scholarly journals Efficacy and Safety of Once-Weekly Thyroxine for Thyroxine-Resistant Hypothyroidism

2019 ◽  
Vol 3 (12) ◽  
pp. 2184-2193 ◽  
Author(s):  
Chellama Jayakumari ◽  
Abilash Nair ◽  
Jabbar Puthiyaveettil Khadar ◽  
Darvin V Das ◽  
Nandini Prasad ◽  
...  
Keyword(s):  
Term Treatment ◽  
Efficacy And Safety ◽  
Poor Control ◽  
Open Label ◽  
Thyroxine Therapy ◽  
Real World Setting ◽  
Long Term Treatment ◽  
Lost To Follow Up

Abstract Context Noncompliance with thyroxine therapy is the most common cause of poor control of hypothyroidism. An open-label prospective study to compare once-weekly thyroxine (OWT) with standard daily thyroxine (SDT) was undertaken. Design Patients taking thyroxine doses of >3 μg/kg/d, with or without normalization of TSH, were included and administered directly observed OWT or nonobserved SDT according to patient preference based on their weight for 6 weeks. Furthermore, patients on OWT were advised to continue the same at home without supervision. Results Twenty six of 34 patients on OWT and 7 of 18 patients on SDT achieved a TSH <10 μIU/mL (P < 0.05), and 2 patients from the SDT arm were lost to follow-up. During home treatment, 15 of 25 at 12 weeks and 19 of 23 contactable patients at a median follow-up of 25 months maintained TSH below target. Thyroxine absorption test was unable to predict normalization of TSH at 6 weeks of OWT therapy. No adverse events were seen with OWT-treated patients over the 12-week follow-up period. OWT has significantly higher efficacy (OR = 5.1) than SDT for patients with thyroxine-resistant hypothyroidism and is not associated with side effects. Conclusion OWT benefits a majority of patients in the long-term treatment of thyroxine-resistant hypothyroidism, in the real-world setting.

Safety of dienogest in the long-term treatment of endometriosis: a one-year, open-label, follow-up study

2009 ◽  
Vol 92 (3) ◽  
pp. S107 ◽  
Author(s):  
C. Seitz ◽  
C. Gerlinger ◽  
T. Faustmann ◽  
T. Strowitzki
Keyword(s):  
Term Treatment ◽  
Open Label ◽  
Follow Up Study ◽  
Long Term Treatment ◽  
One Year

United States open-label glatiramer acetate extension trial for relapsing multiple sclerosis: MRI and clinical correlates

2001 ◽  
Vol 7 (1) ◽  
pp. 33-41 ◽  
Author(s):  
Jerry S Wolinsky ◽  
Ponnada A Narayana ◽  
Kenneth P Johnson ◽  
Keyword(s):  
Glatiramer Acetate ◽  
Term Treatment ◽  
Open Label ◽  
Clinical Correlates ◽  
Long Term Treatment ◽  
Open Label Extension ◽  
Long Term Follow Up ◽  
Relapsing Multiple Sclerosis

After the placebo-controlled extension of the pivotal US trial of glatiramer acetate for the treatment of relapsing multiple sclerosis ended, 208 participants entered an open-label, long-term treatment protocol. Magnetic resonance imaging (MRI) was added to the planned evaluations of these subjects to determine the consequences of long-term treatment on MRI-defined pathology and evaluate its clinical correlates. Of the 147 subjects that remained on long-term follow-up, adequate images were obtained on 135 for quantitative MRI analysis. The initial imaging sessions were performed between June 1998 and January 1999 at 2447+61 days (mean+standard deviation) after the subject's original randomization. Clinical data from a preplanned clinical visit were matched to MRI within 3+51 days. At imaging, 66 patients originally randomized to placebo (oPBO) in the pivotal trial had received glatiramer acetate for 1476+63 days, and 69 randomized to active treatment with glatiramer acetate (oGA) were on drug for 2433+59 days. The number of documented relapses in the 2 years prior to entering the open-label extension was higher in the group originally randomized to placebo (oPBO=1.86+1.78, oGA=1.03+1.28; P=0.002). The annualized relapse rate observed during the open-label study was similar for both groups (oPBO=0.27, +0.45 oGA=0.28+0.40), but the reduction in rate from the placebo-controlled phase was greater for those beginning therapy with GA (oPBO reduced by 0.66+0.71, oGA reduced by 0.23+0.58; P=0.0002). One or more gadolinium enhancing lesions were found in 27.4% of all patients (number of distinct enhancements=1.16+2.52, total enhanced tissue volume=97+26 ml). The risk of having an enhancement was higher in those with relapses during the open-label extension (odds ratio 4.65, 95% confidence interval (CI) 2.0 to 10.7; P=0.001). The odds for finding an enhancement was 2.5 times higher for those patients originally randomized to placebo (CI 1.1 to 5.4; P=0.02) compared to those always on glatiramer acetate. MRI-metrics indicative of chronic pathology, particularly measures of global cerebral tissue loss (atrophy), were uniformly worse for those originally on placebo. These observations enrich our long-term follow up of the clinical consequences of treatment with glatiramer acetate to include its apparent effects on MRI-defined pathology. They show that the effect of glatiramer acetate on enhancements is definite, but modest, consistent with the drug's described mechanisms of action, and that a delay in initiating treatment results in progression of MRI-measured pathology that can be prevented.

Cisapride in the Long-Term Treatment of Chronic Gastroparesis: A 2-Year Open-Label Study

1997 ◽  
Vol 25 (4) ◽  
pp. 182-189 ◽  
Author(s):  
BJ Kendall ◽  
ET Kendall ◽  
I Soykan ◽  
RW McCallum
Keyword(s):  
Gastric Emptying ◽  
Symptom Score ◽  
Gastrointestinal Symptoms ◽  
Symptomatic Improvement ◽  
Term Treatment ◽  
Open Label ◽  
Open Label Study ◽  
Long Term Treatment

The effect of long-term cisapride therapy (20 mg orally three times daily for 2 years) on gastric emptying and gastrointestinal symptoms was investigated in 30 patients with severe gastroparesis (24 idiopathic, 6 diabetic). Symptoms were assessed every 2 months, using an overall symptom score based on six symptoms (anorexia, nausea, vomiting, pain, early satiety and bloating), and a 2-year mean overall symptom score was used for analysis. Gastric emptying was measured at 0, 6, 12, 18 and 24 months. Of the 24 patients who completed the study, 10 showed a significant improvement in gastric emptying ( P < 0.05) and felt improved on therapy, seven patients showing a > 20% improvement in overall symptom score compared to baseline. Results for 15 patients who underwent at least one follow-up gastric-emptying test showed only a weak correlation between individual symptom score and gastric emptying ( r = 0.40). Thus long-term cisapride therapy at the study dose produced long-term symptomatic improvement in 42% of patients with severe gastroparesis, with sustained acceleration of gastric emptying for up to 2 years.

Long-Term Treatment Outcomes for Heroin Dependence: The 11-Year Follow-Up of the ATOS Study

2013 ◽  
Author(s):  
Christina Marel ◽  
Maree Teesson ◽  
Shane Darke ◽  
Katherine Mills ◽  
Joanne Ross ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Term Treatment ◽  
Heroin Dependence ◽  
Long Term Treatment
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