Abstract | BACKGROUND: Frequent and painful nocturnal leg cramps (NLC) require an effective therapy to improve quality of life and sleep performance in patients. METHOD: In a multicenter, prospective, non-interventional study (NIS) data on the effectiveness, tolerability and safety of quinine sulfate were collected in daily medical management in adult patients with frequent and painful nocturnal leg cramps. RESULTS: In total 596 patients were included into the study. Of these, 568 patients finished the study as planned (95.3%). Number, duration and pain intensity of NLC were reduced in the majority of patients after 2 weeks of therapy with quinine sulfate 200 mg OD. Physicians rated global assessment of treatment effect as "good" and "very good" in 535 patients (92.4%) which was concurrent with the patients' rating ("good" and "very good" by 534 patients = 92.2%), based on the full analysis set of 579 patients. Furthermore, quality of life and sleep were improved. Adverse drug reactions were reported in 35/592 patients (5.9%). Severe adverse events were not observed. The total incidence of therapy-associated adverse effects was comparable in the subgroup of patients with concomitant ß-blocker therapy (149/592 patients, 25.2%; totally 10%, subgroup 10.1%). Efficacy and tolerability of quinine sulfate were evaluated as "very good" or "good" by the majority of physicians and patients. CONCLUSIONS:
|
Authors | Hans-Christoph Diener, Werner Baurecht |
Journal | MMW Fortschritte der Medizin
(MMW Fortschr Med)
Vol. 161
Issue Suppl 6
Pg. 24-31
(Oct 2019)
ISSN: 1613-3560 [Electronic] Germany |
Vernacular Title | Chininsulfat in der Therapie nächtlicher Wadenkrämpfe: Verträglichkeit, Compliance, Lebensqualität und Einfluss auf Symptome : Eine multizentrische nichtinterventionelle Studie (NIS) bei Erwachsenen. |
PMID | 31587167
(Publication Type: Journal Article, Multicenter Study)
|
Chemical References |
|
Topics |
- Adult
- Female
- Humans
- Male
- Muscle Cramp
(drug therapy)
- Prospective Studies
- Quality of Life
- Quinine
(therapeutic use)
- Sleep-Wake Transition Disorders
(drug therapy, prevention & control)
- Treatment Outcome
|