Cost-effectiveness of nonsteroidal anti-inflammatory drugs and opioids in the treatment of knee osteoarthritis in older patients with multiple comorbidities.

OBJECTIVE: To evaluate long-term clinical and economic outcomes of naproxen, ibuprofen, celecoxib or tramadol for OA patients with cardiovascular disease (CVD) and diabetes. DESIGN: We used the Osteoarthritis Policy Model to examine treatment with these analgesics after standard of care (SOC) - acetaminophen and corticosteroid injections - failed to control pain. NSAID regimens were evaluated with and without proton pump inhibitors (PPIs). We evaluated over-the-counter (OTC) regimens where available. Estimates of treatment efficacy (pain reduction, occurring in ∼57% of patients on all regimens) and toxicity (major cardiac or gastrointestinal toxicity or fractures, risk ranging from 1.09% with celecoxib to 5.62% with tramadol) were derived from published literature. Annual costs came from Red Book Online(®). Outcomes were discounted at 3%/year and included costs, quality-adjusted life expectancy, and incremental cost-effectiveness ratios (ICERs). Key input parameters were varied in sensitivity analyses. RESULTS: Adding ibuprofen to SOC was cost saving, increasing QALYs by 0.07 while decreasing cost by $800. Incorporating OTC naproxen rather than ibuprofen added 0.01 QALYs and increased costs by $300, resulting in an ICER of $54,800/QALY. Using prescription naproxen with OTC PPIs led to an ICER of $76,700/QALY, while use of prescription naproxen with prescription PPIs resulted in an ICER of $252,300/QALY. Regimens including tramadol or celecoxib cost more but added fewer QALYs and thus were dominated by several of the naproxen-containing regimens. CONCLUSIONS: In patients with multiple comorbidities, naproxen- and ibuprofen-containing regimens are more effective and cost-effective in managing OA pain than opioids, celecoxib or SOC.

Migraine-related healthcare resource use and costs for subjects prescribed fixed-dose combination sumatriptan/naproxen sodium vs. single-entity oral triptans in a managed care population in the USA.

BACKGROUND: Randomized clinical trials have demonstrated that the efficacy of a fixed-dose single-tablet combination containing sumatriptan and naproxen sodium (S/NS) was greater than either of its individual components. Simplifying drug regimens (e.g., via a fixed-dose combination) has been shown to improve "real-world" outcomes by reducing pill burden and treatment regimen complexity, improving adherence, and reducing healthcare resource use and associated costs; however, no studies assessing such outcomes have been conducted to date for the acute treatment of migraine. OBJECTIVE: To assess migraine-related healthcare resource use and associated costs for subjects prescribed S/NS vs. subjects prescribed single-entity oral triptans (SOTs) within a managed care population in the USA. METHODS: In this retrospective analysis of administrative claims data from July 1, 2008 to December 31, 2009 (IMS LifeLink), subjects meeting the following criteria were selected: one or more pharmacy claim(s) for either S/NS or SOT (index date), aged 18-64 years; at least one migraine diagnosis, and continuous enrollment in the 6 months prior to and post the index date. The study population was subsequently stratified for two analyses: triptan-naïve (triptan naïve in the 6-month period prior to the index date) and triptan-switch (triptan user in the 6-month period prior to the index date and switching to another triptan). Subjects prescribed S/NS were propensity-score matched with subjects prescribed SOT (triptan-naïve analysis: 1:3; triptan-switch analysis: 1:1) to assess differences in healthcare resource use and associated costs (2009 US$) between the S/NS and SOT groups. RESULTS: Results from the triptan-naïve and triptan-switch analyses suggest that subjects prescribed S/NS are likely to have similar healthcare resource use patterns as those either newly initiated on an SOT or switching SOTs, as measured by migraine medication use, migraine-related healthcare resource use, and all-cause healthcare resource use. One exception was the observed increased use of opioids in the SOT group compared with the S/NS group (change in mean number of tablets pre-index vs. post-index, S/NS vs. SOT; triptan-naïve analysis: 8.6 vs.18.3, p = 0.045; triptan-switch analysis: -8.2 vs. 17.7; p = 0.120). Total costs from the triptan-naïve analysis indicated that the S/NS group had lower migraine-related (US$744 vs. US$820; p = 0.067) and all-cause healthcare costs (US$4,391 vs. US$4,870; p = 0.040) when compared with the SOT group, driven by savings in medical costs (migraine-related: US$252 vs. US$380; p = 0.001; all-cause: US$3,023 vs. US$3,599; p = 0.014). However, no significant differences were observed for total costs from the triptan-switch analysis (migraine-related healthcare costs, S/NS vs. SOT: US$1,159 vs. US$1,117; p = 0.929; all-cause healthcare costs: US$5,128 vs. US$4,788; p = 0.381). CONCLUSION: Study results suggest similar healthcare resource use patterns and associated costs when comparing S/NS and SOT across a triptan-naïve and triptan-experienced population. While the current study focuses on direct medical costs, future studies should extend beyond such a perspective to explore functional status, productivity, and health-related quality of life and satisfaction, attributes not captured in administrative claims data, but nonetheless important treatment goals.

