Table 2 Nonprimary endpoints used in medical labeling (2000-2012)
From: Potential of patient-reported outcomes as nonprimary endpoints in clinical trials
Product | Date of approval | Indication | PRO measures included |
|---|---|---|---|
Protonix | February 2, 2000 | Short-term treatment in the healing and symptomatic relief of erosive esophagitis | Daily diary: frequency and severity of acid regurgitation, dysphagia, and daytime and nighttime symptoms |
Frova | January 18, 2001 | Acute treatment of migraine with or without aura in adults | Headache diary with associated symptoms |
Foradil | February 16, 2001 | Maintenance treatment of asthma and prevention of bronchospasm in adults and children aged 5 years and older | Daily diary: nighttime asthma symptom score, daytime asthma symptom score, number of inhalations of rescue medication |
Acute prevention of exercise-induced bronchospasm | |||
Nexium | February 20, 2001 | Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis | Daily symptom diary |
Maintenance of symptom resolution and healing of erosive esophagitis | |||
Treatment of heartburn and other symptoms related to GERD | |||
Treatment of patients with H. pylori infection and duodenal ulcer disease | |||
Elidel | December 13, 2001 | Short-term and intermittent long-term therapy in the treatment of mild to moderate atopic dermatitis | Unnamed purities assessment |
Emend | March 27, 2003 | Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy | FLIE |
Nevanac | August 19, 2005 | Treatment of pain and inflammation associated with cataract surgery | Ocular pain scale |
Chantix | May 10, 2006 | Aid to smoking cessation treatment | QSU-Brief |
MNWS | |||
SEI | |||
Vyvanse | February 23, 2007 | Treatment of ADHD | CPRS |
Soliris | March 16, 2007 | Treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis | FACIT-Fatigue |
EORTC QLQ-C30 | |||
Letairis | June 15, 2007 | Treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening | SF-36 Health Survey |
Durezol | June 23, 2008 | Treatment of inflammation and pain associated with ocular surgery | VAS – eye pain/discomfort |
VAS – photophobia | |||
Ampyra | January 22, 2010 | Indicated to improve walking in patients with multiple sclerosis | MSWS-12 |
Egrifta | November 10, 2010 | Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy | Distress associated with belly appearance |
Arcapta | July 1, 2011 | Long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema | Rescue medication use |
Symptom diary | |||
SGRQ | |||
Firazyr | August 25, 2011 | Treatment of acute attacks of hereditary angioedema | Symptom VAS |
Rescue medication | |||
Jakafi | November 16, 2011 | Treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, postpolycythemia vera myelofibrosis and postessential thrombocythemia myelofibrosis | MFSAF diary |
Kalydeco | January 31, 2012 | Treatment of cystic fibrosis in patients aged 6 years and older who have a G551D mutation in the CFTR gene | CFQ-R (symptoms domain) |
Asclera | March 30, 2010 | Treatment of uncomplicated spider veins and uncomplicated reticular veins in the lower extremity | Patient satisfaction using a verbal rating scale |