabalin and duloxetine subjects in their respective pre-versus-post differences in milligrams (mg) of morphine equivalents/30 days used (60.2 mg and 176.9 mg, respectively; p = 0.058)., Conclusion: The significantly higher prevalence of potential DDIs and potential cost impact found in pDPN duloxetine users, relative to pregabalin users, underscore the importance of considering DDIs when selecting a treatment.

Aims: Diabetic peripheral neuropathy (DPN) accompanied by painful symptoms is known as painful DPN (pDPN). This study characterized healthcare resource utilization and costs in patients with DPN, pDPN, and severe pDPN relative to diabetes only., Methods: Four adult cohorts were identified from the Humedica database: type 2 diabetes without DPN (n=288,328); DPN (n=35,050); pDPN (DPN subjects with a pain score ≥1 on a 0-10 numeric rating scale; n=3449); and severe pDPN (pain scores 7-10; n=1824). Resource utilization and costs for 12-months post-diagnosis were compared for diabetes relative to the other cohorts., Results: Demographic characteristics were different across cohorts. Relative to diabetes alone, DPN, pDPN, and severe pDPN were characterized by significantly higher proportions of patients with resource utilization for all resource categories (all P<0.0001); the highest resource use generally observed for severe pDPN. Total annual direct medical costs were $6632 for diabetes only, with costs for DPN ($12,492), pDPN ($27,931), and severe pDPN ($30,755) significantly higher (all P<0.0001); outpatient costs were consistently the primary driver of total costs., Conclusions: Patients with DPN, pDPN, and severe pDPN had significantly greater healthcare resource utilization and costs than patients with diabetes only, with the highest burden associated with severe pDPN., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: To determine prior authorization (PA) impact on healthcare utilization, costs, and pharmacologic treatment patterns for painful diabetic peripheral neuropathy (pDPN) and fibromyalgia (FM)., Methods: This retrospective, observational, longitudinal cohort study used medical and pharmacy claims data. Newly diagnosed patients treated for FM or pDPN between 7/1/2007 and 12/31/2011 were included. PA and no PA groups were matched by propensity score 4:1. Medical resource utilization, direct medical and pharmacy costs, and treatment pattern differences were compared. Pre and postindex differences between PA and no PA cohorts were determined by difference in difference analysis., Results: Analysis of 2,315 FM patients (1,852 PA; 463 no PA) demonstrated greater increases in postindex all-cause costs ($197; P = 0.6673) and disease-related costs ($72; P = 0.4186) in the PA cohort. Analysis of 1,300 pDPN patients (1,040 PA; 260 no PA) demonstrated postindex all-cause cost increases of $1,155 more in the no PA cohort (P = 0.6248); disease-related costs decreased $2,809 more in the no PA cohort (P = 0.4312). Treatment patterns were similar between cohorts; opioid usage was higher in the FM PA cohort (P = 0.0082)., Conclusions: There was no evidence of statistically significant differences between PA and no PA cohorts in either FM or pDPN populations for total all-cause or disease-related costs., (© 2014 World Institute of Pain.)

Introduction: Diabetic peripheral neuropathy (DPN) is a debilitating complication of diabetes and accounts for significant morbidity by pre-disposing the foot to ulceration and lower extremity amputation. Using a large US commercial claims database, this study analyzes the drug class usage and co-morbidities associated with DPN as well as estimates the associated economic burden., Methods: Patients older than 18 and diagnosed with DPN were followed longitudinally for 2 years pre- and post-diagnosis date. Patients were analyzed for age, gender, hospital visits, ER and doctor's office visits, pharmacy claims, co-morbidities, and drug classes prescribed pre- and post-DPN diagnosis. The economic impact post-diagnosis of DPN was compared to the patients' pre-diagnosis resource use., Results: In total, 10,982 incident DPN patients were identified, with a median age of 61 years, and an equal gender distribution. Post-DPN diagnosis, there was a 20% increase in the number of patients visiting hospitals and a 46% increase in the number of visits to hospitals. Further, there was a 46% increase in the annual cost per patient associated with visits to the hospitals, emergency room (ER), doctor's office, and pharmacy claims. As per the analysis presented in this study, increase in the number of visits, cost per visit, and number of patients visiting hospitals, ER and doctor's offices added up to a 46% increase in aggregated cost associated with Medical Resource Utilization (MRU) owing to DPN, with the highest increase (60%) in costs associated with hospitalization of patients with DPN., Conclusion: This study highlights the high economic burden associated with DPN. The results indicate that resource use significantly increases post-diagnosis of DPN, which leads to an increase in costs for payers. A noticeable proportion of patients with DPN had a pain co-diagnosis signifying the need for treatments that can effectively manage painful DPN.

