Graves Ophthalmopathy

Thyroid Associated Ophthalmopathy

Thyroid Associated Orbitopathy

Simvastatin 40mg

Dpt. of Endocrinology, SUS Malmö

Treatment of Graves´Ophthalmopathy With Simvastatin (GO-DS)

Change in 7-point clinical activity score (CAS) after 6 months treatment with simvastatin or no treatment

Number of patients with progression to severe GO in each group (simvastatin, no treatment) during 6 months treatment

Change in Modified clinical activity score after 3 and 6 months treatment with simvastatin or no treatment

Evaluation of conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with simvastatin or no treatment

Quality of life after 6 months treatment with simvastatin or no treatment assessed with the SF36 questionnaire

Quality of life after 6 months treatment with simvastatin or no treatment assessed with the ThyPro questionnaire

Quality of life after 6 months treatment with simvastatin or no treatment assessed with the GO-QoL questionnaire

TRAb after 3 and 6 months treatment with simvastatin or no treatment

TPOAb after 3 and 6 months treatment with simvastatin or no treatment

Lund University

Participants randomized to the prednisone withdrawal group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was given intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered to participants an inpatient or outpatient for a total of 3 to 5 doses. Participants also began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued indefinitely. The steroids were initially given in the operating room intravenously at time of transplant as Solu-medrol (methylprednisolone)and were then switched to daily oral prednisone doses. The participant's dose of prednisone was rapidly decreased until it was completely eliminated by day 6 post-transplant.

Participants randomized to the prednisone maintenance group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was initiated intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered an inpatient or outpatient for a total of 3 to 5 doses. Participants began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued on them indefinitely. The steroids were initially given intravenously in the operating room at time of transplant as Solu-medrol (methylprednisolone) and were then switched to daily oral prednisone tablets. Participants remained on all drugs according to their doctor's standard of care, and the prednisone was not be eliminated.

Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.

Prednisone Withdrawal

Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.

Prednisone Maintenance

Total

Sex: Female, Male

Region of Enrollment

Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.

The Number of Participants With Acute Rejection Episodes

This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial)

The Number of Participants With Treatment Failures

The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge.

Length of Hospital Stay After Transplant

The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions.

The Number of Participants With Hospital Readmissions

The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant.

The Length of Stay Associated With Hospital Readmissions

The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant.

Participant Renal Function as Measured by MDRD Formula

Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function.

Participant Renal Function as Measured by 24 Hour Urine Collection

The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported.

The Number of Participants With Graft Survival

The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival.

Participant Survival

The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician.

The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes.

All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL).

The Number of Participants With Leukopenia

Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant.

The Number of Participants With Infections

Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator.

The Number of Participants With Malignancy

The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study.

The Number of Participants With Hypertension

Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines.

The Number of Participants With Hyperlipidemia

Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months.

The Number of Participants With Bone Disease

Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months.
Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants.

The Number of Participants With Post Transplant Diabetes Mellitus

Height, weight will be used to calculate change in BMI for all participants.

The Number of Participants With Weight Gain

Overall Study

Jennifer Trofe-Clark, Clinical Transplant Research Pharmacist

Transplants and Implants

In this group, participants had prednisone rapidly decreased until completely eliminated by day 6 after transplant. Participants began on 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20mg on day 5, none from day 6-on.

prednisone

Participants in both groups received 3 to 5 doses of an intravenous medication to prevent rejection called Thymoglobulin (rabbit antithymocyte globulin) as per our standard of care. This drug was dosed at 1.5 milligrams/killograms per dose and dosing was then based on body weight. The dose was decreased in half or held if the participant had a low white blood cell count or if the participant a low platelet count. The first dose was given intravenously in the operating room and subsequent intravenous doses were administered either while participants were inpatients or outpatients for a total of 3 to 5 doses for a total of up to 6mg/kg. The number of doses was based on transplant kidney function and risk factors for rejection.

rabbit antithymocyte globulin

Participants in both groups received tacrolimus per our standard of care. This medication helped to prevent rejection and was initially dosed at 0.1-0.2 milligrams/killograms/day in two divided doses, given orally, based on participant's body weight. We then looked at the trough levels of this medication(the lowest level before the next dose), and aimed to keep the trough level between 5-10 nanograms/milliliter throughout the study.

Tacrolimus

Participants in this group continued on prednisone indefinitely. Participants began with 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20 mg days 5-9, 15 mg day 10-19, 10 mg day 20-24, 7.5 mg day 25-29, and 5mg from day 30-on indefinitely.

Prednisone

Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone withdrawal group was 1000mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.

Mycophenolate mofetil

Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone maintenance group was 500 mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea.

Hospital of the University of Pennsylvania

Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant

Randomized, Prospective Single-center Study Comparing a Rapid Discontinuation of Corticosteroids (Steroid Withdrawal) With Corticosteroid Therapy in Kidney Transplantation Using Mycophenolate Mofetil and Tacrolimus Maintenance Therapy

stomach ulcer/triglyceride

Treatment of Graves´Ophthalmopathy With Simvastatin (GO-DS)

Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant

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