Multinational descriptive analysis of the real-world burden of headache using the Migraine Buddy application.

BACKGROUND AND PURPOSE: A large proportion of headache sufferers do not routinely seek medical care. App-based technologies permit the collection of real-world data over time and between countries that can help assess true burden of headache. This study used a mobile phone application to collect information on the real-world burden of self-diagnosed headache and to describe its impact on daily life in headache sufferers who do not routinely seek medical advice. METHODS: This retrospective, non-interventional, cross-sectional study analysed self-reported data from users of the 'Migraine Buddy' app. The main objective was to describe self-reported characteristics of headache and migraine (triggers, duration, frequency), treatment patterns and impact on daily activity in headache sufferers from Australia, Brazil, France, Germany and Japan. Data including demographics, self-diagnosed episode type (headache/migraine), duration, potential triggers and impact on daily activity are reported. All analyses were exploratory and performed per country. RESULTS: Self-reported data were collected from 60,474 users between August 2016 and August 2018. Approximately 90% of users were females; >60% were aged 24-45 years. Over one-third of users reported having two to five episodes of headache or migraine per month; impact included impaired concentration, being slower and missing work or social activities. Variations across countries were observed; within countries, episode characteristics were very similar for self-diagnosed headache versus migraine. CONCLUSIONS: Headache tracking was used to describe the experience, impact and self-management approaches of migraine and headache sufferers in a real-world setting. Headache disorders present a range of important issues for patients that deserve more study and reinforce the need for better approaches to management.

21st century headache: mapping new territory.

BACKGROUND: With headache experienced by up to 75% of adults worldwide in the last year, primary headache disorders constitute a major public health problem, yet they remain under-diagnosed and under-treated. Headache prevalence and burden is changing as society evolves, with headache now occurring earlier in life. Contributing factors, mostly associated with changing life style, such as stress, bad posture, physical inactivity, sleep disturbance, poor diet and excess use of digital technology may be associated with the phenomenon that could be labelled as '21st century headache'. This is especially notable in workplace and learning environments where headache impacts mental clarity and therefore cognitive performance. The headache-related impact on productivity and absenteeism negatively influences an individual's behaviour and quality of life, and is also associated with a high economic cost. Since the majority of sufferers opt to self-treat rather than seek medical advice, substantial knowledge on headache prevalence, causation and burden is unknown globally. Mapping the entire population of headache sufferers can close this knowledge gap, leading to better headache management. The broad use of digital technology to gather real world data on headache triggers, burden and management strategies, in self-treated population will allow these sufferers to access appropriate support and medication, and therefore improve quality of life. CONCLUSION: These data can yield important insights into a substantial global healthcare issue and form the basis for improved patient awareness, professional education, clinical study design and drug development.

Effects of drug cessation after flexible-dose fesoterodine in patients with overactive bladder.

