Exploiting biology for therapeutic gain

2004 ◽  
pp. 417-429
Author(s):  
Richard Gilbertson ◽  
Donald O’rourke
Keyword(s):  
Therapeutic Gain

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

scholarly journals Reactive oxygen species spermine metabolites generated from amine oxidases and radiation represent a therapeutic gain in cancer treatments

2013 ◽  
Vol 43 (3) ◽  
pp. 813-820 ◽  
Author(s):  
ROBERTO AMENDOLA ◽  
MANUELA CERVELLI ◽  
EMILIANO FRATINI ◽  
DAVIDE E. SALLUSTIO ◽  
GIAMPIERO TEMPERA ◽  
...  
Keyword(s):  
Reactive Oxygen Species ◽  
Reactive Oxygen ◽  
Oxygen Species ◽  
Amine Oxidases ◽  
Cancer Treatments ◽  
Therapeutic Gain

Comparison of Traditional and Simultaneous IMRT Boost Technique Basing on Therapeutic Gain Calculation

2008 ◽  
Vol 33 (4) ◽  
pp. 299-302 ◽  
Author(s):  
Krzysztof Slosarek ◽  
Aleksander Zajusz ◽  
Marta Szlag
Keyword(s):  
Therapeutic Gain

scholarly journals Intravenous chlorpromazine in the acute treatment of episodic tension-type headache: a randomized, placebo controlled, double-blind study

2002 ◽  
Vol 60 (3A) ◽  
pp. 537-541 ◽  
Author(s):  
Marcelo Eduardo Bigal ◽  
Carlos Alberto Bordini ◽  
José Geraldo Speciali
Keyword(s):  
Acute Treatment ◽  
Tension Type Headache ◽  
Blind Study ◽  
Number Needed To Treat ◽  
Double Blind Study ◽  
Emergency Rooms ◽  
Double Blind ◽  
Therapeutic Gain ◽  
Type Headache ◽  
To Receive

Acute headache is a very frequent symptom, responsible for a significant percentage of caseload at primary care units and emergency rooms. Chlorpromazine is easily available in such settings. The aim of this study is to conduct a randomized, placebo-controlled, double-blind study to assess the efficacy of chlorpromazine on the acute treatment of episodic tension-type headache. We randomized 30 patients to receive placebo (10 ml of saline intravenous injections) and 30 patients to receive 0.1 mg/Kg chlorpromazine intravenously. We used 7 parameters of analgesic evaluation. Patients receiving chlorpromazine showed a statistically significant improvement (p < 0.05 and p < 0.01) of pain compared to placebo, far up to 30 minutes after the drug administration. The therapeutic gain was 36.7% in 30 minutes and 56.6 % in 60 minutes. The number needed to treat (NNT, the reciprocal or the therapeutic gain) was 2.7 in 30 minutes and 1.8 in 60 minutes. There were reductions in the recurrence and in the use of rescue medication in the chlorpromazine group. We can conclude that intravenous chlorpromazine is an effective drug to relief the pain in tension-type headache.

Client’s Expectancy of Therapeutic Gain

Psychiatry ◽  
1973 ◽  
Vol 36 (2) ◽  
pp. 184-190 ◽  
Author(s):  
Wallace Wilkins
Keyword(s):  
Therapeutic Gain

Efficacy and Adverse Events of Subcutaneous, Oral, and Intranasal Sumatriptan Used for Migraine Treatment: A Systematic Review Based on Number Needed To Treat

Cephalalgia ◽  
1998 ◽  
Vol 18 (8) ◽  
pp. 532-538 ◽  
Author(s):  
P Tfelt-Hansen
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Clinical Trials ◽  
Migraine Treatment ◽  
Number Needed To Treat ◽  
Onset Of Action ◽  
Therapeutic Gain ◽  
Numbers Needed To Treat ◽  
Subcutaneous Sumatriptan ◽  
Speed Of Onset

