ziconotide and Chronic-Disease

ziconotide has been researched along with Chronic-Disease* in 21 studies

Reviews

10 review(s) available for ziconotide and Chronic-Disease

ArticleYear
[Central and peripheral mechanisms in antinociception: current and future perspectives].
    Neuropsychopharmacologia Hungarica : a Magyar Pszichofarmakologiai Egyesulet lapja = official journal of the Hungarian Association of Psychopharmacology, 2008, Volume: 10, Issue:3

    As it is well known opioids are the most powerful drugs used for acute and chronic pain, although, their several serious side effects, such as respiratory depression, mental clouding, constipation, and tolerance dependence producing capacity, as well as large interpatient variability in responses limit their safe everyday use. Furthermore, the treatment of certain types of pain (e.g. neuropathic pain) is not very satisfactorily managed. Consequently, there is a continuous need to find analgesics efficient against chronic neuropathic pain and avoid these side actions and still retain opioid like potency. There are several possible way to find new targets for these purposes. Recently opioid receptors have been identified on peripheral processes of sensory neurons. These findings provide new insights into intrinsic mechanisms of pain control and suggest innovative strategies for developing drugs and alternative approaches to pain treatment. In the effort to discover better analgesic drugs for chronic pain, attention is being paid to specific ion channels at the periphery, include members of transient receptor potential family (TRPV1, capsaicin receptors), as well as P2x receptors, sensitive to purines released from tissue injury. A special tetradotoxin-resistant, voltage dependent type of sodium channel is associated with dorsal root ganglia neurons is blocked by mexiletine, used in chronic pain. A synthetic peptide analogue of marine snail toxin ziconitine blocks N-type calcium channels. GABA and NMDA receptors are also involved in the antinociceptive actions of gabapentin and ketamine, respectively. Furthermore nicotine and analogues (epibatidine) induce analgesia through nicotinic ACh receptors. We studied mostly the peripheral targets of hydrophilic heterocyclic opioids in antinociceptive processes.

    Topics: Amines; Analgesics, Non-Narcotic; Analgesics, Opioid; Animals; Bridged Bicyclo Compounds, Heterocyclic; Calcium Channel Blockers; Chronic Disease; Cyclohexanecarboxylic Acids; Drug Tolerance; Gabapentin; gamma-Aminobutyric Acid; Humans; Ketamine; Mexiletine; Nicotinic Agonists; Nociceptors; omega-Conotoxins; Pain; Pyridines; Receptors, Opioid; Sodium Channels

2008
New aspects in performing interventional techniques for chronic pain.
    Current opinion in supportive and palliative care, 2007, Volume: 1, Issue:2

    We will evaluate the usefulness of the new intrathecal analgesic ziconotide in palliative care medicine. We will also examine the place and efficacy of neurolytic celiac plexus blockade in patients suffering from malignancy in the upper abdomen, after introducing better localization methods of the celiac plexus.. The analgesic effects of intrathecally administered ziconotide have been studied in patients suffering from pain due to AIDS or cancer. The results show a moderate to complete pain relief, significantly better than in placebo groups. However, safety studies show a high incidence of side effects. The technique of neurolytic celiac plexus blocks is refined by endoscopic ultrasound techniques.. The place of ziconotide in palliative care is doubtful due to unpredictable and sometimes long-lasting side effects. Real evidence on the efficacy and duration of neurolytic celiac plexus blocks for relief of pancreatic cancer pain is still not available. Future studies will need to be performed applying validated measurement instruments and assessing the patient's impression of the procedure's demands in terms of physical and mental tolerance.

    Topics: Analgesics, Non-Narcotic; Autonomic Nerve Block; Celiac Plexus; Chronic Disease; Clinical Trials as Topic; Humans; Injections, Spinal; omega-Conotoxins; Pain; Palliative Care

2007
Targeting N-type and T-type calcium channels for the treatment of pain.
    Drug discovery today, 2006, Volume: 11, Issue:5-6

    Severe chronic pain afflicts a large number of people worldwide but satisfactory relief from such pain is difficult to achieve with drugs that are currently available, and so there is a great need for the development of new, efficacious and safe analgesics. Voltage-gated calcium-permeable ion channels are multi-subunit complexes that regulate neuronal excitability, action-potential firing patterns and neurotransmission in nociceptive pathways. Although multiple subtypes of voltage-gated calcium channels exist, pharmacological and ion-channel gene knockdown approaches in animals have revealed N-type and T-type calcium channels to be particularly attractive molecular targets for the discovery and development of new analgesic drugs. The recent approval of Prialt (Elan Pharmaceuticals) provides the ultimate target validation for N-type calcium channels, namely proof that they are key regulators of nociceptive signaling in humans.

