PolyMyalgia Rheumatica Treatment With Methotrexate in Optimal Dose in an Early Disease Phase (PMR MODE): Study Protocol for a Multicenter Double-blind Placebo Controlled Trial.

2021 ◽  
Author(s):  
Thomas Bolhuis ◽  
Diane E. Marsman ◽  
Nathan den Broeder ◽  
Alfons A. den Broeder ◽  
Aatke van der Maas
Keyword(s):  
Controlled Trial ◽  
Composite Endpoint ◽  
Optimal Dose ◽  
Inflammatory Rheumatic Diseases ◽  
Double Blind ◽  
Early Introduction ◽  
Prednisolone Dose ◽  
Patients At Risk ◽  
The Difference ◽  
Set Up

Abstract BackgroundPolymyalgia rheumatica (PMR) is an inflammatory rheumatic disease affecting people older than 50, resulting in pain and stiffness of the neck, shoulder-, and pelvic girdle. To date, glucocorticoids (GC) remain the cornerstone of treatment, but these have several drawbacks. Firstly, a large proportion of patients do not achieve GC-free remission within either the first (over 70%) or second year of treatment (over 50%). Secondly, GC-related adverse events (AE) occur in up to 65% of patients and can be severe.The current EULAR/ACR guidelines for PMR recommend early introduction of methotrexate (MTX) as a GC sparing agent in patients at risk for worse prognosis. However, earlier trials of low to medium quality only studied MTX dosages of 7.5–10 mg/week with no to modest effect. These doses may be suboptimal as MTX is recommended in higher doses (25 mg/week) for other inflammatory rheumatic diseases. The exact role, timing and dose of MTX in PMR remains unclear and therefore our objective is to study the efficacy of MTX 25 mg/week in recently diagnosed PMR patients. MethodsWe set up a double blind, randomized, placebo-controlled superiority trial (PMR MODE) to assess the efficacy of MTX 25 mg/week versus placebo in a 1:1 ratio in 100 recently diagnosed PMR patients according to the 2012 EULAR/ACR criteria. All patients will receive prednisolone 15mg/day, tapered to 0 mg over the course of 24 weeks. In case of primary non-response or disease relapse prednisolone dose will be temporarily increased. Assessments will take place at baseline, 4, 12, 24, 32, and 52 weeks. The primary outcome is the difference in proportion of patients in GC-free remission at week 52. DiscussionNo relapsing PMR patients were chosen, since the the possible benefits of MTX may not outweigh the risks at low doses and effect modification may occur. Accelerated tapering was chosen in order to more easily identify a GC-sparing effect if one exist. A composite endpoint of GC-free remission was chosen as a clinically relevant endpoint for both patients and rheumatologist and may reduce second order (treatment) effects. Trial registrationDutch trial registration, NL8366 Registered on 2020-02-10

scholarly journals A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Shifu Xiao ◽  
Piu Chan ◽  
Tao Wang ◽  
Zhen Hong ◽  
Shuzhen Wang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Controlled Trial ◽  
Drug Effects ◽  
Disease Assessment ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Difference

Abstract Background New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China. Methods We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was − 2.15 points (95% confidence interval, − 3.07 to − 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group. Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated. Trial registration ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014

scholarly journals A double-blind randomized controlled trial of topical Curcuma xanthorrhiza Roxb. on mild psoriasis: clinical manifestations, histopathological features, and K6 expressions

2018 ◽  
Vol 27 (3) ◽  
pp. 178-84 ◽  
Author(s):  
Githa Rahmayunita ◽  
Tjut N.A. Jacoeb ◽  
Endi Novianto ◽  
Wresti Indriatmi ◽  
Rahadi Rihatmadja ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinical Manifestations ◽  
Effective Treatment Option ◽  
Psoriasis Area Severity Index ◽  
Double Blind ◽  
Old Patients ◽  
Mean Values ◽  
Significant Difference ◽  
Curcuma Xanthorrhiza ◽  
The Difference

Background: Curcuma xanthorrhiza Roxb. exerts its anti-inflammatory effects by reducing the concentration of IL-6, IL-8, and phosphorylase kinase, which has role in keratinocyte proliferation. Our study aimed to evaluate the efficacy of C. xanthorrhiza in psoriasis.Methods: From 18 to 59 year-old patients with mild psoriasis, 2 similar lesions were selected. The severity assessment was based on the psoriasis area severity index (PASI), Trozak score, and K6 expression. Using a double-blinded randomized method, lesion was treated with 1% C. xanthorrhiza ointment vs placebo for 4 weeks. The results were analyzed by the chi-square test using STATATM V.12 software (Stata Corp.).Results: The study was conducted in 2010 to 2012 with 17 subjects participated. The median of PASI score were reduced significantly in both lesions, either treated with 1% C. xanthorrhiza ointment vs placebo; however when compared between the group, it was not significant (p=0.520). The Trozak score were reduced in lesions treated with 1% C. xanthorrhiza ointment; but it was not significant (p = 0.306). In lesions treated with placebo, the Trozak score was increased significantly. The difference of Trozak score between lesions treated with C. xanthorrhiza and placebo was significant (p=0.024). There was no significant difference of K6 expression in lesions treated with 1% C. xanthorrhiza ointments or placebo as well as on the difference of mean values of K6 expression between the group (p=0.827).Conclusion: Based on the results, 1% C. xanthorrhiza ointment is effective treatment option for mild psoriasis, but longer follow-up period is suggested to confirm this results. C. xanthorrhiza ointment is safe for topical administration as there were no side effects reported in this study.