Objectives: To evaluate the efficacy, speed of onset, and adverse events of 6 mg subcutaneous, 100 mg oral, and 20 mg intranasal sumatriptan in the treatment of migraine attacks. Design: Systematic review of placebo-controlled randomized clinical trials. Data sources: Thirty trials up to April 1997 retrieved from a systematic literature search (Medline, review papers, handsearching of journals, congress proceedings, manufacturer's database); no restriction on language. Outcome parameters: Numbers needed to treat (NNT) were calculated for relief of headache and for adverse events (when data were available). Therapeutic gain was used to evaluate speed of onset of action. Results: Subcutaneous sumatriptan was more efficacious, combined number needed to treat 2.0 at 1 h, than oral (3.0 at 2 h) and intranasal sumatriptan (3.1 at 2 h). For adverse events, the NNT was 3.0 for subcutaneous and 8.3 for oral sumatriptan. Only limited data on adverse events for intranasal sumatriptan were available. Therapeutic gain analysis during the first 2 h showed that subcutaneous sumatriptan was the fastest-acting form of administration. Conclusions: Subcutaneous sumatriptan in a dose of 6 mg is significantly more efficacious than 100 mg of oral sumatriptan, but causes more adverse events than oral sumatriptan. Subcutaneous sumatriptan is the form with the quickest onset of action. Intranasal sumatriptan has the same efficacy as oral sumatriptan and a quicker onset of action than the oral form, but with a limited therapeutic effect for the first 30 min after administration.

scholarly journals Using PAR4 Inhibition as an Anti-Thrombotic Approach: Why, How, and When?

2019 ◽  
Vol 20 (22) ◽  
pp. 5629 ◽  
Author(s):  
Simeng Li ◽  
Volga Tarlac ◽  
Justin R. Hamilton
Keyword(s):  
Clinical Trial ◽  
Platelet Function ◽  
Therapeutic Potential ◽  
Human Platelets ◽  
Cellular Functions ◽  
Protease Activated Receptors ◽  
The Past ◽  
Therapeutic Gain ◽  
Anti Platelet Drug

Protease-activated receptors (PARs) are a family of four GPCRs with a variety of cellular functions, yet the only advanced clinical endeavours to target these receptors for therapeutic gain to date relates to the impairment of platelet function for anti-thrombotic therapy. The only approved PAR antagonist is the PAR1 inhibitor, vorapaxar—the sole anti-platelet drug against a new target approved in the past 20 years. However, there are two PARs on human platelets, PAR1 and PAR4, and more recent efforts have focused on the development of the first PAR4 antagonists, with first-in-class agents recently beginning clinical trial. Here, we review the rationale for this approach, outline the various modes of PAR4 inhibition, and speculate on the specific therapeutic potential of targeting PAR4 for the prevention of thrombotic conditions.

Onset of action in placebo-controlled migraine attacks trials: A literature review and recommendation

Cephalalgia ◽  
2020 ◽  
pp. 033310242095691
Author(s):  
Peer Tfelt-Hansen ◽  
Hans-Christoph Diener
Keyword(s):  
Randomised Controlled Trials ◽  
Early Time ◽  
New Drugs ◽  
Complete Relief ◽  
Controlled Trials ◽  
Onset Of Action ◽  
Therapeutic Gain ◽  
Randomised Controlled ◽  
Time To Onset ◽  
Time Point

Background Migraine patients want acute treatment to provide complete relief of the migraine attack within 30 minutes. Traditionally, “speed of onset of effect” is evaluated by estimating the time-point for first statistical separation of drug and placebo. The estimated onset of effect can be a few percent difference of patients being pain free in very large randomised, controlled trials. This difference, however, can be clinically irrelevant. Methods Placebo-controlled randomised, controlled trials with pain freedom results from 30 min to 2–4 hours were retrieved from the literature. For each time-point, the therapeutic gain (drug minus placebo) (TG) was calculated. Therapeutic gain for being pain free of 5% was chosen for the definition of “onset of action”, since this is approximately 1/3 of the 16% TG and 1/4 of 21% of TG for sumatriptan 50 mg and 100 mg, respectively. Results A total of 22 time-effect curves based on randomised, controlled trials were analysed. Based on the “onset of action” of 5% pain freedom, the evaluated drugs and administration forms can be classified as follows: i) Early time to onset, ≤30 min (three randomised, controlled trials); ii) medium time to onset, 60 min (nine randomised, controlled trials); iii) delayed time to onset, 90–120 min (10 randomised, controlled trials). Conclusion Only three non-oral administration forms with a triptan (subcutaneous sumatriptan and nasal zolmitriptan) resulted in an “onset of action” at ≥30 min; in the future, early onset of action should be a priority in the development of new drugs or new administration-forms for the treatment of acute migraine attacks.

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