    Topics: Acute Disease; Analgesics; Animals; Calcium Channels, N-Type; Calcium Channels, T-Type; Chronic Disease; Humans; omega-Conotoxins; Pain; Peripheral Nervous System Diseases

2006
Ziconotide--a novel neuron-specific calcium channel blocker for the intrathecal treatment of severe chronic pain--a short review.
    International journal of clinical pharmacology and therapeutics, 2006, Volume: 44, Issue:10

    Worldwide a large number of patients suffer from severe chronic pain even after treatment with opioids following the 3-step analgesic ladder developed by the WHO. Intraspinal agents, including morphine, have been tried as a fourth step. However, approximately 20% of cases remain refractory. Ziconotide, an intrathecal analgesic with orphan drug status, is a novel alternative for the management of chronic intractable pain. Ziconotide is a synthetic peptide based on the toxin of the fish-hunting marine snail, Conus magus. It is the first therapeutic agent in a new pharmacological class of "topically" active analgesics that selectively target neuron-specific (N-type), voltage-gated calcium channels. Ziconotide produces potent analgesia by interruption of Ca-dependent primary afferent transmission of pain signals in the spinal cord. Ziconotide was significantly more effective than placebo in the treatment of chronic malignant (p < 0.001) and non-malignant pain (p < 0.001). In several clinical studies morphine dosages could be substituted by ziconotide. The drug has a lag-time for the onset and offset of analgesia and adverse effects. Initial doses should therefore be low (2.4 microg/day) and titrated slowly (increasing up to a maximum of 21.6 microg/day in increases of 2.4 microg/day no more than twice weekly). The gradual increase in dose helps to reduce the incidence and severity of adverse events which affect primarily the central nervous system (e.g. dizziness, nausea, confusion). Ziconotide maintains its analgesic efficacy over months and does not cause tolerance, dependence or respiratory depression. Following intrathecal infusion ziconotide is distributed within the cerebral spinal fluid (CSF) where its clearance (0.38 ml/min) corresponds to the rate of turnover of the CSF. Negligible amounts of ziconotide are present in the systemic circulation where it is rapidly degraded by proteolysis. In conclusion, ziconotide is a new and valuable alternative analgesic for the acute and long-term treatment of severe pain, especially in patients refractory to opioids.

    Topics: Analgesics, Non-Narcotic; Animals; Calcium Channel Blockers; Calcium Channels, N-Type; Chronic Disease; Drug Administration Schedule; Humans; Injections, Spinal; omega-Conotoxins; Pain; Randomized Controlled Trials as Topic; Severity of Illness Index

2006
Ziconotide: a new nonopioid intrathecal analgesic for the treatment of chronic pain.
    Expert review of neurotherapeutics, 2006, Volume: 6, Issue:10

    Ziconotide is a new nonopioid intrathecal agent recently approved for the treatment of chronic pain. Ziconotide is indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or intrathecal morphine. Ziconotide blocks the N-type calcium channels located in the superficial dorsal horn of the spinal cord, resulting in potent analgesia. The efficacy of ziconotide has been demonstrated in three randomized, placebo-controlled trials in over 500 patients. In addition, its safety has been demonstrated in over 1200 subjects. Ziconotide is a potent analgesic with a narrow therapeutic window. The drug requires a slow titration in order to achieve analgesia while avoiding dose-limiting side effects. This review examines the currently available information on this new analgesic.

