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Biomedical subjects

S Ristic

Publications and source records attributed to S Ristic.

17 recordsLinked to original sources
PubMed2006

Comparison of nateglinide and gliclazide in combination with metformin, for treatment of patients with Type 2 diabetes mellitus inadequately controlled on maximum doses of metformin alone.

AIM: To compare the effects of nateglinide plus metformin with gliclazide plus metformin on glycaemic control in patients with Type 2 diabetes. METHODS: Double-blind, double-dummy, parallel group, randomized, multicentre study over 24 weeks. Patients with inadequate glucose control on maximal doses of metformin were randomized to additionally receive nateglinide (n = 133) or gliclazide (n = 129). Changes from baseline in HbA1c, fasting plasma glucose (FPG) and mealtime glucose and insulin excursions were examined. RESULTS: HbA1c was significantly (P < 0.001) decreased from baseline in both treatment groups (mean changes: nateglinide -0.41%, gliclazide -0.57%), but with no significant difference between treatments. Proportions of patients achieving a reduction of HbA1c >or= 0.5% or an end point HbA1c < 7% were also similar (nateglinide 58.1%, gliclazide 60.2%). Changes from baseline in FPG were similarly significant in both treatment groups (nateglinide -0.63, gliclazide -0.82 mmol/l). Reduction from baseline in maximum postprandial glucose excursion were significant in the nateglinide group only (nateglinide -0.71, gliclazide -0.10 mmol/l; P = 0.037 for difference). Postprandial insulin levels were significantly higher with nateglinide compared with gliclazide. The overall rate of hypoglycaemia events was similar in the nateglinide group compared with the gliclazide group. CONCLUSIONS: No significant difference was seen between nateglinide plus metformin and gliclazide plus metformin in terms of HbA1c. However, the nateglinide combination demonstrated better postprandial glucose control.

Adult↗
PubMed2005

Conversion of azathioprine to mycophenolate mofetil and chronic graft failure progression.

The purpose of the study was to evaluate the impact of conversion from azathioprine (AZA) to mycophenolate mofetil (MMF) on graft function in 35 renal transplant recipients with chronic allograft nephropathy (CAN). The immunosuppressive regimen originally consisted of AZA, cyclosporine (CsA), and prednisone (Pr). At the onset of the study (mean period = 39 posttransplant months), a graft biopsy was performed on all patients who were randomly divided into group 1 (n = 17) in whom MMF was introduced instead of AZA. The remaining 18 subjects (group 2) were maintained on the previous regimen. Two periods were analyzed: period I: 12 months before, and period II: 12 months after biopsy and therapy conversion. Graft function was assessed monthly by measurements of the 24-hour creatinine clearance (CCr). Analysis of variance (ANOVA) was used to compare the differences in CCr and proteinuria between the two groups. No difference was observed in the baseline characteristics, in the incidence of delayed graft function and acute rejection, or in the mean CsA dose. Pathohistological analysis revealed advanced CAN in the majority of patients in both groups. The morphological changes negatively correlated with graft function. The graft function showed parallel deterioration in the two groups; no significant difference was observed in the mean CCr values in the periods studied. Proteinuria was similar for both groups throughout the study. Conversion of AZA to MMF in recipients with CAN, albeit safe, was without significant benefit on the progression of chronic graft failure over the period of a year.

Acute Disease↗
PubMed2005

Improved glycaemic control with dipeptidyl peptidase-4 inhibition in patients with type 2 diabetes: vildagliptin (LAF237) dose response.

