Direct transition to long-acting risperidone - analysis of long-term efficacy

2005 ◽  
Vol 19 (5_suppl) ◽  
pp. 15-21 ◽  
Author(s):  
W. Kissling ◽  
S. Heres ◽  
K. Lloyd ◽  
E. Sacchetti ◽  
P. Bouhours ◽  
...  

This report presents data from the extension phase of a 6-month trial that evaluated the efficacy of risperidone long-acting injectable (RLAI) in stable psychotic patients requiring a treatment change. Patients continued to receive RLAI every 2 weeks for a maximum of 12 months from study entry. Symptoms were assessed using the PANSS after 1, 3, 6, 9 and 12 months of treatment (or treatment endpoint). Remission of severity criteria were defined as ≤3 points in all PANSS items suggested by the Remission in Schizophrenia Working Group. 715 patients (63% male) entered the extension phase and 508 completed the 12-month study. The mean PANSS total score at Day 0 was 74.9±22.7. This was significantly reduced after 1 month (67.7 ±22.3, p≤0.001), with continued improvements over the 12 months of the study until treatment endpoint (59.7±21.9). Significant improvements from Day 0 to endpoint were also seen in the scores for all PANSS subscales and symptom factors. The proportion of patients who met the PANSS severity criteria for remission increased from 29% at Day 0 to 60% at endpoint, and the proportion of patients who met these criteria for ≤ 6 months increased from 24% at Month 6 to 45% at endpoint. Treatment with RLAI for up to 12 months provided significant and sustained improvements in symptom control in patients with schizophrenia. These improvements may help patients to achieve and remain in remission.

2020 ◽  
Vol 5 (06) ◽  
pp. 43-50
Author(s):  
M. Ramadas ◽  
Padmanabha Rugvedi ◽  
Pankaj Kumar Gupta ◽  
Rajiva Kumar Rai ◽  
JLN Sastry

Context: Functional constipation which has no underlying organic causes is difficult to be allopathic treatment for long term due to its side effects and undeniable effect, thus a natural balanced and compatible formulation needs to be validated. Objectives: Current study aimed to assess a poly-herbal formulation in management of functional constipation. Material and Methods: This study was 28 days, two armed, randomized, open labeled, prospective clinical study. 60 clinically confirmed cases of functional constipation patients randomized to receive orally either 2 teaspoonful of PP/JLN/107/09-10 Syrup or 1 teaspoonful of 5- 6 gm of Isabgol powder. Results were analyzed as per Rome II criteria and other associated symptoms like headache, acidity, belching, barborgysmy, flatulence and abdominal dis tension or bloating which are recorded on VAS score. Results: PP/JLN/107/09-10 scored over Isabgol on four out of six parameters of Rome II Criteria viz., frequency of bowel movement, straining at defecation, lumpy I har dstool formation, feeling of incomplete evacuation, feeling of ano-rectal blockage and manual maneuvers (p less than 0.001). Trial drugs showed comparable effects (p > 0.05) in reducing the mean scores of associated symptoms like headache, acidity, belching, borgorgysmy, flatulence and abdominal distension. However, trial drug was found to perform statistically significant result in more number of parameters in comparison to Isabgol. Conclusion: PP/JLN/107/09-10 was found to be effective and safe in reliving functional constipation.


1987 ◽  
Vol 1 (3) ◽  
pp. 151-154 ◽  
Author(s):  
James P. Kemp ◽  
Sami L. Bahna ◽  
Paul Chervinsky ◽  
Gary S. Rachelefsky ◽  
James M. Seltzer ◽  
...  

Loratadine is a new nonsedating long-acting H1-antagonist which has been shown to be effective at various doses in controlling symptoms of spring seasonal allergic rhinitis. In this multicenter, double-blind, parallel study, 313 adolescent and adult patients with moderate to severe, skin-test positive, fall seasonal rhinitis were randomized to receive either loratadine, 10 mg, in the morning and placebo in the evening, clemastine 1 mg. b.i.d., or placebo b.i.d. for 2 weeks. Patients maintained daily diaries of nasal and ocular symptoms and of adverse effects. They were evaluated before and 7 and 14 days after starting treatment. The mean symptom scores on days 7 and 14 showed greater improvement with both loratadine and clemastine treatments than with placebo. The incidence of somnolence in the loratadine group by comparison with the placebo group was not statistically different, whereas clemastine caused significantly more drowsiness than did placebo. We conclude that loratadine, 10 mg, once a day is as effective as clemastine b.i.d. in decreasing the symptoms of fall seasonal rhinitis and the incidence of somnolence with loratadine is not statistically different from that with placebo.