US-Based Drug Cost Parameter Estimation for Economic Evaluations.

INTRODUCTION: In the United States, more than 10% of national health expenditures are for prescription drugs. Assessing drug costs in US economic evaluation studies is not consistent, as the true acquisition cost of a drug is not known by decision modelers. Current US practice focuses on identifying one reasonable drug cost and imposing some distributional assumption to assess uncertainty. METHODS: We propose a set of Rules based on current pharmacy practice that account for the heterogeneity of drug product costs. The set of products derived from our Rules, and their associated costs, form an empirical distribution that can be used for more realistic sensitivity analyses and create transparency in drug cost parameter computation. The Rules specify an algorithmic process to select clinically equivalent drug products that reduce pill burden, use an appropriate package size, and assume uniform weighting of substitutable products. Three diverse examples show derived empirical distributions and are compared with previously reported cost estimates. RESULTS: The shapes of the empirical distributions among the 3 drugs differ dramatically, including multiple modes and different variation. Previously published estimates differed from the means of the empirical distributions. Published ranges for sensitivity analyses did not cover the ranges of the empirical distributions. In one example using lisinopril, the empirical mean cost of substitutable products was $444 (range = $23-$953) as compared with a published estimate of $305 (range = $51-$523). CONCLUSIONS: Our Rules create a simple and transparent approach to creating cost estimates of drug products and assessing their variability. The approach is easily modified to include a subset of, or different weighting for, substitutable products. The derived empirical distribution is easily incorporated into 1-way or probabilistic sensitivity analyses.

Efficiency of naproxen/esomeprazole in association for osteoarthrosis treatment in Spain.

OBJECTIVE: To assess, from the perspective of the National Healthcare System, the efficiency of a fixed-dose combination of naproxen and esomeprazole (naproxen/esomeprazole) in the treatment of osteoarthritis (OA) compared to other NSAID, alone or in combination with a proton pump inhibitor (PPI). METHODS: A Markov model was used; it included different health states defined by gastrointestinal (GI) events: dyspepsia, symptomatic or complicated ulcer; or cardiovascular (CV) events: myocardial infarction, stroke or heart failure. The model is similar to the one used by NICE in its NSAID evaluation of OA published in 2008. The total costs (€, 2012), including drug and event-related costs, and the health outcomes expressed in quality-adjusted life years (QALY) were estimated in patients with increased GI risk, aged 65 or over, for a 1-year time horizon and a 6-month treatment with celecoxib (200mg/day), celecoxib+PPI, diclofenac (150mg/day)+PPI, etoricoxib (60mg/day), etoricoxib+PPI, ibuprofen (1,800mg/day)+PPI, naproxen (1,000mg/day)+PPI or naproxen/esomeprazole (naproxen 1,000mg/esomeprazole 40mg/day). The selected PPI was omeprazole (20mg/day). RESULTS: Naproxen/esomeprazole was a dominant strategy (more effective and less costly) compared to celecoxib, etoricoxib and diclofenac+PPI. Celecoxib+PPI and etoricoxib+PPI were more effective. Considering a cost-effectiveness threshold of €30,000 per additional QALY, naproxen/esomeprazole was cost-effective compared to ibuprofen+PPI and naproxen+PPI with incremental cost-effectiveness ratios (ICER) of €15,154 and €5,202 per additional QALY, respectively. CONCLUSIONS: A fixed-dose combination of naproxen and esomeprazole is a cost-effective, and even dominant, alternative compared to other options in OA patients with increased GI risk.

