PND81 PATIENT GLOBAL IMPRESSION OF CHANGE RELATED TO IMPROVEMENT IN MOST BOTHERSOME SYMPTOM FOLLOWING TREATMENT WITH EPTINEZUMAB

Background A significant proportion of triptan users exhibit an insufficient response or inadequate tolerability to a triptan, and some may develop a contraindication. Lasmiditan, a selective 5-HT1F receptor agonist, may be an option for these individuals. We assessed lasmiditan efficacy in a subgroup of patients in CENTURION (Phase 3 migraine consistency study) who exhibited an insufficient response to triptans, including a subgroup with insufficient response due to efficacy only. Methods Patients were randomized to lasmiditan 200 mg for four attacks, lasmiditan 100 mg for four attacks, or placebo for three and lasmiditan 50 mg for one attack. Triptan insufficient responders were pre-defined as patients with insufficient efficacy or tolerability, or who developed a contraindication. Results In triptan insufficient responders, lasmiditan was superior to placebo ( p < 0.05) for pain freedom beginning at 1 h (both doses); pain relief beginning at 0.5 (200 mg) or 1 h (100 mg); migraine-related disability freedom, much/very much better on the Patient Global Impression of Change, and most bothersome symptom freedom at 2 h; sustained pain freedom; and need for rescue medication. Lasmiditan showed benefit for consistency of effect across attacks for 2-h pain freedom and pain relief. Findings were similar in triptan responders and triptan naïve patients and when the triptan insufficient response definition was based on efficacy only. Conclusions Lasmiditan was efficacious across multiple clinically relevant endpoints in the acute treatment of migraine independent of prior response to triptans. Trial Registration: CENTURION (NCT03670810); SAMURAI (NCT02439320); SPARTAN (NCT02605174)

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485 Efficacy and Safety of Once- and Twice-Nightly Dosing of Lower-Sodium Oxybate in Adults With Idiopathic Hypersomnia

SLEEP ◽

10.1093/sleep/zsab072.484 ◽

2021 ◽

Vol 44 (Supplement_2) ◽

pp. A191-A192

Author(s):

Isabelle Arnulf ◽

Anne Marie Morse ◽

Patricia Chandler ◽

Rupa Parvataneni ◽

Dan Chen ◽

...

Keyword(s):

Sodium Oxybate ◽

Mean Difference ◽

Controlled Study ◽

Efficacy And Safety ◽

Open Label ◽

Double Blind ◽

Patient Global Impression ◽

Idiopathic Hypersomnia ◽

Secondary Endpoints ◽

Global Impression Of Change

Abstract Introduction Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder. In a randomized, controlled study of lower-sodium oxybate (LXB; Xywav™) in adults with IH (NCT03533114), significant differences for LXB compared with placebo were observed in Epworth Sleepiness Scale (ESS; primary efficacy endpoint), self-reported Patient Global Impression of Change (PGIc), and IH Severity Scale (IHSS; key secondary endpoints). In this clinical study, investigators were permitted to initiate LXB dosing on a once-nightly or twice-nightly regimen. Methods Eligible participants aged 18–75 years began LXB treatment, administered once or twice nightly during an open-label treatment/titration and optimization period (OLTTOP; 10–14 weeks); dose amount/regimen could be adjusted during this period. Participants next entered a 2-week, open-label, stable-dose period (SDP), then were randomized to placebo or to continue LXB treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). P values are nominal for this exploratory analysis. Results Of 154 enrolled participants, 40 (26%) initiated LXB treatment on a once-nightly regimen. In the efficacy population (n=115), 27 participants were on a once-nightly regimen during SDP (48.1% of whom initiated treatment once nightly during OLTTOP) and 88 participants were on a twice-nightly regimen during SDP (86.4% of whom initiated treatment twice nightly during OLTTOP). During SDP, median (min, max) LXB total dose was 4.5 (2.5, 6) g/night (once-nightly group) and 7.5 (4.5, 9) g/night (twice-nightly group). ESS scores worsened in participants randomized to placebo vs those continuing LXB in the once-nightly group (n=11 and n=15, respectively; LS mean difference [95% CI]: −4.93 [−7.41, −2.46]; P=0.0004) and twice-nightly group (n=47 and n=41, respectively; LS mean difference [95% CI]: −7.44 [−9.15, −5.72]; P<0.0001). Worsening was also observed in PGIc (once-nightly: 81.8% [placebo] vs 26.7% [LXB]; P=0.0077; twice-nightly: 89.4% [placebo] vs 19.5% [LXB]; P<0.0001) and IHSS score (estimated median difference [95% CI], once-nightly: −9.00 [−16.0, −3.0]; P=0.0028; twice-nightly: −12.00 [−15.0, −8.0]; P<0.0001). Common adverse events included nausea (21.4%), headache (16.2%), anxiety (14.9%), dizziness (11.7%), insomnia (11.7%), and vomiting (10.4%). Conclusion The efficacy and safety of LXB in IH were demonstrated for both once-nightly and twice-nightly regimens. The majority of participants initiated and remained on a twice-nightly regimen. Support (if any) Jazz Pharmaceuticals