1998 ◽  
Vol 16 (2) ◽  
pp. 593-602 ◽  
Author(s):  
J R Berenson ◽  
A Lichtenstein ◽  
L Porter ◽  
M A Dimopoulos ◽  
R Bordoni ◽  
...  

PURPOSE To determine the efficacy and safety of 21 monthly cycles of pamidronate therapy in patients with advanced multiple myeloma. PATIENTS AND METHODS Patients with stage III myeloma and at least one lytic lesion received either placebo or pamidronate 90 mg intravenously administered as a 4-hour infusion monthly for 21 cycles. At study entry, the patients were stratified according to whether they were to receive first-line (stratum 1) or second-line (stratum 2) antimyeloma chemotherapy. Skeletal events (pathologic fracture, radiation or surgery to bone, and spinal cord compression) and hypercalcemia were assessed monthly. RESULTS The results of the first nine previously reported cycles are extended to 21 cycles. Of the 392 randomized patients, efficacy could be evaluated in 198 who received pamidronate and 179 who received placebo. After 21 cycles, the proportion of patients who developed any skeletal event was lower in the pamidronate-group (P = .015). The mean number of skeletal events per year was less in the pamidronate-group (1.3) than in placebo-treated patients (2.2; P = .008). Although survival was not different between the pamidronate-treated group and placebo patients overall, stratum 2 patients who received pamidronate lived longer than those who received placebo (14 v 21 months, P = .041). Pamidronate was safe and well tolerated during the 21 cycles of therapy. CONCLUSION Long-term monthly infusions of pamidronate as an adjunct to chemotherapy are superior to chemotherapy alone in reducing skeletal events in stage III multiple myeloma patients, and may improve the survival of patients on salvage therapy.


Author(s):  
Alekh Kumar ◽  
Nupur Kumari

Background: Tonsillitis is widespread among children and has serious poststreptococcal complications, and both the patients and clinician have to face the question on what is the role and benefit of using long-acting penicillin and whether it is an alternative method of treatment to surgery?. This study was carried out to evaluate the effectiveness of tonsillectomy compared with long-acting penicillin in the treatment of recurrent tonsillitis, comparing their effects on the levels of the antistreptolysin O titer (ASOT).Methods: A total of 100 patients aged 4-15 years with recurrent tonsillitis and signs of chronic tonsillitis, after exclusion of patients with bleeding diathesis, anemia, chronic illness, and criteria of rheumatic fever, were included in this study, they were divided to two groups comprising 50 patients each. The first group was treated by tonsillectomy, whereas the second group was treated using long-acting penicillin monthly for 6 months. They were clinically evaluated, ASOT levels were recorded for all patients before management and after 6 months.Results: The mean ASOT readings before management and after 6 months for the tonsillectomy group were 518.29 and 117.13 IU/ml, respectively (P value <0.004), whereas for the penicillin group, they were 526.70 and 262.98 IU/ml, respectively (P value <0.072).Conclusions: This study demonstrates that the first line of treatment of recurrent chronic tonsillitis is tonsillectomy, as it is both clinically effective and cost-effective for children and that the second line of treatment is long-acting penicillin with a long-term follow-up and in patients have contraindications for surgery such as bleeding diathesis.


1991 ◽  
Vol 125 (4) ◽  
pp. 385-391 ◽  
Author(s):  
J. A. Verhelst ◽  
A. L. Froud ◽  
R. Touzel ◽  
J. A. H. Wass ◽  
G. M. Besser ◽  
...  

