Multiple sclerosis patients treated with intramuscular IFN-β-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence,adherence, quality of life and satisfaction

Objectives: The 12-month observational PERSIST study (NCT01405872) evaluated adherence associated with the intramuscular IFNβ-1a (i.m. IFN-β-1a) autoinjector pen in multiple sclerosis (MS) patients.

Methods: MS patients initiating i.m. IFN-β-1a autoinjector treatment were prospectively assessed for physician-reported persistence (percentage of patients remaining on therapy) and patient-reported outcomes, including adherence (percentage of unmissed injections), compliance (percentage of patients missing no injections), tolerability (injection-site reactions [ISRs] and pain) and satisfaction.

Results: The intent-to-treat population included 232 patients; of the 188 physician-reported 12-month completers, 182 patients remained on treatment (96.8% persistence). Monthly compliance rates were 87.5 – 96.2%. Mean monthly pain scores were 1.5 – 1.8 (scale: 0 = ‘no pain’; 10 = ‘extremely painful’). At 12 months, 73.5% of respondents reported no ISRs, 94.9% were satisfied/very satisfied with the autoinjector and 88.2% found using the device easy/very easy. Injection fear, injection anxiety and need for injection assistance by caregivers decreased from the initial visit to 12 months. No new safety signals were observed.

Conclusions: The autoinjector pen is associated with high levels of persistence, compliance, adherence, and satisfaction, little-to-no pain and low need for caregiver assistance. Although these data are limited by reliance on patient questionnaires and the absence of a direct comparator group, this treatment may reduce barriers to injection therapy, while supporting long-term MS management.     

Healthcare expenditures and patient satisfaction: cost and quality from the consumer's perspective in the US*

ABSTRACT

Background: Both cost and quality of healthcare are major concerns in the United States. Using patient satisfaction as a quality indicator, we seek to identify the relationship between healthcare cost and quality from the perspective of the community-dwelling population in the United States.

Methods: We examined a nationally representative sample of 13?980 adults (age?≥?18 years) in the 2003 Medical Expenditure Panel Survey (MEPS). Given the idiosyncrasies of the cost data distribution, a recently developed extended estimating equation (EEE) model was employed to identify the relationship between patient satisfaction and healthcare expenditure, after controlling for individual demographic covariates, co-morbidity profile, and functional and activity limitations. A series of sensitivity analyses were conducted, in addition, to verify the identified relationship. All statistics were adjusted using the proper sampling weight from the MEPS data.

Results: Average annual healthcare expenditures for 2003 ranged between $3923 and $6073 when grouped by patient satisfaction ratings with a mean value $4779 for all individuals who rated perceived satisfaction of their healthcare. We found that there is no statistically signif­icant relationship between patient satisfaction and total healthcare expenditure (?p?=?0.60) and a non-monotonic relationship is not identified either. All sensitivity analyses results revealed a lack of relationship between patient satisfaction and healthcare expenditures.

Limitations: Patient satisfaction might not reflect the quality of healthcare from an objective clinical standpoint. The identified cost–satisfaction relationship may not be extrapolated to other quality indicators. Due to the cross-sectional study design, no causal relationship could be inferred between patient satisfaction and healthcare expenditure.

Conclusions: Our study adds to the literature on health­care cost and quality by suggesting that the improvement of patient satisfaction may not require additional health­care spending.     

Chronic pain management -can we do better? An interview-based survey in primary care

SUMMARY

Background: Persisting pain is demoralising and debilitating for patients and their carers. Most patients with chronic pain do not need the services of a specialised pain clinic and are appropriately managed by their general practitioner (GP).

Method: Interviewers approached 569 GPs to assess their satisfaction with the management of patients with chronic non-malignant (i.e. non-cancer related) pain (CNMP). The survey was carried out from November 2001 to January 2002 in general practices in the UK. GPs were randomly selected as representative of the basic population who treat CNMP. The survey was conducted in a face-to-face interview in the GP surgery using a questionnaire consisting of 35 open questions covering practice information, treatment of CNMP, pain management and multidisciplinary support.