OBJECTIVE: To determine the course of overactive bladder (OAB) symptoms after 4 weeks of no treatment following a 12-week study of the efficacy and safety of flexible-dose fesoterodine in patients with OAB who were enrolled in the UK healthcare system. There are limited data available on the natural time course of OAB symptoms after the cessation of treatment. PATIENTS AND METHODS: In the open-label UK Study Assessing Flexible-dose Fesoterodine in Adults trial, patients aged ≥18 years with self-reported OAB symptoms for ≥3 months, a mean of at least eight micturitions per 24 h and three or more urgency episodes per 24 h on a 3-day bladder diary at baseline, and at least moderate bladder-related problems reported on the Patient Perception of Bladder Condition (PPBC) at baseline, were treated with fesoterodine for 12 weeks. All patients received fesoterodine 4 mg once daily for the first 4 weeks, at which time they could choose to increase the dose to 8 mg once daily, based on a discussion of treatment efficacy and tolerability with the investigator, or they could remain on fesoterodine 4 mg for the remaining 8 weeks. The 12-week treatment period was followed by a 4-week follow-up period of no fesoterodine treatment. Patients completed 3-day bladder diaries and the PPBC at baseline, week 4, end of treatment (week 12) and end of the follow-up period (week 16); the King's Health Questionnaire at baseline, end of treatment (week 12) and end of the follow-up period (week 16); and the Benefit, Satisfaction and Willingness to Continue questionnaire at week 12. RESULTS: After 12 weeks of fesoterodine treatment, patients had clinically meaningful improvements in bladder diary variables and King's Health Questionnaire domains; 79% (254/322) of patients reported an improvement on the PPBC. After 4 weeks of no treatment, most patients deteriorated back to week 4 levels or worse on all bladder diary and patient-reported outcomes. Patients who expressed a benefit from fesoterodine treatment, satisfaction with their treatment or a willingness to continue treatment showed greater improvement from baseline to week 12 and greater deterioration from week 12 to week 16 than patients who did not respond positively on the Benefit, Satisfaction and Willingness to Continue questionnaire. Both men and women showed a meaningful deterioration in bladder diary variables and patient-reported outcomes at week 16; baseline symptom severity, age and week 4 dose escalation status did not appear to affect outcome deterioration at week 16. CONCLUSIONS: At 4 weeks after fesoterodine was discontinued, patients showed an increase in the frequency of OAB symptoms, an increase in the severity of bladder-related problems and a reduction in health-related quality of life. Many patients with OAB who respond to antimuscarinics may require treatment for more than 12 weeks because symptoms recur as early as 4 weeks after the cessation of therapy.

Safety and efficacy of flexible-dose fesoterodine in British subjects with overactive bladder: insights into factors associated with dose escalation.

INTRODUCTION AND HYPOTHESIS: This study evaluated the efficacy and safety of flexible-dose fesoterodine and factors associated with dose escalation in subjects with overactive bladder (OAB). METHODS: In this 12-week, open-label study, 331 adults with OAB symptoms for ≥3 months, ≥8 micturitions and ≥3 urgency episodes per 24 h and who reported at least "some moderate" bladder-related problems were treated with fesoterodine 4 mg once daily for 4 weeks, with the option to escalate to 8 mg for the remaining 8 weeks based on discussion of efficacy and tolerability with the investigator. Factors influencing dose escalation were identified using stepwise logistic regression. Efficacy was assessed via 3-day bladder diaries and patient-reported outcomes. RESULTS: Of the subjects, 59 % dose escalated at week 4; 93 % of escalators cited insufficient clinical response. The decision to escalate was most often made by the subject (alone or with the investigator). Improvements from baseline were observed in diary and patient-reported outcomes at weeks 4 and 12. Smaller improvements in micturition frequency and worse bladder-related problems at week 4 were significantly associated with increased likelihood of dose escalation; baseline micturition frequency, age, sex, body mass index, antimuscarinic-associated adverse events and OAB symptom duration were not. Non-escalators had greater improvement from baseline to week 4 than escalators; by week 12, improvement was similar among escalators and non-escalators. Fesoterodine was well tolerated. CONCLUSIONS: Treatment with flexible-dose fesoterodine improved bladder diary and patient-reported outcomes. Lower clinical response was related to dose escalation; after escalation, response in escalators approached that of non-escalators.

Paracetamol Use in Patients With Osteoarthritis and Lower Back Pain: Infodemiology Study and Observational Analysis of Electronic Medical Record Data.

