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Adjuvant Treatment of Graves? Ophthalmopathy With NSAID (aGO Study)
This study is currently Recruiting
October 2011 By Region Skane
First Recieved on October 19, 2011
Last Updated on October 21, 2011
AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves?
Background - Already at diagnosis of Graves disease approximately 98% of the patients have
morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors
known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting
observation is that a patient with stable and inactive Graves? disease developed
ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been
shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones
are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma
in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like
indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins
which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J.
Inflammation and adipogenesis are hallmarks of the pathological process in Graves
ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study
demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue
symptoms, eye muscle symptoms and eye protrusion.
Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of
1. To study the frequency of clinical ophthalmopathy in Graves? disease after 12 months
treatment with or without diclofenac.
2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy
after 12 months treatment with or without diclofenac.
3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months
treatment with or without diclofenac.
Study plan and randomisation -
150 patients with newly diagnosed Graves?disease without ophthalmopathy will be treated with
anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18
months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
12 months treatment with diclofenac 50 mg 1x2 in addition to regular treatment for thyrotoxicosis.
12 months treatment without diclofenac in addition to regular treatment for thyrotoxicosis.
T Diclofenac 50 mg twice daily for 12 months
T Methimazole 5 mg 3x2 for 18 months
L-thyroxin approximately 100 to 200 micrograms/day. The dose is adjusted to reach euthyroidism during concomitant treatment with methimazole for 18 months
T Propronalol 40mg 1x1-3 during during 1-3 weeks until the patient has responded to thyrostatics
T Metoprolol 50 mg 1x3 for 1-3 weeks until the patient has responded to thyrostatics
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Graves thyrotoxicosis ( with clinical symptoms)
2. Age 18 - 75 year
3. TSH = 0.2 or < 0.2 and increased fT4 and/or fT3
4. Signed informed consent
1. Pregnancy or breastfeeding, women in childbearing age should use non- barrier
2. Previous treatment of thyroid disease
3. Thyrostatics before radioiodine treatment
4. Hypersensitivity to NSAID or ASA
5. Congestive heartfailure
6. Impaired renal function defined as p-creatinine > 100 mmol/L
7. ASAT or ALAT > 2.5 times the upper limit
9. Coagulopathy including warfarin treatment
11. Previous or active gastric ulcera
12. Inflammatory bowel disease
- Investigator: Mikael Lantz, MD - Study Director - Department of Endocrinology, Skane University Hospital, Malm?, Sweden
- Investigator: Jan Calissendorff, MD - Principal Investigator - Department of Endocrinology, Karolinska Hospital, Stockholm, Sweden
- Investigator: Ove T?rring, MD - Principal Investigator - Department of Internal Medicine, section of Endocrinology, Sodersjukhuset, Stockholm
- Departmenty of Endocrinology, Skane University Hospital
- Department of Endocrinology, Karolinska Hospital
- Department of Internal Medicine, section of Endocrinology, Sodersjukhuset