Objective: To describe the characteristics, treatment, and health care expenditures of Medicare Supplemental-insured patients with painful diabetic peripheral neuropathy (pDPN), post-herpetic neuralgia (PHN), or fibromyalgia., Design: Retrospective cohort study., Setting: United States clinical practice, as reflected within a database comprising administrative claims from 2.3 million older adults participating in Medicare supplemental insurance programs., Subjects: Selected patients were aged ≥65 years, continuously enrolled in medical and prescription benefits throughout years 2008 and 2009, and had ≥1 medical claim with an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code for DPN, PHN, or fibromyalgia, followed within 60 days by a medication or pain intervention procedure used in treating pDPN, PHN, or fibromyalgia during 2008-2009., Outcome Measures: Utilization of, and expenditures on, pain-related and all-cause pharmacotherapy and medical interventions in 2009., Results: The study included 25,716 patients with pDPN (mean age 75.2 years, 51.2% female), 4,712 patients with PHN (mean age 77.7 years, 63.9% female), and 25,246 patients with fibromyalgia (mean age 74.4 years, 73.0% female). Patients typically had numerous comorbidities, and many were treated with polypharmacy. Mean annual expenditures on total pain-related health care and total all-cause health care, respectively, (in 2010 USD) were: $1,632, $24,740 for pDPN; $1,403, $16,579 for PHN; and $1,635, $18,320 for fibromyalgia. In age-stratified analyses, pain-related health care expenditures decreased as age increased., Conclusions: The numerous comorbidities, polypharmacy, and magnitude of expenditures in this sample of Medicare supplemental-insured patients with pDPN, PHN, or fibromyalgia underscore the complexity and importance of appropriate management of these chronic pain patients., (Wiley Periodicals, Inc.)

Background: Structured comparison of pharmacoeconomic analyses for ACEIs and ARBs in patients with type 2 diabetic nephropathy is still lacking. This review aims to systematically review the cost-effectiveness of both ACEIs and ARBs in type 2 diabetic patients with nephropathy., Methods: A systematic literature search was performed in MEDLINE and EMBASE for the period from November 1, 1999 to Oct 31, 2011. Two reviewers independently assessed the quality of the articles included and extracted data. All cost-effectiveness results were converted to 2011 Euros., Results: Up to October 2011, 434 articles were identified. After full-text checking and quality assessment, 30 articles were finally included in this review involving 39 study settings. All 6 ACEIs studies were literature-based evaluations which synthesized data from different sources. Other 33 studies were directed at ARBs and were designed based on specific trials. The Markov model was the most common decision analytic method used in the evaluations. From the cost-effectiveness results, 37 out of 39 studies indicated either ACEIs or ARBs were cost-saving comparing with placebo/conventional treatment, such as amlodipine. A lack of evidence was assessed for valid direct comparison of cost-effectiveness between ACEIs and ARBs., Conclusion: There is a lack of direct comparisons of ACEIs and ARBs in existing economic evaluations. Considering the current evidence, both ACEIs and ARBs are likely cost-saving comparing with conventional therapy, excluding such RAAS inhibitors.

Purpose: The frequency and financial impact of potential drug-drug interactions (DDIs) and drug-condition interactions (DCIs) in patients with painful diabetic peripheral neuropathy (DPN) treated with either pregabalin or duloxetine were compared., Methods: This retrospective cohort study was conducted using a large U.S. administrative claims database. Patients selected for study inclusion had a diagnosis of DPN and were newly initiated on either pregabalin or duloxetine between July 1, 2008, and October 1, 2010. Data on potential DDIs and DCIs were collected. Health care costs were measured as the sum of gross covered payments for all medical and prescription claims incurred during the six months after the index date., Results: The study sample comprised 2499 pregabalin users and 1354 duloxetine users. Among pregabalin users, 48 (1.8%) had at least one potential pregabalin DCI; none had potential pregabalin DDIs. Among duloxetine users, 966 (71%) had at least one potential duloxetine DDI or DCI. The frequencies of potential DDIs and DCIs differed significantly between pregabalin and duloxetine users (p < 0.001). Potential duloxetine DDIs and DCIs were associated with a significant increase in mean health care costs in duloxetine users (p = 0.002). Potential pregabalin DDIs and DCIs were not associated with additional health care costs in pregabalin users., Conclusion: Among patients with painful DPN treated with either pregabalin or duloxetine, the frequency of potential duloxetine DDIs and DCIs was substantially higher than that of pregabalin. Potential DDIs and DCIs were associated with significantly increased health care costs in duloxetine users.

Objective: To characterize patient populations with favorable costs after the initiation of pregabalin for the treatment of painful diabetic peripheral neuropathy (pDPN) relative to duloxetine, gabapentin, and amitriptyline., Methods: Patients were identified from MarketScan having ≥ 1 claim for pDPN (ICD-9-CM codes 250.6 or 357.2) within 60 days of first prescription (index) for pregabalin, duloxetine, gabapentin, or amitriptyline in 2008 and continuous enrollment 12 months pre- and postindex. Pregabalin patients were propensity-score-matched to each comparator. Using cutoff values ≥ 80% proportion of days covered (PDC) and ≥ 65 years for age, pre- to postindex changes in healthcare costs were estimated for pregabalin vs. comparators., Results: Of 987 patients initiated on pregabalin, 349 matched to duloxetine; 987 to gabapentin; 276 to amitriptyline. The pre- to postindex changes in total healthcare costs were similar between cohorts: $3272 with pregabalin vs. $2290 with duloxetine (P = 0.5280); $3687 with pregabalin vs. $5498 with amitriptyline (P = 0.5863); $3869 with pregabalin vs. $4106 with gabapentin (P = 0.8303). For the high-age/high-PDC population, the pre- to postindex differences in mean total costs were significantly lower with pregabalin (P < 0.001) relative to comparators ($3573 vs. $8288 for duloxetine; $1423 vs. $3167 for gabapentin; $2285 vs. $6160 for amitriptyline)., Conclusions: The association of lower total costs among older individuals with pDPN who maintain high adherence to pregabalin therapy relative to key comparators suggests a pharmacoeconomic advantage of pregabalin in this population combined with a need for strategies promoting adherence., (© 2012 The Authors Pain Practice © 2012 World Institute of Pain.)

