Effectiveness of Indapamide/amlodipine Single-pill Combination in Patients With Isolated Systolic Hypertension: Post-hoc Analysis of the ARBALET Study

2021 ◽  
Author(s):  
Zh Kobalava ◽  
Eteri Kolesnik ◽  
E Shavarova ◽  
L Goreva ◽  
L Karapetyan
Keyword(s):  
Clinical Practice ◽  
Systolic Hypertension ◽  
Age Groups ◽  
Real Life ◽  
Isolated Systolic Hypertension ◽  
Open Label ◽  
Post Hoc Analysis ◽  
Single Pill ◽  
Treatment Naïve ◽  
Post Hoc

Abstract Background: Isolated systolic hypertension (ISH) is a major cause of morbidity and mortality. This study evaluated the effectiveness of treatment with an indapamide/amlodipine single-pill combination (SPC) in outpatients with uncontrolled ISH aged over 55 years in real-life clinical practice.Methods: This was a post-hoc analysis of the subgroup of patients with ISH from ARBALET, a 3-month, multicenter, observational, open-label study conducted in Russia among patients with grade I or II hypertension who were either uncontrolled on previous antihypertensive treatment or treatment-naïve. The effectiveness of indapamide/amlodipine SPC was assessed by the change in office systolic blood pressure (SBP) and the rate of target SBP (<140 mmHg) achievement at 2 weeks, 1 month and 3 months, in four age groups: 55-59 years, 60-69 years, 70-79 years, and 80 years or older.Results: The ARBALET study recruited 2217 patients, of whom 626 had ISH and were included in this post-hoc analysis (mean age 66.1±7.8 years; 165 men [26.36%] and 461 women [73.64%]). Target SBP <140 mmHg was achieved in 43%, 75% and 93% of patients at 2 weeks, 1 and 3 months, respectively. SBP decreased from baseline by 18.8±10.5 mmHg, 27.2±10.6 mmHg and 31.8±9.9 mmHg at 2 weeks, 1 month and 3 months, respectively. In the groups of patients aged 55-59, 60-69, 70-79, and ≥80 years, SBP reductions at 3 months compared with baseline were -30.3±9.4, -32.4±9.7, -32.5±10.7, and -28.9±9.6 mmHg, respectively. Conclusion: This post-hoc analysis of the observational ARBALET study showed that indapamide/amlodipine SPC was associated with significant reductions in BP and high rates of target BP achievement in a broad age range of patients with ISH treated in routine clinical practice.Trial registration number: ISRCTN40812831

scholarly journals Open-Label Dose Optimization of Methylphenidate Modified Release Long Acting (MPH-LA): A Post Hoc Analysis of Real-Life Titration from a 40-Week Randomized Trial

2014 ◽  
Vol 34 (9) ◽  
pp. 639-649 ◽  
Author(s):  
Michael Huss ◽  
Ylva Ginsberg ◽  
Torben Arngrim ◽  
Alexandra Philipsen ◽  
Katherine Carter ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Real Life ◽  
Dose Optimization ◽  
Modified Release ◽  
Open Label ◽  
Post Hoc Analysis ◽  
Label Dose ◽  
Long Acting ◽  
Post Hoc

scholarly journals Efficacy of Lurasidone in Antipsychotic-Naive vs. Antipsychotic-Exposed Adolescents with Schizophrenia: Post-Hoc Analysis of a Two-Year, Open-Label Study

CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 147-147
Author(s):  
Christoph Correll ◽  
Michael Tocco ◽  
Andrei Pikalov ◽  
Jay Hsu ◽  
Robert Goldman
Keyword(s):  
Effect Size ◽  
Extension Phase ◽  
Controlled Study ◽  
Open Label ◽  
Antipsychotic Therapy ◽  
Post Hoc Analysis ◽  
Long Term Treatment ◽  
Treatment Naïve ◽  
Post Hoc