    Topics: Analgesics; Analgesics, Non-Narcotic; Animals; Chronic Disease; Drugs, Investigational; Humans; Injections, Spinal; omega-Conotoxins; Pain

2006
A new approach to chronic pain.
    RN, 2005, Volume: 68, Issue:5

    Topics: Analgesics, Non-Narcotic; Chronic Disease; Humans; Infusion Pumps, Implantable; Infusions, Parenteral; omega-Conotoxins; Pain

2005
Ziconotide, an intrathecally administered N-type calcium channel antagonist for the treatment of chronic pain.
    Pharmacotherapy, 2005, Volume: 25, Issue:8

    Ziconotide is a novel peptide that blocks the entry of calcium into neuronal N-type voltage-sensitive calcium channels, preventing the conduction of nerve signals. N-type calcium channels are present in the superficial laminae of the dorsal horn of the spinal cord. In various animal models of pain, intrathecal administration of ziconotide blocked nerve transmission and nociception. The United States Food and Drug Administration recently approved ziconotide intrathecal infusion for the management of severe chronic pain in patients who require intrathecal therapy and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. The drug has a narrow therapeutic window and a lag time for the onset and offset of analgesia and adverse events. In early clinical trials, frequent and severe psychiatric and central nervous system adverse effects were associated with rapid intrathecal infusion (0.4 microg/hr) and frequent up-titration (every 12 hrs). Therefore, patients with psychiatric symptoms are not candidates for this drug. Drug trials of external intrathecal catheters and microinfusion devices demonstrated a 3% risk of meningitis. A low initial infusion rate of 0.1 microg/hour and limiting infusion rate increases to 2-3 times/week are now recommended. Patients responsive to intrathecal ziconotide require an implanted infusion system to receive long-term therapy.

    Topics: Calcium Channel Blockers; Calcium Channels, L-Type; Chronic Disease; Drug Delivery Systems; Drug Interactions; Humans; Infusion Pumps, Implantable; Injections, Spinal; omega-Conotoxins; Pain; Randomized Controlled Trials as Topic; Synaptic Transmission

2005
Targeting chronic and neuropathic pain: the N-type calcium channel comes of age.
    NeuroRx : the journal of the American Society for Experimental NeuroTherapeutics, 2005, Volume: 2, Issue:4

    The rapid entry of calcium into cells through activation of voltage-gated calcium channels directly affects membrane potential and contributes to electrical excitability, repetitive firing patterns, excitation-contraction coupling, and gene expression. At presynaptic nerve terminals, calcium entry is the initial trigger mediating the release of neurotransmitters via the calcium-dependent fusion of synaptic vesicles and involves interactions with the soluble N-ethylmaleimide-sensitive factor attachment protein receptor complex of synaptic release proteins. Physiological factors or drugs that affect either presynaptic calcium channel activity or the efficacy of calcium-dependent vesicle fusion have dramatic consequences on synaptic transmission, including that mediating pain signaling. The N-type calcium channel exhibits a number of characteristics that make it an attractive target for therapeutic intervention concerning chronic and neuropathic pain conditions. Within the past year, both U.S. and European regulatory agencies have approved the use of the cationic peptide Prialt for the treatment of intractable pain. Prialt is the first N-type calcium channel blocker approved for clinical use and represents the first new proven mechanism of action for chronic pain intervention in many years. The present review discusses the rationale behind targeting the N-type calcium channel, some of the limitations confronting the widespread clinical application of Prialt, and outlines possible strategies to improve upon Prialt's relatively narrow therapeutic window.

    Topics: Animals; Calcium Channel Blockers; Calcium Channels, N-Type; Chronic Disease; Humans; Neuralgia; omega-Conotoxins

2005
Ziconotide: neuronal calcium channel blocker for treating severe chronic pain.
    Current medicinal chemistry, 2004, Volume: 11, Issue:23

    Ziconotide (PRIALT) is a neuroactive peptide in the final stages of clinical development as a novel non-opioid treatment for severe chronic pain. It is the synthetic equivalent of omega-MVIIA, a component of the venom of the marine snail, Conus magus. The mechanism of action underlying ziconotide's therapeutic profile derives from its potent and selective blockade of neuronal N-type voltage-sensitive calcium channels (N-VSCCs). Direct blockade of N-VSCCs inhibits the activity of a subset of neurons, including pain-sensing primary nociceptors. This mechanism of action distinguishes ziconotide from all other analgesics, including opioid analgesics. In fact, ziconotide is potently anti-nociceptive in animal models of pain in which morphine exhibits poor anti-nociceptive activity. Moreover, in contrast to opiates, tolerance to ziconotide is not observed. Clinical studies of ziconotide in more than 2,000 patients reveal important correlations to ziconotide's non-clinical pharmacology. For example, ziconotide provides significant pain relief to severe chronic pain sufferers who have failed to obtain relief from opiate therapy and no evidence of tolerance to ziconotide is seen in these patients. Contingent on regulatory approval, ziconotide will be the first in a new class of neurological drugs: the N-type calcium channel blockers, or NCCBs. Its novel mechanism of action as a non-opioid analgesic suggests ziconotide has the potential to play a valuable role in treatment regimens for severe chronic pain. If approved for clinical use, ziconotide will further validate the neuroactive venom peptides as a source of new and useful medicines.