Tropical diabetic hand syndrome (TDHS) is an aggressive type of hand sepsis that results in significant morbidity and mortality among patients with diabetes in the tropics. This study set out to establish a protocol for the holistic management of TDHS to improve digit/hand salvage and function at AIC Kijabe Hospital. This prospective study examined the following demographics of patients presenting to the authors institution between October 2009 and September 2010 with TDHS: their sex, age, comorbidities, length of in-hospital stay, surgical and medical treatment, total cost of treatment, and immediate postdischarge outcomes. A total of 10 patients (3 men and 7 women) were presented with TDHS during the study period. Surgical procedures included a thorough debridement of the hand at initial presentation, followed by procedures aimed at preserving length and hand function, with digit or hand amputation when there was no possibility of salvage. Three hands were salvaged, without the need for an amputation; 2 of these, however, developed severe stiffness with resultant poor function. Fifty percent of the patients developed considerable disability; 3 of these patients had disabilities of the arm, shoulder, and hand, (DASH) scores of >90 at 6 months after treatment. TDHS appears to be more aggressive in some patients than in others; a multidisciplinary approach, with early involvement of the surgical team, and a radical surgical debridement are essential to improved outcomes. Although the goal of medical treatment (ie, glycemic control) is simple and easily achieved, surgical goals (salvage of limb or life, preservation of hand function) are more complex, costly, and difficult to achieve. Educating health care workers, diabetic patients, and their relatives on hand care is an important preventive measure. Diligence in taking antidiabetic medicine, early presentation, and appropriate care of TDHS are required for meaningful improvement in outcomes of patients with diabetes who develop hand sepsis in the tropics.

Objective: To estimate the cost-effectiveness of pregabalin versus usual care (UC) in the management of community-treated patients with refractory painful diabetic peripheral neuropathy (pDPN) in primary care settings (PCS) in Spain., Methods: Data was extracted from a 12-week registry study assessing costs of neuropathic pain in Spain. Pregabalin-naïve outpatients treated with UC or newly prescribed pregabalin were selected for inclusion in the cost-effectiveness analysis. Effectiveness was expressed as quality-adjusted life years (QALY) gain. Perspectives of the Spanish National Health System (NHS) and society (2006) were applied for cost calculations. Results were expressed as incremental cost-effectiveness ratio (ICER). Bootstrapping techniques (10,000 re-samples) were used to obtain the probabilistic ICER and the cost-effectiveness acceptability curve., Results: A total of 189 patients were included in the economic analysis. Compared with UC, pregabalin was associated with higher QALY gain in a period of 12-weeks; 0.0406±0.0343 versus 0.0285±0.0350 (p=0.167). Overall total costs (€1368±1229 vs. €1258±1474; p=0.587) and healthcare costs (€628±590 vs. €469±420; p=0.134) were similar for both pregabalin and UC, respectively. ICERs for pregabalin varied from €5302 (95% CI: dominant; €144,105) for total costs to €14,381 (dominant; €115,648) for healthcare costs. Probabilistic sensitivity analyses showed that 79-84% of ICERs were below the threshold of €30,000/QALY., Conclusion: This study suggests that pregabalin may be cost-effective in the management of community-treated refractory outpatients, with pDPN when compared with usual care in the primary care setting in Spain. These findings may help policy makers when making health decision in the management of diabetes in the community., (Copyright © 2012 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.)

The objective of the current study was to determine the cost-utility of pregabalin versus duloxetine for treating painful diabetic neuropathy (PDN) using a decision tree analysis. Literature searches identified clinical trials and real-world studies reporting the efficacy, tolerability, safety, adherence, opioid usage, health care utilization, and costs of pregabalin and duloxetine. The proportions of patients reported in the included studies were used to determine probabilities in the decision tree model. The base-case model included the Food and Drug Administration (FDA)-approved doses of pregabalin (300 mg/day) and duloxetine (60 mg/day), whereas "real-world" sensitivity analyses explored the effects over a range of doses (pregabalin 75-600 mg/day, duloxetine 20-120 mg/day). A 6-month time horizon and a US third-party payer perspective were chosen for the study. Outcomes from the model were expressed as cost per quality-adjusted life-year (QALY). In the base-case model, duloxetine cost less and was more effective than pregabalin (incremental cost -$187, incremental effectiveness 0.011 QALYs). Results from two real-world sensitivity analyses indicated that duloxetine cost $16,300 and $20,667 more per additional QALY than pregabalin. Using a decision tree model that incorporated both clinical trial and real-world data, duloxetine was a more cost-effective option than pregabalin in the treatment of PDN from the perspective of third-party payers.