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Autonomic conditioning therapy reduces fatigue and improves global impression of change in individuals with post-acute COVID-19 syndrome

10.21203/rs.3.rs-440909/v1 ◽

2021 ◽

Author(s):

David Putrino ◽

Laura Tabacof ◽

Jenna Tosto-Mancuso ◽

Jamie Wood ◽

Mar Cortes ◽

...

Keyword(s):

Physical Therapy ◽

Patient Reported Outcome ◽

Therapy Program ◽

Patient Global Impression ◽

Autonomic Conditioning ◽

Patient Reported ◽

Conditioning Therapy ◽

Physical Therapy Program ◽

Global Impression Of Change

Abstract Post-acute COVID-19 syndrome (PACS) is a collection of persistent and debilitating symptoms lasting weeks to months after acute COVID-19 infection, with fatigue most commonly reported. There is controversy surrounding the role of exercise programs for this condition, due to concerns over the potential to worsen fatigue. We developed a novel physical therapy program known as Autonomic Conditioning Therapy (ACT) for PACS, and report on the preliminary patient-reported outcome (PRO) data from individuals who completed ACT for PACS, compared with those who did not. Seventy-eight (55 [71%] female, median [range] age 43 [12 to 78]) met the inclusion criteria and consented to have their data included in the analyses. A total of 31 (40%) individuals completed ACT for PACS. There was within-group improvement in fatigue in individuals who completed ACT for PACS (mean difference [95% CI] -14 [-27 to -1], p = 0.03), as well as greater between-group impression of change measured on the Patient Global Impression of Change scale (ACT for PACS median [range] 5 [1 to 7], no ACT for PACS 4 [1 to 7], p < 0.01). ACT for PACS is a novel physical therapy program that can reduce fatigue in individuals with PACS.

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Contributions of change in clinical status parameters to Patient Global Impression of Change (PGIC) scores among persons with fibromyalgia treated with milnacipran

Pain ◽

10.1016/j.pain.2010.02.043 ◽

2010 ◽

Vol 149 (2) ◽

pp. 373-378 ◽

Cited By ~ 51

Author(s):

Michael E. Geisser ◽

Daniel J. Clauw ◽

Vibeke Strand ◽

Michael R. Gendreau ◽

Robert Palmer ◽

...

Keyword(s):

Clinical Status ◽

Patient Global Impression ◽

Global Impression Of Change

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149 Deutetrabenazine for the Treatment of Tardive Dyskinesia: Results From an Open-Label, Long-Term Study

CNS Spectrums ◽

10.1017/s1092852918000433 ◽

2018 ◽

Vol 23 (1) ◽

pp. 92-93

Author(s):

Karen E. Anderson ◽

Mat D. Davis ◽

Stewart A. Factor ◽

Robert A. Hauser ◽

L. Fredrik Jarskog ◽

...

Keyword(s):

Tardive Dyskinesia ◽

Involuntary Movement ◽

Treatment Success ◽

Open Label ◽

Dopamine Receptor Antagonists ◽

Long Term Study ◽

Patient Global Impression ◽

Pharmaceutical Industries ◽

Global Impression Of Change

AbstractIntroductionTardive dyskinesia (TD) is an involuntary movement disorder resulting from exposure to dopamine-receptor antagonists. In the 12-week ARM-TD and AIM-TD studies, deutetrabenazine demonstrated significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores at Week 12 compared with placebo, and was generally well tolerated.ObjectiveTo evaluate the efficacy and safety of long-term deutetrabenazine therapy in patients with TD.MethodsPatients with TD who completed the ARM-TD or AIM-TD studies were eligible to enter this open-label, single-arm, long-term safety study after they completed the 1-week washout period and final evaluation in the blinded portion of the trial. Efficacy endpoints included the change in AIMS score from baseline, and treatment success (defined as “much improved” or “very much improved”) on the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC). This analysis reports results up to Week 54.Results304 patients enrolled in the extension study. At Week 54, the mean (standard error) change in AIMS score was –5.1 (0.52). After 6 weeks of deutetrabenazine treatment, the proportion of patients who achieved treatment success was 58% per the CGIC and 53% per the PGIC, and by Week 54 was 72% per the CGIC and 59% per the PGIC, thus demonstrating maintenance or enhancement of benefit over time. Deutetrabenazine was well tolerated for up to 54 weeks, and compared with the ARM-TD and AIM-TD studies, no new safety signals were detected.Conclusions54 weeks of deutetrabenazine treatment was generally efficacious, safe, and well tolerated in patients with TD.Presented at: The American Psychiatric Association 2017 Annual Meeting; May 20–24, 2017; San Diego, California, USA.Funding AcknowledgementsThis study was funded by Teva Pharmaceutical Industries, Petach Tikva, Israel.