OBJECTIVE: A novel treatment option for diabetic patients is the enhancement of incretin hormone activity by inhibition of the enzyme dipeptidyl peptidase-4 (DPP-4). This study was designed to establish a dose of the DPP-4-inhibitor vildagliptin (LAF237) that was effective in reducing HbA1c levels and was safe and well tolerated in patients with type 2 diabetes. PATIENTS AND METHODS: The study of 279 patients with type 2 diabetes consisted of a 4-week run-in phase where patients received placebo and a 12-week active treatment phase where they received one of the following dosages of vildagliptin: 25 mg twice daily, 25, 50 or 100 mg once daily (qd), or placebo. RESULTS: There was a statistically significant reduction in HbA1c levels in the vildagliptin 50 mg qd (p=0.003) and 100 mg qd groups (p=0.004) compared with the placebo group. The mean 4-h postprandial glucose level was significantly reduced from placebo in the vildagliptin 50 mg qd group (p = 0.012) and mean 4-h postprandial insulin was significantly increased from baseline vs. placebo in the vildagliptin 100 mg qd group (p=0.022). The assessment of beta-cell function (HOMA-B) was significantly increased in the vildagliptin 100 mg qd treatment group (p=0.007). The incidence of adverse events was similar in all treatment groups including placebo. CONCLUSIONS: Vildagliptin, at 50 and 100 mg qd, was effective in reducing HbA1c levels compared with placebo in patients with type 2 diabetes. Vildagliptin at dosages up to 100 mg qd appeared safe and well tolerated.

Adamantane↗
PubMed2004

Metabolic control in patients with type 2 diabetes using Humalog Mix50 injected three times daily: crossover comparison with human insulin 30/70.

OBJECTIVE: Patients with type 2 diabetes most frequently use injections of premixed insulin formulations twice daily, but intensified insulin therapy may provide better control. This study was designed to compare metabolic control with three daily injections of Humalog Mix50 or premixed human insulin 30/70 (30 % regular/70 % NPH) twice daily in accordance with normal prescription practice. RESEARCH DESIGN AND METHODS: The study cohort of 40 patients with type 2 diabetes used a two-way, crossover design. Patients were randomized to either Mix50 at each main meal or human insulin 30/70 at breakfast and dinner for 3 months, followed by the alternate treatment for 3 months. Blood glucose was measured by the patients at baseline and at the end of each treatment sequence. No significant carryover effects were observed, so treatment sequences were combined and data analyzed by unpaired t-tests. RESULTS: Mean blood glucose level was significantly (p = 0.010) decreased with Mix50 but not with 30/70 (p = 0.237), and there was a significant difference between treatments at the endpoint (p = 0.035). Fasting blood glucose was increased pre-breakfast and decreased at bedtime with Mix50 but was not significantly changed pre-lunch or dinner or at any time with 30/70 insulin. Blood glucose excursions were significantly decreased with Mix50 after breakfast (p = 0.002), lunch (p < 0.001) and dinner (p = 0.037) but not significantly changed from baseline with 30/70 insulin. The decrease from baseline in HbA (1c) was significantly (p = 0.021) greater with Mix50 than with 30/70 insulin. There were no significant differences between treatments regarding incidence of hypoglycemia or adverse events. CONCLUSIONS: In patients with type 2 diabetes, a regimen of Humalog Mix50 administered three times daily before meals maintains glucose control more effectively than premixed human insulin 30/70 administered before breakfast and dinner.

Aged↗
PubMed2002

Synthesis of some new antianemics I. Iron pullulan complexes of pharmaceutical interest.

First experiments were performed in order to obtain a polynuclear iron(III) complex with pullulan, which could be applied in therapy of sideropenic anemia. Complete synthesis of the complex can be realized with oligomers of depolymerized pullulan at an average molar mass 8000-10,000 g.mol-1. Maximum iron contents of 51.4 mg.cm-3 is effected by pullulan depolymerizates (Mw approximately 9000 g.mol-1, [eta] = 0.085 dl.g-1) at 130 degrees C for 240 min, at pH = 10.5 and at an initial mass ratio Fe/ligand of 1:3. The effected concentrations and complex stability respond to requirements of pharmacological application of parenteral antianemic preparations.

Anemia↗
PubMed2001

Intramuscular injection of insulin lispro or soluble human insulin: pharmacokinetics and glucodynamics in Type 2 diabetes.