Background: Adherence to oral antidiabetic (OAD) medications is essential in achieving glycemic control and slowing the progression of diabeties-related complications such as neuropathic pain. OAD medication adherence has been suboptimal and adding neuropathic pain medications may negatively affect adherence. However, little is known about adherence to neuropathic pain medications by patients with diabetes and how this may be related to OAD medication adherence., Objective: The objectives of our study were to: (1) describe painful diabetic peripheral neuropathy (PDPN) and OAD medication use, (2) determine if PDPN medication adherence differs among individual PDPN medications (ie, tricyclic antidepressants, gabapentin, pregabalin, and duloxetine); and (3) determine if PDPN medication adherence is related to post-index OAD medication adherence while controlling for covariates., Methods: This retrospective prescription claims database study included continuously enrolled Texas Medicaid beneficiaries who were adult (aged 30-64 years) prescribed OAD (pre- and post-index) and PDPN (post-index) medications. Data were extracted from June 1, 2003 to October 31, 2009. The main study outcome was post-index OAD medication adherence. Primary independent variables included PDPN medication adherence and PDPN medication type. Demographic and medication use characteristics served as covariates. Adherence was measured both continuously and dichotomously (80% cut-off) using medication possession ratio (MPR)., Results: The sample's (n = 4277) overall mean MPR (SD) for PDPN medications was 75.4% (23.9%). Mean MPR differed significantly among individual PDPN medications (P < 0.0001) and was highest for duloxetine (85.6% [18.2%]) and lowest for pregabalin (69.4% [24.9%]). Overall mean MPR (SD) for OAD medications decreased significantly (P < 0.0001) from 73.0% (24.3%) in the pre-index period to 64.5% (25.6%) in the post-index period. After controlling for covariates, nonadherers (ie, MPR <80%) to PDPN medications, compared with adherers (ie, MPR ≥80%), were significantly less likely to be adherent to OAD medications in the post-index period (odds ratio = 0.626; 95% CI, 0.545-0.719)., Conclusions: Overall, these data suggest that mean adherence to both PDPN and OAD medications was suboptimal (MPR <80%). Patients who were adherent to PDPN medications were more adherent to OAD medications in the post-index period, but OAD medication adherence was independent of the type of PDPN medication used. OAD adherence decreased from pre- to post-index (ie, when patients were prescribed PDPN medications), which may indicate an opportunity for practitioners to emphasize the importance of OAD adherence in reducing the progression to neuropathy., (Published by Elsevier HS Journals, Inc.)

Background: Pregabalin and duloxetine are two FDA-approved medications for the treatment of pain associated with diabetic peripheral neuropathy (pDPN). The objective of this study was to compare changes in all-cause and pDPN-related health care costs in patients with pDPN initiated on pregabalin or duloxetine., Methods: Patients at least 18 years of age initiating pregabalin or duloxetine between March 1, 2006 and December 31, 2008 were identified from a large U.S. managed care plan database. The date of the first pregabalin or duloxetine prescription was defined as the index date. Patients with claims-based evidence of pDPN and who had continuous enrollment for 6-month pre- and post-index periods were selected for study inclusion. Duloxetine patients with depression or generalized anxiety disorder (GAD) were excluded. All-cause and pDPN-related total health care costs (over 6 month pre-index and post-index periods) were analyzed with difference-in-differences (DiD) models., Results: A total of 2,136 patients (1,785 pregabalin and 351 duloxetine) were identified. No significant differences in gender, age, or pre-index Quan-Charlson comorbidity score were observed between the two cohorts. No significant differences (pregabalin vs. duloxetine) in pre-index to post-index change in mean all-cause health care costs ($1,411 vs. $1,560, P = 0.93) or mean pDPN-related health care costs ($704 vs. -$240, P = 0.22) were found. The DiD models showed no significant difference in all-cause (mean) costs attributable to pregabalin vs. duloxetine therapy between pre-index and post-index periods (mean cost ratio = 0.97, 95% CI: 0.75 to 1.26), but showed that patients receiving pregabalin had a significantly higher increase in pDPN-related costs compared with patients receiving duloxetine (mean cost ratio = 2.35, 95% CI: 1.01 to 5.46). However, the difference (pre- to post-index) in pDPN-related costs attributable to pregabalin vs. duloxetine therapy was nonsignificant (mean cost ratio = 2.30, 95% CI: 0.93 to 5.68) in a sensitivity analysis in which patients with depression and GAD were excluded from both cohorts., Conclusion: No differences were noted in all-cause costs attributable to pregabalin or duloxetine. Although patients receiving pregabalin had a significantly greater pre- to post-index increase in pDPN-related health care costs compared with patients receiving duloxetine, this may have been due to an imbalance in patient exclusion criteria between cohorts. , (© 2011 Pfizer Inc. Pain Practice © 2011 World Institute of Pain.)

A substantial body of literature is available on the natural history of diabetes, but much less is understood of the natural history of painful diabetic peripheral neuropathy (PDPN), a pervasive and costly complication of diabetes mellitus. Multiple mechanisms have been proposed, including polyol pathway activation, advanced glycosylation end-product formation, and vasculopathic changes. Nevertheless, specific treatment modalities addressing these basic issues are still lacking. The mainstay of treatment includes pharmacological management with antidepressants, anticonvulsants, and opioids, but these drugs are often limited by unfavorable side-effect profiles. For over 30 years, spinal cord stimulation (SCS) has been used extensively for the management of various chronic neuropathic pain states. In the past decade, interest in the use of SCS for treatment of PDPN has increased. This article reviews pathophysiological mechanisms of PDPN, proposed mechanisms of SCS, and the role of SCS for the treatment of PDPN.