Cost-effectiveness of duloxetine in chronic low back pain: a Quebec societal perspective.

STUDY DESIGN: Cost-effectiveness model from a Quebec societal perspective using meta-analyses of clinical trials. OBJECTIVE: To evaluate the cost-effectiveness of duloxetine in chronic low back pain (CLBP) compared with other post-first-line oral medications. SUMMARY OF BACKGROUND DATA: Duloxetine has recently received a CLBP indication in Canada. The cost-effectiveness of duloxetine and other oral medications has not previously been evaluated for CLBP. METHODS: A Markov model was created on the basis of the economic model documented in the 2008 osteoarthritis clinical guidelines of the National Institute for Health and Clinical Excellence. Treatment-specific utilities were estimated via a meta-analysis of CLBP clinical trials and a transfer-to-utility regression estimated from duloxetine CLBP trial data. Adverse event rates of comparator treatments were taken from the National Institute for Health and Clinical Excellence model or estimated by a meta-analysis of clinical trials in osteoarthritis using a maximum-likelihood simulation technique. Costs were developed primarily from Quebec and Ontario public sources as well as the published literature and expert opinion. The 6 comparators were celecoxib, naproxen, amitriptyline, pregabalin, hydromorphone, and oxycodone. Subgroup analyses and 1-way and probabilistic sensitivity analyses were performed. RESULTS: In the base case, naproxen, celecoxib, and duloxetine were on the cost-effectiveness frontier, with naproxen the least expensive medication, celecoxib with an incremental cost-effectiveness ratio of $19,881, and duloxetine with an incremental cost-effectiveness ratio of $43,437. Other comparators were dominated. Key drivers included the rates of cardiovascular and gastrointestinal adverse events and proton pump inhibitor usage. In subgroup analysis, the incremental cost-effectiveness ratio for duloxetine fell to $21,567 for a population 65 years or older and to $18,726 for a population at higher risk of cardiovascular and gastrointestinal adverse events. CONCLUSION: The model estimates that duloxetine is a moderately cost-effective treatment for CLBP, becoming more cost-effective for populations older than 65 years or at greater risk of cardiovascular and gastrointestinal events. LEVEL OF EVIDENCE: 1.

NMR spectrometry isotopic fingerprinting: a tool for the manufacturer for tracking active pharmaceutical ingredients from starting materials to final medicines.

In the frame of increasingly stringent quality assessment required by the regulators, the pharmaceutical industry has to face increasingly sophisticated counterfeiting practices. Counterfeits based on deliberate copying of processes or on the infringement of current patents for generic medicines are not straightforward to detect, unless the molecular probe is the active molecule itself. In this context, impurity profiling is limited. A tool based on the determination of intramolecular isotopic profiles has been developed to provide manufacturers of APIs (Active Pharmaceutical Ingredients) with a new solution to meet this double requirement. Stable isotope analyses by NMR gives direct access to site-specific isotope content at natural abundance. In this report, it is shown how both ²H and ¹³C NMR spectrometry can provide complementary and valuable information that could be applied to link APIs to their manufacturing source. Isotopic ¹³C NMR offers additional benefits over ²H NMR in using robust adiabatic polarization transfer methods, leading to a tremendous reduction in experimental time. Two approaches are illustrated. Firstly, the use of ²H and single pulse ¹³C NMR spectra obtained on 20 commercial ibuprofen samples from different origins show that this combined strategy leads to (i) a unique intramolecular isotope identification and (ii) a preliminary classification of the samples according to the synthetic pathways of the main industrial processes. An approach employing polarization transfer methods applied to 11 commercial naproxen samples, for which ²H and single pulse ¹³C NMR spectra are not exploitable and/or are not accessible in reasonable time. The relative and partial intramolecular ¹³C distribution obtained on naproxen by applying this methodology is sufficiently informative to allow the same conclusions as for ibuprofen. The additional benefits that these approaches should bring to API manufacturers are discussed.