Antithrombin Therapy for Severe Preeclampsia

2000 ◽  
Vol 84 (10) ◽  
pp. 583-590 ◽  
Author(s):  
Masahiro Maki ◽  
Toshihiko Terao ◽  
Tsuyomu Ikenoue ◽  
Kazuo Satoh ◽  
Masao Nakabayashi ◽  
...  
Keyword(s):  
Weight Gain ◽  
Perinatal Outcome ◽  
Controlled Trial ◽  
Severe Preeclampsia ◽  
Fetal Weight ◽  
Low Birth Weight Infants ◽  
Double Blind ◽  
Biophysical Profile ◽  
The Difference ◽  
Estimated Fetal Weight

SummaryA double-blind, randomized, placebo-controlled trial was conducted to evaluate whether treatment with Antithrombin (AT) concentrates improved the clinical and perinatal outcome in patients with severe preeclampsia. Severe preeclamptic patients (24 to 35 weeks of gestation, Gestosis Index (GI) > 6 points) were randomized into two groups: 66 received AT and 67 received placebo. There were no statistical differences in the clinical profiles of the two groups. Study drugs were given intravenously once daily for 7 consecutive days. Maternal symptoms were evaluated from the difference of GI between before and after treatment, and fetal findings were evaluated from the changes of the biophysical profile score and the estimated fetal weight gain. Improvement was significantly greater in the AT group for both the GI (p = 0.020) and the estimated fetal weight gain (p = 0.029). The improvement of coagulation parameters was also evaluated. The D-dimer levels increased significantly in the placebo group (p = 0.026), but did not change in the AT group. Gestation was significantly prolonged (p = 0.007), and the number of low-birth weight infants was significantly smaller (p = 0.011) in the AT group. No adverse events related to AT were observed. It is revealed that AT concentrate therapy for preeclampsia is effective and safe, leading to an improved perinatal outcome.

scholarly journals The Evaluation of the Body Weight Lowering Effects of Herbal Extract THI on Exercising Healthy Overweight Humans: A Randomized Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Soo Hyun Cho ◽  
Yoosik Yoon ◽  
Young Yang
Keyword(s):  
Body Weight ◽  
Controlled Trial ◽  
Safety Evaluation ◽  
Hdl Cholesterol ◽  
Treated Group ◽  
The Body ◽  
Herbal Extract ◽  
Double Blind ◽  
The Difference ◽  
Group 2

We investigated the effects of herbal extracts, a mixture of Scutellariae Radix and Platycodi Radix containing the active ingredients Baicalin and Saponin (target herbal ingredient (THI)), on lowering body weight. The present study was a prospective, randomized, double-blind, and placebo-controlled trial carried out at the outpatient department of a hospital over a period of 2 months. Group 1 patients (n=30) received THI, and group 2 patients (n=23) received placebo three times a day before meals. Weight, waist circumference, BMI, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and glucose were measured at baseline and again at the 2nd month. For safety evaluation, various hematological and biochemical parameters were assessed. Values of mean change of weight in the THI-treated group were−1.16±1.41 kg and in the placebo-treated group were−0.24±1.70 kg, respectively. The difference in mean change of weight in the THI-treated group compared with that in the placebo-treated group was statistically significant (P<0.05). The incidence of subjective and objective adverse drug reactions was insignificant (P>0.05). THI was statistically significant in its effectiveness on the weight loss.