AIM: The aim of the study was to compare the pharmacokinetics and glucodynamics of insulin lispro and soluble human insulin following intramuscular (i.m.) injection in patients with Type 2 diabetes with secondary failure of sulphonylureas. METHODS: Single 15-U i.m. doses of insulin lispro or soluble human insulin were administered to 16 patients in a two-way, randomized, crossover design. Glucodynamic and pharmacokinetic parameters were determined over 6 h after insulin injection using clamp techniques. RESULTS: Insulin C(max) was significantly higher (971 +/- 217 vs. 659 +/- 141 pmol/l, P < 0.001) and T(max) was significantly shorter (46.9 +/- 27 vs. 94.7 +/- 50.1 min, P = 0.002) with insulin lispro. Glucose infusion rate (GIR) curves showed clear separation 20 min after injection and were significantly greater for insulin lispro during the 40-60, 60-80 and 80-100-minute time intervals. Total glucose infused was only approximately 5% larger with insulin lispro during the 6-h follow-up, due to lower insulinaemia at later time points. The glucose R(max) and TR(max) were not statistically different between insulin treatments. CONCLUSION: This study shows that i.m. injection of insulin lispro is followed by its more rapid absorption, which results in stronger metabolic effect in the first 2 h when compared with soluble human insulin under the same test conditions. Diabet. Med. 18, 562-566 (2001)

Blood Glucose↗
PubMed2001

Busulfan-induced loss of Ph chromosome in chronic myeloid leukemia.

We report a 44-yr-old female with Philadelphia chromosome positive chronic myeloid leukemia who was initially treated with busulfan, and clinical remission has been achieved. After 4 yr, low-dose busulfan therapy was started again and induced bone marrow aplasia. The patient spontaneously has recovered from aplasia, and complete cytogenetic remission with loss of Ph+ chromosome in bone marrow has been achieved. However, reverse-transcription-polymerase chain reaction analysis showed presence of the bcr-abl transcript in bone marrow.

Adult↗
PubMed2001

Complete median nerve transection as a complication of carpal tunnel release with a carpal tunnel tome.

A 48 year-old right-hand-dominant man presented to our institution with paresthesia and loss of feeling along the median nerve distribution of the right hand 1 week after undergoing minimally open carpal tunnel release with the Biomet Indiana Tome at another hospital. At surgery, transection of the median nerve was discovered and repaired. This is the first report of a complete median nerve transection using the revised carpal tunnel tome with a single-pass technique.

Carpal Tunnel Syndrome↗
PubMed2001

Treatment of type 1 diabetes with insulin lispro during Ramadan.

OBJECTIVE: To compare insulin lispro with regular human insulin with respect to blood glucose control and frequency of hypoglycaemia in patients with type 1 diabetes who wished to fast during the month of Ramadan. RESEARCH DESIGN AND METHODS: Insulin lispro or regular human insulin was given together with NPH insulin, twice daily before the morning and evening meals, for two weeks each in an open-label, randomised, cross-over design, and 64 patients completed the protocol. Blood glucose was self-monitored at fasting morning and evening, and 1-h and 2-h after the post-sunset meal on three consecutive days at the end of each treatment period. RESULTS: The 2-h blood glucose excursion after the post-sunset meal was significantly (p=0.026) lower with insulin lispro (2.50 +/- 0.46 mmol/l) than with regular human insulin (3.47 +/- 0.49 mmol/l). Daily insulin doses did not differ between treatments but compliance with recommended time of injection was better with insulin lispro. Hypoglycaemia incidence (insulin lispro, 15 (23.4%) patients; regular human insulin 31 (48.4%) patients; p=0.004) and frequency (insulin lispro, 0.70 +/- 0.19; regular human insulin 2.25 +/- 0.36 episodes/patient/30 days; p<0.001) were lower with insulin lispro. Five (22.7%) of the episodes during insulin lispro occurred during the nocturnal period compared with 27 (36.5%) of the episodes while on regular human insulin. CONCLUSIONS: Glycaemic control, measured by postprandial glycemic excursions, was improved and hypoglycaemia was significantly reduced with insulin lispro compared with regular human insulin. Patients with type 1 diabetes who insist on fasting during Ramadan may be better managed with insulin lispro.