Cost analysis of flavocoxid compared to naproxen for management of mild to moderate OA.

OBJECTIVE: Flavocoxid is a medical food used for the clinical dietary management of osteoarthritis (OA). The acquisition cost of flavocoxid is higher than most traditional, generic NSAIDs. However, flavocoxid may have more favorable gastrointestinal (GI) toxicity resulting in lower overall costs. These costs have not been previously examined. This study provides a decision analytic model to assess the net costs of using flavocoxid for OA from a Medicare perspective. RESEARCH DESIGN AND METHODS: A decision model was developed to estimate the total costs associated with flavocoxid versus naproxen for the management of Medicare patients with mild to moderate OA. Probabilities were obtained from literature and expert opinion, and costs were obtained from Medicare. Sensitivity analyses were conducted by varying probabilities and costs within clinically relevant ranges. RESULTS: The base case resulted in flavocoxid having lower total annual costs ($1482 per patient) compared to naproxen ($1592). Flavocoxid remained the lowest cost option when the cost inputs were varied by 25% (above and below the base case), and when the probability of GI events with flavocoxid were varied by 25%. However, when GI rates from the literature and implied relative risks from the expert panel were used, or if the cost of PPIs was $0, then naproxen was the less costly alternative, though saving less than the annual cost of flavocoxid. Key limitations were the limited outcomes in the model (only GI events), lack of consideration of adherence or combination therapy, and the reliance on expert opinion due to a lack of data for flavocoxid. CONCLUSIONS: In patients over 65 years of age who suffer from mild to moderate OA, flavocoxid may result in lower overall costs, despite a higher acquisition cost. Managed care organizations should consider total health care costs in the decision to include flavocoxid as a covered benefit.

Cost effectiveness of etoricoxib versus celecoxib and non-selective NSAIDS in the treatment of ankylosing spondylitis.

To evaluate the cost effectiveness of etoricoxib (90 mg/day) relative to celecoxib (200 or 400 mg/day), and the non-selective NSAIDs naproxen (1000 mg/day) and diclofenac (150 mg/day) in the initial treatment of ankylosing spondylitis (AS) from the UK NHS perspective. A Bayesian cost-effectiveness model was developed to estimate the costs and benefits associated with initiating AS treatment with etoricoxib, celecoxib, diclofenac or naproxen. Efficacy, safety and medical resource and cost data were obtained from the literature. The obtained efficacy estimates were synthesized with a mixed treatment comparison meta-analysis. Treatment benefit and degree of disease activity, as reflected with Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, were related to QALYs and AS-specific costs (related to BASDAI). Other cost outcomes related to drug acquisition, and gastrointestinal and cardiovascular safety. Uncertainty in the source data was translated into uncertainty in cost-effectiveness estimates and therefore decision uncertainty. Costs and outcomes were discounted at 3.5% per annum. There was a >98% probability that treatment with etoricoxib results in greater QALYs than the other interventions. Over a 30-year time horizon, starting AS treatment with etoricoxib was associated with about 0.4 more QALYs than the other interventions. At 2 years there was a 77% probability that etoricoxib had the lowest cost. This increased to >99% at 30 years. Etoricoxib is expected to save 13 620 UK pounds (year 2007 values) relative to celecoxib (200/400 mg), 9957 UK pounds relative to diclofenac and 9863 UK pounds relative to naproxen. For a willingness-to-pay ceiling ratio of 20 000 UK pounds per QALY, there was a >97% probability that etoricoxib was the most cost-effective treatment. Additional analysis with different assumptions, including celecoxib 200 mg, and ignoring cost-offsets associated with improvements in disease activity, supported these findings. This economic evaluation suggests that, from the UK NHS perspective, etoricoxib is the most cost-effective initial NSAID treatment for AS patients.