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IMPROVEMENT IN INCONTINENCE QUALITY OF LIFE (I-QOL) AND PATIENT GLOBAL IMPRESSION OF CHANGE (PGIC) MEASURES IN WOMEN WITH STRESS URINARY INCONTINENCE (SUI) FOLLOWING TREATMENT WITH [S,S] - REBOXETINE (SSRBX)

The Journal of Urology ◽

10.1016/s0022-5347(08)60321-3 ◽

2008 ◽

Vol 179 (4S) ◽

pp. 111-111

Author(s):

Norman Zinner ◽

David Scholfield ◽

Koshika Soma ◽

Amanda Darekar ◽

Tara Symonds ◽

...

Keyword(s):

Quality Of Life ◽

Urinary Incontinence ◽

Stress Urinary Incontinence ◽

Patient Global Impression ◽

Global Impression Of Change

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The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgia. A Randomized, Double-blind, Placebo-controlled Trial

The Journal of Rheumatology ◽

10.3899/jrheum.080734 ◽

2009 ◽

Vol 36 (2) ◽

pp. 398-409 ◽

Cited By ~ 172

Author(s):

PHILIP J. MEASE ◽

DANIEL J. CLAUW ◽

R. MICHAEL GENDREAU ◽

SRINIVAS G. RAO ◽

JAY KRANZLER ◽

...

Keyword(s):

Controlled Trial ◽

Response To Therapy ◽

Response Criteria ◽

Individual Response ◽

Double Blind ◽

Patient Global Impression ◽

Sf 36 ◽

Pain Visual Analog Scale ◽

Global Impression Of Change ◽

Multiple Symptoms

Objective.To evaluate the safety and efficacy of milnacipran, a dual norepinephrine and serotonin reuptake inhibitor, in the treatment of fibromyalgia (FM).Methods.A 27-week, randomized, double-blind, multicenter study compared milnacipran 100 and 200 mg/day with placebo in the treatment of 888 patients with FM. Two composite responder definitions were used to classify each patient’s individual response to therapy. “FM responders” concurrently satisfied response criteria for improvements in pain (visual analog scale 24-h morning recall), patient global impression of change (PGIC), and physical functioning (SF-36 Physical Component Summary); while “FM pain responders” concurrently satisfied response criteria for improvements in pain and PGIC.Results.At the primary endpoint, after 3-month stable dose treatment, a significantly higher percentage of milnacipran-treated patients met criteria as FM responders versus placebo (milnacipran 200 mg/day, p = 0.017; milnacipran 100 mg/day, p = 0.028). A significantly higher percentage of patients treated with milnacipran 200 mg/day also met criteria as FM pain responders versus placebo (p = 0.032). Significant pain reductions were observed after Week 1 with both milnacipran doses. At 15 weeks, milnacipran 200 mg/day led to significant improvements over placebo in pain (realtime, daily and weekly recall; all measures, p < 0.05), PGIC (p < 0.001), fatigue (p = 0.016), cognition (p = 0.025), and multiple SF-36 domains. Milnacipran was safe and well tolerated by the majority of patients during 27 weeks of treatment; nausea and headache were the most common adverse events.Conclusion.Milnacipran is safe and effective for the treatment of multiple symptoms of FM.

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Aminophylline for treatment of postdural puncture headache

Neurology ◽

10.1212/wnl.0000000000005351 ◽

2018 ◽

Vol 90 (17) ◽

pp. e1523-e1529 ◽

Cited By ~ 6

Author(s):

Chuanjie Wu ◽

Dongsheng Guan ◽

Ming Ren ◽

Zhengfei Ma ◽

Changming Wan ◽

...

