Effect of a long-term, oral fixed dose with a combination of aledronate and cacitriol on the cancellous bone microarchitecture in ovariectomized rats

Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97 weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3—9 mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase. Stable patients who completed open-label treatment could be randomized to continued cariprazine (3, 6, or 9 mg/d) or placebo for double-blind treatment (up to 72 weeks). The primary efficacy parameter was time to relapse (worsening of symptom scores, psychiatric hospitalization, aggressive/violent behavior, or suicidal risk); clinical measures were implemented to ensure safety in case of impending relapse. A total of 264/765 patients completed open-label treatment; 200 eligible patients were randomized to double-blind placebo (n = 99) or cariprazine (n = 101). Time to relapse was significantly longer in cariprazine — versus placebo-treated patients (P = .0010, log-rank test). Relapse occurred in 24.8% of cariprazine- and 47.5% of placebo-treated patients (hazard ratio [95% CI] = 0.45 [0.28, 0.73]). Akathisia (19.2%), insomnia (14.4%), and headache (12.0%) were reported in ≥ 10% of patients during open-label treatment; there were no cariprazine adverse events ≥ 10% during double-blind treatment. Long-term cariprazine treatment was significantly more effective than placebo for relapse prevention in patients with schizophrenia. The long-term safety profile in this study was consistent with the safety profile observed in previous cariprazine clinical trials. ClincalTrials.gov identifier: NCT01412060. Key words: schizophrenia; cariprazine; long-term treatment; relapse prevention; randomized controlled trial; oral antipsychotics

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Long-Term Efficacy and Tolerability of a Fixed-Dose Combination of Antihypertensive Agents

Clinical Drug Investigation ◽

10.2165/11587390-000000000-00000 ◽

2011 ◽

pp. 1 ◽

Cited By ~ 2

Author(s):

Yiqun Wu ◽

Yonghua Hu ◽

Xun Tang ◽

Liu He ◽

Tao Ren ◽

...

Keyword(s):

Antihypertensive Agents ◽

Fixed Dose Combination ◽

Fixed Dose ◽

Term Efficacy ◽

Dose Combination

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Long-term efficacy and safety of imiquimod 5% and fluorouracil 1% creams in medical monotherapy of complex eyelid basal cell carcinomas

European Journal of Ophthalmology ◽

10.1177/11206721211035614 ◽

2021 ◽

pp. 112067212110356

Author(s):

Manpreet Singh ◽

Aditi Mehta Grewal ◽

Himanshi Singh ◽

Manjula Sharma ◽

Manpreet Kaur ◽

...

Keyword(s):

Basal Cell ◽

Side Effect ◽

The Elderly ◽

Fixed Dose ◽

Side Effect Profile ◽

Efficacy And Safety ◽

Term Efficacy ◽

Basal Cell Carcinomas ◽

Double Blinded

Purpose: To study the long-term efficacy and safety of local application of imiquimod 5% and fluorouracil 1% creams in complex eyelid basal cell carcinomas (BCCs). Methods: A retrospective, non-comparative study in biopsy-proven, complex (involving canthi or >50% of eyelid length) eyelid BCC patients who were medically unfit for surgical procedures. All patients were medically treated with either of the creams using fixed-dose regimens for a minimum of 3 months. All received oral vitamin C 500 mg QID for 3 months as an adjunct for collagen healing. A minimum of “post-treatment” follow-up of 12 months was observed. Results: Of total 30 patients, imiquimod 5% and fluorouracil 1% were used in 16 and 14 patients, respectively. The mean age of our patients was 70.5 years. The co-morbidities included – severe coronary artery disease using blood-thinners ( n = 19), poorly controlled diabetes ( n = 12), poorly controlled hypertension ( n = 6), on nebulization ( n = 3), and tuberculosis with pulmonary fibrosis ( n = 2). Complete clinical tumor resolution was noted in 10 and 8 patients over 12 and 16.5 weeks, respectively, in imiquimod and fluorouracil groups. Periocular skin erythema, chemical conjunctivitis, and skin depigmentation were seen in all the patients of imiquimod group. On the other hand, the local side-effect profile in fluorouracil patients was limited. Conclusion: The medical treatment of complex eyelid BCC is a useful alternative to surgery in the elderly with significant co-morbidities. It provides a promising long-term relief with a tolerable side-effect profile. A prospective, randomized, double-blinded trial would provide stronger evidence for the efficacy of these drugs.

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