Search results for "Tolerability"
showing 10 items of 372 documents
Aceclofenac versus naproxen in the treatment of ankylosing spondylitis: A double-blind, controlled study
1994
Abstract The efficacy and tolerability of aceclofenac and naproxen sodium in the treatment of ankylosing spondylitis (AS) were evaluated and compared in this double-blind, multicenter, controlled study. Of the 130 patients who entered the study, 126 patients met the inclusion criteria. Efficacy was evaluated at baseline, 15 days, and 1, 2, and 3 months using a visual analog scale for spontaneous pain, a zero to three-point scale for pain on movement and pain at rest, and measurements of chest expansion, hand-to-floor distance, Schober's test, and normal daily activities. No significant between-group differences were seen for any of the variables at baseline, except hand-to-floor distance. B…
Efficacy, tolerability, and effects on quality of life of inhaled salmeterol and oral theophylline in patients with mild-to-moderate chronic obstruct…
1998
Abstract The aims of management in mild-to-moderate stable chronic obstructive pulmonary disease (COPD) are to improve symptoms and quality of life (QOL), reduce decline in lung function, prevent and treat complications, increase survival while maintaining QOL, and minimize the adverse effects of treatment. Bronchodilator therapy is the keystone of improving COPD symptoms and functional capacity. The primary objective of this open-label study was to compare the efficacy and tolerability of salmeterol 50 μg BID administered by metered-dose inhaler versus oral, titrated, sustained-release theophylline BID, both given for 3 months to patients with a clinical history of chronic bronchitis. The …
549 An RNA-lipoplex (RNA-LPX) vaccine demonstrates strong immunogenicity and promising clinical activity in a Phase I trial in cutaneous melanoma pat…
2021
BackgroundLipo-MERIT is an ongoing, first-in-human, open-label, dose-escalation Phase I trial investigating safety, tolerability and immunogenicity of BNT111 in patients with advanced melanoma. BNT111 is an RNA-LPX vaccine targeting the melanoma tumor-associated antigens (TAAs) New York esophageal squamous cell carcinoma 1 (NY-ESO-1), tyrosinase, melanoma-associated antigen 3 (MAGE-A3), and transmembrane phosphatase with tensin homology (TPTE). A previous exploratory interim analysis showed that BNT111, alone or combined with immune checkpoint inhibition (CPI), has a favorable adverse event (AE) profile, gives rise to antigen-specific T-cell responses and induces durable objective responses…
The Tolerability of Nilvadipine Compared to Nifedipine in Patients with Essential Hypertension
1992
In one multicenter, double-blind study, 659 hypertensive patients were treated for 16 weeks with either nilvadipine (n = 326) or nifedipine (n = 333). The major objective of the study was to compare the compatibility of the two calcium antagonists with regard to hepatic compatibility and side-effect profiles. The dosages were chosen so that the effective blood pressure reduction in both groups was equally good (mean decreases in systolic pressure of 27 +/- 12 mm Hg with nilvadipine and 26 +/- 15 mm Hg with nifedipine, and in diastolic pressure of 18 +/- 6 mm Hg with nilvadipine and 19 +/- 7 mm Hg with nifedipine). The mean heart rate was slightly lowered by about 2 beats/min by both substan…
Effects of gemfibrozil in hyperlipidemic patients with or without diabetes
1993
Abstract Four hundred sixty-one hyperlipidemic men and women, aged 23 to 73 years, with (n = 200) or without (n = 261) non-insulin-dependent diabetes mellitus were included in a study designed to evaluate the efficacy and tolerability of 1,200 mg of gemfibrozil given once daily for 24 weeks. All lipid values improved significantly in both diabetic and nondiabetic patients during treatment. The number of patients with the atherogenic predictor ratio of low-density:high-density lipoprotein cholesterol (HDL-C:LDL-C) >5 decreased by 95% in both patient groups. The number of patients in the highest-risk subgroup with the combination risk factors of LDL-C:HDL-C >5 and triglyceride levels >200 mg/…
Aceclofenac versus piroxicam in the management of osteoarthritis of the knee: A double-blind controlled study
1994
Abstract The objective of this study was to compare the efficacy and tolerability of aceclofenac tablets 100 mg twice daily with piroxicam tablets 20 mg once daily in the treatment of osteoarthritis of the knee or gonarthritis. A randomized, double-blind, controlled study of 3 months' duration was conducted in patients with gonarthritis diagnosed according to the World Health Organization criteria. A total of 212 patients were recruited; 205 patients fully complied with the inclusion-exclusion criteria. Of these, 103 received aceclofenac and 102 received piroxicam. Fourteen patients in the aceclofenac group and 12 patients in the piroxicam group who failed to complete the 3-month treatment …
Long-term treatment with the ace inhibitor captopril, alone or in combination with hydrochlorothiazide, in elderly hypertensives: Effects on blood pr…
1993
Abstract The efficacy and tolerability of long-term treatment with the angiotensin converting enzyme inhibitor captopril was evaluated in elderly hypertensive subjects. One hundred thirty patients were studied (61 men and 69 women; mean age, 68.33 ± 5.49 years), all with mild to moderate arterial hypertension (mild = 90–105 mmHg; moderate = 105–115 mmHg). Patients with secondary hypertension were excluded from the study. After a 2-week drug washout, patients were given captopril 25 to 100 mg/day alone or in combination with hydrochlorothiazide (HCTZ) 25 mg/day for 15 weeks. After 2 weeks of treatment, significant decreases in systolic and diastolic blood pressures were observed (P
Observational study on safety and tolerability of duloxetine in the treatment of female stress urinary incontinence in German routine practice
2013
Aims To evaluate the safety and tolerability of duloxetine during routine clinical care in women with stress urinary incontinence (SUI) in Germany, and in particular, to identify previously unrecognized safety issues as uncommon adverse reactions, and the influence of confounding factors present in clinical practice on the safety profile of duloxetine.
Amisulpride versus flupentixol in schizophrenia with predominantly positive symptomatology - a double-blind controlled study comparing a selective D …
1998
The benzamide amisulpride (ASP) is a selective D2-like dopamine antagonist, while flupentixol (FPX), a thioxanthene, blocks D2-like, D1-like and 5-HT2 receptors. To evaluate efficacy and safety of ASP and to investigate the importance of an additional D1-like antagonism for antipsychotic effects and extrapyramidal tolerability, a randomized double-blind multi-center study versus FPX as reference drug was performed for 6 weeks in 132 patients suffering from acute schizophrenia (DSM-III-R) with predominant positive symptomatology. Doses were initially fixed (ASP: 1000 mg/day; FPX: 25 mg/day) but could be reduced by 40% in case of side effects (mean daily doses: ASP: 956 mg; FPX: 22.6 mg). Int…
Abstract CT202: IVAC MUTANOME: Individualized vaccines for the treatment of cancer
2015
Abstract Cancer arises from the accumulation of genomic alterations and epigenetic changes that constitute a hallmark of cancer. Owing to the molecular heterogeneity in cancer, only a minor fraction of patients profit from approved therapies. Available targeted therapies can only address alterations common to a particular type of cancer and induce transient effects due to the generation of resistant sub-clones. In contrast, the IVAC MUTANOME project aims to immunologically target multiple cancer mutations uniquely expressed in a given patient's tumor. The IVAC MUTANOME approach should be applicable to the majority of patients irrespective of the tumor entity and offers the potential to expl…