BACKGROUND: Lower back pain (LBP) and osteoarthritis (OA) are common musculoskeletal disorders and account for around 17.0% of years lived with disability worldwide; however, there is a lack of real-world data on these conditions. Paracetamol brands are frequently prescribed in France for musculoskeletal pain and include Doliprane, Dafalgan, and Ixprim (tramadol-paracetamol). OBJECTIVE: The objective of this retrospective study was to understand the journey of patients with LBP or OA when treated with paracetamol. METHODS: Three studies were undertaken. Two studies analyzed electronic medical records from general practitioners (GPs) and rheumatologists of patients with OA or LBP, who had received at least one paracetamol prescription between 2013 and 2018 in France. Data were extracted, anonymized, and stratified by gender, age, and provider specialty. The third study, an infodemiology study, analyzed associations between terms used on public medical forums and Twitter in France and the United States for OA only. RESULTS: In the first 2 studies, among patients with LBP (98,998), most (n=92,068, 93.0%) saw a GP, and Doliprane was a first-line therapy for 87.0% (n=86,128) of patients (71.0% [n=61,151] in combination with nonsteroidal anti-inflammatory drugs [NSAIDs] or opioids). Among patients with OA (99,997), most (n=84,997, 85.0%) saw a GP, and Doliprane was a first-line therapy for 83.0% (n=82,998) of patients (62.0% [n=51,459] in combination). Overall, paracetamol monotherapy prescriptions decreased as episodes increased. In the third study, in line with available literature, the data confirmed that the prevalence of OA increases with age (91.5% [212,875/232,650] above 41 years), OA is more predominant in females (46,530/232,650, 20.0%), and paracetamol use varies between GPs and rheumatologists. CONCLUSIONS: This health surveillance analysis provides a better understanding of the journey for patients with LBP or OA. These data confirmed that although paracetamol remains the most common first-line analgesic for patients with LBP and OA, usage varies among patients and health care specialists, and there are concerns over efficacy.

A Prospective Real-World Study Exploring Associations Between Passively Collected Tracker Data and Headache Burden Among Individuals with Tension-Type Headache and Migraine.

INTRODUCTION: Prevalence and burden of headache disorders in real-world settings is relatively unstudied. We explored the associations between passively collected activity data, headache burden, and quality of life in headache sufferers. METHODS: Data from wearable activity tracking devices and daily short questionnaires were collected over 12 weeks to assess occurrence of headache, activity, quality of life and self-rated health. Variables were analyzed using a series of mixed-effects models and stratified based on headache type. Multiple linear and logistic regressions were used to analyze treatment preferences. RESULTS: Behaviors inferred from activity tracker data suggested that individuals slept more, had reduced physical activity, and had lower maximum heart rate on days with headache. As headache-specific impact on quality of life increased, activity and maximum heart rate decreased and sleep increased. Headache days with higher self-rated health were associated with less napping, higher step count and maximum heart rate, correlating with increased activity. Migraineurs experienced greater burden in everyday life compared with tension-type headache sufferers. CONCLUSION: This study adds to existing evidence that activity trackers can be used to quantify headache burden in real-world settings and aid in understanding symptom management.

The impact of overactive bladder on mental health, work productivity and health-related quality of life in the UK and Sweden: results from EpiLUTS.

OBJECTIVE: • To examine the prevalence and burden of overactive bladder (OAB) with bother in the UK and Sweden compared to OAB without bother and no/minimal OAB/lower urinary tract (LUTS) symptoms, respectively. PATIENTS AND METHODS: • A cross-sectional population-representative survey was conducted via the Internet in the UK, Sweden and USA. • Participants rated the frequency and bother of OAB and LUTS. Patient outcomes included the Overactive Bladder Questionnaire Short Form, Patient Perception of Bladder Condition, Short Form-12, Hospital Anxiety and Depression Scale-Anxiety and Hospital Anxiety and Depression Scale-Depression, as well as questions about treatment seeking and work productivity. • OAB was defined as urgency at least sometimes or the presence of urinary urgency incontinence. Three subgroups were compared: no/minimal symptoms, OAB without bother and OAB with bother. • Analyses were conducted by gender and country using general linear and logistic regression models to examine bothersome OAB and treatment seeking. RESULTS: • Survey response was 59.2%; 10,000 people (4724 men and 5276 women) participated. • The prevalence of OAB with bother at least 'somewhat' was 10.9% and 14.6% for men in the UK and Sweden, and 22.5% and 33.7% for women in the UK and Sweden, respectively. • Men and women with bothersome OAB were significantly more likely to seek treatment, report the lowest levels of health-related quality of life and work productivity and the highest levels of anxiety and depression compared to those with no/minimal symptoms and OAB without bother. • Greater symptom severity of urgency, urgency urinary incontinence, frequency, nocturia, and increasing levels of anxiety were strongly predictive of OAB bother in both men and women. • Predictors of treatment seeking included frequency, bother as a result of urgency, and lower levels of depressive symptoms in men, and frequency, nocturia and urgency in women. CONCLUSIONS: • OAB is common in the UK and Sweden, and women are more likely to be affected then men. • The impact of OAB is evident across generic and condition-specific domains of health-related quality of life.

