Economic Impact of Preoperative Meloxicam IV Administration in Total Knee Arthroplasty: A Randomized Trial Sub-Study.

We evaluated the economic impact associated with preoperative meloxicam IV 30 mg vs placebo administration among adult total knee arthroplasty (TKA) recipients enrolled in Phase IIIB NCT03434275 trial. Data on total hospital costs and length of stay (LOS) obtained from the trial were compared between meloxicam IV 30 mg and placebo groups. Patients in the meloxicam IV 30 mg vs placebo group (n = 93 vs 88) incurred an adjusted $2,266 (95% CI: -$1,035, $5,116; p = 0.

Safety and Efficacy of Perioperative Intravenous Meloxicam for Moderate-to-Severe Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial.

Objective: To evaluate the effect of perioperative meloxicam IV 30 mg on opioid consumption in primary total knee arthroplasty (TKA).

Design: Multicenter, randomized, double-blind, placebo-controlled trial.

Subjects: In total, 181 adults undergoing elective primary TKA.

Meloxicam for intravenous use: review of its clinical efficacy and safety for management of postoperative pain.

Meloxicam for intravenous use (meloxicam iv.) is a nanocrystal formulation with improved dissolution properties and shortened time to peak plasma concentrations versus oral meloxicam. In Phase III and IIIb trials, 30 mg once daily relieved pain following pre- or postoperative administration in orthopedic, abdominal and colorectal surgeries.

Preoperative intravenous meloxicam for moderate-to-severe pain in the immediate post-operative period: a Phase IIIb randomized clinical trial in 55 patients undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis.

Evaluate safety/efficacy of intravenous meloxicam in a colorectal enhanced recovery after surgery protocol. Adults undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis received meloxicam IV 30 mg (n = 27) or placebo (n = 28) once daily beginning 30 min before surgery. Adverse events: meloxicam IV, 85%; placebo, 93%.

Safety, Tolerability, and Effect on Opioid Use of Meloxicam IV Following Orthopedic Surgery.

Objective: A Phase 3 randomized multicenter, double-blind, placebo-controlled trial (NCT02720692) compared once-daily intravenous (IV) meloxicam 30 mg to placebo, when added to the standard of care pain management regimens, in adults with moderate-to-severe pain following major elective surgery and concluded that meloxicam IV had a safety profile similar to placebo and reduced opioid consumption.

Methods: In this post hoc subgroup analysis of orthopedic surgery subjects, 379 subjects received meloxicam IV 30 mg or IV-administered placebo every 24 hrs for ≤7 doses. Safety was assessed via AEs, laboratory tests, vital signs, and ECG, with an emphasis on specific AEs, including injection site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound healing events.

Analgesic Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-Severe Pain After Open Abdominal Hysterectomy: A Phase 2 Randomized Clinical Trial.

Background: An intravenous (IV) formulation of meloxicam was developed for moderate-to-severe pain management. This study evaluated the safety and efficacy of meloxicam IV after open abdominal hysterectomy. Meloxicam IV is an investigational product not yet approved by the US Food and Drug Administration.

A Phase 3, Randomized, Placebo-Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery.

An intravenous (IV) formulation of meloxicam is being studied for moderate to severe pain management. This phase 3, randomized, multicenter, double-blind, placebo-controlled trial evaluated the safety of once-daily meloxicam IV 30 mg in subjects following major elective surgery. Eligible subjects were randomized (3:1) to receive meloxicam IV 30 mg or placebo administered once daily.

Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects.

Background And Objectives: To describe the safety and tolerability of intravenous meloxicam compared with placebo across all phase II/III clinical trials.

Methods: Safety data and opioid use from subjects with moderate to severe postoperative pain who received ≥1 dose of intravenous meloxicam (5-60 mg) or placebo in 1 of 7 studies (4 phase II; 3 phase III) were pooled. Data from intravenous meloxicam 5 mg, 7.

Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-severe Pain Following Abdominoplasty.

Background: A nanocrystal intravenous (IV) formulation of meloxicam is being studied with the aim of providing postoperative analgesia.

Methods: This randomized, multicenter, double-blind, placebo-controlled trial evaluated meloxicam IV 30 mg or placebo (≤ 3 doses) in 219 subjects undergoing abdominoplasty. The primary endpoint was the summed pain intensity difference over 24 hours postdose (SPID).

Efficacy and Safety of Intravenous Meloxicam in Patients With Moderate-to-Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-controlled Trial.

Objective: To evaluate the analgesic efficacy and safety of a novel intravenous (IV) formulation of meloxicam (30 mg) in patients with moderate-to-severe pain following a standardized, unilateral bunionectomy with first metatarsal osteotomy and internal fixation.

Materials And Methods: Patients who met the criteria for moderate-to-severe postoperative pain were randomized to receive bolus injections of meloxicam IV 30 mg (n=100) or placebo (n=101) administered once daily. The primary efficacy endpoint was the Summed Pain Intensity Difference over 48 hours (SPID48).

Evaluation of the safety and efficacy of an intravenous nanocrystal formulation of meloxicam in the management of moderate-to-severe pain after bunionectomy.

Objective: This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of an intravenous (IV) nanocrystal formulation of meloxicam in subjects with moderate-to-severe pain following a standardized unilateral bunionectomy.

Methods: Fifty-nine subjects aged 18-72 years were randomized to receive doses of either 30 mg (n=20) or 60 mg (n=20) meloxicam IV or placebo (n=19), administered once daily as bolus IV injections over 15-30 seconds (two or three doses). Safety, the primary objective, was assessed by physical examination, clinical laboratory tests, and the incidence of adverse events (AEs).

