[Tolerability, compliance, quality of life, and clinical outcome during treatment with quinine sulfate in patients with nocturnal calf cramps. A multicenter non-interventional study (NIS) in adults].

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:

The present NIS confirms effectiveness and tolerability of the therapy with quinine sulfate in daily clinical routine for adult patients with frequent and painful nocturnal leg cramps.

• 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

• Quinine

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