    Topics: Amino Acid Sequence; Animals; Calcium Channel Blockers; Chronic Disease; Humans; Molecular Sequence Data; omega-Conotoxins; Pain

2004
An evaluation of intrathecal ziconotide for the treatment of chronic pain.
    Expert opinion on investigational drugs, 2000, Volume: 9, Issue:10

    Ziconotide, the synthetic form of cone snail peptide pi-conotoxin MVIIA, is a neurone-specific N-type calcium channel blocker with an analgesic and neuroprotective effect. Intrathecal ziconotide has been recommended for approval by the FDA for the management of chronic pain. Spinally administered ziconotide produces analgesia by blocking neurotransmitter release from primary nociceptive afferents and prevents the propagation of pain signals to the brain. It has an advantage over intrathecal morphine in that there is no development of tolerance after prolonged use. Systemic toxicity is considerably reduced by administration of smaller doses intrathecally and selective delivery to the site of action in the nervous system. Nevertheless, there are neurological adverse effects due to delay in clearance of ziconotide from the neural tissues. Overall, ziconotide has a favourable risk/benefit ratio with advantages over several currently available intrathecal therapies for pain.

    Topics: Animals; Calcium Channel Blockers; Chronic Disease; Humans; Injections, Spinal; omega-Conotoxins; Pain

2000

Trials

4 trial(s) available for ziconotide and Chronic-Disease

ArticleYear
Long-term intrathecal ziconotide for chronic pain: an open-label study.
    Journal of pain and symptom management, 2009, Volume: 37, Issue:3

    This open-label multicenter study evaluated the long-term safety and efficacy of intrathecal ziconotide and included 78 patients with chronic pain who had completed one of two previous ziconotide clinical trials. Each patient's initial ziconotide dose was based on his or her dose from the study of origin and was adjusted as necessary on the basis of adverse events and analgesic effect. The median ziconotide dose was 6.48 mcg/day (range, 0.00-120.00 mcg/day) at the Initial Visit and ranged from 5.52 to 7.20 mcg/day across all study visits. The most commonly reported new adverse events that were considered ziconotide related were memory impairment (11.3%); dizziness, nystagmus, and speech disorder (8.5% each); nervousness and somnolence (7.0% each); and abnormal gait (5.6%). There was no evidence of increased adverse event incidence at higher cumulative ziconotide doses. Elevations in creatine kinase were noted, but the proportion of patients with creatine kinase elevations did not change from the Initial Visit to the Termination Visit (4.1% each). Stable mean Visual Analog Scale of Pain Intensity scores during the three years of the study suggested no evidence of increased pain intensity with increased duration of ziconotide exposure. Long-term treatment with ziconotide appeared to be well tolerated and effective in patients whose response to ziconotide and ability to tolerate the drug had been previously demonstrated.

    Topics: Analgesics, Non-Narcotic; Chronic Disease; Female; Humans; Injections, Spinal; Long-Term Care; Male; Middle Aged; omega-Conotoxins; Pain; Pain Measurement

2009
Intrathecal ziconotide for severe chronic pain: safety and tolerability results of an open-label, long-term trial.
    Anesthesia and analgesia, 2008, Volume: 106, Issue:2

