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Biomedical subjects

I Lancranjan

Publications and source records attributed to I Lancranjan.

At least 37 records · Page 2Linked to original sources

Resumption of pituitary and ovarian activity post-partum: endocrine and ultrasonic observations in bromocriptine-treated women.

The resumption of pituitary and ovarian activity was investigated by hormonal measurements and ultrasound scanning in 45 healthy post-partum women who were treated with bromocriptine. Bromocriptine, 50 mg (Parlodel LAR) was administered within 24 h post-partum. Plasma luteinizing hormone, follicle stimulating hormone, oestradiol, progesterone and prolactin concentrations were measured repeatedly and correlated with ultrasound measurements. Forty-one of the 45 women completed the study. A prompt fall in prolactin levels to normal (non-pregnant) values was observed within 24 h post-partum. Hereafter, a rapid return of the normal menstrual cycle was observed. Endocrine evidence of ovulation was obtained in 19/41 women within 1 month post-partum. Ultrasound measurements started at day 10 and were repeated regularly in 40 women. Ultrasound evidence of ovulation was found in 25/40 women. Ultrasound findings appeared not to correspond with the hormonal measurements. It is concluded that the resumption of pituitary and ovarian secretory functions post-partum is not always paralleled by a concomitant recovery of normal follicular growth and ovulation. Application of a progesterone threshold to judge resumption of ovulation post-partum should be reconsidered.

Adolescent↗

Efficacy of a new long-acting injectable form of bromocriptine in hyperprolactinaemic patients.

OBJECTIVE: The objective of this study was to assess the relationship of different doses of a long-acting bromocriptine preparation (Parlodel LAR) to the degree and duration of PRL suppression. We also measured circulating bromocriptine levels and altered tolerability of the drug. DESIGN: A double-blind randomized study of three different doses 25, 50 and 100 mg of Parlodel LAR. PATIENTS: Twenty-one female patients (seven patients/dose) with both tumoral and non-tumoral hyperprolactinaemia. MEASUREMENTS: After a single injection of Parlodel LAR 25, 50 or 100 mg, serum PRL and plasma bromocriptine levels were assessed during a follow-up of 60 days together with changes in clinical symptoms and signs of hyperprolactinaemia. RESULTS: Serum PRL levels normalized in 19 of 21 patients. The suppression of PRL secretion lasted 28 days in four of seven patients treated with either 25 or 50 mg Parlodel LAR and in five of seven patients who received Parlodel LAR 100 mg. In five of seven patients treated with the 100 mg dose, serum PRL levels were still within the normal range on day 60. Plasma bromocriptine levels remained therapeutically active for 28 days in all three groups. On day 60 they were within the therapeutic range only in the 100 mg group. Clinical data show a rapid disappearance of symptoms and signs of hyperprolactinaemia. Adverse events were mostly mild and transient. CONCLUSIONS: These data support the excellent efficacy and good tolerability of Parlodel LAR in patients with hyperprolactinaemia.

Adult↗

Treatment of macroprolactinomas with the long-acting and repeatable form of bromocriptine: a report on 29 cases.

Twenty-nine patients with macroprolactinomas were treated by monthly intramuscular injections of the long-acting and repeatable form of bromocriptine (Parlodel-LAR) in doses ranging from 50-150 mg. They were divided into two groups: group I consisted of 22 patients who received Parlodel LAR before transsphenoidal adenomectomy; group II was composed of 7 patients with earlier neurosurgery and of 2 patients from group I not cured by transsphenoidal adenomectomy. Duration of therapy varied from 1-12 months, and a total of 104 injections was given. At nadir day, serum PRL levels were situated between less than 1% and 43% of pretreatment values. At day 28 after the first injection, serum PRL levels varied between less than 1% to 139% of initial values. No difference could be detected between the two groups regarding the percent of PRL inhibition. Long-term treatment with Parlodel-LAR resulted in a sustained inhibition of PRL secretion, except for 1 case. Resumption of menstrual cycles occurred in 4 out of 15 women and correction of hypogonadism in 4 out of 14 men. Amelioration of disturbed visual fields was recorded in 3 out of 8 patients. Diminution of the adenoma volume was radiologically documented in 14 out of 22 cases. Only few and mild side effects were recorded. One patient with partial adrenal deficiency suffered from a syncope, but this was prevented by hydrocortisone supplementation during the subsequent Parlodel-LAR administration. In conclusion, Parlodel-LAR proved effective in the treatment of macroprolactinomas, achieving rapid inhibition of PRL secretion, and in some patients amelioration of hypopituitarism, reduction in tumor size, and improvement in visual fields, and caused no serious side effects. It is a valuable preparation to surgery and can also be used in long-term medical therapy.

