Biomedical subjects

G Monza

Publications and source records attributed to G Monza.

14 recordsLinked to original sources

PubMed2000

Efficacy and tolerability of a new estradiol delivering matrix patch (Estraderm MX) in postmenopausal women.

OBJECTIVE: To examine the efficacy and tolerability of a new matrix patch delivering estradiol (E2 Matrix) at doses of 0.05 and 0.10 mg per day (Estraderm MX 50, 100) in the treatment of moderate to severe postmenopausal symptoms. METHODS: A total of 254 postmenopausal women were randomized to receive treatment with E2 Matrix 0.10 mg (N = 86), E2 Matrix 0.05 mg (N = 82), or placebo (N = 86) in a double-blind, double-dummy fashion for a period of 12 weeks continuously. Patches were applied twice weekly to the buttocks with each patient wearing two patches at all times. The primary efficacy criterion was the difference from baseline of the mean number of moderate to severe hot flushes per 24 h during the last 2 weeks of treatment. Other efficacy variables included reduction in hot flushes at 4 and 8 weeks, reduction in daytime flushing and night sweats, and Kupperman Index at 4, 8, and 12 weeks. RESULTS: E2 Matrix 0.10 and 0.05 mg were both significantly superior to placebo in reducing hot flushes per 24 h after 4, 8, and 12 weeks of treatment (P < 0.001). Also, for all other efficacy parameters studied, both dosage strengths of E2 Matrix were statistically significantly superior to placebo at all time points (P < 0.001). Local tolerability was good in both groups. A slight increase in estrogen related adverse effects (breast tenderness, leukorrhoea) was seen with the 0.10 mg patch. Adhesion of patches and compliance were good. Overall systemic tolerability was good in both treated groups. However, a 4.8% overall incidence of endometrial hyperplasia was observed in patients with an intact uterus. CONCLUSIONS: This new matrix patch offers an effective and well tolerated dosage form for delivery of 0.05 and 0.1 mg estradiol per day. It may be particularly suitable for those women who experience local sensitivity to alcohol-containing systems. In light of the observed hyperplasia after treatment in five patients, estrogen therapy should as yet be supplemented monthly with a progestogen in women with an intact uterus.

Administration, Cutaneous↗

PubMed1998

Double-blind evaluation of short-term analgesic efficacy of orally administered diclofenac, diclofenac plus codeine, and diclofenac plus imipramine in chronic cancer pain.

A prospective double-blind randomized trial was conducted on 184 cancer patients with moderate to severe chronic pain to evaluate the analgesic efficacy and tolerability of diclofenac alone (50 mg q.i.d.) or in combination with a weak opioid (codeine 40 mg q.i.d.), or with an anti-depressant (imipramine, 10 or 25 mg t.i.d.). All demographic and clinical characteristics including cancer type, presence of bone metastases, baseline pain severity, neuropathic and nociceptive pain, and depressive state, were well balanced between the three treatment groups. The main analysis of the study was on the VAS scores at visit 2 (day 4). The mean VAS values for both associations imipramine plus diclofenac and codeine plus diclofenac were similar to the association placebo plus diclofenac. Patients on imipramine plus diclofenac and on placebo plus diclofenac were withdrawn mainly for inadequate efficacy, while patients on codeine plus diclofenac discontinued equally for inadequate efficacy or adverse events. In conclusion, in a short-term evaluation the addition of a tricyclic anti-depressant or a weak opioid to diclofenac did not provide further analgesia with respect to diclofenac administration alone.

Administration, Oral↗

PubMed1996

Lack of microbial proliferation and phototoxic potential of a new matrix patch for estradiol delivery.