Objective: To explore the clinical characteristics, medical costs and its influencing factors in diabetics with amputation., Methods: The data of diabetic amputation for the whole year of 2010 at 39 central municipal Class 3A hospitals all across China were retrospectively analyzed according to a unified protocol, including demographic characteristics, diabetic complications, classification of diabetic foot disease, level and prognosis of amputation and medical costs at hospitals., Results: Among them, 28.2% of all amputated patients or 39.5% of non-traumatic patients were diabetics. There were 313 males and 162 females. The average age and duration of diabetes were (66 ± 12) years and (130 ± 94) months. The level of HbA1c was 8.9% ± 2.4%. Among all amputated diabetics, the concurrent conditions included neuropathy (50.1%), peripheral artery disease (74.8%), nephropathy (28.4%) and retinopathy (25.9%). The patients with foot ulcer at Wagner 4 (50.3%) were more common. Among them, 67.5% had minor amputation with a median hospitalization stay of 33.0 (24.0 - 45.0) days and a medical cost of 26 138 (16 155 - 46 021) yuan RMB. The duration of diabetes, diabetic complications, severity and location of ulcers and amputation level influenced their hospitalization durations and medical costs., Conclusion: The patients with diabetes and amputation are elder with more chronic diabetic complications and uncontrolled hyperglycemia. Most of them have complications of local gangrene and require minor amputation at admission. Their hospital stays are longer and medical costs higher significantly correlated with diabetic complications, severity and location of foot ulcers and level of amputations.

Objective: To characterize comorbidities, pain-related pharmacotherapy, and healthcare resource use among patients with painful diabetic peripheral neuropathy (pDPN) newly prescribed pregabalin or gabapentin in clinical practice., Methods: Using the LifeLink(™) Health Plan Claims Database, patients with pDPN (ICD-9-CM codes 357.2 or 250.6) newly prescribed (index event) gabapentin (n = 1,178; 56.9 ± 10.3 years old) were identified and propensity score-matched with patients initiated on pregabalin (n = 1,178; 56.4 ± 9.8 years old). Comorbidities, pain-related pharmacotherapy, and healthcare resource use/costs were examined during the 12-month pre-index and follow-up periods., Results: Both cohorts were characterized by multiple comorbidities and substantial use of pain-related and adjunctive medications. In the pregabalin cohort, the use of tricyclic antidepressants significantly decreased (16.0% vs. 13.2%) and nonsteroidal anti-inflammatory drugs (30.8% vs. 34.8%), muscle relaxants (19.2% vs. 22.9%), anticonvulsants (14.4% vs. 18.1%), benzodiazepines (22.3% vs. 25.0%), and topical agents (7.0% vs. 9.8%) increased (P < 0.05) in the follow-up period. In the gabapentin cohort, there were significant increases (P < 0.05) in the use of short-acting (55.4% vs. 61.2%) and long-acting (9.4% to 12.8%) opioids, serotonin-norepinephrine re-uptake inhibitors (14.2% vs. 16.7%), anticonvulsants (7.1% vs. 19.2%), benzodiazepines (19.1% vs. 24.3%), sedative/hypnotics (14.9% vs. 18.0%), and tramadol (13.3% vs. 16.8%). There were significant increases (P < 0.05) in pharmacy, outpatient, and total costs in both cohorts and in costs of physician office visits in the gabapentin cohort. There was no difference in postindex median total costs between the pregabalin and gabapentin cohorts ($16,137 vs. $15,766)., Conclusions: Patients with pDPN prescribed pregabalin and gabapentin had a substantial comorbidity and pain medication burden. Although healthcare costs increased in both groups, the increase in pain medication burden was higher in the gabapentin group. Direct medical costs were similar for both groups. Given the human and economic burden of pDPN, future research may benefit from a focus on efficacy parameters to further differentiate treatment options., (© 2011 The Authors. Pain Practice © 2011 World Institute of Pain.)

Introduction: Although the American Association of Neuromuscular and Electrodiagnostic Medicine recommends that electrodiagnostic procedures should be performed by physicians with specialty training, these procedures are increasingly being performed by non-specialists., Methods: We used a nationally representative sample of Medicare beneficiaries with diabetes who used electrodiagnostic services in 2006 to examine whether specialists and non-specialists were different in the rates of identifying common neuromuscular conditions., Results: Specialists (neurologists and physiatrists) performed 62% of electrodiagnostic consultations; non-specialist physicians and non-physicians performed 31% and 5%, respectively. After adjusting for age, race/ethnicity, diabetes severity, and comorbidities, specialists were 1.26-9 times more likely than non-physicians to diagnose polyneuropathy, lumbosacral radiculopathy, cervical radiculopathy, carpal tunnel syndrome, and ulnar neuropathy. Almost 80% of electrodiagnostic studies performed by specialists included electromyography testing; fewer than 13% by non-specialists did., Conclusions: Inadequate use of electromyography and fewer specific diagnoses suggest that many non-specialists perform insufficiently comprehensive electrodiagnostic studies., (Copyright © 2011 Wiley Periodicals, Inc.)