Abstract. Quinagolide (CV 205-502, Sandoz), an octahydrobenzo (g) quinoline, is a new non-ergot dopamine agonist which has specific D2 receptor activity and a long half-life, making it suitable for once-daily treatment. Recent uncontrolled reports have suggested that quinagolide may be successfully used for the clinical management of hyperprolactinemia with fewer adverse reactions than bromocriptine. This study is the first to compare quinagolide in a double-blind manner with bromocriptine, given only once-daily instead of the usual multidose regimen. In the first phase we compared, in 7 hyperprolactinemic patients, the effects over 24 h of a single oral dose of 0.05 mg quinagolide with 2.5 mg bromocriptine. Compared with placebo, both bromocriptine and quinagolide showed potent PRL-inhibiting and GH-releasing effects, with comparable effects at 24 h; no significant changes were observed in TSH, LH, FSH or cortisol. Twelve hyperprolactinemic patients were then randomized to receive either once-daily bromocriptine or quinagolide in incremental doses for a period of six months. Both drugs were found to be equally effective, and no differences were seen either in adverse reactions or PRL levels during repeated diurnal sampling. We therefore conclude that quinagolide and bromocriptine are therapeutically equivalent in long-term use, and both are equally effective when given once a day. However, some patients intolerant of bromocriptine may respond better to quinagolide, and vice versa.


2019 ◽  
Vol 76 (15) ◽  
pp. 1097-1103 ◽  
Author(s):  
Jennifer L Koehl ◽  
David E Zimmerman ◽  
Patrick J Bridgeman

Abstract Purpose The use of buprenorphine, methadone, and long-acting naltrexone for treatment of opioid use disorder (OUD) is discussed, including a review of current literature detailing treatment approaches and action steps to optimize treatment in acute care and office-based settings. Summary The U.S. epidemic of opioid-related deaths has been driven by misuse of prescription opioids and, increasingly, illicit drugs such as heroin, fentanyl, and fentanyl analogs, necessitating a refocusing of treatment efforts on expanding access to life-saving, evidence-based OUD pharmacotherapy. Inpatient treatment of opioid withdrawal includes acute symptom control through a combination of nonopioid medications and long-term pharmacotherapy to lessen opioid craving and facilitate stabilization and recovery. Methadone and buprenorphine reduce opioid craving, increase treatment retention, reduce illicit opioid use, and increase overall survival. Buprenorphine has logistical advantages over methadone, such as greater flexibility of treatment setting and less risk of adverse effects. Studies have shown the efficacy of long-acting injectable naltrexone to be comparable to that of buprenorphine if patients are detoxified prior to initiation of therapy; however, patients with active OUD are often not able to complete the week-long period of opioid abstinence needed prior to initiation of naltrexone injections. Although buprenorphine is preferred by many patients and can be prescribed in office-based settings, there remains a paucity of physicians certified to prescribe it. Conclusion Buprenorphine has become the medication of choice for many patients with OUD, but its use is limited by the low number of physicians certified to prescribe the agent. Other agents studied for treatment of OUD include methadone and naltrexone.


2017 ◽  
Vol 41 (S1) ◽  
pp. S312-S312
Author(s):  
A. Baatout ◽  
U. Ouali ◽  
R. Jomli ◽  
H. Elkefi ◽  
A. Oumaya ◽  
...  

IntroductionAddiction is often underdiagnosed in bipolar disorder (BD), although it is frequent and known to complicate its clinical course.ObjectivesThe aim of our study was to study socio-demographic and clinical factors associated with addiction in BD patients.MethodsThis is a retrospective, cross-sectional, descriptive and comparative study on 100 patients followed in our department and diagnosed with BD type I according to DSM 5. Demographic and clinical data was compared across the groups: Addiction + (A + ) and Addiction–(A − ).ResultsNighteen patients had an addiction co-morbidity (A + ), whereas 81 had not (A − ). The mean age of the (A + ) group was 39.47 years whereas it was 42.52 years in the (A − ) group. Males represented 68.4% of the (A + ) group and 48.1% of the (A − ) group. Age of illness onset was lower in the (A + ) group (mean = 23.16, median = 21) compared to the (A − ) group (mean = 26.04, median = 27). Addiction co-morbidity was significantly associated with predominant manic polarity (P = 0.03). All (A + ) patients presented mood episodes with psychotic features, whereas psychotic features were only found in 86.6% of (A − ) patients. Co-morbid addiction was significantly associated with a higher number of mood episodes (P = 0.04), a higher number and duration of hospitalisations (P = 0.02, P = 0.015), and a poorer compliance (P = 0.07). All A+ subjects received antipsychotics, and they were significantly more to receive long-acting antipsychotics (P = 0.06).ConclusionsAddictions worsen the prognosis of bipolar disorder and require specific therapeutic strategies. They deserve therefore the particular attention of clinicians.Disclosure of interestThe authors have not supplied their declaration of competing interest.