Results: 504 (88.6%) of GPs completed the structured questionnaire. 81% of GPs believed that a significant number of patients received suboptimal management. Optimal control of symptoms was estimated to occur in less than half of patients. The main barriers to achieving good pain control were identified as side-effects of therapies (74%) and patient compliance (58%). 60% of respondents expressed concerns regarding efficacy of available therapies. Although 91% of GPs considered specialised pain services as beneficial, only 14% of patients were referred to hospital for symptom management. 96% of GPs felt that the management of chronic pain could be improved in their locality and 81% expressed an interest in relevant training.

Conclusion: Most GPs believe that the management of chronic pain can be improved. Further education of all healthcare professionals who manage patients in pain is needed to bring about such a change.     

Pharmacotherapy strategies in chronic prostatitis/chronic pelvic pain syndrome management

Importance of the field: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is one of the most common diagnoses arising out of urologic office visits. It is a costly problem and sufferers compare the effect of this syndrome on quality of life as being similar to the effects of diabetes mellitus and myocardial infarction. The syndrome is variable in presentation and symptom management and efficacy will vary between inflicted men.

Areas covered in this review: CP/CPPS is not highly responsive to therapy. As such, it is often a waxing and waning illness with symptoms in multiple domains, including urinary symptoms, pain and ejaculatory dysfunction. The pharmacotherapeutic options and management strategies for CP/CPPS presented in this review are based on the published literature from September 1989 to January 2010. When available, randomized, placebo-controlled studies were reviewed to aid in making definitive recommendations for treatment strategies.

What the reader will gain: The reader will be familiarized with the commonly used classes of pharmaceutical and non-pharmaceutical therapies. Readers will then use the efficacy data to inform treatment decisions for patients with disparate symptomatology. This will be crystallized in the author's treatment algorithm and summary statement.

Take home message: Many practitioners use antimicrobials as a first-line agent, particularly a fluoroquinolone, such as levofloxacin. Trimethoprim/sulfamethoxazole is another medication alternative, with comparable response rates. Many afflicted men will have significant improvement on a 4- to 6-week regimen of a fluoroquinolone antibiotic. Second-line pharmacotherapy includes alpha-blockers, 5-alpha reductase inhibitors and anti-inflammatories for men with urinary symptoms or pain as a predominant symptom domain. Other pharmacotherapy includes steroids, glycosaminoglycans and phytotherapy. Surgical options are generally not recommended for CP/CPPS. Despite the lack of curative therapies, effective symptom management can be achieved with knowledge of the classes of pharmacotherapy. Therapeutic decisions can be based on the symptoms of the patient. Pelvic floor physical therapy is a useful second-line therapy in the author's opinion, but randomized controlled trials and standardization of technique for CP/CPPS are needed before recommendations can be substantiated.     

Single-use autoinjector for peginterferon-β1a treatment of relapsing-remitting multiple sclerosis: safety,tolerability and patient evaluation data from the Phase IIIb ATTAIN study

Objectives: A sub-study to evaluate safety, tolerability, ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-β_1a (a pegylated interferon-β_1a in clinical development) in a subset of relapsing-remitting multiple sclerosis (MS) patients participating in ATTAIN, a long-term dose-frequency blinded extension of the Phase III randomized ADVANCE study.

Methods: Over 8 weeks, patients self-administered peginterferon-β_1a 125 µg or placebo every 2 weeks (two injections via manual pre-filled syringe [PFS]; two injections via single-use autoinjector). Primary end points were incidence of adverse events (AEs), patient assessment of injection pain score (10-point Visual Analog Scale), and clinician assessment of injection site reactions (ISRs). Secondary objectives included patient assessment of ease-of-use and satisfaction with the autoinjector and evaluation of autoinjector training materials.

Results: In 39 patients, the safety profile of peginterferon-β_1a was similar when delivered via autoinjector or PFS; AEs were mostly mild or moderate in severity. Clinicians and patients reported a similar tolerability profile using both PFS and autoinjector, and pain scores were low (< 1), with no reports of clinician-assessed ISRs after administration with the autoinjector. Patients perceived the single-use autoinjector to be easy to use and convenient; overall patient satisfaction with the autoinjector and accompanying training materials was high.

Conclusion: The safety and tolerability profile of peginterferon-β_1a delivered via autoinjector was similar to delivery via PFS. Patients found the autoinjector easy to use and convenient; this device may simplify the injection process for MS patients who require long-term therapy, thereby potentially improving patient’s quality of life and adherence.     