Adult↗

A long-acting repeatable form of bromocriptine as long-term treatment of prolactin-secreting macroadenomas: a multicenter study.

OBJECTIVE: To assess the efficacy and tolerability of monthly injections of the long-acting repeatable bromocriptine in patients with macroprolactinomas. DESIGN: Open and prospective trial. SETTING: This multicenter trial was carried out in seven university hospitals. PATIENTS: Forty-two patients with prolactin (PRL)-secreting macroadenomas. INTERVENTIONS: Fifty to 200 mg of the drug were administered intragluteally every 28 days for 6 to 24 months. MAIN OUTCOME MEASURES: The efficacy was assessed by repetitive plasma PRL measurements, visual field determinations, and computed tomography scan examinations. RESULTS: After the first 50-mg injection, the mean percentage decrease of PRL levels was 71% from baseline on day 14; between days 1 and 28, PRL levels were suppressed to normal in nine cases, and a clear tumor shrinkage was documented in 21% of the patients. Normalization of PRL secretion was obtained in 62%, and a clear-cut reduction in tumor size in 50% of the patients after 6 months of treatment. CONCLUSIONS: The long-acting repeatable form of bromocriptine was a well tolerated and quickly effective treatment in most of these patients with macroprolactinomas.

Adenoma↗

Effect of dopamine agonist medication on prolactin producing pituitary adenomas. A morphological study including immunocytochemistry, electron microscopy and in situ hybridization.

Conventional light microscopy, immunocytochemistry, electron microscopy and in situ hybridization were used to evaluate the effect of dopamine agonists (bromocriptine-LAR and bromocriptine) on the morphology of surgically removed prolactin (PRL)-producing pituitary adenomas. Dopamine agonist therapy resulted in decrease of serum PRL, clinical improvement and tumour shrinkage. Using light and electron microscopy cellular atrophy, interstitial and perivascular fibrosis were noted; in several tumours connective tissue accumulation was pronounced. The cellular response was not uniform. In some adenomas populations of large cells and small cells were distinguished. The large cells contained immunoreactive PRL and expressed the PRL gene indicating resistance to dopamine agonists. It appears that these cells retained the potential to secrete PRL and proliferate despite exposure to dopamine agonists. In the small cells, PRL immunoreactivity and PRL gene expression decreased providing evidence that both PRL release and synthesis were blocked. Small cells can persist in tumours after discontinuation of dopamine agonist medication suggesting these small cells are irreversibly suppressed and are not capable of regaining their endocrine function and proliferative capability. The formation of irreversibly suppressed PRL cells may explain why some PRL-producing adenomas do not recur after withdrawal of dopamine agonists.

Adenoma↗

Efficacy and tolerability of a long-acting intramuscularly injectable depot preparation of bromocriptine: the results of a double blind study.

The tolerability and efficacy of a long-acting im applicable form of bromocriptine (Parlodel LAR) was tested in a double-blind approach in 20 patients with hyperprolactinemia or prolactinoma, 17 of them complaining of persistent side effects on oral treatment with dopamine agonists. The study-code revealed similar characteristics for age, sex, weight, clinical symptoms and previous therapy in both groups but prolactin serum levels were higher in the verum group even though the difference was not significant. In all 10 patients receiving Parlodel LAR prolactin serum concentrations were significantly suppressed and tumor size was reduced in 5 of the 9 patients with visible tumors when controlled after 28 days. In contrast, no significant change in serum prolactin levels was observed in the placebo group and tumor size of all visible tumors was not altered. Side effects typically reported for dopamine agonists started 3 h after application in the verum group and were significantly different to the unspecific side effects reported in the placebo group during the first 72 h. Thereafter systemic tolerability was indistinguishable between both groups. The local tolerability at the injection site was excellent for both, Parlodel LAR and placebo.