Adolescent↗
PubMed2000

Examination of the anatomic relationship of the proximal germinal nail matrix to the extensor tendon insertion.

The purpose of this study was to delineate the relationship of the terminal extensor tendon insertion to the proximal limit of the germinal nail matrix. Sixteen fresh-frozen human cadaver fingers without any evidence of trauma (average age, 55 years; 3 males and 1 female) were used for this study. Under x25 magnification the proximal limit of the germinal nail matrix and the terminal bony insertion of the extensor tendon were identified. The distance from the terminal tendon insertion to the germinal nail matrix was ascertained using precision calipers. The average distance from the terminal extensor tendon insertion to the proximal edge of the germinal nail matrix was found to be 1.2 mm. We conclude that the proximal limit of the germinal matrix is extremely close to the terminal extensor tendon bony insertion. When the extensor tendon insertion is visualized during operative exposures of the dorsum of the distal phalanx, care should be taken to avoid damaging the germinal matrix. Conversely, when the nail bed is being completely excised, visualization of the insertion of the extensor tendon will indicate that further proximal dissection is not required.

Adolescent↗
PubMed2000

The assessment and treatment of nerve dysfunction after trauma around the elbow.

Nerve dysfunction after trauma around the elbow can lead to significant long-term pain and functional deficit. Fortunately, most of these injuries are neurapraxias that will recover spontaneously after conservative treatment. The necessity and time frame for surgical intervention for specific patterns of nerve dysfunction remains controversial. Often surgical exploration exacerbates rather than alleviates the presenting nerve problem. Distal humeral shaft fractures, elbow dislocations, Monteggia fracture-dislocations, supracondylar fractures in children, and proximal forearm trauma all have been associated with various types of nerve injuries with a variable degree of recovery. The early recognition of nerve dysfunction combined with appropriate treatment measures is the key to successful outcome.

Adult↗
PubMed2000

[News of Humalog and Humalog mix in the treatment of type 2 diabetes].

Fast-acting insulin analog (lispro insulin), as well as slow/fast-acting analog mixtures (NPL-lispro insulin) allow a better control of postprandial glycemia in type 1 and type 2 diabetic patients (35% mean reduction in area under curve for postprandial glycemia, 2 mmol/l reduction in postprandial glucose peak), as compared with regular insulin or conventional mixtures of NPH and regular insulin. Analog pharmacokinetics allow to procede to insulin injection immediately before meal, which is convenient for the patients. When used alone, lispro insulin has no impact on basal glycemia, whereas twice daily injections of NPL-lispro mixtures allow a 1.8 mmol/l mean reduction of basal glycemia, as compared with conventional mixtures, meaning a more specific effect of NPL intermediate insulin. Other premeal blood glucose levels (lunch and dinner) are not improved by lispro insulin. Most studies did not establish a clear reduction in HbA1c with insulin analogs. When this is the case, this reduction averages 1.5% and could be more frequently observed in studies dealing with type 2 diabetic patients. Finally, the reduced incidence of delayed hypoglycemic episodes, which is one of the most attractive effects of insulin analogs, was only reported in a minority of studies. Surprisingly, the reduction of hypoglycemia incidence with analogs was more frequently reported in type 2 diabetics than in type 1 patients. Thus fast-acting insulin analogs feature interesting characteristics, noteworthy immediate premeal injection and a better postprandial glucose control. However, it is established that the determination of diabetes complications (particularly microangiopathy) mostly relies on average glucose control and not solely on postprandial glycemia. Indeed, most studies suggest that insulin analogs are at least as efficient as conventional insulins on HbA1c, but possibly not more.

Blood Glucose↗
PubMed1999

Acceptability and safety of a new 3.0 ml re-usable insulin pen (HumaPen) in clinical use.