Efficacy of almotriptan 12.5 mg in achieving migraine-related composite endpoints: a double-blind,randomized, placebo-controlled study in patients with previous poor response to sumatriptan 50 mg

ABSTRACT

Background: Triptans are not identical and migraine sufferers respond differently to different triptans. Few studies have evaluated the efficacy of switching triptans in migraine patients who have shown poor response to another agent.

Objective: To investigate the efficacy and tolerability of almotriptan 12.5?mg in patients who did not achieve 2‐h pain relief with sumatriptan 50?mg.

Methods: This double-blind, placebo-controlled study recruited patients with IHS-defined migraine and at least 2 previous unsatisfactory responses to sumatriptan. Those who did not achieve pain relief (moderate or severe pain decreasing to mild or no pain) 2?h after taking oral sumatriptan 50?mg on an open-label basis for the treatment of their first migraine attack during this trial (Attack 1) were randomized to receive either oral almotriptan 12.5?mg or placebo for the treatment of their next migraine attack (Attack 2).

Results: Of 302 patients receiving sumatriptan 50?mg for the treatment of their first migraine attack, 221 (73%) did not achieve 2‐h pain relief and were randomized to almotriptan 12.5?mg or placebo for the treatment of Attack 2. The majority (70%) of randomized patients treating their headache in Attack 2 reported severe pain at baseline characterizing this as a difficult-to-treat population. In the intent-to-treat population (n = 198), significantly more patients in the almotriptan group compared with the placebo group achieved 2‐h complete relief (free from pain and migraine-associated symptoms) at 2?h (17.1% vs. 4.4%; p < 0.05) and sustained pain free (20.9% vs. 9.0%; p < 0.05). Adverse events of mild-to-moderate intensity occurred in 7.1% of patients in the almotriptan group compared to 5.1% in the placebo group (not statistically different).

Conclusion: Almotriptan is more effective than placebo and similarly well-tolerated for the acute treatment of migraine in patients who responded poorly to oral sumatriptan.     

Health economic impact of olopatadine compared to branded and generic sodium cromoglycate in the treatment of seasonal allergic conjunctivitis in the UK

ABSTRACT

Objective: This study estimated the health economic impact of olopatadine (Opatanol^*) compared to branded cromoglycate (Opticrom^?) and generic sodium cromoglycate in the treatment of seasonal allergic conjunctivitis (SAC) in the UK.

Design and setting: This was a modelling study performed from the perspective of the UK's National Health Service (NHS).

Methods: A decision model was constructed depicting the management of SAC sufferers who are 4 years of age or above over a typical allergy season of 4 months and considers the decision by a GP to initially treat a patient with olopatadine, branded or generic cromoglycate. The analysis assumed both drugs to be equally effective. Consequently, a cost-minimisation analysis was performed to identify the least costly alternative.

Main outcome measures and results: Starting treatment with olopatadine is expected to lead to a healthcare cost of £92 (95% CI: £46; £150) over 4 months compared to £109 (95% CI: £65; £166) with branded cromoglycate and £95 (95% CI: £51; £152) with generic cromoglycate, resulting in a 16% and 3% reduction in healthcare costs respectively over 4 months of treatment. This cost-difference is primarily due to fewer GP visits among olopatadine-treated patients.

Conclusion: Use of olopatadine instead of branded or generic cromoglycate affords an economic benefit to the NHS. Hence, within the limitations of the model, olopatadine is the preferred first-line treatment for use in SAC sufferers, since it is expected to lead to fewer GP visits, thereby releasing healthcare resources for alternative use.     

The need for fundamental reforms in the pain research field to develop innovative drugs

Introduction: Chronic pain is a major healthcare issue owing to its high prevalence, significant physical and emotional burden on the patients, and huge financial burden on the society. The efficacy of currently available medications is unsatisfactory owing to their limited effect size and the low responder rate (less than 50%). Thus, there is a large unmet need for innovative therapies for chronic pain.