A Randomized Double-Blind Controlled Trial of Intravenous Meloxicam in the Treatment of Pain Following Dental Impaction Surgery.

Unlabelled: This randomized, controlled phase 2 study was conducted to evaluate the analgesic efficacy, safety, and tolerability of single intravenous (IV) doses of 15 mg, 30 mg, and 60 mg meloxicam compared with oral ibuprofen 400 mg and placebo after dental impaction surgery. The primary efficacy end point was the sum of time-weighted pain intensity differences for 0-24 hours postdose. Among 230 evaluable subjects, meloxicam IV 60 mg produced the greatest reduction in pain, followed by the 30-mg and 15-mg doses.

A single- and multiple-dose study to investigate the pharmacokinetics of epelsiban and its metabolite, GSK2395448, in healthy female volunteers.

An open-label single- and repeat-dose study was conducted to investigate the pharmacokinetics, safety, and tolerability of ascending doses of epelsiban in healthy female volunteers (n = 48). The pharmacokinetics of the epelsiban metabolite, GSK2395448, were also assessed. Epelsiban was readily absorbed and parent and metabolite readily appeared in plasma.

Assessing Colonic Exposure, Safety, and Clinical Activity of SRT2104, a Novel Oral SIRT1 Activator, in Patients with Mild to Moderate Ulcerative Colitis.

Background: Sirtuins are a class of proteins with important physiologic roles in metabolism and inflammation. Sirtuin (silent mating type information regulation 2 homolog) 1, or SIRT1, activation is an unexplored therapeutic approach for the treatment of ulcerative colitis (UC).

Methods: Patients with mild to moderately active UC were blindly randomized to 50 mg or 500 mg daily of SRT2104, a selective activator of SIRT1, for 8 weeks.

Safety and efficacy of epelsiban in the treatment of men with premature ejaculation: a randomized, double-blind, placebo-controlled, fixed-dose study.

Aim: To assess the efficacy and safety of the selective oxytocin receptor antagonist epelsiban in the treatment of premature ejaculation (PE).

Methods: Double-blind, randomized, parallel-group, placebo-controlled, stopwatch-monitored, phase 2, multicenter study (GSK557296; NCT01021553) conducted in men (N=77) 18-55 years of age, with PE defined as per International Society for Sexual Medicine consensus definition. Patients provided informed consent prior to a 4-week un-medicated run-in to determine baseline intravaginal ejaculatory latency times (IELT) recorded in an electronic diary.

Use and outcomes of intracytoplasmic sperm injection for non-male factor infertility.

Objective: To determine whether intracytoplasmic sperm injection (ICSI) is associated with improved outcomes for non-male factor infertility.

Design: We examined the patient characteristics associated with treatment choice-ICSI and conventional in vitro fertilization (IVF)-among patients without a diagnosis of male factor infertility and compared outcomes between the two groups, adjusting for patient characteristics using multivariate regression models.

Setting: Academic fertility center.

Assessment of patient concern and adequacy of informed consent regarding infertility resulting from prostate cancer treatment.

Objectives: To address in a questionnaire-based study the frequency at which fertility is a concern for men when they consider their prostate cancer treatment options. A secondary aim was to assess the rate at which men were informed of the fertility implications of prostate cancer treatment by their physician before their selection of a treatment option.

Methods: Two questionnaires were used.

Sildenafil improves cardiac output and exercise performance during acute hypoxia, but not normoxia.

Sildenafil causes pulmonary vasodilation, thus potentially reducing impairments of hypoxia-induced pulmonary hypertension on exercise performance at altitude. The purpose of this study was to determine the effects of sildenafil during normoxic and hypoxic exercise. We hypothesized that 1) sildenafil would have no significant effects on normoxic exercise, and 2) sildenafil would improve cardiac output, arterial oxygen saturation (SaO2), and performance during hypoxic exercise.

Herniorrhaphy with polypropylene mesh causing inguinal vasal obstruction: a preventable cause of obstructive azoospermia.

Objective: To report a multiinstitutional experience of men presenting with infertility secondary to inguinal hernia repair using polypropylene mesh.

Summary Background Data: An estimated 80% of inguinal hernia operations involve placement of a knitted polypropylene mesh to form a "tension-free" herniorrhaphy. The prosthetic mesh induces a chronic foreign-body fibroblastic response creating scar tissue that imparts strength to the floor and leads to fewer recurrences.

Female sexual arousal: a behavioral analysis.

Objective: This study was designed to assess female sexual arousal by using a combination of physiologic measures and self-reported level of arousal.

Design: Twenty subjects viewed a 23-minute sequence of randomly ordered relaxation and erotic tapes, both with and without auditory stimulus. The physiologic parameters of vaginal blood flow, galvanic skin resistance, respiration, pulse, and blood pressure, as well as self-reported level of arousal, were simultaneously recorded and correlated with video segments.

Vasectomy and prostate cancer characteristics of patients referred for prostate biopsy.

Purpose: The prospect of an association between vasectomy and prostate cancer has gained widespread attention and has potentially influenced patterns of referral. In patients referred for prostate needle biopsies we compared the incidence and characteristics of prostate cancer in those reporting a history of vasectomy to those denying prior vasectomy.

Materials And Methods: A total of 585 consecutive prostate biopsy procedures were performed on 522 veterans during a 42-month period.