OBJECTIVES: To examine the potential of a new matrix system developed for estradiol delivery to cause microbial proliferation under the occluded site or to cause acute phototoxicity reactions. METHODS: Twenty healthy post-menopausal women participated in a microbial proliferation study and 11 in a phototoxicity study. Both studies were single centre, single blind and placebo controlled. Microbial proliferation was assessed by quantitative counts of the total aerobic bacterial population and of eight individual species before patch application and after removal following a 4 day application period on the abdomen. Acute phototoxicity potential was assessed following an 8 h application period on the abdomen by irradiating the application site after patch removal with ultra violet A radiation and visible light and evaluating the sites for up to 48 h post irradiation. Non-irradiated active and placebo patches on the other side of the abdomen served as controls. RESULTS: Total aerobic bacterial populations both before and after the matrix patch application period were low as expected for dry skin. Separate counts of microbial species were also low and did not change in any meaningful or consistent manner after patch application. In the phototoxicity study, mild erythema was observed in some patients at 0, 0.5 and 24 h post patch removal with no differences between irradiated and non-irradiated sites. CONCLUSIONS: These two studies demonstrate that a new matrix patch developed for estradiol delivery does not promote microbial proliferation under the occluded patch site or cause acute phototoxicity following removal.

Adult↗

PubMed1992

Changes in unbound and total valproic acid concentrations after replacement of carbamazepine with oxcarbazepine.

Total and free valproic acid (VPA) concentrations were measured in patients switched from a combined VPA and carbamazepine (CBZ) to a combined VPA and oxcarbazepine (OXC) therapy, both administered in individualized daily doses. Four young epileptic patients (13-17 years old) were studied for a 12-week period, total and free VPA concentrations being analyzed just before and 4 h after the morning dose, at the end of VPA and CBZ therapy, and 2 and 10 weeks after CBZ was replaced by OXC. The expected increase in the level/dose (L/D) ratio of total VPA observed at the end of the study was preceded by a clear-cut increase in the L/D ratio of free VPA, which led to VPA-related side effects and required the retitration of VPA daily doses.

Adolescent↗

PubMed1991

Antiepileptic drugs as 'tracers' of disease. A calculation of the prevalence of epilepsy through an analysis of drug consumption. The Group for the Study of Epilepsy in General Practice.

Antiepileptic drug (AED) consumption, expressed according to a standardized measurement of the average daily doses of each active principle (the defined daily dose, DDD), was assessed as a source of morbidity data to calculate the prevalence of AED takers. In a population of 51,220 from three areas in Italy (Arcisate, Treviglio, S. Giovanni Rotondo) all the patients treated with AEDs, traced by the local general practitioners, were examined by a neurologist. The diagnosis of epilepsy was confirmed in 199 of 223 AED takers, giving an overall prevalence rate of 3.94 per 1,000 (Arcisate 3.96; Treviglio 4.04; S. Giovanni Rotondo 3.89). There was a significant overlap between the observed and expected number of AED takers (the latter obtained from regional sales and expressed in DDD). Prevalence rates calculated from drug sales were 5.58 in Arcisate and 6.11 in Treviglio. The ratio of patients with epilepsy to AED takers in the two areas was 0.7 and corresponded to the mean proportion of AEDs prescribed for epilepsy in the years 1983-1988 by a sample of Italian physicians. Although the prevalence rate calculated from AED sales tends to approximate that of treated epilepsy, AEDs can be reasonably used as 'tracers' of disease for the easy access to drug sales in Italy, the appropriateness of the DDD as a standard measure of the daily doses of AED, the steady pattern of consumption, the comparability of data covering different areas and periods, and the stable proportion of drugs delivered for epilepsy.

Adolescent↗

PubMed1990

A randomized, within-patient, cross-over, placebo-controlled trial on the efficacy and tolerability of the tricyclic antidepressants chlorimipramine and nortriptyline in central pain.