Areas covered: In this review, the author points out the need for fundamental reforms in pain research. For the last several decades, drug discovery research has extensively focused on designing new therapies using animal models of chronic pain. It has, however, made insufficient progress with respect to the launch of innovative analgesic drugs, because the translation from preclinical to clinical stages has not been satisfactory. Thus, the strategies for developing innovative analgesic drugs are discussed.

Expert opinion: Points to be considered in the discovery of drugs for pain relief include: (1) the exclusion of bias incorporation and the alignment of clinical and preclinical endpoints in the assessment of analgesic efficacy; (2) the understanding of primary unmet needs; (3) the assessment of new therapies by biomarker-prioritized frameworks, and (4) the stratification of chronic pain sufferers.     

Modelling the resource implications and budget impact of managing cow milk allergy in Australia

ABSTRACT

Objective: To estimate the resource implications and budget impact of current clinical practice for managing cow milk allergy (CMA) in Australia, from the perspective of the publicly funded healthcare system.

Methods: A decision model was constructed using published clinical outcomes and clinician-derived resource utilisation estimates. The model was used to estimate the expected 6-monthly levels of healthcare resource use and corresponding costs attributable to managing 6150 new CMA sufferers following referral to a specialist.

Results: The expected 6-monthly costs of managing 6150 newly-diagnosed infants with CMA following referral to a specialist was an estimated (Australian dollars, AU$) AU$6.5 million at 2006/07 prices. Clinical nutrition preparations were found to be the primary cost driver accounting for 62% of the total 6-monthly cost and clinician visits were the secondary cost driver accounting for up to a further 28% of the total 6-monthly cost. Sensitivity analysis showed there would be fewer visits to hospital-based paediatric gastroenterologists and paediatric immunologists/allergists if all newly-diagnosed patients were prescribed an amino acid formula (AAF) following referral to a specialist, instead of being managed according to current practice.

Conclusion: CMA imposes a substantial burden on the publicly funded healthcare system in Australia. However, using an AAF as the initial treatment for CMA can potentially release limited hospital resources for alternative use within the paediatric healthcare system.     

Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women

ABSTRACT

Objective: To evaluate patient satisfaction with the follitropin alfa prefilled pen (Gonal.f RFF Pen ), compared with previously used injectable gonadotropins (vial/ampoules and syringe), in women undergoing ovulation induction (OI).

Research design and methods: Women aged 18–40 years undergoing OI for oligoanovulatory infertility were enrolled from nine US fertility centers in this prospective, open-label clinical trial. Participants received recombinant follitropin alfa using a prefilled pen. Patient satisfaction was determined using a pre-treatment questionnaire to assess gonadotropin treatments undertaken within 6 months of study initiation and an in-treatment questionnaire to assess satisfaction with the prefilled pen.

Main outcome measures: The primary endpoint was the proportion of patients who preferred the prefilled pen compared to previous injectable gonadotropin therapies. Efficacy and safety were also assessed.

Results: Seventy-three subjects were screened for the study; 62 enrolled, were treated with the follitropin alfa pre-filled pen, and 61 completed the in-treatment questionnaire. Sixty-one of 61 patients who stated a preference preferred the prefilled pen to previous injectable gonadotropin therapies (61/61; 100%; 95% confidence interval: [94.1–100.0%]). One patient did not state a preference. Of these 61 patients, 54 (89%) found that the prefilled pen instructions were easy to understand compared to 17 of 59 (29%) who thought instructions for the conventional syringes were easy to understand. When preparing their dose, significantly fewer patients contacted their healthcare provider two or more times during the treatment cycle when receiving treatment with the prefilled pen (2/61, 3%) than during the first treatment cycle with prior gonadotropin treatment, 11/59 (19%, p = 0.007). The pen interfered slightly or not at all with patients’ normal daily activities in 61 of 61 patients (100%) versus 50 of 59 patients (85%) who had this opinion regarding injections during their prior treatment cycles (?p = 0.003). All 61 patients who stated a method of injection preference found the prefilled pen less stressful to use than syringes and would recommend the pen to another woman considering gonadotropin treatment. A total of 10/62 (16%) subjects reported 18 treatment-emergent adverse events (AEs). Two cases of ovarian hyperstimulation syndrome occurred post-treatment and one serious AE occurred (post-treatment ectopic pregnancy). Injection site reactions were generally mild to moderate, with mild itching (6 patients, 9.7%) and moderate redness in one patient. Fifteen patients reported mild redness (24.2%). Mild bruising (21.0%), mild pain (33.9%), and mild burning (32.3%) were also reported by patients. Seven patients (11.3%) had moderate pain.