AbstractBackgroundFew studies have examined treatment response in adolescents with schizophrenia who are treatment-naive; and there is no placebo-controlled study that we are aware of in first episode treatment-naive patients with schizophrenia. The aim of this analysis was to evaluate the long-term efficacy of lurasidone in antipsychotic-naive adolescents with schizophrenia.MethodPatients aged 13–17 years with schizophrenia, and a PANSS total score ≥70 and <120, were randomized to 6 weeks of double-blind (DB) treatment with lurasidone (40 or 80 mg/day) or placebo. Six-week completers were eligible to enroll in a 2-year open-label extension phase receiving lurasidone flexibly dosed from 20–80 mg/day. In a post-hoc analysis, efficacy was evaluated for 2 patient groups based on treatment status prior to entering the initial 6-week DB study (treatment naïve [TN] vs. treated previously [TP]). Treatment-naïve was defined as never having received antipsychotic treatment. Efficacy measures included the PANSS total score and the Clinical Global Impression, Severity (CGI-S) score. Level of functioning was assessed using the Children’s Global Assessment Scale (CGAS), with a score of 70 representing normative levels of functioning.ResultsA total of 50 TN and 221 TP patients completed the 6-week DB study and entered the extension study; and 30 (60.0%) TN and 126 (57.0%) TP patients completed 104 weeks. During the initial 6 weeks of DB treatment, mean change in PANSS total score at endpoint was greater for lurasidone vs. placebo in both the TN group (−25.0 vs. −14.4; P<0.02; effect size, 0.75), and in the TP group (−17.3 vs. −10.0; P<0.001; effect size, 0.45). During OL extension phase treatment with lurasidone, mean change from DB baseline in the PANSS total score for TN and TP patients, at week 52 was −32.6 (n=38) and −28.1 (n=151), respectively; and at week 104 was −33.6 (n=30) and −29.2 (n=126), respectively. Mean change from DB baseline in CGI-S score at both weeks 52 and 104 was −1.8 for TN patients and −1.5 for TP patients. At DB baseline mean CGAS scores indicated significant functional impairment in both the TN and TP patients (CGAS=48 and 43, respectively). During OL treatment with lurasidone, mean change (from DB baseline) in the CGAS score at Weeks 52 and 104, respectively, was +22.0 and +22.9 in TN patients, and +21.1 and +22.9 in TP patients. During OL treatment with lurasidone, mean observed change from DB baseline in the weight (in kg,) at Weeks 52 and 104, respectively, was +4.2 and +4.8 in TN patients, and +4.0 and +5.0 in TP patients. These weight increases are consistent with expected weight gains in adolescents during a 2-year period (based on CDC growth charts).ConclusionsIn this post-hoc analysis of a 2-year study, adolescents with schizophrenia who had received no previous antipsychotic therapy showed greater improvement compared to previously treated patients during both short- and long-term treatment with lurasidone.FundingSunovion Pharmaceuticals Inc.

scholarly journals Use of angiotensin II receptor blockers alone and in combination with other drugs: a large clinical experience trial

2001 ◽  
Vol 2 (1_suppl) ◽  
pp. S217-S222
Author(s):  
Matthew R Weir ◽  
Rebecca Y Wang
Keyword(s):  
Blood Pressure ◽  
Essential Hypertension ◽  
Systolic Hypertension ◽  
Large Scale ◽  
Candesartan Cilexetil ◽  
Antihypertensive Drugs ◽  
Isolated Systolic Hypertension ◽  
Open Label ◽  
Background Therapy ◽  
Receptor Blockers