Objective: Research has shown that painful diabetic peripheral neuropathy (pDPN) is associated with worse health outcomes. However, among pDPN patients, few studies have examined the relationship between the severity of pain and health outcomes., Design: The current project included pDPN patients (N=1506) from the 2006, 2007, and 2008 waves of the National Health and Wellness Survey., Outcome Measures: Health status (Short Form [SF]-12), work productivity (Work Productivity and Activity Impairment questionnaire), and health care resource use in the past 6 months were compared among pDPN patients with mild, moderate, and severe pain, adjusting for demographics and clinical characteristics., Results: More than half (51.2%) of the patients reported their pain as severe, 45.2% reported moderate pain, and 3.7% reported mild pain. Those with severe pain reported significantly lower levels of health status, higher levels of work and activity impairment, and higher levels of resource use relative to the other groups. Annual per-patient costs for those with severe pain were $12,856, $3927, and $16,783 for direct, indirect, and total costs, respectively. Both direct and total costs were significantly higher in this group relative to both mild and moderate pain patients., Conclusions: These results suggest that pain severity contributes substantially to the health outcomes of pDPN patients and that greater resources should be allocated to the management of patients with severe pain., (Wiley Periodicals, Inc.)

Objective: To examine the impact of medication choice between duloxetine or pregabalin on medication adherence and direct healthcare costs among patients with diabetic peripheral neuropathic pain (DPNP)., Methods: A retrospective cohort study design was used with a large US national administrative claims database. Commercially-insured DPNP patients aged 18-64 years who initiated duloxetine or pregabalin in 2006 were selected, with the first initiation date as the index date. All selected patients had 12 months continuous enrollment in the pre- and post-index periods, and were grouped into the duloxetine or pregabalin cohort based on the index agent. The duloxetine and pregabalin cohorts were constructed via propensity score stratification with similar demographics, co-morbid medical conditions, pre-index healthcare utilization and costs, and prior treatment patterns. Medication possession ratio (MPR), proportion of patients with MPR ≥ 0.8 and healthcare costs over the 12-month post-index period were compared between cohorts., Results: Both the duloxetine (n = 794) and pregabalin (n = 1779) cohorts had a mean age of 56 years, and 58% of female. Common co-morbid conditions among duloxetine and pregabalin patients were cardiovascular disease (82.5 vs. 82.2%), neuropathic pain other than DPNP (71.1 vs. 72.7%), osteoarthritis (39.0 vs. 41.3%), and low back pain (29.4 vs. 30.5%). More than 73% of the patients had opioid use prior to the initiation of duloxetine or pregabalin. Among patients with similar demographic, clinical and economic characteristics, and prior treatment patterns, duloxetine-treated patients had significantly higher MPR (0.34 vs. 0.13), higher proportion of patients with MPR ≥ 0.8 (15.5 vs. 0.7%), and significantly lower total healthcare costs ($34,146 vs. 34,897) over the 12-month post-index period than pregabalin-treated patients (all p < 0.05)., Conclusions: Commercially-insured DPNP patients initiating duloxetine had significantly higher medication adherence and lower healthcare costs than those initiating pregabalin.

Objective: To evaluate treatment patterns and costs among patients with painful diabetic peripheral neuropathy (pDPN) newly prescribed pregabalin or duloxetine in usual care settings., Methods: Using the PharMetrics® Database, patients with pDPN (ICD-9-CM codes 357.2 or 250.6x) newly prescribed pregabalin or duloxetine were identified. Patients initiated on duloxetine (n=713; mean age 55.4 ± 9.5 years) were propensity score-matched with patients initiated on pregabalin (n=713; mean age 56.3 ± 9.3 years). Prevalence of comorbidities, pain-related pharmacotherapy and healthcare resource use/costs (pharmacy, outpatient, inpatient, total) were examined during the 12 months preceding (pre-index) and following (follow-up) the date of the first pregabalin or duloxetine prescription., Results: Both cohorts had multiple comorbidities and a substantial pain medication burden. Among pregabalin patients, use of other anticonvulsants (35.6% vs. 24.7%) and tricyclic antidepressants significantly decreased (18.2% vs. 13.7%) and serotonin-norepinephrine reuptake inhibitors (SNRIs) increased (7.9 % vs. 12.9%) in the follow-up period; all P values <0.05. Among duloxetine patients, use of other SNRIs (8.7% vs. 5.2%) and selective serotonin reuptake inhibitors decreased significantly (32.1% vs. 18.9%) in the follow-up period, but there were increases for anticonvulsants (42.1% vs. 48.4%), benzodiazepines (25.5% vs. 32%), and sedative/hypnotics (22.6% vs. 25.8%); all P values <0.05. Among pregabalin and duloxetine patients there were increases (P<0.05) in pharmacy, outpatient, and total healthcare costs from the pre-index to the follow-up period. Total medication costs in the follow-up period were significantly higher for duloxetine (median $6,763 [IQR $3,970-$10,914]) relative to pregabalin (median $6,059 [IQR $3,277-$9,865]); P=0.0017., Conclusions: Patients with pDPN prescribed pregabalin and duloxetine were characterized by a substantial comorbidity and pain medication burden. Although there were no differences in total healthcare costs, medication costs were significantly higher in the duloxetine cohort relative to the pregabalin cohort., (© 2010 World Institute of Pain.)