Antidepressant drugs are increasingly used in the management of chronic pain. They are mainly prescribed for cancer-related pain and central pain, e.g. phantom or stump pain, post-herpetic neuropathy. However, no controlled clinical trials have validated their in either pathology. Thus, physicians still do not know whether antidepressants are really effective and which might be best. It is still debated whether the effect of antidepressants in the management of chronic pain is limited to the amelioration of frequently concomitant depression or extends to pain itself. To verify both the analgesic effect of tricyclic antidepressants, and the possible relationship between their antidepressant effect and the relief of central pain, we carried out a randomized, within-patient (cross-over) placebo-controlled study in patients suffering from central pain. The results clearly indicate the better analgesic effect of tricyclic antidepressants over placebo (p less than 0.0001). Within the antidepressants tested, chlorimipramine, a blocker of serotonin reuptake, is significantly more effective (p less than 0.0001) than notriptyline, a blocker of noradrenaline reuptake. Finally, the antinociceptive effect is independent of the effects of the two drugs on the symptoms of depression.

Adult↗

PubMed1988

Treatment of anxiety with ketazolam in elderly patients.

In a multicenter, double-blind trial, 63 elderly patients who had experienced a generalized anxiety disorder for at least one month were randomly assigned to receive 15 mg of ketazolam (n = 31) or placebo (n = 32) daily for 15 days. At the end of this period, if their total scores on the Hamilton Anxiety Rating Scale had decreased by at least 25%, treatment was continued unchanged for a further 15 days. Patients who did not respond to treatment were given an additional 15 mg of ketazolam daily. During the initial 15 days, 83% of the ketazolam-treated patients and 43% of the placebo patients responded to treatment (P < 0.01). During the second 15-day period, the anxiety scores of the ketazolam-treated patients continued to decline significantly, whereas the placebo patients showed no improvement. According to the investigators' assessments of severity of anxiety and patients' ratings of treatment effectiveness, ketazolam was significantly superior to placebo.

Aged↗

PubMed1985

Diclofenac and pirprofen modify pituitary and hypothalamic beta-endorphin concentrations.

We provide evidence that both Diclofenac and Pirprofen, two cyclooxygenase inhibitors with a potent analgesic effect both in the experimental animal and in man, induce a significant and long lasting decrease in pituitary beta-endorphin concentrations, together with an increase of the hypothalamic concentrations of the peptide. We suggest that this effect might participate in the potent analgesic effect of the two compounds, that exceeds the one expected by drugs of this class.

Animals↗

PubMed1985

Baclofen prolongs the analgesic effect of fentanyl in man.

Pretreatment with baclofen prolonged the duration of fentanyl-induced analgesia from 18 to 30 min in patients undergoing neurosurgical anaesthesia (fentanyl plus nitrous oxide in oxygen). This observation is consistent with a potentiating effect of GABA on opioid analgesia.

Adult↗

PubMed1985

Controlled trial of two nonsteroidal anti-inflammatory drugs in postoperative pain relief: a 12-hour evaluation.

A double-blind, parallel-group trial was performed comparing efficacy and tolerability of two nonsteroidal anti-inflammatory drugs (NSAIDs)--pirprofen and noramidopyrine--in patients with postoperative pain. Thirty-four patients who had undergone orthopedic surgery were treated: 17 were given pirprofen (400 mg/4 ml) and 17 noramidopyrine (1 gm/2 ml). The first dose of medication was administered intramuscularly 30 minutes after the close of anesthesia, and a second administration was allowed six hours later if pain intensity did not decrease by 50% of initial visual analogue scale (VAS) values. Efficacy was tested both by the physician, using a rating scale, and by the patients, using a standard 100-mm VAS just before the administration of trial treatment and 2, 4, 6, and 12 hours later. The number of administrations of trial medication was also used as a criterion of efficacy. Both compounds significantly decreased (P less than 0.001) pain intensity (VAS assessment) over the trial period, but the effect of pirprofen lasted longer than that of noramidopyrine: only one of 17 patients who received pirprofen requested the second administration compared with ten of 17 patients who received noramidopyrine (P = 0.0019). The physician's evaluation performed after six hours evidenced the superiority of pirprofen (P less than 0.02) in comparison with noramidopyrine. No differences were recorded in heart rate, blood pressure, respiratory rate, or body temperature, and no unwanted effect was reported. These data provide evidence that treatment with NSAIDs can result in a well tolerated suppression of postoperative pain.