Adolescent↗

Comparison between a slow-release oral preparation of bromocriptine and regular bromocriptine in patients with hyperprolactinemia: a double blind, double dummy study.

The efficacy and tolerability of a slow-release preparation of bromocriptine (Parlodel SRO) were compared to those of conventional bromocriptine (Parlodel R) in a double blind, double dummy study of 12 hyperprolactinemic women (plasma PRL 81.3 +/- 4.73, ng/ml mean +/- SEM). For 2 weeks, the patients received 2.5 mg b.i.d. Parlodel R or 5 mg once daily Parlodel SRO; for the following 2 weeks, the dose of the drugs was doubled. The patients were then treated, in an open study, with 2.5-10 mg daily Parlodel SRO for 6 months. Both preparations caused a prompt and sharp PRL fall. Hormone levels remained inhibited over the whole month of observation with both preparations. Daily PRL profiles were very close with either drug although morning PRl levels were slightly higher during Parlodel SRO than during Parlodel R administration. Doubling the doses of the two drugs did not result in further significant lowering of PRL values. During the 6-month study with Parlodel SRO, plasma PRL further decreased and normalized in 11 of 12 patients. Clinical improvement occurred in the majority of cases. Tolerability of Parlodel SRO appeared to be better, though without statistically significant differences, than that of Parlodel R. Side effects were less important with the former compound in their number, severity and duration. In conclusion, thanks to its favourable pharmacological profile, Parlodel SRO appears to be a valuable alternative to regular bromocriptine in the management of hyperprolactinemia.

Administration, Oral↗

Chronic treatment with parlodel LAR of patients with prolactin-secreting tumours. Different responsiveness of micro- and macroprolactinomas.

UNLABELLED: Forty-one patients with prolactinoma (25 micro-, 16 macroprolactinomas) were treated with a long-acting injectable preparation of bromocriptine (Parlodel LAR, Sandoz), 25-100 mg (mostly 50 mg) in every 4-8 weeks for as long as 43 months (median 19 months). The first injection caused a prompt fall of plasma PRL which reached its nadir value after 3 days. Thereafter, hormone levels remained well below initial values for 4 weeks or longer, though with the tendency, more pronounced in microprolactinoma patients, to rise again toward baseline. The prevalence of PRL normalization was greater in the macro- than in the microprolactinoma group. By repeated injections plasma PRL could be kept close to or within the normal limits in most of the patients. However, the extent of PRL inhibition was significantly greater in macro- than in microprolactinoma patients (p less than 0.01). Clinical improvement occurred in the majority of the patients, shrinkage of the tumour in 50% of them. Adverse reactions were generally mild or of moderate severity and subsided spontaneously in 24 h. They were less frequent (NS) and less severe (p less than 0.05) in macro- than in microprolactinoma patients. IN CONCLUSION: a. injectable bromocriptine (Parlodel LAR) is a highly effective preparation particularly suitable for the long-term treatment of tumourous hyperprolactinemia; b. patients with macroprolactinoma exhibit, compared with microprolactinoma patients, better responsiveness and better tolerability to injectable bromocriptine.

Adolescent↗

A new oral slow release form of bromocriptine, Parlodel SRO, in the chronic treatment of 26 hyperprolactinemic patients.

Parlodel SRO, a new slow release form of bromocriptine, was studied in 26 patients with tumoral and non-tumoral hyperprolactinemia. Prior to the treatment, serum prolactin (PRL) levels ranged from 45 ng/ml to 7000 ng/ml and they decreased to within the normal range in all but one patient after 7 days-1 year of treatment with this new formulation of bromocriptine. The clinical improvement paralleled the normalization of PRL secretion. Tolerability was rated good or very good in 24 patients, even in the three patients who had been intolerant of oral Parlodel. In conclusion, Parlodel SRO administered as a single daily dose resulted in very effective lowering of serum PRL in patients with hyperprolactinemic disorders.

Administration, Oral↗

Oral and injectable long-lasting bromocriptine preparations in hyperprolactinemia: comparison of their prolactin lowering activity, tolerability and safety.