Keyword(s):

Adverse Events ◽

Early Stage ◽

Standing Position ◽

Postdural Puncture Headache ◽

Intention To Treat ◽

Headache Severity ◽

Patient Global Impression ◽

Significant Difference ◽

Vas Scores ◽

Global Impression Of Change

ObjectiveTo investigate the efficacy and safety of IV aminophylline for patients with postdural puncture headache (PDPH).MethodsWe randomly assigned patients to groups receiving either 250 mg IV aminophylline or a placebo within 3 hours of symptom onset once daily for 2 consecutive days. The primary endpoint was headache severity 8 hours after treatment. We assessed this using visual analog scale (VAS) scores taken from patients in a standing position. We also recorded posttreatment VAS score changes, Patient Global Impression of Change (PGIC) scores, and adverse events. We performed an intention-to-treat analysis.ResultsWe enrolled 126 patients with PDPH at 5 centers in China (62 assigned to the aminophylline group and 64 to the placebo group). The median age was 37 years, and 96 (76.2%) patients were women. Compared to the placebo-treated patients, the aminophylline-treated patients had significantly lower mean VAS scores 8 hours after treatment (5.34 vs 2.98, p < 0.001) and were significantly more likely to report improvements on the PGIC (39.1% vs 72.6%, p < 0.01). This therapeutic effect was already evident at the 30-minute time point and persisted for 2 days. There was no significant difference in the incidence of adverse events (4.8% vs 1.6%, p = 0.589).ConclusionsIV aminophylline is an effective and safe early-stage treatment for patients with PDPH.ClinicalTrials.gov identifierNCT02522013.Classification of evidenceThis study provides Class I evidence that for people with PDPH, IV aminophylline reduces headache severity.

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Clinical impact of confinement due to the COVID-19 pandemic on patients with fibromyalgia: A cohort study

10.21203/rs.3.rs-93711/v1 ◽

2020 ◽

Author(s):

Javier Rivera ◽

Isabel Castrejón ◽

Laura Vallejo-Slocker ◽

Martin Offenbächer ◽

Juan Molina-Collada ◽

...

Keyword(s):

Daily Living ◽

Clinical Manifestations ◽

Repeated Measurements ◽

Anxiety And Depression ◽

Passive Coping ◽

Patient Global Impression ◽

Clinical Impairment ◽

Index Of Severity ◽

Global Impression Of Change

Abstract Background: Data on the effect of the COVID-19 pandemic on fibromyalgia (FM) patients are lacking. FM patients often experience clinical impairment with stress situations.The objective of this study was to determine whether severity of FM increases because of confinement due to the COVID-19 pandemic.Methods: Prospective study including patients from the Combined Index of Severity of Fibromyalgia (ICAF) cohort who met the 2010 ACR FM criteria. In this cohort, all patients have a periodical evaluation of their quality of life through two questionnaires, the ICAF -which assesses the ability to perform daily living activities, anxiety and depression-, and through the Patient Global Impression of Change (PGIC), which assesses overall change after a therapeutical intervention. Pre and post-confinement measurements were analyzed. Inferential statistical analysis and ANOVA for repeated measurements were used.Results: A total of 93 patients received a phone consultation, (95.5% females), mean (SD) age of 48.23 (8.38) years. Four patients were excluded as presenting COVID-19 and 51 (57%) completed the post-confinement ICAF. Following confinement, 25 (49%) patients got worse (group worse) and 26 (51%) patients experienced no change or improved (group stable). Comparisons between pre and post confinement ICAF did not show significant differences in both groups. Passive coping was significantly different in group worse in pre-confinement evaluation. In the 80% of patients with passive coping predominance there were no change in coping strategy.Conclusions: No clinical impairment due to COVID-19 confinement occurred. The perceived worsening among FM patients relies primarily on how patients cope with their disease, without a real impact on clinical manifestations.

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What is the clinical relevance of the Numerical rating scale for pain?

10.1093/med/9780198834359.003.0059 ◽

2018 ◽

Author(s):

Felicia Cox

Keyword(s):

Chronic Pain ◽

Pain Intensity ◽

Rating Scale ◽

Numerical Rating Scale ◽

Clinical Importance ◽

Patient Global Impression ◽

Numerical Rating ◽

Group A ◽

Clinically Significant ◽

Global Impression Of Change

The landmark paper discussed in this chapter is ‘Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale’, published by Farrar et al. in 2001. The numerical rating scale is now the standard instrument used in chronic pain studies to measure pain intensity. Farrar et al. determined the changes in pain intensity that were clinically significant for studies of chronic pain while measuring the patient’s global impression of change. The paper used pooled data from ten recent studies of pregabalin in 2,724 subjects. The authors reported a consistent relationship between pain intensity and patient global impression of change, regardless of study, disease type, age, sex, study result, or treatment group. A reduction of approximately two points on the numerical rating scale, or of 30% in the global impression of change of pain intensity, represented a clinically important difference.

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