| 1. |
- Hagell, Peter, et al.
(författare)
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Apomorphine formulation influences subcutaneous complications in continuous apomorphine pump therapy for Parkinson’s disease
- 2017
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Ingår i: Movement Disorders.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Objective: To explore if the occurrence and severity of subcutaneous (sc) nodules is influenced by the pharmaceutical formulation of apomorphine used for sc infusion in advanced Parkinson’s disease (PD).Background: Apomorphine infusion is an effective therapy in advanced PD, but a limitation is troublesome sc nodules. Various chemically non-identical apomorphine formulations are available. Anecdotal clinical experience has suggested that shifting from one of these (Apo-Go PumpFill; apoGPF) to another (Apomorphine PharmSwed; apoPS, developed in Sweden) may influence the occurrence and severity of sc nodules.Methods: In this multicenter open-label prospective observational study, 15 people with advanced PD (mean PD- duration, 13.4 years; median Hoehn & Yahr, IV) on apoGPF since a mean of 2.1 years and with troublesome sc nodules were switched to apoPS. Ongoing interventions to treat existing nodules (ultrasound, massage, Hirudoid cream) continued, and apomorphine as well as other drugs was managed according to clinical routines. Data were collected between May 2015 and March 2017; at baseline, at the time of switching (about 2 weeks later), and up to 1.7-4.2 (mean, 2.5) months post-switch follow-up. Primary outcomes were total nodule numbers, size (mm diameter for the 5 worst nodules), consistency (scored 0-3 for the 5 worst nodules), and associated skin changes (scored 0-4 for the 5 worst nodules) and pain (scored 0-5). Patients also rated their perceived PD severity and motor complications (UPDRS IV). Patient preferences 5-12 months post-switch (2-9 months after follow-up) were also recorded.Results: Apomorphine and L-dopa doses did not change over the observation period (P≥0.400). Baseline nodule numbers (7.4 vs. 4.6; P<0.003), size (92.9 vs. 54.1 mm; P=0.016), consistency (11 vs. 5; P=0.003), skin changes (3 vs. 1.5; P=0.205), and average pain (1 vs. 0; P=0.020) improved 11 weeks post-switch. Patient-reported PD severity (P=0.020) and motor fluctuations improved (P=0.051), whereas dyskinesias tended to increase (P=0.205). At 5-12 months post-switch, 13 patients had decided to remain on apoPS; mainly due to improved nodules.Conclusions: These observations suggest that apoPS may have a better safety profile compared to apoGPF in terms of sc nodule occurrence and severity. There is a need for larger, randomized controlled studies for firmer conclusions.
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| 2. |
- Hagell, Peter, et al.
(författare)
-
Apomorphine formulation influences subcutaneous complications in continuous apomorphine pump therapy for Parkinson’s disease
- 2017
-
Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Objective: To explore if the occurrence and severity of subcutaneous (sc) nodules is influenced by the pharmaceutical formulation of apomorphine used for sc infusion in advanced Parkinson’s disease (PD). Background: Apomorphine infusion is an effective therapy in advanced PD, but a limitation is troublesome sc nodules. Various chemically non-identical apomorphine formulations are available. Anecdotal clinical experience has suggested that shifting from one of these (Apo-Go PumpFill; apoGPF) to another (Apomorphine PharmSwed; apoPS, developed in Sweden) may influence the occurrence and severity of sc nodules. Methods: In this multicenter open-label prospective observational study, 15 people with advanced PD (mean PD- duration, 13.4 years; median Hoehn & Yahr, IV) on apoGPF since a mean of 2.1 years and with troublesome sc nodules were switched to apoPS. Ongoing interventions to treat existing nodules (ultrasound, massage, Hirudoid cream) continued, and apomorphine as well as other drugs was managed accordingto clinical routines. Data were collected between May 2015 and March 2017; at baseline, at the time of switching (about 2 weeks later), and up to 1.7-4.2 (mean, 2.5) months post-switch follow-up. Primary outcomes were total nodule numbers, size (mm diameter for the 5 worst nodules), consistency (scored 0-3 for the 5 worst nodules), and associated skin changes (scored 0-4 for the 5 worst nodules) and pain (scored 0-5). Patients also rated their perceived PD severity and motor complications (UPDRS IV). Patient preferences 5-12 months post-switch (2-9 months after follow-up) were also recorded. Results: Apomorphine and L-dopa doses did not change over the observation period (P≥0.400). Baseline nodule numbers (7.4 vs. 4.6; P<0.003), size (92.9 vs. 54.1 mm; P=0.016), consistency (11 vs. 5; P=0.003), skin changes (3 vs. 1.5; P=0.205), and average pain (1 vs. 0; P=0.020) improved 11 weeks post-switch. Patient-reported PD severity (P=0.020) and motor fluctuations improved (P=0.051), whereas dyskinesias tended to increase (P=0.205). At 5-12 months post-switch, 13 patients had decided to remain on apoPS; mainly due to improved nodules. Conclusions: These observations suggest that apoPS may have a better safety profile compared to apoGPF in terms of sc nodule occurrence and severity. There is a need for larger, randomized controlled studies for firmer conclusions.