Conclusions: In this open-label, non-comparative study, patients undergoing OI preferred administering gonadotropins using the follitropin alfa prefilled pen compared to their prior use of vials/ampoules and a syringe. Patients using the prefilled pen found it less stressful, easier to use and more convenient than a conventional syringe and would recommend the pen to another woman considering gonadotropin treatment.     

Adopting early intervention for substance use disorders: a preliminary study of primary healthcare professionals in New York State

Abstract

Aims: Research has reported a lack of practice of early intervention for substance use disorders among primary healthcare professionals, and only a fraction of patients were asked about their substance use when visiting a primary healthcare office. This study examines conditions that may influence the adoption of early intervention [i.e., screening, brief intervention and referral to treatment (SBIRT)] among primary healthcare professionals. Methods: A pilot survey was emailed to primary care physicians, nurse practitioners, and physician assistants in New York State, and 248 recipients responded to the survey. Findings: Three areas appear to be associated with the adoption of SBIRT: percentage of respondents’ patients using marijuana (β?=?0.14; p?<?0.05); perceived ability to perform intervention (β?=?0.32; p?<?0.05); and perception of early intervention as a responsibility of primary care professionals (β?=?0.29; p?<?0.05). Conclusions: Training and education to promote SBIRT for primary care workers should focus on increasing their favourable attitudes towards the intervention as a strategy of preventive medicine and include the knowledge of the infrastructure of services for substance use disorders, especially for medical providers who see large numbers of patients at a high risk for alcohol and drug misuse.     

Chronic abdominal pain in irritable bowel syndrome – current and future therapies

Introduction: Irritable bowel syndrome (IBS) is a functional gut disorder that typically manifests in early adult years. One of the two major symptoms of the disease is chronic, visceral pain. The patients report pain as the most distressing symptom with the greatest impact on quality of life, challenging both to patients and healthcare providers.

Areas covered: This review focuses on the pathophysiology of abdominal pain in IBS and describes current treatment possibilities. It also covers latest findings that may lead to novel pharmacological options in IBS pain management.

Expert commentary: Pain is the main contributor to severity in IBS. Seeking pain alleviation is the most common reason that IBS sufferers consult with their physicians. Not all patients report being satisfied with available treatments for pain in IBS and there is a pressing need to find new, more efficient therapies for this syndrome.     

Modelling the resource implications and budget impact of new reimbursement guidelines for the management of cow milk allergy in Finland

ABSTRACT

Objective: To assess the impact of the decision by Kela (The Social Insurance Institution) to adopt guidelines for the management of food allergies in children, developed by the Finnish Medical Society Duodecim, as the basis for reimbursing clinical nutrition preparations for the treatment of cow milk allergy (CMA) in Finland.

Methods: A decision model was constructed using published clinical outcomes and clinician-derived resource utilisation estimates. The model was used to estimate the net resource implications and associated costs of Kela's new policy for the annual cohort of 1443 new CMA sufferers over the first 6 months following referral to a specialist. The analysis was conducted from the perspective of Kela, patients and Finnish society.

Results: Kela's new policy for reimbursing clinical nutrition preparations for the treatment of CMA is expected to increase healthcare resource use, including a 10% increase in the number of specialist visits over the first 6 months following referral. Consequently, Kela's 6-monthly expenditure on 1443 new CMA sufferers following referral is expected to increase by 12% from €889?389 to €992?761. Additionally, parents’ costs are expected to increase by 10% and fathers’ absenteeism from work to increase by 11% within the first 6 months following referral.

Conclusion: It is important to validate guidelines in clinical practice before their implementation. Within the limitations of our model, Kela's new criteria for reimbursing clinical nutrition preparations for the treatment of CMA is expected to increase healthcare resource use in paediatric departments in public hospitals in Finland and increase costs to Kela, patients and Finnish society.     