Bromocriptine, a D2 receptor agonist, has been widely used in tumoral and non-tumoral hyperprolactinemia, in reducing both plasma prolactin levels and in restoring fertility and/or menses in most patients. In this study a comparison between the injectable repeatable and the oral slow release formulations of bromocriptine (Parlodel LAR and Parlodel SRO) is reported, with respect to their effectiveness, tolerability and safety. Eleven patients with hyperprolactinemia, submitted to both treatments, were studied for a period of 1-24 months. Among the four patients with macroprolactinoma, three reached normoprolactinemia without complaining of side-effects, with both formulations, while the remaining patient became intolerant of the oral form after 1 year, and is presently being treated with the injectable formulation without presenting any side-effects. Among the five patients with microprolactinoma, two patients had a good response to both drugs; two patients did not reach normoprolactinemia with the injectable formulations, but a progressive decrease of prolactin levels was obtained with Parlodel SRO therapy, and the remaining patient was completely intolerant of the oral form without complaining of side-effects with Parlodel LAR. Two patients had non-tumoral hyperprolactinemia: one was intolerant of both drugs and one tolerated both formulations very well. In conclusion, Parlodel LAR and Parlodel SRO are very effective compounds in the medical treatment of hyperprolactinemic syndromes. The availability of these differing formulations improves the medical therapy, allowing a better choice of therapeutic regimen according to the effectiveness of, and tolerability to, the different drug formulations. In this way also, with poorly tolerant patients, it is possible to choose the better tolerated and more effective formulation of the drug.

Adult↗

Prevention of nausea and vomiting in cisplatin-treated patients by a selective 5-hydroxytryptamine (5-HT3) receptor antagonist, ICS 205-930.

The results of an open study designed to evaluate the prevention of cisplatin-induced emesis by the specific 5-HT3 receptor antagonist ICS 205-930 are reported. Fifty-four cancer patients, treated with diverse chemotherapy regimens, all including cisplatin (greater than = 50 mg/m2), received ICS 205-930 for a total of 165 courses. ICS 205-930 (10 mg) was given i.v. immediately before the cisplatin infusion and a second 10-mg dose was given immediately after. In 109 courses (66%) the patients did not have any vomiting episodes. Nausea was absent in 44.8% of courses. More than 3 vomiting episodes occurred only in 17 (10.4%) courses, and severe nausea only in 11 (6.6%). ICS 205-930 was extremely well tolerated. Mild headache occurred during 7 courses (4.2%) in 4 patients, hypotension during 5 courses (3%) in 3 patients and lipothymia in 2 courses (1.2%) in 2 patients. These results suggest that ICS 205-930 is an effective and well tolerated antiemetic drug in patients receiving cisplatin chemotherapy.

Adult↗

Rapid and long-lasting suppression of prolactin secretion and shrinkage of prolactinomas after injection of long-acting repeatable form of bromocriptine (Parlodel LAR).

Five patients with PRL-secreting macroadenoma and nine patients with PRL-secreting microadenoma or idiopathic hyperprolactinaemia were treated with monthly administrations of long-acting bromocriptine suitable for repeatable injections (Parlodel LAR) for 1-12 cycles of treatment. A significant shrinkage of tumour mass and the recovery of visual field defects were observed in patients with macroprolactinoma. Plasma PRL levels decreased to 16.8 and 18.1% of pretreatment values, in macroprolactinoma and idiopathic or microadenomatous hyperprolactinaemic subjects, respectively, during the first cycle of treatment, reaching the normal range in three patients of each group. During the following cycles of treatment, two patients with macroprolactinoma and one patient with idiopathic or microadenomatous hyperprolactinaemia became normoprolactinaemic. Adverse reactions generally did not last beyond the first days of administration and decreased with the progression of the treatment. In conclusion, its effectiveness and the fact that it is well tolerated, may suggest that this form of bromocriptine may be used as a first therapeutic approach for patients with PRL-secreting adenomas, particularly when shrinkage of a macroadenoma is urgently required.

Adolescent↗

Lactation inhibition by a single injection of a new depot-bromocriptine.

