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  • Title: [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].
    Author: Diener HC, Baurecht W.
    Journal: MMW Fortschr Med; 2019 Oct; 161(Suppl 6):24-31. PubMed ID: 31587167.
    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.
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