Non-invasive patient-controlled analgesia in the management of acute postoperative pain in the hospital setting

Objective: Acute postoperative pain is experienced by the majority of hospitalized patients undergoing surgical procedures, with many reporting inadequate pain relief and/or high levels of dissatisfaction with their pain management. Patient-controlled analgesia (PCA) ensures patient involvement in acute pain control, a key component for implementing a quality management system. This narrative article overviews the clinical evidence for conventional PCA and briefly discusses new, non-invasive PCA systems, namely the sufentanil sublingual tablet system (SSTS) and the fentanyl iontophoretic transdermal system (FITS).

Methods: A Medline literature search (“patient-controlled analgesia” and “acute postoperative pain”) was conducted to 1 April 2017; results from the main clinical trials are discussed. Additional literature was identified from the reference lists of cited publications.

Results: Moderate to low quality evidence supports opioid-based intravenous PCA as an efficacious alternative to non-patient-controlled systemic analgesia for postoperative pain. However, despite the benefits of PCA, conventional intravenous PCA is limited by system-, drug- and human-related issues. The non-invasive SSTS and FITS have demonstrated good efficacy and safety in placebo- and intravenous morphine PCA-controlled trials, and are associated with high patient/healthcare practitioner satisfaction/ease of care ratings and offer early patient mobilization.

Conclusions: Evidence-based guidelines for acute postoperative pain management support the use of multimodal regimens in many situations. As effective and safe alternatives to conventional PCA, and with the added benefits of being non-invasive, easy to use and allowing early patient mobilization, the newer PCA systems may complement multimodal approaches, or potentially replace certain regimens, in hospitalized patients with acute postoperative pain.     

Costs,quality of life,treatment satisfaction and compliance in patients with β-thalassemia major undergoing iron chelation therapy: the ITHACA study

ABSTRACT

Objectives: Iron chelation treatment (ICT) in β-thalassemia major (β-TM) patients undergoing blood transfusions can cause low satisfaction, low compliance, with possible negative consequences on treatment success, patients' wellbeing, and costs. The purpose was to estimate the societal burden attributable to β-TM in terms of direct and indirect costs, health-related quality-of-life (HRQoL), satisfaction and compliance with ICT in patients undergoing transfusions and ICT.

Research design and methods: The naturalistic, multicenter, longitudinal Italian-THAlassemia-Cost-&-Outcomes-Assessment (ITHACA) cost-of-illness study was conducted involving patients of any age, on ICT for at least 3 years, who were enrolled at 8 Italian Thalassemia Care Centers. Costs were estimated from the societal perspective, quantified with tariffs, prices, or net earnings valid in 2006.

Results: One-hundred and thirty-seven patients were enrolled (median age = 28.3, 3–48 years, 49.6% male) and retrospectively observed for a median of 11.6 months. Mean direct costs were €1242/patient/month, 55.5% attributable to ICT, 33.2% attributable to transfusions. Relevant quantity and quality of productivity was lost. Both physical and mental components of HRQoL were compromised. Little difficulties remembering to take ICT and positive satisfaction with the perceived effectiveness of therapy were declared, but not good levels of satisfaction with acceptance, perception of side effects and burden of ICT.

Conclusions: The management of β-TM patients undergoing transfusions and ICT is efficacious, although costly, but overall benefits were not always perceived as optimal by patients. Efforts must be focused to improve patients' acceptance and satisfaction with their therapy; this would contribute to a better compliance and hence an increase in treatment effectiveness and patients' overall wellbeing, with expected improved allocation of human and economic resources.     

IMPACT OF LEUPROLIDE ACETATE DISEASE MANAGEMENT PROGRAM ON PATIENT OUTCOMES

ABSTRACT

Background: Patient compliance and completion of a recommended course of therapy is strongly associated with improvement in patient outcomes.

Objectives: To implement and evaluate the impact of the Lupron Depot patient education/disease management program.

Methods: This is a prospective follow-up study of 3157 patients receiving Lupron therapy. Patients were evaluated at the beginning of therapy, and then received printed educational materials as well as live educational sessions over the telephone. Patients were instructed to report any encountered/suspected side effects to a 24-hour hotline. Additional telephone interviews were conducted as needed for education and disease management.