Adult↗

PubMed1985

Pirprofen in postoperative course following cataract extraction: a controlled trial.

In a double-blind, between-patient trial, a new cyclo-oxygenase inhibitor, pirprofen (800 mg/day), was compared with indomethacin (100 mg/day) and placebo in 56 patients undergoing cataract extraction. Treatment started 48 h before operation and continued for eight days. Patients were examined on days 1, 3 and 6 for objective signs of inflammation and pain. Both active drugs proved to have good anti-inflammatory action, clearly superior to placebo. No unwanted effects or modifications in laboratory parameters other than those related to the antiphlogistic effect were reported.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1984

Diclofenac increases beta-endorphin plasma concentrations.

Plasma and ventricular cerebro-spinal fluid (CSF) Beta-endorphin concentrations were evaluated after chromatographic separation in patients carrying a ventricular shunt before and after the administration of diclofenac or placebo. In the same subjects the ventricular CSF concentrations of the serotonin and the catecholamine metabolites 5-hydroxyindole-acetic acid (5-HIAA), homovanillic acid (HVA) and MOPEG were also evaluated. Plasma, but not ventricular, Beta-endorphin concentrations increased significantly after diclofenac, while placebo was ineffective. No significant changes in ventricular 5-HIAA, HVA or MOPEG levels were observed. These data suggest a role for Beta-endorphin in the analgesic effect of diclofenac.

Adult↗

PubMed1982

Growth hormone response to thyrotropin-releasing hormone in liver cirrhosis: unique alteration in anterior pituitary responsiveness to hypothalamic hormones.

Patients with chronic liver diseases were evaluated for: 1) the ability of somatostatin to affect the thyrotropin-releasing hormone (TRH) induced growth hormone (GH) rise; 2) the competence of luteinizing-hormone releasing hormone (LH-RH) to release GH; 3) the non-specific releasing effect of TRH and LH-RH on other anterior pituitary (AP) hormones. In 6 patients, infusion of somatostatin (100 micrograms iv bolus + 375 micrograms i.v. infusion) completely abolished the TRH (400 micrograms i.v.)-induced GH rise; in none of 12 patients, of whom 7 were GH-responders to TRH, did LH-RH (100 micrograms i.v.) cause release of GH; 4) finally, LH-RH (12 patients) did not increase plasma prolactin (PRL) and TRH (7 patients) did not evoke a non-specific release of gonadotropins. It is concluded that: 1) abnormal GH-responsiveness to TRH is the unique alteration in AP responsiveness to hypothalamic hormones present in liver cirrhosis; 2) the mechanism(s) subserving the altered GH response to TRH is different from that underlying the TRH-induced GH rise present in another pathologic state i.e. acromegaly, a condition in which the effect of TRH escapes somatostatin suppression and LH-RH evokes GH and PRL release.

Adult↗

PubMed1982

[Behavior of plasma renin activity in acute myocardial infarct].

Plasma renin activity (PRA) was measured in 23 patients (pts.) affected by myocardial infarction (AMI), and in a control group of 4 normal subjects, during bed rest. A blood sample was drawn every 12 hours to determine PRA pattern curve during 5 days in Coronary Care Unit. The initial PRA was in the normal range in all pts., but it rose subsequently. The highest level was reached on the 4th day. The mean value of PRA at this time was significantly higher than the initial one (p less than 0.01). Such increasing PRA was not correlated with age, sex, infarction site, infarction dimension, pain, blood pressure, arrhythmias, bed rest. At variance with the experience of others, we were not able to show a significant correlation between PRA and plasma K+ levels. Diuretic and/or beta-blocker agents too, did not influence this increase of PRA in AMI. Our results are compared with those previously reported in the literature and the possible pathophysiological mechanisms are discussed.

Adult↗