    Ziconotide is a non-opioid drug indicated for management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted and who are intolerant of or refractory to other treatments.. Six-hundred and forty-four patients with severe chronic pain participated in this open-label, multicenter study. Ziconotide titration was followed by long-term infusion. Efficacy assessments included the Visual Analog Scale of Pain Intensity. Safety was assessed via adverse events (AEs), vital signs, and routine laboratory values.. One-hundred and nineteen patients received ziconotide for > or = 360 days; total exposure was 350.9 patient years. Median duration of ziconotide therapy was 67.5 days (range, 1.2-1215.5 days); mean dose at last infusion was 8.4 microg/d (range, 0.048-240.0 microg/d). Median Visual Analog Scale of Pain Intensity scores at baseline, month 1, and the last available observation up to month 2 were 76 mm (range, 4-100 mm), 68 mm (range, 0-100 mm), and 73 mm (range, 0-100 mm), respectively. Most patients (99.7%) experienced > or = 1 AE. Most AEs were of mild (43.5%) or moderate (42.3%) severity; 58.6% of AEs were considered unrelated to ziconotide. The most commonly reported AEs (> or = 25% of patients) included nausea, dizziness, headache, confusion, pain, somnolence, and memory impairment. Clinically significant abnormalities (> 3 times the upper limit of normal) in creatine kinase levels were reported in 0.9% of patients at baseline, 5.7% at month 1, and 3.4% at ziconotide discontinuation. No drug-related deaths, IT granulomas, or permanent adverse sequelae occurred with ziconotide therapy.. We conclude that long-term IT ziconotide is an option for patients with severe, refractory chronic pain.

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ambulatory Care; Chronic Disease; Female; Gastrointestinal Diseases; Humans; Infusion Pumps; Male; Middle Aged; omega-Conotoxins; Pain; Time

2008
Open-label, multicenter study of combined intrathecal morphine and ziconotide: addition of morphine in patients receiving ziconotide for severe chronic pain.
    Pain medicine (Malden, Mass.), 2008, Volume: 9, Issue:3

    To assess the safety and efficacy of adding intrathecal morphine to intrathecal ziconotide in patients treated with stable ziconotide doses.. Multicenter, open-label study with a 4-week morphine titration phase during which ziconotide was held constant and an extension phase during which dosing of either drug could vary.. Outpatient clinics.. Patients with suboptimal pain relief receiving stable ziconotide doses (> or = 4.8 microg/day) in one of two ongoing ziconotide trials.. Ziconotide dosing remained constant during the titration phase; intrathecal morphine titration was based on each patient's daily systemic opioid dose at the study's start. During the extension phase, intrathecal ziconotide and morphine dosing were adjusted per investigator discretion.. Safety was assessed primarily via adverse events. Efficacy was analyzed via percentage change on the visual analog scale of pain intensity and in weekly systemic opioid consumption.. Twenty-five patients enrolled. The most common (> or = 10% of patients in either study phase) study drug-related (i.e., ziconotide/morphine combination [or ziconotide monotherapy in the extension phase only]) treatment-emergent adverse events included dizziness, peripheral edema, pruritus, and nausea. From the initial visit to week 4, visual analog scale of pain intensity scores improved by a mean of 26.3% (95% confidence interval: 15.6%-37.1%) but varied during the extension phase (mean percentage change from the initial visit ranged from -0.4% at week 16 to -35.0% at week 72). Mean percentage decrease in systemic opioid consumption from the initial visit was 49.1% at week 4 and 51.2% at week 56 of the extension phase.. Intrathecal morphine, combined with stable intrathecal ziconotide doses, reduced pain in patients with previously suboptimal pain relief on ziconotide monotherapy.

    Topics: Adult; Aged; Analgesics, Non-Narcotic; Analgesics, Opioid; Animals; Chronic Disease; Drug Therapy, Combination; Female; Humans; Injections, Spinal; Male; Middle Aged; Morphine; omega-Conotoxins; Pain; Pain Measurement; Treatment Outcome

2008
A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain.
    Journal of pain and symptom management, 2006, Volume: 31, Issue:5

    Safety and efficacy data from a study of slow intrathecal (IT) ziconotide titration for the management of severe chronic pain are presented. Patients randomized to ziconotide (n = 112) or placebo (n = 108) started IT infusion at 0.1 microg/hour (2.4 microg/day), increasing gradually (0.05-0.1 microg/hour increments) over 3 weeks. The ziconotide mean dose at termination was 0.29 microg/hour (6.96 microg/day). Patients' baseline Visual Analogue Scale of Pain Intensity (VASPI) score was 80.7 (SD 15). Statistical significance was noted for VASPI mean percentage improvement, baseline to Week 3 (ziconotide [14.7%] vs. placebo [7.2%; P = 0.036]) and many of the secondary efficacy outcomes measures. Significant adverse events (AEs) reported in the ziconotide group were dizziness, confusion, ataxia, abnormal gait, and memory impairment. Discontinuation rates for AEs and serious AEs were comparable for both groups. Slow titration of ziconotide, a nonopioid analgesic, to a low maximum dose resulted in significant improvement in pain and was better tolerated than in two previous controlled trials that used a faster titration to a higher mean dose.