Efficacy and Safety of Diclofenac + Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study.

INTRODUCTION: Back and neck pain are common musculoskeletal disorders. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are frequently used to reduce pain and inflammation with fewer systemic side effects and drug interactions compared with oral NSAIDs. This study assessed efficacy and tolerability of a topical combination of capsaicin + diclofenac to treat acute back/neck pain. METHODS: In a randomized, double-blind, controlled, multicenter, parallel group trial, 746 patients were treated twice-daily for 5 days with diclofenac 2% + capsaicin 0.075%, diclofenac 2%, capsaicin 0.075% or placebo. Efficacy assessments included change and area under the curve in pain on movement for the worst procedure (POMWP), change in pressure algometry, and number of patients with decrease in POMWP of ≥ 30% and ≥ 50%. Adverse events (AEs) were recorded. RESULTS: Change in POMWP between baseline and day 2 evening, 1 h after drug application, demonstrates superiority of the combination (- 3.05 cm) versus diclofenac alone (- 2.33 cm) and placebo (- 2.45 cm), but not capsaicin alone (- 3.26 cm). AEs were consistent with known safety profiles. CONCLUSION: Capsaicin alone and capsaicin + diclofenac showed superior benefit compared with placebo. However, diclofenac alone demonstrated efficacy comparable with placebo, and therefore its addition to capsaicin added no increased pain relief over capsaicin alone. TRIAL REGISTRATION: ClinicalTrials.gov identifier; NCT02700815.

A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain.

BACKGROUND: Ibuprofen is a well-established analgesic for acute pain symptoms. In several acute pain models, caffeine has demonstrated an analgesic adjuvant effect. This randomized trial (NCT03003000) was designed to compare the efficacy of a fixed-dose combination of ibuprofen and caffeine with ibuprofen or placebo for the treatment of acute lower back/neck pain. METHODS: Patients with acute lower back/neck pain resulting in pain on movement (POM) ≥5 on a 10-point numerical rating scale were randomized 2:2:1 to receive orally, three times daily for 6 days, 400 mg ibuprofen+100 mg caffeine, 400 mg ibuprofen or placebo, respectively. The primary endpoint was change in POMWP (POM triggering highest pain score at baseline [worst procedure]) between baseline and the morning of day 2. Key secondary endpoints included POMWP area under curve (AUC) between baseline and the morning of day 4 (POMWPAUC72h) and day 6 (POMWPAUC120h). RESULTS: In total, 635 patients were randomized (256 ibuprofen + caffeine: 253 ibuprofen: 126 placebo). Active treatments exhibited similar reductions in POMWP, with an adjusted mean reduction of 1.998 (standard error [SE]: 0.1042) between baseline and day 2 for ibuprofen, 1.869 (SE: 0.1030) for ibuprofen + caffeine and 1.712 (SE: 0.1422) for placebo. Similar results were observed for POMWPAUC72h and POMWPAUC120h. Safety and tolerability was as expected. CONCLUSION: A decrease in lower back/neck pain, indicated by reduced POMWP, was shown in all active treatment arms; however, treatment effects were small versus placebo. Ibuprofen plus caffeine was not superior to ibuprofen alone or placebo for the treatment of acute lower back/neck pain in this setting.