Objective: The aim of the current study was to examine the health outcomes of patients suffering from painful diabetic peripheral neuropathy (pDPN) over a 3-year period, relative to patients with diabetes but without neuropathic pain and controls., Design: The current study included participants who completed three consecutive waves of the National Health and Wellness Survey (2006-2008). These participants were categorized into one of three groups: those with pDPN (N=290), those with diabetes but without pDPN ("diabetes without pDPN group"; N=1,037), and those not diagnosed with diabetes ("control group"; N=8,162)., Outcome Measures: Health status (Short Form-12v2), work productivity (Work Productivity and Activity Impairment Questionnaire), and resource use were examined with repeated-measures models adjusting for demographic and clinical factors., Results: The pDPN group reported significantly lower levels of physical quality of life. Moreover, physical quality of life scores for the pDPN group decreased at a significantly faster rate over a 3-year period relative to other groups. In addition, the pDPN patients reported significantly higher levels of impairment of work productivity and activity, greater resource use, and higher total 3-year per-patient costs., Conclusions: Confirming and expanding upon the literature, our results indicate a significantly worse trajectory of quality of life outcomes over time and long-term increased total costs for pDPN patients relative to non-pDPN diabetes patients and controls., (Wiley Periodicals, Inc.)

Objective: To examine the relationship between average daily dose (ADD) of duloxetine, adherence to therapy, and health-care costs among patients with diabetic peripheral neuropathic pain (DPNP)., Methods: A retrospective analysis of commercially insured DPNP patients was conducted among those aged 18 to 64 years who initiated duloxetine therapy between Ocotober 1, 2004 and December 31, 2006. The dispense date of the first duloxetine prescription was defined as the index date. All duloxetine prescriptions over the 12-month post-index period were used to assess ADD and adherence. Four study cohorts were constructed based on ADD: 30 mg, 31 to 59 mg, 60 mg; and >60 mg. High adherence was defined as having a medication possession ratio for duloxetine of ≥0.8. Health-care costs over 12-month post-index period were estimated. Multiple regression models were used to examine the association between ADD, adherence, and health-care costs., Results: The study sample included 1,351 DPNP patients (mean age: 55 years; male: 41%). Twelve percent of patients had a duloxetine ADD of 30 mg, 17% of 31 to 59 mg, 56% of 60 mg, and 15% of >60 mg. Patients with ADD of 30 mg (>60 mg) were significantly less (more) likely to adhere to duloxetine therapy compared with those in the 60 mg cohort. Controlling for cross-cohort demographic and clinical differences, patients with ADD of 30 mg, 31 to 59 mg, or >60 mg had significantly higher total health-care costs than those with ADD of 60 mg (adjusted differences: $6,090, $6,320, $6,466 for 30 mg, 31 to 59 mg, >60 mg, respectively, all P < 0.05)., Conclusion: The findings suggest that having an ADD of 60 mg for duloxetine among commercially insured DPNP patients is associated with improved medication adherence and lower health-care costs., (© 2010 The Authors. Pain Practice © 2010 World Institute of Pain.)

Objective: To examine changes in opioid use and healthcare costs among commercially insured patients with diabetic peripheral neuropathic pain (DPNP) who initiated duloxetine versus other standard of care (SOC) medications (tricyclic antidepressants, venlafaxine, gabapentin, pregabalin)., Research Design and Methods: Using an administrative claims database, patients with DPNP aged 18-64 who initiated duloxetine or SOC between March 1, 2005 and December 31, 2005 were identified. Initiation was defined as a 90-day clean period without the available study medication. Selected patients had 12 months of continuous enrollment before and after the index date, and at least one opioid dispensed in the prior 90 days. Duloxetine and SOC patients were further classified into continuous and non-continuous users based on whether the medication possession ratio was > or =0.8. Total opioid days, number of opioid prescriptions dispensed, and cumulative morphine equivalents were examined over the 12-month pre- and post-index periods. Multivariate regressions were applied to assess the changes (pre-index minus post-index) in opioid use (total, short-acting vs. long-acting) and healthcare costs, controlling for demographic and clinical characteristics., Results: The study sample included 1281 patients: 98 duloxetine continuous, 243 duloxetine non-continuous, 195 SOC continuous, and 745 SOC non-continuous users. Controlling for demographic and clinical characteristics, duloxetine non-continuous and SOC (continuous and non-continuous) patients had significantly less reduction in total opioid days (-24.4, -23.7, -18.5, respectively, all p < 0.05) from the 12-month pre-index to the post-index period than duloxetine continuous patients. Compared with duloxetine non-continuous, SOC continuous, and SOC non-continuous users, duloxetine continuous users had a greater reduction in short-acting hydrocodone use (difference between the 12 month pre-index and post-index periods) in terms of the total number of prescriptions dispensed (adjusted differences: 1.5, 1.7, 1.7, respectively, all p < 0.05), total supply days (adjusted differences: 28.1, 27.3, 29.7, respectively, all p < 0.05), and morphine equivalent dosage (adjusted differences: 1290 mg, 1132 mg, 1127 mg, respectively, all p < 0.05). Duloxetine non-continuous patients had significantly higher adjusted total ($12,729, p < 0.05) and inpatient costs ($14,993, p < 0.05) than duloxetine continuous patients., Limitations: Due to the use of a retrospective administrative claims database, this study is subject to selection bias between study cohorts, misidentification of DPNP and/or other comorbidities, and an inability to confirm adherence to therapy or assess indirect costs and costs of over-the-counter medications., Conclusions: Among commercially insured patients with DPNP, continuous treatment with duloxetine was associated with a reduction in opioid use between the 12-month pre- and post-index periods compared with treatment with SOC or non-continuous treatment with duloxetine. Duloxetine continuous patients also incurred lower subsequent healthcare costs than non-continuous duloxetine patients.