Results: A total of 3,153 patients were enrolled in the study, and a total of 1356 telephone-conferences were conducted. Patient compliance with therapy increased from 74% to 98.6%. This program promoted proper utilization of healthcare resources, minimized ER visits and reduced disease complications with an estimated cost savings of $4,020,140. While the frequency of several side effects such as headache, general pain and hot flashes was similar to what was previously reported, the frequency of others was significantly higher e.g., weight changes 14.8% (compared with 3%), joint disorder/pain 76.7% (compared with 7.8–11.7%), depression 35.5% (compared with 10.8%), and night sweats 48.6% (compared with 5.3%). Possible Lupron-induced hypertension that required drug treatment was discovered in 7.04% of the population. Subjective analysis revealed improvement in patient satisfaction with the program.

Conclusion: Patient education and follow-up programs are essential to improve patient outcomes. These programs also add to our understanding of adverse effects of medications.     

How treatment priorities influence triptan preferences in clinical practice: perspectives of migraine sufferers,neurologists, and primary care physicians

ABSTRACT

Background: In treating migraine sufferers, physicians can choose from among seven triptans with different attributes.

Objective: To develop a system for selecting an oral triptan based on treatment priorities of migraine sufferers, neurologists, and primary care physicians (PCPs) in the United States, and evidence-based performance of triptans in clinical trials.

Methods: The TRIPSTAR project combines data on the treatment preferences of migraineurs and physicians with results from a meta-analysis of individual triptans, which evaluated their effectiveness on various clinical endpoints. Telephone interviews with migraine sufferers, neurologists, and PCPs were conducted to elicit individual views on the relative importance of a prespecified set of acute treatment outcomes. Four hundred and fifteen migraine sufferers, both triptan-experienced and triptan-naive, were interviewed. Also, 200 board-certified neurologists and 200 PCPs provided information on migraine patients from their clinical practice. A multi-attribute decision model for selecting an oral triptan was constructed using attribute importance weights collected at telephone interview and the meta-analysis data, which were drawn from 53 clinical trials of 6 oral triptans.

Results: Efficacy attributes were rated significantly more important than tolerability or consistency in selecting an oral triptan, according to migraine sufferers and physicians. Freedom from cardiovascular adverse events was the most important tolerability attribute, according to migraine sufferers and physicians alike. Pain free at 1?h was the most important lower-level efficacy attribute for migraine sufferers, while sustained pain free was most important for physicians. When weighted treatment attributes were combined with meta-analysis data in a multi-attribute decision model, almotriptan 12.5?mg, eletriptan 80?mg, and rizatriptan 10?mg were significantly closer to the hypothetical ideal triptan than was sumatriptan 100?mg. Triptans selected by the model were generally closer to the patient-specific ideal triptan than were the triptans prescribed by physicians.

Conclusions: Almotriptan, eletriptan, and rizatriptan were the three triptans closest to the ideal, from the perspectives of migraine sufferers, PCPs, and neurologists alike. The TRIPSTAR model may be a potentially useful decision-support tool to help physicians select the triptan most likely to produce a successful outcome in migraine sufferers.     

Is complicated grief a risk factor for substance use? A comparison of substance-users and normative grievers

Background: There are no studies to date which have examined complicated grief (CG) symptomatology in substance use disorder (SUD) populations specifically. This study aimed to determine if the presence of symptoms of CG is more frequent among drug dependent patients than a control group and identify which variables could be associated with the symptomatology of CG.

Method: Sociodemographic variables, drug and bereavement related characteristics, CG symptomatology and perceived social support were examined in a sample of 196 bereaved SUD patients (78.1% men). The control group was formed by 100 bereaved non-addicted participants (73% men). A multiple linear regression analysis was conducted to identify which variables were associated with symptoms of CG.

Results: The presence of symptoms of CG among SUD patients was 34.2%, in comparison to 5% in the control group. Respondents with a higher CG symptomatology include: those being widowed (β=?0.165), those who had lost a sibling (β?=?0.253), those who had experienced a traumatic death (β?=?0.158), those without working status (β=?0.005). By contrast, being from the control group (β=??0.157), reporting secondary education (β?=??0.201) and perceived social support (β?=??0.146) were found to be protective factors.

Conclusions: These findings highlight the importance of diagnosing and treating those bereaved individuals with SUD who appear to be particularly vulnerable to develop CG symptomatology.