Recently, long-acting injectable forms of bromocriptine have become available for the prevention of lactation. The first developed depot-form was very effective, but had the disadvantage of a slowly metabolized carrier. we investigated the pharmacokinetics, efficacy, tolerance and safety of 40 and 50 mg of a new rapidly eliminated depot-form in 61 postpartum women. Bromocriptine rapidly increased after injection and prolactin was effectively suppressed during the study-period of 60 days. Overall efficacy was very good or good in 98% and no rebound lactation occurred. Sixteen women experienced side effects. Tolerance at the injection site was good and safety tests did not show abnormalities. There were no differences between the two dosages. We conclude that this new depot-bromocriptine is a safe, well tolerated and effective drug in the suppression of prolactin and the prevention of post-partum lactation.

Adult↗

Parlodel LAR in the treatment of macroprolactinomas.

Eight patients with macroprolactinomas were treated with a long-acting injectable form of bromocriptine, depot-bromocriptine (Parlodel LAR). With the exception of one male patient who had partial and short-lasting suppression of PRL levels after two injections and who underwent a second adenomectomy, the patients were given Parlodel LAR injections at 28-day intervals for six months. In all patients, there was a significant fall in serum PRL levels after the first injection. PRL secretion was suppressed to within the normal range in 3 of 7 patients on long-term treatment. PRL was consistently within the normal range in 2 patients from the sixth week and in one, from the 14th week onwards. In the other 4 of 7 patients, a marked suppression of PRL secretion, resumption of menses, and normal libido and potency were recorded. In 3 of 8 patients, no adverse effects were noted. Two patients reported short-lasting nausea, one vomiting, one constipation and in 2 patients, orthostatic dizziness occurred after the first injection. Subsequent injections, however, were well tolerated systematically and locally. Five patients had CT scan evidence of tumour shrinkage. A very large tumour virtually disappeared after the first injection of 50 mg depot-bromocriptine in one patient. The decrease of serum PRL secretion within the first 12 hours after injection did not predict normalization of serum PRL levels during long-term treatment, whereas the fall of serum PRL levels to below 5% of the basal values within the first months of treatment could be a good indicator for the final outcome.

Adult↗

Rhinorrhea following dopamine agonist therapy of invasive macroprolactinoma.

We report on the occurrence of CSF rhinorrhea in a group of 17 patients harbouring macroprolactinomas who were treated with a dopamine agonist (DA, bromocriptine) alone or the combination of DA and transcranial operation. In 2 out of 17 cases shrinkage of tumour remnants during therapy with the oral or injectable form of bromocriptine was responsible for delayed occurrence of rhinorrhea. Operative procedures for successful closure of the fistulae were mandatory in both cases.

Adult↗

Return of gonadotropic function in postpartum women during bromocriptine treatment.

The rapid postpartum return of gonadotropic function during bromocriptine treatment was investigated through hormonal measurements in 15 women. Luteinizing hormone (LH) was measured by a novel and specific assay that does not cross-react with human chorionic gonadotropin (hCG). Prolactin was effectively suppressed by bromocriptine and hCG was cleared within 2 weeks. During the first week, both follicle-stimulating hormone (FSH) and LH were undetectable. The return of FSH and LH secretion occurred in the second postpartum week and initially was characterized by a high FSH/LH ratio. The causes of the 1-week delay in resumption of pituitary gonadotropin secretion are not known, but endogenous opioids may play a role. The possible relation between the high FSH/LH ratio and low LH pulse frequency also is discussed.

Bromocriptine↗

Effectiveness of a single injectable dose of bromocriptine long acting in the treatment of macroprolactinomas.

The aim of the present study was to investigate the effect of a new galenic injectable form of bromocriptine (Parlodel LA), characterized by sustained release of bromocriptine for 4-6 weeks, in 3 patients with prolactin-secreting macroadenomas through a 42-day follow-up. The following parameters were considered: decrease of plasma prolactin levels, reduction of tumor size studied by seriate CT scan controls and recovery of eventual visual fields impairments. Parlodel LA induced a sharp decrease of plasma prolactin levels for at least 42 days, without reaching normal values. This treatment also caused a rapid and marked shrinkage of tumors in all patients. Moreover, in two patients with constriction of visual fields a clear and progressive improvement in one and only a slight amelioration in the other were observed. There were almost no side effects except for mild nausea in one patient and transient orthostatic in another. These results demonstrate that Parlodel LA produces a long-lasting reduction of plasma prolactin levels and a rapid shrinkage of the tumor with almost no side effects.

Adenoma↗