    Topics: Adult; Aged; Analgesics, Non-Narcotic; Chronic Disease; Double-Blind Method; Female; Humans; Injections, Spinal; Male; Middle Aged; omega-Conotoxins; Pain; Placebos

2006

Other Studies

7 other study(ies) available for ziconotide and Chronic-Disease

ArticleYear
Effect of ω-conotoxin MVIIA and Phα1β on paclitaxel-induced acute and chronic pain.
    Pharmacology, biochemistry, and behavior, 2013, Volume: 114-115

    The treatment with the chemotherapeutic agent paclitaxel produces a painful peripheral neuropathy, and is associated with an acute pain syndrome in a clinically significant number of patients. However, no standard therapy has been established to manage the acute pain or the chronic neuropathic pain related to paclitaxel. In the present study, we evaluated the analgesic potential of two N-type voltage-gated calcium channel (VGCC) blockers, ω-conotoxin MVIIA and Phα1β, on acute and chronic pain induced by paclitaxel. Adult male rats were treated with four intraperitoneal injections of paclitaxel (1+1+1+1mg/kg, in alternate days) and the development of mechanical hyperalgesia was evaluated 24h (acute painful stage) or 15days (chronic painful stage) after the first paclitaxel injection. Not all animals showed mechanical hyperalgesia 24h after the first paclitaxel injection, but those that showed developed a more intense mechanical hyperalgesia at the chronic painful stage. Intrathecal administration (i.t.) of ω-conotoxin MVIIA (3-300pmol/site) or Phα1β (10-300pmol/site) reduced the mechanical hyperalgesia either at the acute or at the chronic painful stage induced by paclitaxel. When administered at the acute painful stage, ω-conotoxin MVIIA (300pmol/site, i.t.) and Phα1β (300pmol/site, i.t.) prevented the worsening of chronic mechanical hyperalgesia. Furthermore, Phα1β (30-300pmol/site, i.t.) elicited less adverse effects than ω-conotoxin MVIIA (10-300 pmol/site, i.t.). Taken together, our data evidence the involvement of N-type VGCC in pain sensitization induced by paclitaxel and point out the potential of Phα1β as a safer alternative than ω-conotoxin MVIIA to treat the pain related to paclitaxel.

    Topics: Acute Disease; Analgesics; Animals; Behavior, Animal; Chronic Disease; Male; omega-Conotoxins; Paclitaxel; Pain; Rats; Rats, Wistar; Spider Venoms

2013
[Recommendations for the management of chronic pain by intrathecal ziconotide].
    MMW Fortschritte der Medizin, 2010, Oct-14, Volume: 152 Suppl 3

    Topics: Analgesics, Non-Narcotic; Catheters, Indwelling; Chronic Disease; Dose-Response Relationship, Drug; Drug Administration Schedule; Germany; Humans; Infusion Pumps; Injections, Spinal; omega-Conotoxins; Pain

2010
Cost-effectiveness of ziconotide in intrathecal pain management for severe chronic pain patients in the UK.
    Current medical research and opinion, 2009, Volume: 25, Issue:8

    To examine the cost-effectiveness of using intrathecal ziconotide in the treatment of severe chronic pain compared to best supportive care for patients with intractable chronic pain in the United Kingdom.. Using a simulation model, the analysis evaluated the cost and health economic consequences of using ziconotide as a treatment for severe chronic pain. The modelled population and clinical data were based on a randomised controlled trial in which the main outcome was reduction in pain as measured by the visual analogue scale of pain intensity (VASPI). Resource use data were elicited using a modified Delphi panel and costed using published sources. Utility values were derived from a separate research study. The main outcome measure was the cost per quality-adjusted life-year (QALY). Extensive scenario analysis was conducted to evaluate parameter uncertainty.. Overall, findings were robust to most assumptions. The cost-effectiveness of ziconotide compared to best supportive care (BSC) was pound 27,443 per QALY (95% CI pound 18,304-38,504). Scenarios were investigated in which discount rates, the time horizon, the threshold for qualifying as a responder, pump-related assumptions, utilities, ziconotide drug dose, and the patient discontinuation rate with ziconotide were varied. The most sensitive parameter was the dosage of ziconotide: using the lower and upper bounds of the average ziconotide dosage observed in the long-term open-label study changed the incremental cost-effectiveness ratio (ICER) to pound 15,500 [pound 8206-25,405] and pound 44,700 [pound 30,541-62, 670].. Ziconotide may offer an economically feasible alternative solution for patients for whom current treatment is inappropriate or ineffective. The main study limitation is that some model inputs, mainly related to resource use, are based on assumptions or expert interviews.