Unlabelled: Knowledge of the health care costs associated with neuropathic pain is limited. Existing studies have not directly compared the health care costs of different neuropathic pain conditions, and patients with neuropathic pain have not been compared with control subjects with the same underlying conditions (for example, diabetes). To determine health care costs associated with postherpetic neuralgia (PHN) and painful diabetic peripheral neuropathy (DPN), patients with these conditions were selected from 2 different administrative databases of health care claims and respectively matched to control subjects who had a diagnosis of herpes zoster without persisting pain or a diagnosis of diabetes without neurological complications using propensity scores for demographic and clinical factors. Total excess health care costs attributable to PHN and painful DPN and excess costs for inpatient care, outpatient/professional services, and pharmacy expenses were calculated. The results indicated that the annual excess health care costs associated with peripheral neuropathic pain in patients of all ages range from approximately $1600 to $7000, depending on the specific pain condition. Total excess health care costs associated with painful DPN were substantially greater than those associated with PHN, which might reflect the great medical comorbidity associated with DPN., Perspective: The data demonstrate that the health care costs associated with 1 peripheral neuropathic pain condition cannot be extrapolated to other neuropathic pain conditions. The results also increase understanding of the economic burden of PHN and painful DPN and provide a basis for evaluating the impact on health care costs of new interventions for their treatment and prevention., (Copyright 2010 American Pain Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Diabetic neuropathy (DN) is a common complication associated with diabetes. This study assesses the prevalence of other diabetes-related complications or comorbidities among DN patients and its marginal contribution to health care charges., Methods: Using administrative claims database, we studied commercially insured patients below 65 years old with at least one claim of DN anytime from July 2004 through June 2005 (Year 1). Using propensity scoring, a 10:1 ratio of demographically matched controls with diabetes but no DN was constructed. Both DN patients and controls had 12 months of continuous enrollment in Year 1 and Year 2 (July 2005-June 2006). We compared the Year 1 prevalence of other diabetes-associated complications or comorbidities between DN patients and diabetic controls. Controlling for comorbidities, we used multivariate regressions to examine the incremental impact of DN or any other diabetes-related complication or comorbidity on Year 2 health care charges., Results: A higher percentage of DN patients had at least one other diabetes-related complication or comorbidity than diabetic controls. Individuals with DN had a higher prevalence of each individual other diabetes-related complication or comorbidity. Controlling for comorbidities, the presence of any other diabetes-related complication or comorbidity was statistically associated with higher outpatient pharmacy and total charges for both DN patients and controls. Total and outpatient pharmacy charges were also significantly higher for DN patients than for controls, among those with or without any other diabetes-related complications or comorbidities., Conclusions: DN can occur in the absence of other diabetes-related complications or comorbidities. The presence of DN and any other diabetes-related complications or comorbidities significantly increases health care charges.

Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of lacosamide, a new agent for use as adjunctive treatment in partial-onset seizures and a potential agent for treatment of neuropathic pain., Data Sources: A MEDLINE search (1966-July 2009) was conducted using the key words lacosamide, harkoseride, SPM-927, ADD-234037, epilepsy, anticonvulsant, and neuropathic pain. Bibliographies of all articles retrieved were also reviewed., Study Selection and Data Extraction: All studies including humans and published in English with data describing lacosamide for the adjunctive treatment of partial-onset seizures and for treatment of neuropathic pain were reviewed., Data Synthesis: Lacosamide is a functionalized amino acid molecule that selectively enhances the slow inactivation of voltage-gated sodium channels and interacts with the collapsin-response mediator protein-2. With its bioavailability of approximately 100%, minimal protein binding, and few drug-drug interactions, lacosamide has a favorable pharmacokinetic profile. Recent data suggest that lacosamide may have a role as adjunctive treatment of partial-onset seizures. Open-label studies showed a 14-47% reduction in seizure frequency, while placebo-controlled trials demonstrated a 26-40% reduction in seizure frequency. The 50% responder rates ranged from 32.7% to 41.2% with varying doses of lacosamide. Although lacosamide use is not approved by the Food and Drug Administration for treatment of neuropathic pain, studies demonstrated reductions of 2.01-3.60 in pain scale scores. The most common adverse effects, occurring in greater than 10% of subjects in the clinical trials, include arthralgia, ataxia, blurred vision, diplopia, dizziness, fatigue, headache, injection site pain (only in intravenous studies), nausea, tremor, upper respiratory tract infection, and vomiting., Conclusions: Lacosamide is an effective agent for adjunctive treatment of refractory partial-onset seizures. Its exact role in the treatment of neuropathic pain needs to be determined.