A new re-usable insulin pen (the HumaPen) was tested in a multinational study in patients with Type 1 (45.1%) or Type 2 (54.9%) diabetes. Prior to study entry, patients used either syringes or a comparison pen. Patients changed to the HumaPen for all insulin injections during the 5-to 7-week study and a 12- to 13-week extension period. Acceptability of the HumaPen was assessed from a questionnaire completed at the end of the study by 72 previous syringe users and 209 previous pen users. HumaPen features considered easy/very easy by pre-study syringe users or pre-study pen users were correcting a mis-dialled dose (97.2%; 95.1%, respectively), reading the dose numbers (95.8%; 97.1%) and ease of learning (95.8%; 92.3%). Convenience, comfort and ease of use were stated to be better by a majority of pre-study syringe users and similar by pre-study pen users. At the end of the initial study, 73.6% of syringe users and 55.5% of previous pen users said they would continue to use the HumaPen, and 171 patients continued into the extension. As expected, the most common adverse event was hyperglycaemia but the majority were mild and none caused discontinuation from HumaPen use. The main reason for not continuing into the extension period, and for return of pens, was the injection force, which was subsequently reduced by modification of design and production prior to launch. The HumaPen therefore appeared well accepted and safe in this global study and a majority said they would recommend it to other patients.

Adolescent↗
PubMedDate not supplied

Screening for Down's syndrome and neural tube defect in Croatia. A regional prospective study.

OBJECTIVE: The purpose of this study was to investigate the efficiency of second-trimester maternal serum screening for Down's syndrome and open neural tube defects using alpha-fetoprotein and free beta-human chorionic gonadotropin as serum markers. METHODS: 3, 188 women underwent testing between 14th and 22nd week of pregnancy. Of all tested patients, 25.4% were >/=35 years old. A cut-off risk of >/=1:250 for Down's syndrome and MS-AFP >/=2.0 MoM for open neural tube defect were considered screen-positive. RESULTS: The detection rate for Down's syndrome was 77.8% (7/9) with 8.2% screen-positive rate (7.9% false-positive rate). When evaluated separately, in patients younger than 35 and in those >/=35 years old, the screen-positive rates were 3.1 and 23.3%, respectively. A total of 52 (1.6%) were found screen-positive for open neural tube defect; 2 cases of encephalocela and 1 case of gastroschisis were confirmed prenatally. CONCLUSION: The respectable number of cases with trisomy 21 identified in this study confirms that routine mid-trimester screening for Down's syndrome including MS-AFP, free beta-hCG and maternal age is useful in identifying pregnancies at increased risk.

Adult↗
PubMedDate not supplied

Safety and efficacy of insulin lispro in patients with diabetes mellitus.

Lispro is a human insulin analogue with a very rapid onset of action, and a shorter duration of activity than soluble insulin. In order to assess the therapeutical value of lispro, we have had an open-label, non-comparative study, for 12 weeks, involving 19 IDDM patients. The treatment regimen with lispro and Humulin N has been adapted depending on each patient characteristics. Patients attended three visits, and the main metabolic control parameters included values of hemoglobin Alc, fasting and postprandial blood glucose monitoring. The patients themselves monitored their blood glucose using a glucometer. The mean age value of 19 patients (8 females and 11 males) was 22.32 (+/- 13.59) years. In patients previously receiving insulin treatment, therapy with lispro insulin significantly reduced postprandial glucose values. Lispro has been administered t.i.d. in 14 patients, and b.i.d. in 5 patients. At visit 1, mean value of HbAlc was 10.32% (+/- 1.63%); at visit 3, mean HbAlc was 9.90% (+/- 1.59%). Total insulin daily dose and the rate of short and long acting insulin did not change from visit 1 to visit 3. There has been reported only one serious adverse event during the study: a ketoacidosis due to a technical dosing error. Ten patients have reported mild hypoglycemic episodes. The outcomes of clinical study and of Quality of Life Questionnaire suggests that lispro--the first human insulin analogue used in humans--is effective, safe, and it is broadening beneficially the spectrum of insulins.

Adolescent↗