An economic model of long-term use of celecoxib in patients with osteoarthritis.

BACKGROUND: Previous evaluations of the cost-effectiveness of the cyclooxygenase-2 selective inhibitor celecoxib (Celebrex, Pfizer Inc, USA) have produced conflicting results. The recent controversy over the cardiovascular (CV) risks of rofecoxib and other coxibs has renewed interest in the economic profile of celecoxib, the only coxib now available in the United States. The objective of our study was to evaluate the long-term cost-effectiveness of celecoxib compared with nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in a population of 60-year-old osteoarthritis (OA) patients with average risks of upper gastrointestinal (UGI) complications who require chronic daily NSAID therapy. METHODS: We used decision analysis based on data from the literature to evaluate cost-effectiveness from a modified societal perspective over patients' lifetimes, with outcomes expressed as incremental costs per quality-adjusted life-year (QALY) gained. Sensitivity tests were performed to evaluate the impacts of advancing age, CV thromboembolic event risk, different analytic horizons and alternate treatment strategies after UGI adverse events. RESULTS: Our main findings were: 1) the base model incremental cost-effectiveness ratio (ICER) for celecoxib versus nsNSAIDs was $31,097 per QALY; 2) the ICER per QALY was $19,309 for a model in which UGI ulcer and ulcer complication event risks increased with advancing age; 3) the ICER per QALY was $17,120 in sensitivity analyses combining serious CV thromboembolic event (myocardial infarction, stroke, CV death) risks with base model assumptions. CONCLUSION: Our model suggests that chronic celecoxib is cost-effective versus nsNSAIDs in a population of 60-year-old OA patients with average risks of UGI events.

Minimizing complications from nonsteroidal antiinflammatory drugs: cost-effectiveness of competing strategies in varying risk groups.

OBJECTIVE: To appraise the cost-effectiveness of competing therapeutic strategies in patient cohorts eligible for aspirin prophylaxis with varying degrees of gastrointestinal (GI) and cardiovascular risk. METHODS: Cost-effectiveness and cost-utility analyses were performed to evaluate 3 competing strategies for the management of chronic arthritis: 1) a generic nonselective nonsteroidal antiinflammatory drug (NSAID(NS)) alone; 2) NSAID(NS) plus a proton pump inhibitor (PPI); and 3) a cyclooxygenase 2-selective inhibitor (coxib) alone. Cost estimates were from a third-party payer perspective. The outcomes were incremental cost per ulcer complication avoided and incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analysis was performed to evaluate the impact of varying patient GI risks and aspirin use. RESULTS: In average-risk patients, the NSAID(NS) + PPI strategy costs an incremental 45,350 US dollars per additional ulcer complication avoided and 309,666 US dollars per QALY gained compared with the NSAID(NS) strategy. The coxib strategy was less effective and more expensive than the NSAID(NS) + PPI strategy. Sensitivity analysis revealed that the NSAID(NS) + PPI strategy became the dominant approach in patients at high risk for an NSAID adverse event (i.e., patients taking aspirin with > or =1 risk factor for a GI complication). CONCLUSION: Generic nonselective NSAIDs are most cost-effective in patients at low risk for an adverse event. However, the addition of a PPI to a nonselective NSAID may be the preferred strategy in patients taking aspirin or otherwise at high risk for a GI or cardiovascular adverse event.

Cost-effectiveness of treatment strategies for osteoarthritis of the knee in Taiwan.