    Topics: Adult; Aged; Chronic Disease; Cost-Benefit Analysis; Double-Blind Method; Humans; Injections, Spinal; Middle Aged; Models, Theoretical; Neuroprotective Agents; omega-Conotoxins; Pain; Pain Measurement; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; Severity of Illness Index; United Kingdom

2009
Treatment challenges and complications with ziconotide monotherapy in established pump patients.
    Pain physician, 2006, Volume: 9, Issue:2

    The U.S. Food and Drug Administration (FDA) recently approved Ziconotide intrathecal infusion for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of, or refractory to, other methods of treatment, including intrathecal morphine. Ziconotide is approved as a monotherapy, but there are challenges associated with the decision to wean intrathecal opioids for Ziconotide alone. Maintaining adequate analgesia and managing opioid withdrawal symptoms may be difficult. Additionally, a variety of adverse physiological, cognitive and psychiatric events may be associated with this new drug. Patients with pretreatment psychiatric disorders may be at increased risk for treatment complications.. To present a report of a case series describing treatment challenges and complications associated with the decision to convert established pump patients from intrathecal opioid therapy to Ziconotide monotherapy.. Three established pump patients, refractory to intrathecal opioid therapy, were converted to Ziconotide monotherapy. All of these patients experienced significant emotional distress or psychological symptoms that threatened the success of the treatment. Achieving adequate analgesia, reducing Ziconotide to mitigate adverse physiological effects, managing opioid withdrawal symptoms, and supportive psychological consultation were combined to achieve successful outcomes in two of our three patients.. This report describes challenges associated with the decision to convert established pump patients from intrathecal opioid therapy to Ziconotide monotherapy. Inadequate analgesia, adverse medication effects, and opioid withdrawal symptoms can precipitate a stressful situation that may be perceived as dangerous or threatening by patients who are predisposed to anxiety. Screening patients for psychiatric disorders, anxiety-proneness and/or vulnerability to stress should be considered to reduce the risk of treatment complications. A multimodal approach is strongly advocated, including rapid responses of treating physicians and nurses along with strong psychological support.

    Topics: Calcium Channel Blockers; Chronic Disease; Female; Humans; Infusion Pumps, Implantable; Male; Middle Aged; Models, Biological; omega-Conotoxins; Pain Measurement; Pain, Intractable; Treatment Outcome

2006
[New medications; ziconotide].
    Nederlands tijdschrift voor geneeskunde, 2006, Nov-04, Volume: 150, Issue:44

    Ziconotide is a synthetic analogue of a peptide found in the poison of the marine snail Conus magus. Ziconotide blocks N-type calcium channels, which play an important role in the transmission of pain signals in the dorsal ganglia of the spinal cord. The drug is indicated for 'severe chronic pain' and is administered intrathecally.

    Topics: Analgesics, Non-Narcotic; Chronic Disease; Humans; omega-Conotoxins; Pain

2006
Peptide leads new class of chronic pain drugs.
    Nature biotechnology, 2005, Volume: 23, Issue:4

    Topics: Calcium Channel Blockers; Calcium Channels, N-Type; Chronic Disease; gamma-Aminobutyric Acid; Humans; NAV1.8 Voltage-Gated Sodium Channel; Neurons, Afferent; omega-Conotoxins; Pain; Peptides; Pregabalin; Sodium Channels

2005
A toxin against pain.
    Scientific American, 2005, Volume: 292, Issue:4

    Topics: Analgesics, Non-Narcotic; Animals; Chronic Disease; Clinical Trials as Topic; Drug Costs; Drug Design; Humans; Mollusk Venoms; omega-Conotoxins; Pain; Technology, Pharmaceutical

2005