2018 ◽  
Vol 178 (4) ◽  
pp. 321-329 ◽  
Author(s):  
Christian J Strasburger ◽  
Anders Mattsson ◽  
Patrick Wilton ◽  
Ferah Aydin ◽  
Judith Hey-Hadavi ◽  
...  

Pegvisomant monotherapy is effective and safe in treatment of acromegaly. However, some clinicians combine pegvisomant with somatostatin analogues (SSA) or dopamine agonist (DA). In this analysis of ACROSTUDY, a long-term non-interventional study, the use of combination regimens was evaluated. Based on their baseline treatment, 2043 patients were retrospectively categorized as: long-acting SSA combined with pegvisomant, ‘Combo SSA’ 768 patients (38%); DA combined with pegvisomant, ‘Combo DA’ 123 (6%); pegvisomant monotherapy, ‘Peg mono’ 1128 (55%). Treatment patterns changed over the 10-year period, with recent patients more likely to receive any combination (20% in 2003 vs 54% in 2012). Combo SSA use varied widely among countries from 22% to 78%. Exposure periods of the three treatment modalities were defined from pegvisomant start until the last visit in ACROSTUDY; patients could switch treatment categories. At year 4, IGF-I was normal in 62% of Combo SSA, 63% of Combo DA and 65% of Peg mono groups. Pegvisomant was initiated as daily injections in 94% of patients in the Peg mono group, 66% of Combo SSA and 91% of Combo DA patients. During 6169 years of treatment exposure, 3424 adverse events (AEs) were reported in 946 (51%) patients, of which 617 (18%) were serious and 401 (12%) were considered treatment related. The reported incidence of serious AEs and treatment-related non-serious AEs were similar among the three treatment modalities. This analysis describes real-world clinical care and shows favorable efficacy and safety for Peg mono and combinations. Novel findings include an increased use of combination therapy over time and variability in treatment modalities between countries.


Blood ◽  
2004 ◽  
Vol 103 (9) ◽  
pp. 3282-3286 ◽  
Author(s):  
Claire E. Farel ◽  
Doreen G. Chaitt ◽  
Barbara K. Hahn ◽  
Jorge A. Tavel ◽  
Joseph A. Kovacs ◽  
...  

Abstract Studies establishing that intermittent subcutaneous interleukin-2 (IL-2) therapy can lead to substantial CD4 cell increases in many HIV-infected patients have generally been of limited duration. We studied 77 patients participating in active longitudinal studies of subcutaneous IL-2 therapy at our center in order to determine the long-term feasibility of this approach. Following initial induction, patients in each trial were eligible to receive intermittent 5-day cycles of subcutaneous IL-2 treatment at individualized doses and frequencies capable of maintaining CD4 counts at postinduction levels. The mean duration of study participation to date is 5.9 years (range, 1.0-9.3 years). Mean baseline CD4 cell count and CD4 percent values of 0.521 × 109/L (521 cells/μL) and 27% have risen to 1.005 × 109/L (1005 cells/μL) and 38%, respectively, at 90 months. The mean number of subcutaneous IL-2 cycles required to achieve and maintain these increases was 10 cycles (range, 3-29 cycles), and the current mean interval of cycling required to maintain these elevations is 39 months (median, 35 months; range, 2-91 months). We conclude that subcutaneous IL-2 therapy is capable of maintaining CD4 cell increases for an extended period using a remarkably low frequency of intermittent cycling. These observations may contribute to patients' acceptance of subcutaneous IL-2 as a favorable long-term treatment strategy. (Blood. 2004;103:3282-3286)


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