OBJECTIVE: To evaluate the cost-effectiveness of 3 treatment strategies for osteoarthritis (OA) of the knee: naproxen, celecoxib, and hyaluronan. METHODS: We developed a decision model to estimate the costs and effectiveness of 3 treatment strategies: 250 mg naproxen 3 times daily for 26 weeks, 100 mg celecoxib twice daily for 26 weeks, and 25 mg hyaluronan by intraarticular injection once per week for 5 weeks followed by conventional treatment for 21 weeks. The probabilities and utility data were obtained by surveying the literature and consulting experts. Cost data were obtained from insurance reimbursement data of National Taiwan University Hospital and were converted to 2002 US dollars. The timeframe of the decision tree was 26 weeks. Outcomes were expressed in aggregated costs, quality-adjusted life-years (QALY), and the incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed on most variables. RESULTS: The expected total costs for the naproxen, celecoxib, and hyaluronan strategies were US$498.98, US$547.80, and US$678.00, respectively. The ICER of the celecoxib strategy compared with the naproxen strategy was US$21,226 per QALY gained. The ICER of the hyaluronan strategy versus the celecoxib strategy was US$42,000 per QALY gained. The ICER of the hyaluronan strategy decreased to about US$25,000 per QALY gained if the weekly treatment cost of hyaluronan was decreased to US$31. CONCLUSION: Celecoxib treatment results in a reasonable cost-effectiveness ratio for patients with OA of the knee. Hyaluronan treatment, however, may not be an economically attractive choice under the current healthcare scenario in Taiwan.

Developing an economic rationale for the use of selective COX-2 inhibitors for patients at risk for NSAID gastropathy.

Arthritis causes considerable patient morbidity and substantial health care resource utilization. One important contributing component to the overall cost burden of this condition is the variety of expenditures attributable to the adverse effects of arthritis therapy. Nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) are a mainstay of medical treatment for patients with arthritis because of their well-established anti-inflammatory and analgesic effects. Generally well tolerated, traditional NSAIDs nevertheless cause adverse gastrointestinal (GI) effects in a proportion of patients. Because nonselective NSAIDs are so widely used, these GI adverse events cause significant morbidity and mortality, accounting for substantial additional health care expenditures. Data from controlled investigations document the enhanced GI safety of cyclooxygenase (COX)-2-selective inhibitors, or coxibs, when compared with nonselective NSAIDs. As a result of this improved safety profile, patients treated with coxibs use significantly fewer GI-related health care resources (eg, medications, procedures) than patients treated with nonselective NSAIDs. Thus, available clinical and economic data suggest that the use of coxibs has the potential to result in important clinical GI benefits at an acceptable incremental cost for all chronic NSAID users. For individuals who are at an increased risk of developing GI complications attributable to NSAIDs, coxibs are clearly a cost-effective treatment option.

Ibuprofen versus other non-steroidal anti-inflammatory drugs: use in general practice and patient perception.

OBJECTIVE: To investigate whether ibuprofen was as well-regarded by patients as other non-steroidal anti-inflammatory drugs (NSAIDs). DESIGN: Questionnaire sent to 1137 consecutive recipients of an NSAID prescription from 21 doctors in six general practices with computerized records. Patient responses were subsequently linked to data held on the practice records. SETTING: General practices in and around Nottingham, selected to reflect local variations in number of partners, list size, geographical location, deprivation, prescribing burden and prescribing rate. SUBJECTS: Unselected patients receiving NSAIDs prescribed for all indications for use. MAIN OUTCOME MEASURES: Effectiveness of ibuprofen and other NSAIDs, possible drug related adverse events, patients' overall satisfaction with ibuprofen and other NSAIDs, factors associated with choice of ibuprofen, drug costs of ibuprofen and other NSAIDs. RESULTS: The main NSAIDs used were ibuprofen, diclofenac and naproxen. Ibuprofen use ranged from 1.0% of prescriptions in one practice to 69.1% in another. Although ibuprofen was generally prescribed in low doses, it was perceived by patients as being as effective as the other NSAIDs used, even after allowing for severity of the pre-treatment condition. Overall, 50.5% of patients rated their NSAID the best treatment they had received for their condition with no differences between individual drugs. CONCLUSIONS: Ibuprofen is as highly regarded as other NSAIDs when used in similar circumstances. Switching patients to ibuprofen may be a realistic way of reducing financial and medical costs associated with NSAIDs.

Pharmacoepidemiology of non-steroidal anti-inflammatory drug use in Nottingham general practices.