Angiotensin II (Ang II) receptor blockers are the newest class of antihypertensive drugs to be developed. No large-scale clinical trials have been performed to evaluate their efficacy alone, or in combination with other drugs. A large-scale, eight week, open-label, non-placebo-controlled, single-arm trial evaluated the efficacy, tolerability and dose-response of candesartan cilexetil, 16—32 mg once-daily, either as monotherapy or as part of combination therapy, in a diverse hypertensive population in actual practice settings. 6465 patients with high blood pressure, of whom 52% were female and 16% African American, with a mean age of 58 years, were included. 5446 patients had essential hypertension and 1014 patients had isolated systolic hypertension. In order to be included in this study, patients had either untreated or uncontrolled hypertension (systolic blood pressure (SBP) 140—179 mmHg and/or diastolic blood pressure (DBP) 90—109 mmHg inclusive at baseline), despite a variety of other antihypertensive drugs. Of the 5156 patients with essential hypertension and at least one post baseline efficacy measurement, the mean pretreatment blood pressure (BP) was 156/97 mmHg. Candesartan cilexetil monotherapy reduced mean SBP/DBP by 18.0/12.2 mmHg. Similarly, in the 964 patients with isolated systolic hypertension and at least one post baseline efficacy measurement, candesartan cilexetil monotherapy reduced SBP/DBP from 158/81 by 16.5/4.5 mmHg. Candesartan cilexetil was similarly effective when employed as add-on therapy. When added to baseline antihypertensive medication in 51% of the patients with essential hypertension not achieving BP control, additional reduction in BP was achieved regardless of the background therapy, including diuretics (17.8/11.7 mmHg) calcium antagonists (16.6/11.2 mmHg), beta-blockers (16.5/10.4 mmHg), angiotensin-converting enzyme inhibitors (ACE-I) (15.3/10.0 mmHg), and alpha blockers (16.4/10.4 mmHg). Likewise, when candesartan cilexetil was used as add-on therapy in patients with isolated systolic hypertension, there was a consistent further reduction of mean SBP/DBP, regardless of the background therapy. Moreover, these monotherapeutic or add-on efficacy benefits were seen regardless of age (<65 or >65 years), gender, or race. Despite the open-label design of the study which enhances efficacy owing to the placebo effect, the Ang II receptor blocker, candesartan cilexetil either alone, or as an add-on therapy, is highly effective for assisting in the control of systolic and diastolic hypertension.

Poster 55: Relief of Spasticity-Related Pain with Botulinum Neurotoxin-A (BoNT-A) in Real Life Practice. Post-Hoc Analysis from a Large International Cohort Series

PM&R ◽  
2018 ◽  
Vol 10 ◽  
pp. S25-S26
Author(s):  
Bruce Rubin ◽  
Stephen Ashford ◽  
Jorge Jacinto ◽  
Klemens Fheodoroff ◽  
Pascal Maisonobe ◽  
...  
Keyword(s):  
Botulinum Neurotoxin ◽  
Real Life ◽  
Botulinum Neurotoxin A ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals 08 Evidence Base for Treatment of Osteoporosis in Older People

2019 ◽  
Vol 48 (Supplement_4) ◽  
pp. iv3-iv3
Author(s):  
Tahir Masud
Keyword(s):  
Oldest Old ◽  
Age Groups ◽  
Osteoporotic Fractures ◽  
Osteoporosis Treatment ◽  
Fracture Reduction ◽  
Older Population ◽  
Term Care ◽  
Treatment Of Osteoporosis ◽  
Post Hoc Analysis ◽  
Post Hoc

Abstract After the age of fifty years the prevalence of osteoporosis and incidence of osteoporotic fractures rise substantially with age. It is ironic however that the pivotal trials for the common drugs used to treat osteoporosis mainly recruited participants under the age of 80 years leading some to question the use of these drugs in the older population. This talk explores the evidence accumulated for the treatment of osteoporosis in the frailer older population. The FOSIT trial showed a 47% reduction in non-vertebral fractures with alendronate in people up to 84 years, and a study in long term care in those up to 91 years showed a significant improvement in bone density at the spine and hip. A post hoc analysis of the risedronate HIP trial in people aged 70-100 years with established osteoporosis showed a 47% reduction in hip fractures. In the zoledronic acid Horizon studies fractures were significantly reduced in a population up to the age of 89 years and mortality was reduced by 28%, with half of the participants being older than 75 years. Interestingly a post hoc analysis showed that those participants who ended up having only a single infusion had a reduction of all clinical fractures at 3 years. The Freedom trial of denosumab was performed in a population aged up to 90 years with significant fracture reduction across all age groups. Studies with the anabolic agent teriparatide showed that vertebral and non-vertebral fracture reduction occurred in both the under and over 75 age groups. Trials with the recently developed agents abaloparatide and romosozumab have shown significant fracture reductions in populations up to ages of 86 and 90 years respectively. There is now enough evidence to suggest that the oldest old should be considered for osteoporosis treatment as well having a focus on falls reduction.

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