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| 3. |
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| 4. |
- Memedi, Mevludin, et al.
(författare)
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Self-assessments and motor tests via telemetry in a 36-month levodopa-carbidopa intestinal gel infusion trial
- 2014
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Objective: The aim of this study was to investigate if a telemetry test battery can be used to measure effects of Parkinson’s disease (PD) treatment intervention and disease progression.Methods: Sixty-five patients diagnosed with advanced PD were recruited in an open longitudinal 36-month study; 35 treated with levodopa-carbidopa intestinal gel (LCIG) and 30 were candidates for switching from oral PD treatment to LCIG. They utilized a test battery, consisting of self-assessments of symptoms and fine motor tests (tapping and spiral drawings), four times per day in their homes during week-long test periods. The repeated measurements were summarized into an overall test score (OTS) to represent the global condition of the patient during a test period. Clinical assessments included ratings on Unified PD Rating Scale (UPDRS) and 39-item PD Questionnaire (PDQ-39) scales.Results: In LCIG-naïve patients, mean OTS compared to baseline was significantly improved from the first test period on LCIG treatment until month 24. In LCIG-non-naïve patients, there were no significant changes in mean OTS, except at month 36 (P<0.01). The OTS correlated adequately with total UPDRS (rho = 0.59) and total PDQ-39 (0.59).Conclusions: PD symptoms can be remotely monitored over time with this test battery. The trends of the test scores were similar to the trends of clinical rating scores. Correlations between OTS and clinical rating scales were adequate indicating that the test battery contains important elements of the information of the well-established scales.
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| 5. |
- Memedi, Mevludin, 1983-, et al.
(författare)
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Self-reported symptoms and motor tests via telemetry in a 36-month levodopa-carbidopa intestinal gel infusion trial
- 2013
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Objective: To determine if a home environment test battery can be used to measure effects of Parkinson’s disease (PD) treatment intervention and disease progression.Background: Sixty-five patients diagnosed with advanced PD were recruited in an open longitudinal 36-month study. On inclusion, 35 of them were treated with continuous intraduodenal administration of a levodopa-carbidopa intestinal gel (LCIG) and 30 patients were candidates for switching from conventional oral PD treatment to LCIG. They utilized a test battery, consisting of self-assessments and fine motor tests (tapping and spiral drawings), in their homes. Assessments were performed four times per day during week-long test periods. For the majority of these test periods, UPDRS and PDQ-39 ratings were performed at the start of the period.Methods: The test battery time series were summarized into scores for representing symptom severities over test periods. Six conceptual dimensions were defined; four subjectively-reported: ‘Walking’, ‘Satisfied’, ‘Dyskinesia’ and ‘Off’, and two objectively-measured: ‘Tapping’ and ‘Spiral’. In addition, an overall test score (OTS) was defined to represent the overall condition of a patient during a test period.Results: In LCIG-naïve patients, mean OTS improved startingf rom the first test period on LCIG treatment and this improvement remained statistically significant until month 24 (figure). In contrast to objectively-measured dimensions, mean scores of subjectively-reported dimensions improved significantly throughout the study. In LCIG-non-na€ıve patients, there were no significant changes in mean OTS, except at month 36 (p < 0.01). The OTS correlated adequately with total UPDRS (rho 5 0.59) and total PDQ-39 (0.59).Conclusions: Using the test battery it is possible to monitor PD symptoms over time. The trends of the test scores were strikingly similar to the trends of the clinical rating scores. Correlations between OTS and the rating scales were adequate indicating that the test battery contains important elements of the information of these well-established scales.
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