AIM: To investigate the pharmacoepidemiology of NSAID usage in Nottingham general practices. DESIGN: Questionnaire sent to 1137 consecutive recipients of an NSAID prescription from 21 doctors in six general practices with computerized records. Patient responses were subsequently linked to data held on the practice records. SETTING: General practices in and around Nottingham, selected to reflect local variations in number of partners, list size, geographical location, deprivation, prescribing burden and prescribing rate. SUBJECTS: Unselected patients receiving NSAIDs prescribed for all indications. MAIN OUTCOME MEASURES: Indication for treatment, differences in prescribing to different age groups, compliance and overall scheme drug exposure, drug effectiveness and tolerability, possible drug-related adverse events, patients' overall satisfaction with treatment and estimated costs of care. RESULTS: NSAIDs were used for a wide range of conditions and only a small number of patients had rheumatoid arthritis. The main drugs used were ibuprofen, diclofenac and naproxen. Patients making short-term use of NSAIDs had low compliance if they experienced adverse drug effects, whilst conversely in long-term users, those with high compliance reported more adverse drug effects. Calculated compliance did not vary with age although older patients (over 65 years) claimed in their questionnaires to be more compliant than younger patients. Half the patients reported good or complete symptom relief. Half of those questions (and two thirds of those with good or complete symptom relief) rated their NSAID as the best treatment they had received for their current condition. The frequency of gastrointestinal adverse events was higher in the young and the old, which correlated with the use of anti-ulcer drugs, and increased with the total number of medications used. CONCLUSIONS: NSAIDs are used for a wide-range of conditions. They give symptom relief to, and are perceived as effective by, most patients taking them.

Assessing physician choice of nonsteroidal antiinflammatory drugs in a health maintenance organization.

OBJECTIVE: To develop a categorization scheme for grouping various nonsteroidal antiinflammatory drugs (NSAIDs) by relative safety; to develop a method to quantify the appropriateness of the initial and subsequent choices of NSAID therapy; to assess whether NSAID prescribing was consistent with the developed criteria; to examine the cost of inappropriate, acute NSAID use as defined by the established criteria. DESIGN: Retrospective drug utilization review focusing on NSAIDs. SETTING/PARTICIPANTS: Members aged > or = 18 years of a 40,000-person southeastern Michigan health maintenance organization. MAIN OUTCOME MEASURES: (1) Appropriateness of therapy using a four-level safety classification system for the NSAIDs developed by a consensus process; criteria based on safety under the assumption that any particular NSAID is equally likely to be effective when dosed appropriately; (2) evaluation of progression of NSAID therapy using the NSAID Therapy Progression Formula. RESULTS: For acute patients, almost half of the prescriptions were for ibuprofen and 33 percent were for naproxen. Ibuprofen usage accounted for 16 percent of total NSAID cost and naproxen agents accounted for over 50 percent of that cost. Potential cost savings of approximately $82,000 probably would have occurred had a 50 percent interchange rate for ibuprofen been acceptable. For chronic patients, 85 percent were treated with one or two NSAIDs; treatments were of reasonable high quality when compared by safety profiles. There was low use of ibuprofen in patients who only received one NSAID. CONCLUSIONS: NSAID usage assessment in a large population was achieved by developing a classification and scoring system based on NSAID safety; in this population, prescribing patterns were generally consistent with established criteria; however, when considering cost, improvement in initial NSAID selection for acute patients was possible.

The economic consequences of NSAID-induced gastropathy: the French context.

The costs of treating gastroduodenal ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs) are shown to increase the total cost of NSAID treatment to the Assurance-Maladie, the French national health insurance system. This increased cost is termed the iatrogenic cost factor, and is defined as the ratio of the shadow price of an NSAID to its reimbursed cost. The shadow price is calculated from estimates of the incidence of NSAID-induced gastropathies, the cost of the drug, and the hospital and ambulatory costs of treating the gastropathies. The resulting iatrogenic cost factors are estimated as 1.36 for naproxen, 1.48 for sulindac, 1.65 for diclofenac, 1.67 for piroxicam, 2.00 for ketoprofen, and 2.12 for etodolac.