Effect of prebiotic (fructooligosaccharide) on uremic toxins of chronic kidney disease patients: a randomized controlled trial

2018 ◽  
Vol 34 (11) ◽  
pp. 1876-1884 ◽  
Author(s):  
Christiane Ishikawa Ramos ◽  
Rachel Gatti Armani ◽  
Maria Eugenia Fernandes Canziani ◽  
Maria Aparecida Dalboni ◽  
Carla Juliana Ribeiro Dolenga ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Uremic Toxins ◽  
Trophic Factors ◽  
Secondary Outcome ◽  
Model Assessment ◽  
Double Blind ◽  
The Difference

Abstract Background Microbial-derived uremic toxins, p-cresyl sulfate (PCS), indoxyl sulfate (IS) and indole 3-acetic acid (IAA), have been associated with the burden of chronic kidney disease (CKD). Prebiotics have emerged as an alternative to modulate the gut environment and to attenuate toxin production. This trial aims to investigate the effect of a prebiotic fructooligosaccharide (FOS) on uremic toxins of non-dialysis-dependent CKD (NDD-CKD) patients. Methods A double-blind, placebo-controlled, randomized trial was conducted for 3 months. In all, 50 nondiabetic NDD-CKD patients [estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2], aged 18–80 years, were allocated to prebiotic (FOS, 12 g/day) or placebo (maltodextrin, 12 g/day) groups. Primary outcomes were changes in serum (total and free) and urinary (total) PCS. Secondary outcomes included changes in IS, IAA, serum markers of intestinal permeability (zonulin), gut-trophic factors (epidermal growth factor and glucagon-like peptide-2), eGFR, inflammation (high sensitive c-reactive protein and interleukin-6), homeostatic model assessment-insulin resistance, lipid profile and gastrointestinal symptoms. Results From 50 participants (54% men, 57.3 ± 14.6 years and eGFR 21.4 ± 7.6 mL/min/1.73 m2), 46 completed the follow-up. No changes in dietary intake or gastrointestinal symptoms were observed. There was a trend in the difference of serum total ΔPCS (treatment effect adjusted for baseline levels: −12.4 mg/L; 95% confidence interval (−5.6 to 0.9 mg/L; P = 0.07) and serum-free Δ%PCS [intervention −8.6 (−41.5 to 13.9%) versus placebo 3.5 (−28.8 to 85.5%); P = 0.07] between the groups. The trend in the difference of serum total ΔPCS was independent of eGFR and dietary protein:fiber ratio intake. No difference was found in urinary PCS. Aside from the decreased high-density lipoprotein cholesterol in the intervention, no differences were observed in the change of IS, IAA or other secondary outcome between the groups. Conclusions Our result suggests the potential of FOS in reducing serum total and free PCS in nondiabetic NDD-CKD patients.

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

scholarly journals A 36-week Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group, Phase 3 Clinical Trial of Sodium Oligomannate for Mild-to-Moderate Alzheimer's Dementia

2020 ◽  
Author(s):  
Shifu Xiao ◽  
Piu Chan ◽  
Tao Wang ◽  
Zhen Hong ◽  
Shuzhen Wang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Controlled Trial ◽  
Drug Effects ◽  
Disease Assessment ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Difference

Abstract Background: New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide which reconstitutes gut microbiota, reduces neuroinflammation, decreases amyloid deposition, and improves cognition in AD animal models. The first phase 3 clinical trial of GV-971 has been completed in China. Methods: We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results: 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time-point, measurable at the week 4 visit and continuing throughout the trial. The difference between groups in change from baseline was −2.15 points (95% confidence interval, −3.07 to −1.23; P<0.0001; effect size 0.531) after 36 weeks treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group.Conclusions: GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well tolerated. Trial registration: ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014.

scholarly journals Efficacy and safety of single-inhaler triple therapy of glycopyrronium, formoterol, and fluticasone in patients with chronic obstructive pulmonary disease: a double-blind, randomised controlled trial

2021 ◽  
pp. 00255-2021
Author(s):  
Sundeep Salvi ◽  
Akash Balki ◽  
Srikanth Krishnamurthy ◽  
Sagar Panchal ◽  
Saiprasad Patil ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Controlled Trial ◽  
Dual Therapy ◽  
Fixed Dose ◽  
Comparable Efficacy ◽  
Chronic Obstructive ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Copd Patients ◽  
The Difference

BackgroundInvestigating the safety and efficacy of single-inhaler triple therapy with glycopyrronium (GB) 12.5 μg/formoterol fumarate (FF) 12 μg/fluticasone propionate (FP) 250 μg, compared to GB 50 μg co-administered with a fixed dose of FF 12 μg/FP 250 μg in subjects with COPD.MethodsA phase 3, randomised, double-blind, active-control, parallel-group, noninferiority study conducted at 20 sites across India. COPD patients aged ≥40 to ≤75 years, with FEV1/FVC <0.70, using mono/dual therapy with ICS, LAMA, or LABA for ≥1 month, were included. Subjects were randomised 1:1 to GB/FF/FP or GB+FF/FP for 12 weeks. Primary efficacy endpoint was the change from baseline in trough FEV1 at the end of 12 weeks. The study is registered with the Clinical Trials Registry of India (CTRI Reg No: CTRI/2019/01/017156).ResultsBetween March 23, 2019 and February 14, 2020, 396 subjects were enrolled, 198 patients each in the fixed-triple (GB/FF/FP) and open-triple (GB+FF/FP) groups. The difference in LSM changes in predose FEV1 from baseline at 12 weeks was noninferior between the groups (p<0.05). The LSM change from baseline in postdose FEV1 was comparable (p=0.38). Superiority test showed comparable efficacy (p =0.12) for the difference in mean change from baseline in trough FEV1 between the groups. Adverse events (mild or moderate) were recorded in 25.3% and 24.9% of subjects in the GB/FF/FP and GB+FF/FP groups.ConclusionsFixed triple therapy with GB/FF/FP provides comparable bronchodilation and lung function improvement like open triple therapy. It is safe and well-tolerated in symptomatic COPD patients with a history of exacerbations.

A Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Trial of O-(β-Hydroxyetnyl)-Rutosides in Chronic Arm Oedema Resulting from Breast Cancer Treatment

1995 ◽  
Vol 10 (2) ◽  
pp. 51-55 ◽  
Author(s):  
P. S. Mortimer ◽  
C. Badger ◽  
I. Clarke ◽  
J. Pallett
Keyword(s):  
Breast Cancer ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Controlled Clinical Trial ◽  
Point Scale ◽  
Carcinoma Of The Breast ◽  
Double Blind ◽  
Parallel Group ◽  
Royal Marsden Hospital ◽  
The Difference

Objective: To assess the efficacy of O-(β-hydroxyethyl)-rutosides (HR) in the treatment of breast-cancer-related lymphoedema. Design: A double-blind, randomized, parallel-group, placebo-controlled clinical trial. Setting: Lymphoedema clinic, Royal Marsden Hospital, London, UK. Patients: Forty-six females with unilateral lymphoedema of the arm secondary to therapy for carcinoma of the breast. Main outcome measures: Arm volume, symptom assessment on a five-point scale. Results: The difference in arm volumes was significantly better for HR than placebo at 6 months, but not at 1–5 months. Conclusion: HR appears to stabilize the patients' condition against increasing lymphoedema in the placebo group.

Abstract 194: Rosuvastatin Reduces Progression of Carotid Atherosclerosis within 12 Months of Treatment: The METEOR Trial

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Michiel L Bots ◽  
Joel S Raichlen ◽  
Gregory W Evans ◽  
Mike K Palmer ◽  
Daniel H O’Leary ◽  
...  
Keyword(s):  
Carotid Artery ◽  
Controlled Trial ◽  
Intima Media Thickness ◽  
Carotid Intima Media Thickness ◽  
Rate Of Change ◽  
Double Blind ◽  
Atherosclerosis Progression ◽  
Media Thickness ◽  
The Difference ◽  
The Individual

Background: In several statin trials, vascular event rates for treatment groups begin to separate 1 year after commencement of treatment. For atherosclerosis progression, the temporal sequence of the effect has not been defined. We sought to determine the earliest time point at which significant differences in atherosclerosis progression rates were detectable after initiation of statin therapy using data from the METEOR trial (Measuring Effects on intima media Thickness: an Evaluation Of Rosuvastatin). Methods: METEOR was a double-blind, randomized, placebo-controlled trial among 984 low risk subjects, which studied the effect of LDL lowering with 40 mg rosuvastatin on the rate of change in carotid intima media thickness (CIMT) over time. Ultrasound assessments were made at 12 carotid artery sites at baseline and every 6 months up to two years. In these analyses, the data were cut at 6 months, 1 year, and 18 months, and compared with analysis of all data at 2 years, using the same statistical method. Results: The difference in rate of maximum CIMT progression for all carotid artery sites (primary endpoint - near and far walls of the left and right common carotid artery [CCA], carotid bulb and internal carotid artery) between the rosuvastatin and placebo groups was apparent 6 months after baseline (0.0023 mm/yr and 0.0106 mm/yr, respectively p =0.36). After 12 months CIMT progression rates were significantly different between groups: 0.0032 mm/yr and 0.0133 mm/yr (p=0.049). This divergence grew with further follow-up: − 0.0009 mm/yr and 0.0131 mm/yr after 18 months (p<0.0001), and − 0.0014 mm/yr and 0.0131 mm/yr after 24 months of treatment (p<<178>0.0001). For the individual carotid artery segments, significant differences were seen at 12 months for the mean CIMT of the CCA, and at 18 months for the maximum CIMT of the bulb and the CCA. Conclusion: Aggressive LDL lowering with rosuvastatin exerts its beneficial effect on atherosclerosis during the first year of treatment, which parallels the timing of event rate reduction seen in clinical trials. These findings suggest that, in trials examining the effects of treatment on CIMT progression, a duration of 12 months may be adequate, given sufficient sample size, high precision of measurements, and treatment effect.

Sign in / Sign up

Export Citation Format

Share Document